Trial Outcomes & Findings for Coping Together After Breast Cancer (NCT NCT03930797)
NCT ID: NCT03930797
Last Updated: 2024-07-11
Results Overview
Patients' self-reported sexual function will be measured using the 19-item Female Sexual Function Index (FSFI).Total scale scores range from 2 to 36, with higher scores indicating higher functioning. Mean change scores will be reported: positive mean change scores indicate increase in sexual functioning over time while negative mean change scores indicate decrease in sexual functioning over time.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
240 participants
Primary outcome timeframe
Baseline up to 6 weeks
Results posted on
2024-07-11
Participant Flow
All participants receive one telephone intervention or the other (IE or LHT); due to this, randomization occurs after the first telephone session is already scheduled so as not to waste randomization slots on couples who have no intention of following through with sessions. As such, participants may be "lost" prior to randomization if they complete consent/baseline but never schedule their first telephone session.
Participant milestones
| Measure |
Intimacy Enhancement
Participants attend four sessions (60-75 minutes) consisting of education and skills training to enhance physical and emotional intimacy.
Intimacy Enhancement: The IE intervention is grounded in cognitive behavioral couple therapy and sex therapy, and includes education and skills training with a focus on the following major topics: understanding effects of breast cancer on sex and intimacy; goal-setting; communication skills; problem-solving and engaging in activities to build intimacy; identifying and restructuring negative or inflexible thoughts; and planning ahead and preparing for challenges. Participants will be asked to participate in written and behavioral activities at home between sessions to strengthen skills acquisition.
|
Living Healthy Together
Participants attend four sessions (60-75 minutes) consisting of information and support across a range of breast cancer-related topics.
Living Healthy Together: The Living Healthy Together (LHT) intervention focuses on delivering education and support to breast cancer survivors and their partners across a range of topics including social support, sleep and fatigue, stress and stress management, nutrition, and physical activity. Participants will be asked to engage actively with the material and to review readings and intervention material between sessions.
|
|---|---|---|
|
Overall Study
STARTED
|
122
|
118
|
|
Overall Study
COMPLETED
|
119
|
108
|
|
Overall Study
NOT COMPLETED
|
3
|
10
|
Reasons for withdrawal
| Measure |
Intimacy Enhancement
Participants attend four sessions (60-75 minutes) consisting of education and skills training to enhance physical and emotional intimacy.
Intimacy Enhancement: The IE intervention is grounded in cognitive behavioral couple therapy and sex therapy, and includes education and skills training with a focus on the following major topics: understanding effects of breast cancer on sex and intimacy; goal-setting; communication skills; problem-solving and engaging in activities to build intimacy; identifying and restructuring negative or inflexible thoughts; and planning ahead and preparing for challenges. Participants will be asked to participate in written and behavioral activities at home between sessions to strengthen skills acquisition.
|
Living Healthy Together
Participants attend four sessions (60-75 minutes) consisting of information and support across a range of breast cancer-related topics.
Living Healthy Together: The Living Healthy Together (LHT) intervention focuses on delivering education and support to breast cancer survivors and their partners across a range of topics including social support, sleep and fatigue, stress and stress management, nutrition, and physical activity. Participants will be asked to engage actively with the material and to review readings and intervention material between sessions.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
3
|
10
|
Baseline Characteristics
Measure given to patient participants only.
Baseline characteristics by cohort
| Measure |
Patient Intimacy Enhancement
n=61 Participants
Participants attend four sessions (60-75 minutes) consisting of education and skills training to enhance physical and emotional intimacy.
Intimacy Enhancement: The IE intervention is grounded in cognitive behavioral couple therapy and sex therapy, and includes education and skills training with a focus on the following major topics: understanding effects of breast cancer on sex and intimacy; goal-setting; communication skills; problem-solving and engaging in activities to build intimacy; identifying and restructuring negative or inflexible thoughts; and planning ahead and preparing for challenges. Participants will be asked to participate in written and behavioral activities at home between sessions to strengthen skills acquisition.
|
Patient Living Healthy Together
n=59 Participants
Participants attend four sessions (60-75 minutes) consisting of information and support across a range of breast cancer-related topics.
Living Healthy Together: The Living Healthy Together (LHT) intervention focuses on delivering education and support to breast cancer survivors and their partners across a range of topics including social support, sleep and fatigue, stress and stress management, nutrition, and physical activity. Participants will be asked to engage actively with the material and to review readings and intervention material between sessions.
|
Partner Intimacy Enhancement
n=61 Participants
Participants attend four sessions (60-75 minutes) consisting of education and skills training to enhance physical and emotional intimacy.
Intimacy Enhancement: The IE intervention is grounded in cognitive behavioral couple therapy and sex therapy, and includes education and skills training with a focus on the following major topics: understanding effects of breast cancer on sex and intimacy; goal-setting; communication skills; problem-solving and engaging in activities to build intimacy; identifying and restructuring negative or inflexible thoughts; and planning ahead and preparing for challenges. Participants will be asked to participate in written and behavioral activities at home between sessions to strengthen skills acquisition.
|
Partner Living Healthy Together
n=59 Participants
Participants attend four sessions (60-75 minutes) consisting of information and support across a range of breast cancer-related topics.
