Trial Outcomes & Findings for The Sexual Health of Rectal Cancer Patients (NCT NCT00712751)
NCT ID: NCT00712751
Last Updated: 2026-08-26
Results Overview
The FSFI (Female Sexual Functioning Index) is a brief, self-report measure of female sexual function. The 19 items use a 5-point Likert scale ranging from 1-5 with higher scores indicating greater levels of sexual function. The total score for the Female Sexual Function Index (FSFI) ranges from a minimum of 2.0 to a maximum of 36.0
COMPLETED
149 participants
4 months post-baseline (follow-up 1)
2026-08-26
Participant Flow
Participant milestones
| Measure |
Usual Care (UC)
usual care (UC) which is the standard care that patients receive
questionnaires: Participants randomized to the Usual Care arm will receive standard care . For women, this is defined as the care that participants who are not in the intervention receive; we will ask these participants what psychosocial care they are receiving to track usual care. For men, "usual care" will consist of a standardized referral to the men's Sexual Medicine Program at MSKCC and written information in the form of the American Cancer Society (ACS) booklet on Sexuality after Cancer. Individuals randomized to Usual Care will not receive any additional counseling sessions from the study interventionists until they are done with the follow up interviews and then it will be offered to them. Follow up questionnaires will assess all study participants at 4 and 8 months after baseline.
|
Cancer Survivorship Intervention-Sexual Health (CSI-SH)Plus Usual Care (US)
Cancer Survivorship Intervention-Sexual Health (CSI-SH)plus Usual Care (US)
CSI-SH- Cancer Survivorship Intervention: This involves four 1-hour individual sessions with three additional telephone booster/review sessions provided in between the four sessions. Sessions can be completed in person or conducted over the phone. Although every effort will be made to complete the booster session in between counseling sessions, if the patient is unavailable to complete the booster calls they may be skipped. Sessions one and two will focus on rehabilitation techniques and tools will be provided and discussed with participants during these first two sessions.
|
|---|---|---|
|
Overall Study
STARTED
|
69
|
80
|
|
Overall Study
COMPLETED
|
61
|
47
|
|
Overall Study
NOT COMPLETED
|
8
|
33
|
Reasons for withdrawal
| Measure |
Usual Care (UC)
usual care (UC) which is the standard care that patients receive
questionnaires: Participants randomized to the Usual Care arm will receive standard care . For women, this is defined as the care that participants who are not in the intervention receive; we will ask these participants what psychosocial care they are receiving to track usual care. For men, "usual care" will consist of a standardized referral to the men's Sexual Medicine Program at MSKCC and written information in the form of the American Cancer Society (ACS) booklet on Sexuality after Cancer. Individuals randomized to Usual Care will not receive any additional counseling sessions from the study interventionists until they are done with the follow up interviews and then it will be offered to them. Follow up questionnaires will assess all study participants at 4 and 8 months after baseline.
|
Cancer Survivorship Intervention-Sexual Health (CSI-SH)Plus Usual Care (US)
Cancer Survivorship Intervention-Sexual Health (CSI-SH)plus Usual Care (US)
CSI-SH- Cancer Survivorship Intervention: This involves four 1-hour individual sessions with three additional telephone booster/review sessions provided in between the four sessions. Sessions can be completed in person or conducted over the phone. Although every effort will be made to complete the booster session in between counseling sessions, if the patient is unavailable to complete the booster calls they may be skipped. Sessions one and two will focus on rehabilitation techniques and tools will be provided and discussed with participants during these first two sessions.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
5
|
2
|
|
Overall Study
Protocol Violation
|
1
|
2
|
|
Overall Study
Withdrawal by Subject
|
1
|
3
|
|
Overall Study
Participants lives outside of US and was not included
|
1
|
0
|
|
Overall Study
Participants were randomized to intervention but did not receive intervention
|
0
|
17
|
|
Overall Study
Started intervention but did not finish.
|
0
|
9
|
Baseline Characteristics
The Sexual Health of Rectal Cancer Patients
Baseline characteristics by cohort
| Measure |
Usual Care (UC)
n=69 Participants
usual care (UC) which is the standard care that patients receive
questionnaires: Participants randomized to the Usual Care arm will receive standard care . For women, this is defined as the care that participants who are not in the intervention receive; we will ask these participants what psychosocial care they are receiving to track usual care. For men, "usual care" will consist of a standardized referral to the men's Sexual Medicine Program at MSKCC and written information in the form of the American Cancer Society (ACS) booklet on Sexuality after Cancer. Individuals randomized to Usual Care will not receive any additional counseling sessions from the study interventionists until they are done with the follow up interviews and then it will be offered to them. Follow up questionnaires will assess all study participants at 4 and 8 months after baseline.