Living Healthy Together: The Living Healthy Together (LHT) intervention focuses on delivering education and support to breast cancer survivors and their partners across a range of topics including social support, sleep and fatigue, stress and stress management, nutrition, and physical activity. Participants will be asked to engage actively with the material and to review readings and intervention material between sessions.
|
Total
n=240 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
50.39 years
STANDARD_DEVIATION 9.60 • n=61 Participants
|
51.12 years
STANDARD_DEVIATION 9.97 • n=59 Participants
|
52.26 years
STANDARD_DEVIATION 10.37 • n=61 Participants
|
52.64 years
STANDARD_DEVIATION 11.15 • n=59 Participants
|
51.60 years
STANDARD_DEVIATION 10.26 • n=240 Participants
|
|
Sex: Female, Male
Female
|
61 Participants
n=61 Participants
|
59 Participants
n=59 Participants
|
0 Participants
n=61 Participants
|
3 Participants
n=59 Participants
|
123 Participants
n=240 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=61 Participants
|
0 Participants
n=59 Participants
|
61 Participants
n=61 Participants
|
56 Participants
n=59 Participants
|
117 Participants
n=240 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=61 Participants
|
0 Participants
n=59 Participants
|
1 Participants
n=61 Participants
|
1 Participants
n=59 Participants
|
3 Participants
n=240 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
60 Participants
n=61 Participants
|
57 Participants
n=59 Participants
|
60 Participants
n=61 Participants
|
58 Participants
n=59 Participants
|
235 Participants
n=240 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=61 Participants
|
2 Participants
n=59 Participants
|
0 Participants
n=61 Participants
|
0 Participants
n=59 Participants
|
2 Participants
n=240 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=61 Participants
|
1 Participants
n=59 Participants
|
0 Participants
n=61 Participants
|
0 Participants
n=59 Participants
|
1 Participants
n=240 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=61 Participants
|
1 Participants
n=59 Participants
|
0 Participants
n=61 Participants
|
1 Participants
n=59 Participants
|
3 Participants
n=240 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=61 Participants
|
0 Participants
n=59 Participants
|
0 Participants
n=61 Participants
|
0 Participants
n=59 Participants
|
0 Participants
n=240 Participants
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=61 Participants
|
7 Participants
n=59 Participants
|
8 Participants
n=61 Participants
|
8 Participants
n=59 Participants
|
31 Participants
n=240 Participants
|
|
Race (NIH/OMB)
White
|
52 Participants
n=61 Participants
|
48 Participants
n=59 Participants
|
53 Participants
n=61 Participants
|
48 Participants
n=59 Participants
|
201 Participants
n=240 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=61 Participants
|
2 Participants
n=59 Participants
|
0 Participants
n=61 Participants
|
2 Participants
n=59 Participants
|
4 Participants
n=240 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=61 Participants
|
0 Participants
n=59 Participants
|
0 Participants
n=61 Participants
|
0 Participants
n=59 Participants
|
0 Participants
n=240 Participants
|
|
Region of Enrollment
United States
|
61 participants
n=61 Participants
|
59 participants
n=59 Participants
|
61 participants
n=61 Participants
|
59 participants
n=59 Participants
|
240 participants
n=240 Participants
|
|
Level of Sexual Concerns
|
6.18 units on a scale
STANDARD_DEVIATION 1.90 • n=61 Participants • Measure given to patient participants only.
|
6.32 units on a scale
STANDARD_DEVIATION 1.99 • n=59 Participants • Measure given to patient participants only.
|
—
|
—
|
6.25 units on a scale
STANDARD_DEVIATION 1.94 • n=120 Participants • Measure given to patient participants only.
|
|
Length of Relationship (years)
|
21.65 years
STANDARD_DEVIATION 11.66 • n=61 Participants • Measure given to patient participants only
|
20.54 years
STANDARD_DEVIATION 12.29 • n=59 Participants • Measure given to patient participants only
|
—
|
—
|
21.10 years
STANDARD_DEVIATION 11.94 • n=120 Participants • Measure given to patient participants only
|
|
Time Since Diagnosis (months)
|
28.69 months
STANDARD_DEVIATION 14.77 • n=61 Participants • Measure given to patient participants only
|
31.32 months
STANDARD_DEVIATION 13.02 • n=59 Participants • Measure given to patient participants only
|
—
|
—
|
29.98 months
STANDARD_DEVIATION 13.94 • n=120 Participants • Measure given to patient participants only
|
|
Time Since Treatment Completion (months)
|
20.40 months
STANDARD_DEVIATION 13.04 • n=61 Participants • Measure given to patient participants only
|
23.55 months
STANDARD_DEVIATION 12.52 • n=59 Participants • Measure given to patient participants only
|
—
|
—
|
21.95 months
STANDARD_DEVIATION 12.83 • n=120 Participants • Measure given to patient participants only
|
|
Education
Less than high school
|
0 Participants
n=61 Participants
|
0 Participants
n=59 Participants
|
1 Participants
n=61 Participants
|
1 Participants
n=59 Participants
|
2 Participants
n=240 Participants
|
|
Education
High school
|
6 Participants
n=61 Participants
|
8 Participants
n=59 Participants
|
13 Participants
n=61 Participants
|
11 Participants
n=59 Participants
|
38 Participants
n=240 Participants
|
|
Education
Some college
|
19 Participants
n=61 Participants
|
12 Participants
n=59 Participants
|
14 Participants
n=61 Participants
|
13 Participants
n=59 Participants
|
58 Participants
n=240 Participants
|
|
Education
College degree
|
23 Participants
n=61 Participants
|
18 Participants
n=59 Participants
|
16 Participants
n=61 Participants
|
21 Participants
n=59 Participants
|
78 Participants
n=240 Participants
|
|
Education
Graduate school
|
13 Participants
n=61 Participants
|
21 Participants
n=59 Participants
|
17 Participants
n=61 Participants
|
13 Participants
n=59 Participants
|
64 Participants
n=240 Participants
|
|
Employment
Employed full time/part time
|
42 Participants
n=61 Participants
|
43 Participants
n=59 Participants
|
48 Participants
n=61 Participants
|
45 Participants
n=59 Participants
|
178 Participants
n=240 Participants
|
|
Employment
Unemployed/on disability
|
15 Participants
n=61 Participants
|
12 Participants
n=59 Participants
|
5 Participants
n=61 Participants
|
5 Participants
n=59 Participants
|
37 Participants
n=240 Participants
|
|
Employment
Retired
|
4 Participants
n=61 Participants
|
4 Participants
n=59 Participants
|
8 Participants
n=61 Participants
|
9 Participants
n=59 Participants
|
25 Participants
n=240 Participants
|
|
Relationship Status
Married
|
58 Participants
n=60 Participants • Measure given to patient participants only. One IE patient and one LHT patient did not respond to this item on the survey.
|
49 Participants
n=58 Participants • Measure given to patient participants only. One IE patient and one LHT patient did not respond to this item on the survey.
|
—
|
—
|
107 Participants
n=118 Participants • Measure given to patient participants only. One IE patient and one LHT patient did not respond to this item on the survey.
|
|
Relationship Status
Cohabitating, not married
|
2 Participants
n=60 Participants • Measure given to patient participants only. One IE patient and one LHT patient did not respond to this item on the survey.
|
9 Participants
n=58 Participants • Measure given to patient participants only. One IE patient and one LHT patient did not respond to this item on the survey.
|
—
|
—
|
11 Participants
n=118 Participants • Measure given to patient participants only. One IE patient and one LHT patient did not respond to this item on the survey.
|
|
Sexual Orientation
Heterosexual/straight
|
59 Participants
n=61 Participants
|
56 Participants
n=59 Participants
|
61 Participants
n=61 Participants
|
55 Participants
n=59 Participants
|
231 Participants
n=240 Participants
|
|
Sexual Orientation
Homosexual/lesbian/gay
|
0 Participants
n=61 Participants
|
2 Participants
n=59 Participants
|
0 Participants
n=61 Participants
|
1 Participants
n=59 Participants
|
3 Participants
n=240 Participants
|
|
Sexual Orientation
Bisexual
|
2 Participants
n=61 Participants
|
1 Participants
n=59 Participants
|
0 Participants
n=61 Participants
|
3 Participants
n=59 Participants
|
6 Participants
n=240 Participants
|
|
Patient Clinical Tumor Stage
cT1
|
39 Participants
n=61 Participants • Data available for patient participants only
|
36 Participants
n=59 Participants • Data available for patient participants only
|
—
|
—
|
75 Participants
n=120 Participants • Data available for patient participants only
|
|
Patient Clinical Tumor Stage
cT2
|
16 Participants
n=61 Participants • Data available for patient participants only
|
15 Participants
n=59 Participants • Data available for patient participants only
|
—
|
—
|
31 Participants
n=120 Participants • Data available for patient participants only
|
|
Patient Clinical Tumor Stage
cT3
|
4 Participants
n=61 Participants • Data available for patient participants only
|
6 Participants
n=59 Participants • Data available for patient participants only
|
—
|
—
|
10 Participants
n=120 Participants • Data available for patient participants only
|
|
Patient Clinical Tumor Stage
cT4
|
2 Participants
n=61 Participants • Data available for patient participants only
|
2 Participants
n=59 Participants • Data available for patient participants only
|
—
|
—
|
4 Participants
n=120 Participants • Data available for patient participants only
|
|
Patient Surgery Received
Lumpectomy
|
24 Participants
n=61 Participants • Data available for patient participants only
|
25 Participants
n=59 Participants • Data available for patient participants only
|
—
|
—
|
49 Participants
n=120 Participants • Data available for patient participants only
|
|
Patient Surgery Received
Mastectomy with reconstruction
|
24 Participants
n=61 Participants • Data available for patient participants only
|
22 Participants
n=59 Participants • Data available for patient participants only
|
—
|
—
|
46 Participants
n=120 Participants • Data available for patient participants only
|
|
Patient Surgery Received
Mastectomy without reconstruction
|
13 Participants
n=61 Participants • Data available for patient participants only
|
12 Participants
n=59 Participants • Data available for patient participants only
|
—
|
—
|
25 Participants
n=120 Participants • Data available for patient participants only
|
|
Patient Radiotherapy Received
Radiotherapy received
|
48 Participants
n=61 Participants • Data available for patient participants only
|
45 Participants
n=59 Participants • Data available for patient participants only
|
—
|
—
|
93 Participants
n=120 Participants • Data available for patient participants only
|
|
Patient Radiotherapy Received
Radiotherapy not received
|
13 Participants
n=61 Participants • Data available for patient participants only
|
14 Participants
n=59 Participants • Data available for patient participants only
|
—
|
—
|
27 Participants
n=120 Participants • Data available for patient participants only
|
|
Patient Chemotherapy Received
Chemotherapy received
|
40 Participants
n=61 Participants • Data available for patient participants only
|
31 Participants
n=59 Participants • Data available for patient participants only
|
—
|
—
|
71 Participants
n=120 Participants • Data available for patient participants only
|
|
Patient Chemotherapy Received
Chemotherapy not received
|
21 Participants
n=61 Participants • Data available for patient participants only
|
28 Participants
n=59 Participants • Data available for patient participants only
|
—
|
—
|
49 Participants
n=120 Participants • Data available for patient participants only
|
|
Patient Immunotherapy Received
Immunotherapy received
|
13 Participants
n=61 Participants • Data available for patient participants only
|
12 Participants
n=59 Participants • Data available for patient participants only
|
—
|
—
|
25 Participants
n=120 Participants • Data available for patient participants only
|
|
Patient Immunotherapy Received
Immunotherapy not received
|
48 Participants
n=61 Participants • Data available for patient participants only
|
47 Participants
n=59 Participants • Data available for patient participants only
|
—
|
—
|
95 Participants
n=120 Participants • Data available for patient participants only
|
|
Patient Endocrine Therapy Received