|
Cancer Survivorship Intervention-Sexual Health (CSI-SH)Plus Usual Care (US)
n=80 Participants
Cancer Survivorship Intervention-Sexual Health (CSI-SH)plus Usual Care (US)
CSI-SH- Cancer Survivorship Intervention: This involves four 1-hour individual sessions with three additional telephone booster/review sessions provided in between the four sessions. Sessions can be completed in person or conducted over the phone. Although every effort will be made to complete the booster session in between counseling sessions, if the patient is unavailable to complete the booster calls they may be skipped. Sessions one and two will focus on rehabilitation techniques and tools will be provided and discussed with participants during these first two sessions.
|
Total
n=149 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
55.46 years
n=31 Participants
|
57.40 years
n=49 Participants
|
56.5 years
n=80 Participants
|
|
Sex: Female, Male
Female
|
37 Participants
n=31 Participants
|
35 Participants
n=49 Participants
|
72 Participants
n=80 Participants
|
|
Sex: Female, Male
Male
|
32 Participants
n=31 Participants
|
45 Participants
n=49 Participants
|
77 Participants
n=80 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=31 Participants
|
3 Participants
n=49 Participants
|
7 Participants
n=80 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
61 Participants
n=31 Participants
|
73 Participants
n=49 Participants
|
134 Participants
n=80 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=31 Participants
|
4 Participants
n=49 Participants
|
8 Participants
n=80 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=31 Participants
|
0 Participants
n=49 Participants
|
0 Participants
n=80 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=31 Participants
|
3 Participants
n=49 Participants
|
5 Participants
n=80 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=31 Participants
|
0 Participants
n=49 Participants
|
0 Participants
n=80 Participants
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=31 Participants
|
6 Participants
n=49 Participants
|
14 Participants
n=80 Participants
|
|
Race (NIH/OMB)
White
|
59 Participants
n=31 Participants
|
69 Participants
n=49 Participants
|
128 Participants
n=80 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=31 Participants
|
0 Participants
n=49 Participants
|
0 Participants
n=80 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=31 Participants
|
2 Participants
n=49 Participants
|
2 Participants
n=80 Participants
|
|
Region of Enrollment
United States
|
69 Participants
n=31 Participants
|
80 Participants
n=49 Participants
|
149 Participants
n=80 Participants
|
PRIMARY outcome
Timeframe: 4 months post-baseline (follow-up 1)Population: Males were not evaluated for this objective
The FSFI (Female Sexual Functioning Index) is a brief, self-report measure of female sexual function. The 19 items use a 5-point Likert scale ranging from 1-5 with higher scores indicating greater levels of sexual function. The total score for the Female Sexual Function Index (FSFI) ranges from a minimum of 2.0 to a maximum of 36.0
Outcome measures
| Measure |
Usual Care (UC)
n=37 Participants
usual care (UC) which is the standard care that patients receive
questionnaires: Participants randomized to the Usual Care arm will receive standard care . For women, this is defined as the care that participants who are not in the intervention receive; we will ask these participants what psychosocial care they are receiving to track usual care. For men, "usual care" will consist of a standardized referral to the men's Sexual Medicine Program at MSKCC and written information in the form of the American Cancer Society (ACS) booklet on Sexuality after Cancer. Individuals randomized to Usual Care will not receive any additional counseling sessions from the study interventionists until they are done with the follow up interviews and then it will be offered to them. Follow up questionnaires will assess all study participants at 4 and 8 months after baseline.
|
Cancer Survivorship Intervention-Sexual Health (CSI-SH)Plus Usual Care (US)
n=35 Participants
Cancer Survivorship Intervention-Sexual Health (CSI-SH)plus Usual Care (US)
CSI-SH- Cancer Survivorship Intervention: This involves four 1-hour individual sessions with three additional telephone booster/review sessions provided in between the four sessions. Sessions can be completed in person or conducted over the phone. Although every effort will be made to complete the booster session in between counseling sessions, if the patient is unavailable to complete the booster calls they may be skipped. Sessions one and two will focus on rehabilitation techniques and tools will be provided and discussed with participants during these first two sessions.
|
|---|---|---|
|
Change in Female Sexual Functioning Index (FSFI) Total Score for Women From Baseline to Follow-up 1
|
2.04 units on a scale
Standard Deviation 10.69
|
5.19 units on a scale
Standard Deviation 9.82
|
PRIMARY outcome
Timeframe: 8 months post-baseline (follow up 2)Population: Males were not evaluated for this objective
The FSFI is a brief, self-report measure of female sexual function. The 19 items use a 5-point Likert scale ranging from 1-5 with higher scores indicating greater levels of sexual function. The total score for the Female Sexual Function Index (FSFI) ranges from a minimum of 2.0 to a maximum of 36.0
Outcome measures
| Measure |
Usual Care (UC)
n=37 Participants
usual care (UC) which is the standard care that patients receive
questionnaires: Participants randomized to the Usual Care arm will receive standard care . For women, this is defined as the care that participants who are not in the intervention receive; we will ask these participants what psychosocial care they are receiving to track usual care. For men, "usual care" will consist of a standardized referral to the men's Sexual Medicine Program at MSKCC and written information in the form of the American Cancer Society (ACS) booklet on Sexuality after Cancer. Individuals randomized to Usual Care will not receive any additional counseling sessions from the study interventionists until they are done with the follow up interviews and then it will be offered to them. Follow up questionnaires will assess all study participants at 4 and 8 months after baseline.