Endocrine therapy received
|
44 Participants
n=61 Participants • Data available for patient participants only
|
48 Participants
n=59 Participants • Data available for patient participants only
|
—
|
—
|
92 Participants
n=120 Participants • Data available for patient participants only
|
|
Patient Endocrine Therapy Received
Endocrine therapy not received
|
17 Participants
n=61 Participants • Data available for patient participants only
|
11 Participants
n=59 Participants • Data available for patient participants only
|
—
|
—
|
28 Participants
n=120 Participants • Data available for patient participants only
|
|
Patient Ovarian Suppression therapy Received
Ovarian suppression received
|
14 Participants
n=61 Participants • Data available for patient participants only
|
11 Participants
n=59 Participants • Data available for patient participants only
|
—
|
—
|
25 Participants
n=120 Participants • Data available for patient participants only
|
|
Patient Ovarian Suppression therapy Received
Ovarian suppression not received
|
47 Participants
n=61 Participants • Data available for patient participants only
|
48 Participants
n=59 Participants • Data available for patient participants only
|
—
|
—
|
95 Participants
n=120 Participants • Data available for patient participants only
|
|
Patient Currently Receiving Endocrine/Ovarian Suppression Therapy
Currently receiving endocrine/ovarian suppression therapy
|
45 Participants
n=61 Participants • Data available for patient participants only
|
43 Participants
n=59 Participants • Data available for patient participants only
|
—
|
—
|
88 Participants
n=120 Participants • Data available for patient participants only
|
|
Patient Currently Receiving Endocrine/Ovarian Suppression Therapy
Not currently receiving endocrine/ovarian suppression therapy
|
16 Participants
n=61 Participants • Data available for patient participants only
|
16 Participants
n=59 Participants • Data available for patient participants only
|
—
|
—
|
32 Participants
n=120 Participants • Data available for patient participants only
|
|
Patient Gynecologic Surgeries
Oophorectomy
|
18 Participants
n=61 Participants • Data available for patient participants only
|
11 Participants
n=59 Participants • Data available for patient participants only
|
—
|
—
|
29 Participants
n=120 Participants • Data available for patient participants only
|
|
Patient Gynecologic Surgeries
Hysterectomy
|
15 Participants
n=61 Participants • Data available for patient participants only
|
9 Participants
n=59 Participants • Data available for patient participants only
|
—
|
—
|
24 Participants
n=120 Participants • Data available for patient participants only
|
|
Patient Gynecologic Surgeries
No gynecologic surgery
|
28 Participants
n=61 Participants • Data available for patient participants only
|
39 Participants
n=59 Participants • Data available for patient participants only
|
—
|
—
|
67 Participants
n=120 Participants • Data available for patient participants only
|
|
Patient Menopausal Status
Post-menopausal
|
46 Participants
n=61 Participants • Data available for patient participants only
|
34 Participants
n=59 Participants • Data available for patient participants only
|
—
|
—
|
80 Participants
n=120 Participants • Data available for patient participants only
|
|
Patient Menopausal Status
Pre-menopausal
|
13 Participants
n=61 Participants • Data available for patient participants only
|
16 Participants
n=59 Participants • Data available for patient participants only
|
—
|
—
|
29 Participants
n=120 Participants • Data available for patient participants only
|
|
Patient Menopausal Status
Peri-menopausal
|
2 Participants
n=61 Participants • Data available for patient participants only
|
9 Participants
n=59 Participants • Data available for patient participants only
|
—
|
—
|
11 Participants
n=120 Participants • Data available for patient participants only
|
PRIMARY outcome
Timeframe: Baseline up to 6 weeksPopulation: Only patient participants' data was analyzed for this aim. Of 61 IE patients, one did not return the 6-week follow-up assessment. Of 59 LHT patients, 4 did not return the 6-week follow-up assessment
Patients' self-reported sexual function will be measured using the 19-item Female Sexual Function Index (FSFI).Total scale scores range from 2 to 36, with higher scores indicating higher functioning. Mean change scores will be reported: positive mean change scores indicate increase in sexual functioning over time while negative mean change scores indicate decrease in sexual functioning over time.
Outcome measures
| Measure |
Intimacy Enhancement
n=60 Participants
Participants attend four sessions (60-75 minutes) consisting of education and skills training to enhance physical and emotional intimacy.
Intimacy Enhancement: The IE intervention is grounded in cognitive behavioral couple therapy and sex therapy, and includes education and skills training with a focus on the following major topics: understanding effects of breast cancer on sex and intimacy; goal-setting; communication skills; problem-solving and engaging in activities to build intimacy; identifying and restructuring negative or inflexible thoughts; and planning ahead and preparing for challenges. Participants will be asked to participate in written and behavioral activities at home between sessions to strengthen skills acquisition.
|
Living Healthy Together
n=55 Participants
Participants attend four sessions (60-75 minutes) consisting of information and support across a range of breast cancer-related topics.