|
Cancer Survivorship Intervention-Sexual Health (CSI-SH)Plus Usual Care (US)
n=35 Participants
Cancer Survivorship Intervention-Sexual Health (CSI-SH)plus Usual Care (US)
CSI-SH- Cancer Survivorship Intervention: This involves four 1-hour individual sessions with three additional telephone booster/review sessions provided in between the four sessions. Sessions can be completed in person or conducted over the phone. Although every effort will be made to complete the booster session in between counseling sessions, if the patient is unavailable to complete the booster calls they may be skipped. Sessions one and two will focus on rehabilitation techniques and tools will be provided and discussed with participants during these first two sessions.
|
|---|---|---|
|
Change in Female Sexual Functioning Index (FSFI) Total Score for Women From Baseline to Follow-up 2
|
0.85 units on a scale
Standard Deviation 10.03
|
2.63 units on a scale
Standard Deviation 11.76
|
PRIMARY outcome
Timeframe: 4 months post-baseline (follow up 1)Population: Females were not evaluated for this outcome measure.
The IIEF is a 15-item questionnaire designed to assess erectile functioning. Scores of 0 to 5 are awarded to each of the 15 questions. The five domains assessed include Erectile Function (Max score 30), Orgasmic Function (Max score 10), Sexual Desire (Max score 10), Intercourse Satisfaction (Max score 15) and Overall Satisfaction (Max score 10). Overall Scoring: 1-10: Severe Erectile Dysfunction, 11-16: Moderate dysfunction,17-21: Mild to moderate dysfunction, 22-25: Mild dysfunction, 26-30: No dysfunction. Higher scores indicate better sexual function/better outcome.
Outcome measures
| Measure |
Usual Care (UC)
n=32 Participants
usual care (UC) which is the standard care that patients receive
questionnaires: Participants randomized to the Usual Care arm will receive standard care . For women, this is defined as the care that participants who are not in the intervention receive; we will ask these participants what psychosocial care they are receiving to track usual care. For men, "usual care" will consist of a standardized referral to the men's Sexual Medicine Program at MSKCC and written information in the form of the American Cancer Society (ACS) booklet on Sexuality after Cancer. Individuals randomized to Usual Care will not receive any additional counseling sessions from the study interventionists until they are done with the follow up interviews and then it will be offered to them. Follow up questionnaires will assess all study participants at 4 and 8 months after baseline.
|
Cancer Survivorship Intervention-Sexual Health (CSI-SH)Plus Usual Care (US)
n=45 Participants
Cancer Survivorship Intervention-Sexual Health (CSI-SH)plus Usual Care (US)
CSI-SH- Cancer Survivorship Intervention: This involves four 1-hour individual sessions with three additional telephone booster/review sessions provided in between the four sessions. Sessions can be completed in person or conducted over the phone. Although every effort will be made to complete the booster session in between counseling sessions, if the patient is unavailable to complete the booster calls they may be skipped. Sessions one and two will focus on rehabilitation techniques and tools will be provided and discussed with participants during these first two sessions.
|
|---|---|---|
|
Changes International Index of Erectile Function (IIEF) for Men From Baseline to Follow up 1
Erectile Function
|
0.50 units on a scale
Standard Deviation 3.64
|
5.14 units on a scale
Standard Deviation 5.05
|
|
Changes International Index of Erectile Function (IIEF) for Men From Baseline to Follow up 1
Orgasmic Function
|
0.41 units on a scale
Standard Deviation 1.78
|
2.29 units on a scale
Standard Deviation 3.07
|
|
Changes International Index of Erectile Function (IIEF) for Men From Baseline to Follow up 1
Sexual Desire
|
-0.31 units on a scale
Standard Deviation 1.44
|
1.36 units on a scale
Standard Deviation 1.45
|
|
Changes International Index of Erectile Function (IIEF) for Men From Baseline to Follow up 1
Intercourse Satisfaction
|
-0.41 units on a scale
Standard Deviation 3.53
|
3.07 units on a scale
Standard Deviation 3.32
|
|
Changes International Index of Erectile Function (IIEF) for Men From Baseline to Follow up 1
Overall Satisfaction
|
-0.07 units on a scale
Standard Deviation 2.51
|
2.00 units on a scale
Standard Deviation 2.35
|
PRIMARY outcome
Timeframe: 8 months post-baseline (follow-up 2)Population: Females were not evaluated for this outcome measure
The IIEF is a 15-item questionnaire designed to assess erectile functioning. Scores of 0 to 5 are awarded to each of the 15 questions. The five domains assessed include Erectile Function (Max score 30), Orgasmic Function (Max score 10), Sexual Desire (Max score 10), Intercourse Satisfaction (Max score 15) and Overall Satisfaction (Max score 10). Overall Scoring: 1-10: Severe Erectile Dysfunction, 11-16: Moderate dysfunction,17-21: Mild to moderate dysfunction, 22-25: Mild dysfunction, 26-30: No dysfunction. Higher scores indicate better sexual function/better outcome.
Outcome measures
| Measure |
Usual Care (UC)
n=32 Participants
usual care (UC) which is the standard care that patients receive
questionnaires: Participants randomized to the Usual Care arm will receive standard care . For women, this is defined as the care that participants who are not in the intervention receive; we will ask these participants what psychosocial care they are receiving to track usual care. For men, "usual care" will consist of a standardized referral to the men's Sexual Medicine Program at MSKCC and written information in the form of the American Cancer Society (ACS) booklet on Sexuality after Cancer. Individuals randomized to Usual Care will not receive any additional counseling sessions from the study interventionists until they are done with the follow up interviews and then it will be offered to them. Follow up questionnaires will assess all study participants at 4 and 8 months after baseline.
|
Cancer Survivorship Intervention-Sexual Health (CSI-SH)Plus Usual Care (US)
n=45 Participants
Cancer Survivorship Intervention-Sexual Health (CSI-SH)plus Usual Care (US)
CSI-SH- Cancer Survivorship Intervention: This involves four 1-hour individual sessions with three additional telephone booster/review sessions provided in between the four sessions. Sessions can be completed in person or conducted over the phone. Although every effort will be made to complete the booster session in between counseling sessions, if the patient is unavailable to complete the booster calls they may be skipped. Sessions one and two will focus on rehabilitation techniques and tools will be provided and discussed with participants during these first two sessions.
|
|---|---|---|
|
Changes in International Index of Erectile Function (IIEF) for Men From Baseline to Follow up 2
Erectile Function
|
-0.94 units on a scale
Standard Deviation 7.32
|
2.29 units on a scale
Standard Deviation 3.54
|
|
Changes in International Index of Erectile Function (IIEF) for Men From Baseline to Follow up 2
Orgasmic Function
|
-0.08 units on a scale
Standard Deviation 2.12
|
1.21 units on a scale
Standard Deviation 3.45
|
|
Changes in International Index of Erectile Function (IIEF) for Men From Baseline to Follow up 2
Sexual Desire
|
-0.75 units on a scale
Standard Deviation 1.78
|
0.29 units on a scale
Standard Deviation 0.99
|
|
Changes in International Index of Erectile Function (IIEF) for Men From Baseline to Follow up 2
Intercourse Satisfaction
|
-1.21 units on a scale
Standard Deviation 4.03
|
1.21 units on a scale
Standard Deviation 3.47
|
|
Changes in International Index of Erectile Function (IIEF) for Men From Baseline to Follow up 2
Overall Satisfaction
|
-0.50 units on a scale
Standard Deviation 2.69
|
1.14 units on a scale
Standard Deviation 1.79
|
SECONDARY outcome
Timeframe: 4 months post-baseline (follow up 1)Population: The Number Analyzed reflect the number of women and men analyzed for each arm.
The IES-R is a self-report measure designed to assess current subjective distress for any specific life event. Respondents rate each item in the IES-R on a scale of 0 (not at all), 1 (a little bit), 2 (moderately), 3 (quite a bit) and 4 (extremely) according to the past 7 days with regard to cancer and its treatment. the total score for the IES-R assessment can range from 0-88. In general, the higher the score, the more severely a person's life is disrupted by a traumatic event.
Outcome measures
| Measure |
Usual Care (UC)
n=69 Participants
usual care (UC) which is the standard care that patients receive
questionnaires: Participants randomized to the Usual Care arm will receive standard care . For women, this is defined as the care that participants who are not in the intervention receive; we will ask these participants what psychosocial care they are receiving to track usual care. For men, "usual care" will consist of a standardized referral to the men's Sexual Medicine Program at MSKCC and written information in the form of the American Cancer Society (ACS) booklet on Sexuality after Cancer. Individuals randomized to Usual Care will not receive any additional counseling sessions from the study interventionists until they are done with the follow up interviews and then it will be offered to them. Follow up questionnaires will assess all study participants at 4 and 8 months after baseline.