Living Healthy Together: The Living Healthy Together (LHT) intervention focuses on delivering education and support to breast cancer survivors and their partners across a range of topics including social support, sleep and fatigue, stress and stress management, nutrition, and physical activity. Participants will be asked to engage actively with the material and to review readings and intervention material between sessions.
|
|---|---|---|
|
Change in Self-Reported Patient Sexual Function
|
6.41 score on a scale
Standard Deviation 7.35
|
0.90 score on a scale
Standard Deviation 6.99
|
SECONDARY outcome
Timeframe: Baseline up to 6 weeksPopulation: Only male partner participants' data were included in this analysis. Of 61 IE partners, one did not complete the 6-week follow-up assessment. Of 59 LHT partners, 2 were female, 3 did not return the 6-week follow-up assessment, and 1 did not have sufficient data to calculate a change score.
Partners' (male) self-reported sexual function will be measured using the 15-item International Index of Erectile Function (IIEF). Total scale scores range from 1 to 75, with higher scores indicating a higher level of sexual functioning. Change in mean male partner IIEF score over time will be reported. Positive mean change scores indicate increase in sexual functioning.
Outcome measures
| Measure |
Intimacy Enhancement
n=60 Participants
Participants attend four sessions (60-75 minutes) consisting of education and skills training to enhance physical and emotional intimacy.
Intimacy Enhancement: The IE intervention is grounded in cognitive behavioral couple therapy and sex therapy, and includes education and skills training with a focus on the following major topics: understanding effects of breast cancer on sex and intimacy; goal-setting; communication skills; problem-solving and engaging in activities to build intimacy; identifying and restructuring negative or inflexible thoughts; and planning ahead and preparing for challenges. Participants will be asked to participate in written and behavioral activities at home between sessions to strengthen skills acquisition.
|
Living Healthy Together
n=53 Participants
Participants attend four sessions (60-75 minutes) consisting of information and support across a range of breast cancer-related topics.
Living Healthy Together: The Living Healthy Together (LHT) intervention focuses on delivering education and support to breast cancer survivors and their partners across a range of topics including social support, sleep and fatigue, stress and stress management, nutrition, and physical activity. Participants will be asked to engage actively with the material and to review readings and intervention material between sessions.
|
|---|---|---|
|
Change in Self-Reported Partner Sexual Function
|
2.48 score on a scale
Standard Deviation 12.92
|
1.00 score on a scale
Standard Deviation 12.19
|
SECONDARY outcome
Timeframe: Baseline up to 6 weeksPopulation: Only patient participants' data were used for this analysis. Of 61 IE patients, one did not complete the 6-week follow-up assessment. Of 59 LHT patients, 4 did not complete the 6-week follow-up assessment.
Patient sexual distress will be measured using the 13-item Female Sexual Distress Scale-Revised (FSDS-R). Total scale scores range from 0 to 52. Higher scores indicate higher levels of sexual distress. Change in patient mean sexual distress score over time will be reported. Negative mean change scores indicate decrease in sexual distress.
Outcome measures
| Measure |
Intimacy Enhancement
n=60 Participants
Participants attend four sessions (60-75 minutes) consisting of education and skills training to enhance physical and emotional intimacy.
Intimacy Enhancement: The IE intervention is grounded in cognitive behavioral couple therapy and sex therapy, and includes education and skills training with a focus on the following major topics: understanding effects of breast cancer on sex and intimacy; goal-setting; communication skills; problem-solving and engaging in activities to build intimacy; identifying and restructuring negative or inflexible thoughts; and planning ahead and preparing for challenges. Participants will be asked to participate in written and behavioral activities at home between sessions to strengthen skills acquisition.
|
Living Healthy Together
n=55 Participants
Participants attend four sessions (60-75 minutes) consisting of information and support across a range of breast cancer-related topics.
Living Healthy Together: The Living Healthy Together (LHT) intervention focuses on delivering education and support to breast cancer survivors and their partners across a range of topics including social support, sleep and fatigue, stress and stress management, nutrition, and physical activity. Participants will be asked to engage actively with the material and to review readings and intervention material between sessions.
|
|---|---|---|
|
Change in Self-Reported Patient Sexual Distress
|
-7.82 score on a scale
Standard Deviation 9.49
|
-4.40 score on a scale
Standard Deviation 8.98
|
SECONDARY outcome
Timeframe: Baseline up to 6 weeksPopulation: Only patient participants' data were used for this analysis. Of 61 IE patients, one did not complete the 6-week follow-up assessment. Of 59 LHT patients, 4 did not complete the 6-week follow-up assessment.
Patient self-reported relationship intimacy will be measured using the 17-item Miller Social Intimacy Scale (MSIS). This scale assesses emotional intimacy, closeness and trust toward an individual's partner. Scores range from 17 to 170, with higher scores indicating higher levels of intimacy. Change in patient mean relationship intimacy score over time will be reported. Positive mean change scores indicate increase in relationship intimacy.
Outcome measures
| Measure |
Intimacy Enhancement
n=60 Participants
Participants attend four sessions (60-75 minutes) consisting of education and skills training to enhance physical and emotional intimacy.
Intimacy Enhancement: The IE intervention is grounded in cognitive behavioral couple therapy and sex therapy, and includes education and skills training with a focus on the following major topics: understanding effects of breast cancer on sex and intimacy; goal-setting; communication skills; problem-solving and engaging in activities to build intimacy; identifying and restructuring negative or inflexible thoughts; and planning ahead and preparing for challenges. Participants will be asked to participate in written and behavioral activities at home between sessions to strengthen skills acquisition.
|
Living Healthy Together
n=55 Participants
Participants attend four sessions (60-75 minutes) consisting of information and support across a range of breast cancer-related topics.