|
Cancer Survivorship Intervention-Sexual Health (CSI-SH)Plus Usual Care (US)
n=80 Participants
Cancer Survivorship Intervention-Sexual Health (CSI-SH)plus Usual Care (US)
CSI-SH- Cancer Survivorship Intervention: This involves four 1-hour individual sessions with three additional telephone booster/review sessions provided in between the four sessions. Sessions can be completed in person or conducted over the phone. Although every effort will be made to complete the booster session in between counseling sessions, if the patient is unavailable to complete the booster calls they may be skipped. Sessions one and two will focus on rehabilitation techniques and tools will be provided and discussed with participants during these first two sessions.
|
|---|---|---|
|
Change in Impact of Events Scale-Revised (IES-R) Total Score for Women and Men From Baseline to Follow up 1
Women
|
1.27 units on a scale
Standard Deviation 13.49
|
-5.72 units on a scale
Standard Deviation 14.42
|
|
Change in Impact of Events Scale-Revised (IES-R) Total Score for Women and Men From Baseline to Follow up 1
Men
|
-2.89 units on a scale
Standard Deviation 10.89
|
-6.08 units on a scale
Standard Deviation 14.51
|
SECONDARY outcome
Timeframe: 8 months post-baseline (follow up 2)Population: The Number Analyzed reflect the number of women and men analyzed for each arm.
The IES-R is a self-report measure designed to assess current subjective distress for any specific life event. Respondents rate each item in the IES-R on a scale of 0 (not at all), 1 (a little bit), 2 (moderately), 3 (quite a bit) and 4 (extremely) according to the past 7 days with regard to cancer and its treatment. the total score for the IES-R assessment can range from 0-88. In general, the higher the score, the more severely a person's life is disrupted by a traumatic event.
Outcome measures
| Measure |
Usual Care (UC)
n=69 Participants
usual care (UC) which is the standard care that patients receive
questionnaires: Participants randomized to the Usual Care arm will receive standard care . For women, this is defined as the care that participants who are not in the intervention receive; we will ask these participants what psychosocial care they are receiving to track usual care. For men, "usual care" will consist of a standardized referral to the men's Sexual Medicine Program at MSKCC and written information in the form of the American Cancer Society (ACS) booklet on Sexuality after Cancer. Individuals randomized to Usual Care will not receive any additional counseling sessions from the study interventionists until they are done with the follow up interviews and then it will be offered to them. Follow up questionnaires will assess all study participants at 4 and 8 months after baseline.
|
Cancer Survivorship Intervention-Sexual Health (CSI-SH)Plus Usual Care (US)
n=80 Participants
Cancer Survivorship Intervention-Sexual Health (CSI-SH)plus Usual Care (US)
CSI-SH- Cancer Survivorship Intervention: This involves four 1-hour individual sessions with three additional telephone booster/review sessions provided in between the four sessions. Sessions can be completed in person or conducted over the phone. Although every effort will be made to complete the booster session in between counseling sessions, if the patient is unavailable to complete the booster calls they may be skipped. Sessions one and two will focus on rehabilitation techniques and tools will be provided and discussed with participants during these first two sessions.
|
|---|---|---|
|
Change in Impact of Events Scale-Revised (IES-R) Total Score for Women and Men From Baseline to Follow up 2
Women
|
-2.41 units on a scale
Standard Deviation 12.24
|
-5.94 units on a scale
Standard Deviation 16.23
|
|
Change in Impact of Events Scale-Revised (IES-R) Total Score for Women and Men From Baseline to Follow up 2
Men
|
-6.21 units on a scale
Standard Deviation 11.29
|
-8.95 units on a scale
Standard Deviation 16.62
|
SECONDARY outcome
Timeframe: 4 months post-baseline (follow up 1)Population: Males were not evaluated for this outcome measure
The BSI (Brief Symptom Inventory) consists of 53 items. Participants rate the extent to which they have been bothered (0 ="not at all" to 4="extremely") in the past week by various symptoms. Higher scores indicate greater emotional distress. The BSI uses a 5-point Likert scale (0 = Not at all, 4 = Extremely), with rankings characterizing the intensity of distress during the past seven days. Scores are calculated as follows: Sum the item scores and divide by the number of items to obtain the mean score. Higher scores indicate greater emotional distress.
Outcome measures
| Measure |
Usual Care (UC)
n=37 Participants
usual care (UC) which is the standard care that patients receive
questionnaires: Participants randomized to the Usual Care arm will receive standard care . For women, this is defined as the care that participants who are not in the intervention receive; we will ask these participants what psychosocial care they are receiving to track usual care. For men, "usual care" will consist of a standardized referral to the men's Sexual Medicine Program at MSKCC and written information in the form of the American Cancer Society (ACS) booklet on Sexuality after Cancer. Individuals randomized to Usual Care will not receive any additional counseling sessions from the study interventionists until they are done with the follow up interviews and then it will be offered to them. Follow up questionnaires will assess all study participants at 4 and 8 months after baseline.