Living Healthy Together: The Living Healthy Together (LHT) intervention focuses on delivering education and support to breast cancer survivors and their partners across a range of topics including social support, sleep and fatigue, stress and stress management, nutrition, and physical activity. Participants will be asked to engage actively with the material and to review readings and intervention material between sessions.
|
|---|---|---|
|
Change in Patients' Self-Reported Relationship Intimacy
|
7.58 score on a scale
Standard Deviation 15.96
|
5.85 score on a scale
Standard Deviation 12.63
|
SECONDARY outcome
Timeframe: Baseline up to 6 weeksPopulation: Only partner participants' data were used for this analysis. Of 61 IE partners, one did not complete the 6-week follow-up assessment. Of 59 LHT partners, 4 did not complete the 6-week follow-up assessment.
Partner self-reported relationship intimacy will be measured using the 17-item Miller Social Intimacy Scale (MSIS). This scale assesses emotional intimacy, closeness and trust toward an individual's partner. Scores range from 17 to 170, with higher scores indicating higher levels of intimacy. Change in patient mean relationship intimacy score over time will be reported. Positive mean change scores indicate increase in relationship intimacy.
Outcome measures
| Measure |
Intimacy Enhancement
n=60 Participants
Participants attend four sessions (60-75 minutes) consisting of education and skills training to enhance physical and emotional intimacy.
Intimacy Enhancement: The IE intervention is grounded in cognitive behavioral couple therapy and sex therapy, and includes education and skills training with a focus on the following major topics: understanding effects of breast cancer on sex and intimacy; goal-setting; communication skills; problem-solving and engaging in activities to build intimacy; identifying and restructuring negative or inflexible thoughts; and planning ahead and preparing for challenges. Participants will be asked to participate in written and behavioral activities at home between sessions to strengthen skills acquisition.
|
Living Healthy Together
n=55 Participants
Participants attend four sessions (60-75 minutes) consisting of information and support across a range of breast cancer-related topics.
Living Healthy Together: The Living Healthy Together (LHT) intervention focuses on delivering education and support to breast cancer survivors and their partners across a range of topics including social support, sleep and fatigue, stress and stress management, nutrition, and physical activity. Participants will be asked to engage actively with the material and to review readings and intervention material between sessions.
|
|---|---|---|
|
Change in Partners' Self-Reported Relationship Intimacy
|
6.35 score on a scale
Standard Deviation 13.80
|
5.77 score on a scale
Standard Deviation 14.37
|
SECONDARY outcome
Timeframe: Baseline up to 6 weeksPopulation: Only patient participants' data were used for this analysis. Of 61 IE patients, one did not complete the 6-week follow-up assessment. Of 59 LHT patients, 4 did not complete the 6-week follow-up assessment.
Patient self-reported relationship quality will be measured using the 7-item Dyadic Adjustment Scale (DAS-7). Total scale scores range from 0 to 36. Higher scores indicate higher relationship quality. Change in mean relationship quality score over time will be reported. Positive mean change scores indicate increase in relationship quality.
Outcome measures
| Measure |
Intimacy Enhancement
n=60 Participants
Participants attend four sessions (60-75 minutes) consisting of education and skills training to enhance physical and emotional intimacy.
Intimacy Enhancement: The IE intervention is grounded in cognitive behavioral couple therapy and sex therapy, and includes education and skills training with a focus on the following major topics: understanding effects of breast cancer on sex and intimacy; goal-setting; communication skills; problem-solving and engaging in activities to build intimacy; identifying and restructuring negative or inflexible thoughts; and planning ahead and preparing for challenges. Participants will be asked to participate in written and behavioral activities at home between sessions to strengthen skills acquisition.
|
Living Healthy Together
n=55 Participants
Participants attend four sessions (60-75 minutes) consisting of information and support across a range of breast cancer-related topics.
Living Healthy Together: The Living Healthy Together (LHT) intervention focuses on delivering education and support to breast cancer survivors and their partners across a range of topics including social support, sleep and fatigue, stress and stress management, nutrition, and physical activity. Participants will be asked to engage actively with the material and to review readings and intervention material between sessions.
|
|---|---|---|
|
Change in Patients' Self-Reported Relationship Quality
|
1.20 score on a scale
Standard Deviation 4.34
|
2.49 score on a scale
Standard Deviation 4.59
|
SECONDARY outcome
Timeframe: Baseline up to 6 weeksPopulation: Only partner participants' data were used for this analysis. Of 61 IE partners, one did not complete the 6-week follow-up assessment. Of 59 LHT partners, 4 did not complete the 6-week follow-up assessment.
Partner self-reported relationship quality will be measured using the 7-item Dyadic Adjustment Scale (DAS-7). Total scale scores range from 0 to 36. Higher scores indicate higher relationship quality. Change in mean relationship quality score over time will be reported. Positive mean change scores indicate increase in relationship quality.
Outcome measures
| Measure |
Intimacy Enhancement
n=60 Participants
Participants attend four sessions (60-75 minutes) consisting of education and skills training to enhance physical and emotional intimacy.
Intimacy Enhancement: The IE intervention is grounded in cognitive behavioral couple therapy and sex therapy, and includes education and skills training with a focus on the following major topics: understanding effects of breast cancer on sex and intimacy; goal-setting; communication skills; problem-solving and engaging in activities to build intimacy; identifying and restructuring negative or inflexible thoughts; and planning ahead and preparing for challenges. Participants will be asked to participate in written and behavioral activities at home between sessions to strengthen skills acquisition.
|
Living Healthy Together
n=55 Participants
Participants attend four sessions (60-75 minutes) consisting of information and support across a range of breast cancer-related topics.