|
Cancer Survivorship Intervention-Sexual Health (CSI-SH)Plus Usual Care (US)
n=35 Participants
Cancer Survivorship Intervention-Sexual Health (CSI-SH)plus Usual Care (US)
CSI-SH- Cancer Survivorship Intervention: This involves four 1-hour individual sessions with three additional telephone booster/review sessions provided in between the four sessions. Sessions can be completed in person or conducted over the phone. Although every effort will be made to complete the booster session in between counseling sessions, if the patient is unavailable to complete the booster calls they may be skipped. Sessions one and two will focus on rehabilitation techniques and tools will be provided and discussed with participants during these first two sessions.
|
|---|---|---|
|
Changes in Depression and Anxiety Symptom Dimension Scores of Brief Symptom Inventory (BSI) for Women From Baseline to Follow up 1
Depression
|
0.01 units on a scale
Standard Deviation 0.59
|
-0.15 units on a scale
Standard Deviation 0.72
|
|
Changes in Depression and Anxiety Symptom Dimension Scores of Brief Symptom Inventory (BSI) for Women From Baseline to Follow up 1
Anxiety
|
0.02 units on a scale
Standard Deviation 0.45
|
-0.15 units on a scale
Standard Deviation 0.70
|
SECONDARY outcome
Timeframe: 8 months post-baseline (follow up 2)The BSI (Brief Symptom Inventory) consists of 53 items. Participants rate the extent to which they have been bothered (0 ="not at all" to 4="extremely") in the past week by various symptoms. Higher scores indicate greater emotional distress. The BSI uses a 5-point Likert scale (0 = Not at all, 4 = Extremely), with rankings characterizing the intensity of distress during the past seven days. Scores are calculated as follows: Sum the item scores and divide by the number of items to obtain the mean score. Higher scores indicate greater emotional distress.
Outcome measures
| Measure |
Usual Care (UC)
n=37 Participants
usual care (UC) which is the standard care that patients receive
questionnaires: Participants randomized to the Usual Care arm will receive standard care . For women, this is defined as the care that participants who are not in the intervention receive; we will ask these participants what psychosocial care they are receiving to track usual care. For men, "usual care" will consist of a standardized referral to the men's Sexual Medicine Program at MSKCC and written information in the form of the American Cancer Society (ACS) booklet on Sexuality after Cancer. Individuals randomized to Usual Care will not receive any additional counseling sessions from the study interventionists until they are done with the follow up interviews and then it will be offered to them. Follow up questionnaires will assess all study participants at 4 and 8 months after baseline.
|
Cancer Survivorship Intervention-Sexual Health (CSI-SH)Plus Usual Care (US)
n=35 Participants
Cancer Survivorship Intervention-Sexual Health (CSI-SH)plus Usual Care (US)
CSI-SH- Cancer Survivorship Intervention: This involves four 1-hour individual sessions with three additional telephone booster/review sessions provided in between the four sessions. Sessions can be completed in person or conducted over the phone. Although every effort will be made to complete the booster session in between counseling sessions, if the patient is unavailable to complete the booster calls they may be skipped. Sessions one and two will focus on rehabilitation techniques and tools will be provided and discussed with participants during these first two sessions.
|
|---|---|---|
|
Changes in Depression and Anxiety Symptom Dimension Scores of Brief Symptom Inventory (BSI) for Women From Baseline to Follow up 2
Anxiety
|
0.05 units on a scale
Standard Deviation 0.67
|
-0.03 units on a scale
Standard Deviation 0.40
|
|
Changes in Depression and Anxiety Symptom Dimension Scores of Brief Symptom Inventory (BSI) for Women From Baseline to Follow up 2
Depression
|
-0.02 units on a scale
Standard Deviation 0.51
|
-0.18 units on a scale
Standard Deviation 0.67
|
SECONDARY outcome
Timeframe: 4 months post-baseline (follow up 1)EORTC QLQ-C30 (European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire ) is a well-validated instrument that assesses health-related quality of life in cancer patients. It is composed of 30-items, which factor into scales that evaluate physical functioning and role functioning, as well as emotional, social, and cognitive functioning and global QOL. Three symptom scales measure fatigue, pain, and emesis, while six single items assess financial impact, dyspnea, sleep disturbance, appetite, diarrhea, and constipation. The EORTC QLQ-C30 Summary Score is calculated from the mean of 13 of the 15 QLQ-C30 scales (the Global Quality of Life scale and the Financial Impact scale are not included). All of the scales and measures range in score from 0 to 100. A high scale score represents a higher response level/better outcome.