Living Healthy Together: The Living Healthy Together (LHT) intervention focuses on delivering education and support to breast cancer survivors and their partners across a range of topics including social support, sleep and fatigue, stress and stress management, nutrition, and physical activity. Participants will be asked to engage actively with the material and to review readings and intervention material between sessions.
|
|---|---|---|
|
Change in Partners' Self-Reported Relationship Quality
|
1.65 score on a scale
Standard Deviation 4.26
|
1.27 score on a scale
Standard Deviation 3.69
|
SECONDARY outcome
Timeframe: Baseline up to 6 weeksPopulation: Only patient participants' data were used for this analysis. Of 61 IE patients, one did not complete the 6-week follow-up assessment. Of 59 LHT patients, 4 did not complete the 6-week follow-up assessment.
Patients' self-reported anxiety will be measured using the 7-item Generalized Anxiety Disorder scale (GAD-7). Total scale scores range from 0 to 21. Higher scores indicate higher levels of anxiety. Change in mean anxiety score over time will be reported. Negative mean change scores indicate decrease in anxiety.
Outcome measures
| Measure |
Intimacy Enhancement
n=60 Participants
Participants attend four sessions (60-75 minutes) consisting of education and skills training to enhance physical and emotional intimacy.
Intimacy Enhancement: The IE intervention is grounded in cognitive behavioral couple therapy and sex therapy, and includes education and skills training with a focus on the following major topics: understanding effects of breast cancer on sex and intimacy; goal-setting; communication skills; problem-solving and engaging in activities to build intimacy; identifying and restructuring negative or inflexible thoughts; and planning ahead and preparing for challenges. Participants will be asked to participate in written and behavioral activities at home between sessions to strengthen skills acquisition.
|
Living Healthy Together
n=55 Participants
Participants attend four sessions (60-75 minutes) consisting of information and support across a range of breast cancer-related topics.
Living Healthy Together: The Living Healthy Together (LHT) intervention focuses on delivering education and support to breast cancer survivors and their partners across a range of topics including social support, sleep and fatigue, stress and stress management, nutrition, and physical activity. Participants will be asked to engage actively with the material and to review readings and intervention material between sessions.
|
|---|---|---|
|
Change in Patients' Self-Reported Anxiety
|
-0.70 score on a scale
Standard Deviation 3.25
|
0.07 score on a scale
Standard Deviation 3.83
|
SECONDARY outcome
Timeframe: Baseline up to 6 weeksPopulation: Only partner participants' data were used for this analysis. Of 61 IE partners, one did not complete the 6-week follow-up assessment. Of 59 LHT partners, 4 did not complete the 6-week follow-up assessment.
Partners' self-reported anxiety will be measured using the 7-item Generalized Anxiety Disorder scale (GAD-7). Total scale scores range from 0 to 21. Higher scores indicate higher levels of anxiety. Change in mean anxiety score over time will be reported. Negative mean change scores indicate decrease in anxiety.
Outcome measures
| Measure |
Intimacy Enhancement
n=60 Participants
Participants attend four sessions (60-75 minutes) consisting of education and skills training to enhance physical and emotional intimacy.
Intimacy Enhancement: The IE intervention is grounded in cognitive behavioral couple therapy and sex therapy, and includes education and skills training with a focus on the following major topics: understanding effects of breast cancer on sex and intimacy; goal-setting; communication skills; problem-solving and engaging in activities to build intimacy; identifying and restructuring negative or inflexible thoughts; and planning ahead and preparing for challenges. Participants will be asked to participate in written and behavioral activities at home between sessions to strengthen skills acquisition.
|
Living Healthy Together
n=55 Participants
Participants attend four sessions (60-75 minutes) consisting of information and support across a range of breast cancer-related topics.
Living Healthy Together: The Living Healthy Together (LHT) intervention focuses on delivering education and support to breast cancer survivors and their partners across a range of topics including social support, sleep and fatigue, stress and stress management, nutrition, and physical activity. Participants will be asked to engage actively with the material and to review readings and intervention material between sessions.
|
|---|---|---|
|
Change in Partners' Self-Reported Anxiety
|
-0.98 score on a scale
Standard Deviation 2.95
|
0.27 score on a scale
Standard Deviation 2.80
|
SECONDARY outcome
Timeframe: Baseline up to 6 weeksPopulation: Only patient participants' data were used for this analysis. Of 61 IE patients, one did not complete the 6-week follow-up assessment. Of 59 LHT patients, 4 did not complete the 6-week follow-up assessment.
Patients' self-reported depression will be measured using the 9-item Patient Health Questionnaire (PHQ-9). Total scale scores range from 0 to 27. Higher scores indicate higher levels of depression. Change in mean depression score over time will be reported. Negative mean change scores indicate decrease in depression.
Outcome measures
| Measure |
Intimacy Enhancement
n=60 Participants
Participants attend four sessions (60-75 minutes) consisting of education and skills training to enhance physical and emotional intimacy.
Intimacy Enhancement: The IE intervention is grounded in cognitive behavioral couple therapy and sex therapy, and includes education and skills training with a focus on the following major topics: understanding effects of breast cancer on sex and intimacy; goal-setting; communication skills; problem-solving and engaging in activities to build intimacy; identifying and restructuring negative or inflexible thoughts; and planning ahead and preparing for challenges. Participants will be asked to participate in written and behavioral activities at home between sessions to strengthen skills acquisition.
|
Living Healthy Together
n=55 Participants
Participants attend four sessions (60-75 minutes) consisting of information and support across a range of breast cancer-related topics.
Living Healthy Together: The Living Healthy Together (LHT) intervention focuses on delivering education and support to breast cancer survivors and their partners across a range of topics including social support, sleep and fatigue, stress and stress management, nutrition, and physical activity. Participants will be asked to engage actively with the material and to review readings and intervention material between sessions.
|
|---|---|---|
|
Change in Patients' Self-Reported Depressive Symptoms
|
-0.99 score on a scale
Standard Deviation 4.36
|
-0.74 score on a scale
Standard Deviation 3.31
|
SECONDARY outcome
Timeframe: Baseline up to 6 weeksPopulation: Only partner participants' data were used for this analysis. Of 61 IE partners, one did not complete the 6-week follow-up assessment. Of 59 LHT partners, 4 did not complete the 6-week follow-up assessment.
Partners' self-reported depression will be measured using the 9-item Patient Health Questionnaire (PHQ-9). Total scale scores range from 0 to 27. Higher scores indicate higher levels of depression. Change in mean depression score over time will be reported. Negative mean change scores indicate decrease in depression.
Outcome measures
| Measure |
Intimacy Enhancement
n=60 Participants
Participants attend four sessions (60-75 minutes) consisting of education and skills training to enhance physical and emotional intimacy.
Intimacy Enhancement: The IE intervention is grounded in cognitive behavioral couple therapy and sex therapy, and includes education and skills training with a focus on the following major topics: understanding effects of breast cancer on sex and intimacy; goal-setting; communication skills; problem-solving and engaging in activities to build intimacy; identifying and restructuring negative or inflexible thoughts; and planning ahead and preparing for challenges. Participants will be asked to participate in written and behavioral activities at home between sessions to strengthen skills acquisition.
|
Living Healthy Together
n=55 Participants
Participants attend four sessions (60-75 minutes) consisting of information and support across a range of breast cancer-related topics.
Living Healthy Together: The Living Healthy Together (LHT) intervention focuses on delivering education and support to breast cancer survivors and their partners across a range of topics including social support, sleep and fatigue, stress and stress management, nutrition, and physical activity. Participants will be asked to engage actively with the material and to review readings and intervention material between sessions.
|
|---|---|---|
|
Change in Partners' Self-Reported Depressive Symptoms
|
-0.61 score on a scale
Standard Deviation 2.47
|
-0.16 score on a scale
Standard Deviation 4.10
|
Adverse Events
Intimacy Enhancement Patients
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Living Healthy Together Patients
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Intimacy Enhancement Partners
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Living Healthy Together Partners
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Intimacy Enhancement Patients
n=61 participants at risk
Participants attend four sessions (60-75 minutes) consisting of education and skills training to enhance physical and emotional intimacy.
Intimacy Enhancement: The IE intervention is grounded in cognitive behavioral couple therapy and sex therapy, and includes education and skills training with a focus on the following major topics: understanding effects of breast cancer on sex and intimacy; goal-setting; communication skills; problem-solving and engaging in activities to build intimacy; identifying and restructuring negative or inflexible thoughts; and planning ahead and preparing for challenges. Participants will be asked to participate in written and behavioral activities at home between sessions to strengthen skills acquisition.
|
Living Healthy Together Patients
n=59 participants at risk
Participants attend four sessions (60-75 minutes) consisting of information and support across a range of breast cancer-related topics.
Living Healthy Together: The Living Healthy Together (LHT) intervention focuses on delivering education and support to breast cancer survivors and their partners across a range of topics including social support, sleep and fatigue, stress and stress management, nutrition, and physical activity. Participants will be asked to engage actively with the material and to review readings and intervention material between sessions.
|
Intimacy Enhancement Partners
n=61 participants at risk
Participants attend four sessions (60-75 minutes) consisting of education and skills training to enhance physical and emotional intimacy.
Intimacy Enhancement: The IE intervention is grounded in cognitive behavioral couple therapy and sex therapy, and includes education and skills training with a focus on the following major topics: understanding effects of breast cancer on sex and intimacy; goal-setting; communication skills; problem-solving and engaging in activities to build intimacy; identifying and restructuring negative or inflexible thoughts; and planning ahead and preparing for challenges. Participants will be asked to participate in written and behavioral activities at home between sessions to strengthen skills acquisition.
|
Living Healthy Together Partners
n=59 participants at risk
Participants attend four sessions (60-75 minutes) consisting of information and support across a range of breast cancer-related topics.
Living Healthy Together: The Living Healthy Together (LHT) intervention focuses on delivering education and support to breast cancer survivors and their partners across a range of topics including social support, sleep and fatigue, stress and stress management, nutrition, and physical activity. Participants will be asked to engage actively with the material and to review readings and intervention material between sessions.
|
|---|---|---|---|---|
|
Psychiatric disorders
Self-reported distress
|
4.9%
3/61 • Adverse events were tracked over the course of study participation (6 months).
|
10.2%
6/59 • Adverse events were tracked over the course of study participation (6 months).
|
3.3%
2/61 • Adverse events were tracked over the course of study participation (6 months).
|
6.8%
4/59 • Adverse events were tracked over the course of study participation (6 months).
|
Additional Information
Dr. Jennifer Reese, Associate Professor
Fox Chase Cancer Center
Phone: 215-214-3223
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place