Outcome measures
| Measure |
Usual Care (UC)
n=37 Participants
usual care (UC) which is the standard care that patients receive
questionnaires: Participants randomized to the Usual Care arm will receive standard care . For women, this is defined as the care that participants who are not in the intervention receive; we will ask these participants what psychosocial care they are receiving to track usual care. For men, "usual care" will consist of a standardized referral to the men's Sexual Medicine Program at MSKCC and written information in the form of the American Cancer Society (ACS) booklet on Sexuality after Cancer. Individuals randomized to Usual Care will not receive any additional counseling sessions from the study interventionists until they are done with the follow up interviews and then it will be offered to them. Follow up questionnaires will assess all study participants at 4 and 8 months after baseline.
|
Cancer Survivorship Intervention-Sexual Health (CSI-SH)Plus Usual Care (US)
n=35 Participants
Cancer Survivorship Intervention-Sexual Health (CSI-SH)plus Usual Care (US)
CSI-SH- Cancer Survivorship Intervention: This involves four 1-hour individual sessions with three additional telephone booster/review sessions provided in between the four sessions. Sessions can be completed in person or conducted over the phone. Although every effort will be made to complete the booster session in between counseling sessions, if the patient is unavailable to complete the booster calls they may be skipped. Sessions one and two will focus on rehabilitation techniques and tools will be provided and discussed with participants during these first two sessions.
|
|---|---|---|
|
Change in European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Total Score for Women From Baseline to Follow up 1
|
1.48 units on a scale
Standard Deviation 21.06
|
4.9 units on a scale
Standard Deviation 18.79
|
SECONDARY outcome
Timeframe: 8 months post-baseline (follow up 2)EORTC QLQ-C30 (European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire ) is a well-validated instrument that assesses health-related quality of life in cancer patients. It is composed of 30-items, which factor into scales that evaluate physical functioning and role functioning, as well as emotional, social, and cognitive functioning and global QOL. Three symptom scales measure fatigue, pain, and emesis, while six single items assess financial impact, dyspnea, sleep disturbance, appetite, diarrhea, and constipation. The EORTC QLQ-C30 Summary Score is calculated from the mean of 13 of the 15 QLQ-C30 scales (the Global Quality of Life scale and the Financial Impact scale are not included). All of the scales and measures range in score from 0 to 100. A high scale score represents a higher response level/better outcome.
Outcome measures
| Measure |
Usual Care (UC)
n=37 Participants
usual care (UC) which is the standard care that patients receive
questionnaires: Participants randomized to the Usual Care arm will receive standard care . For women, this is defined as the care that participants who are not in the intervention receive; we will ask these participants what psychosocial care they are receiving to track usual care. For men, "usual care" will consist of a standardized referral to the men's Sexual Medicine Program at MSKCC and written information in the form of the American Cancer Society (ACS) booklet on Sexuality after Cancer. Individuals randomized to Usual Care will not receive any additional counseling sessions from the study interventionists until they are done with the follow up interviews and then it will be offered to them. Follow up questionnaires will assess all study participants at 4 and 8 months after baseline.
|
Cancer Survivorship Intervention-Sexual Health (CSI-SH)Plus Usual Care (US)
n=35 Participants
Cancer Survivorship Intervention-Sexual Health (CSI-SH)plus Usual Care (US)
CSI-SH- Cancer Survivorship Intervention: This involves four 1-hour individual sessions with three additional telephone booster/review sessions provided in between the four sessions. Sessions can be completed in person or conducted over the phone. Although every effort will be made to complete the booster session in between counseling sessions, if the patient is unavailable to complete the booster calls they may be skipped. Sessions one and two will focus on rehabilitation techniques and tools will be provided and discussed with participants during these first two sessions.
|
|---|---|---|
|
Change in European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Total Score for Women From Baseline to Follow up 2
|
3.14 units on a scale
Standard Deviation 15.88
|
3.39 units on a scale
Standard Deviation 17.57
|
SECONDARY outcome
Timeframe: 4 months post-baseline (follow up 1)The Sexual Self-Esteem and Relationship Questionnaire (SEAR) is a 14-item measure that assesses sexual relationship satisfaction, sexual self-esteem, and overall relationship satisfaction. This measure was developed for use in men with ED. The items are scored on a 5-point Likert scale with higher scores indicating higher sexual satisfaction and sexual self-esteem. Higher scores indicated a more favorable response (0 = least favorable, 100 = most favorable). The Sexual Bother (SB) subscale of the Prostate-Health Related QOL (PHR-QOL) questionnaire is a 4-question scale that assesses men on a 5-point Likert scale (0-20). The four questions assess how sexual function has impacted close relationships, how big a problem it has been, if the patients have felt ashamed or embarrassed by their sexual function, and if it has impacted their ability to enjoy life. Higher scores indicate better outcomes (better functioning; less bother).
Outcome measures
| Measure |
Usual Care (UC)
n=32 Participants
usual care (UC) which is the standard care that patients receive
questionnaires: Participants randomized to the Usual Care arm will receive standard care . For women, this is defined as the care that participants who are not in the intervention receive; we will ask these participants what psychosocial care they are receiving to track usual care. For men, "usual care" will consist of a standardized referral to the men's Sexual Medicine Program at MSKCC and written information in the form of the American Cancer Society (ACS) booklet on Sexuality after Cancer. Individuals randomized to Usual Care will not receive any additional counseling sessions from the study interventionists until they are done with the follow up interviews and then it will be offered to them. Follow up questionnaires will assess all study participants at 4 and 8 months after baseline.
|
Cancer Survivorship Intervention-Sexual Health (CSI-SH)Plus Usual Care (US)
n=45 Participants
Cancer Survivorship Intervention-Sexual Health (CSI-SH)plus Usual Care (US)
CSI-SH- Cancer Survivorship Intervention: This involves four 1-hour individual sessions with three additional telephone booster/review sessions provided in between the four sessions. Sessions can be completed in person or conducted over the phone. Although every effort will be made to complete the booster session in between counseling sessions, if the patient is unavailable to complete the booster calls they may be skipped. Sessions one and two will focus on rehabilitation techniques and tools will be provided and discussed with participants during these first two sessions.
|
|---|---|---|
|
Change in Male-specific Variables (SEAR and Sexual Bother Subscale of the PHR-QOL) for Men From Baseline to Follow up 1
Sexual Self-Esteem and Relationship Questionnaire (SEAR
|
4.94 units on a scale
Standard Deviation 18.21
|
11.61 units on a scale
Standard Deviation 20.39
|
|
Change in Male-specific Variables (SEAR and Sexual Bother Subscale of the PHR-QOL) for Men From Baseline to Follow up 1
Sexual Bother (SB) subscale of the Prostate-Health Related QOL (PHR-QOL)
|
-0.14 units on a scale
Standard Deviation 2.16
|
-3.00 units on a scale
Standard Deviation 3.31
|
SECONDARY outcome
Timeframe: 8 months post-baseline (follow up 2)The Sexual Self-Esteem and Relationship Questionnaire (SEAR) is a 14-item measure that assesses sexual relationship satisfaction, sexual self-esteem, and overall relationship satisfaction. This measure was developed for use in men with ED. The items are scored on a 5-point Likert scale with higher scores indicating higher sexual satisfaction and sexual self-esteem. Higher scores indicated a more favorable response (0 = least favorable, 100 = most favorable). The Sexual Bother (SB) subscale of the Prostate-Health Related QOL (PHR-QOL) questionnaire is a 4-question scale that assesses men on a 5-point Likert scale (0-20). The four questions assess how sexual function has impacted close relationships, how big a problem it has been, if the patients have felt ashamed or embarrassed by their sexual function, and if it has impacted their ability to enjoy life. Higher scores indicate better outcomes (better functioning; less bother).
Outcome measures
| Measure |
Usual Care (UC)
n=32 Participants
usual care (UC) which is the standard care that patients receive
questionnaires: Participants randomized to the Usual Care arm will receive standard care . For women, this is defined as the care that participants who are not in the intervention receive; we will ask these participants what psychosocial care they are receiving to track usual care. For men, "usual care" will consist of a standardized referral to the men's Sexual Medicine Program at MSKCC and written information in the form of the American Cancer Society (ACS) booklet on Sexuality after Cancer. Individuals randomized to Usual Care will not receive any additional counseling sessions from the study interventionists until they are done with the follow up interviews and then it will be offered to them. Follow up questionnaires will assess all study participants at 4 and 8 months after baseline.
|
Cancer Survivorship Intervention-Sexual Health (CSI-SH)Plus Usual Care (US)
n=45 Participants
Cancer Survivorship Intervention-Sexual Health (CSI-SH)plus Usual Care (US)
CSI-SH- Cancer Survivorship Intervention: This involves four 1-hour individual sessions with three additional telephone booster/review sessions provided in between the four sessions. Sessions can be completed in person or conducted over the phone. Although every effort will be made to complete the booster session in between counseling sessions, if the patient is unavailable to complete the booster calls they may be skipped. Sessions one and two will focus on rehabilitation techniques and tools will be provided and discussed with participants during these first two sessions.
|
|---|---|---|
|
Change in Male-specific Variables (SEAR and Sexual Bother Subscale of the PHR-QOL) for Men From Baseline to Follow up 2
Sexual Self-Esteem and Relationship Questionnaire (SEAR
|
3.61 units on a scale
Standard Deviation 18.45
|
12.70 units on a scale
Standard Deviation 19.55
|
|
Change in Male-specific Variables (SEAR and Sexual Bother Subscale of the PHR-QOL) for Men From Baseline to Follow up 2
Sexual Bother (SB) subscale of the Prostate-Health Related QOL (PHR-QOL)
|
-1.94 units on a scale
Standard Deviation 3.57
|
-2.50 units on a scale
Standard Deviation 4.01
|
Adverse Events
Usual Care (UC)
Cancer Survivorship Intervention-Sexual Health (CSI-SH)Plus Usual Care (US)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Christian Nelson, PhD
Memorial Sloan Kettering Cancer Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place