Trial Outcomes & Findings for Understanding Shared Psychobiological Pathways (NCT NCT00245219)
NCT ID: NCT00245219
Last Updated: 2024-02-26
Results Overview
The Mental Health Component Scale of the Medical Outcomes Study Short Form 36(SF-36) consists of a norm-based weighted average of the following subscales: Vitality, Social Functioning, Role Limitations due to Emotional Problems and Mental health. In the present study, scores ranged from a maximum of 72 (high levels of mental health) to a minimum of 12 (low levels of mental health).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
245 participants
Primary outcome timeframe
Baseline, Time 2 (2 weeks post-intervention) and Time 3 (6 months post-intervention)
Results posted on
2024-02-26
Participant Flow
Participants were recruited from local oncologists' offices. We contacted 915 eligible patients, of whom 245 provided informed consent and were randomized to an intervention group. The most frequently reported reasons for refusal were unwillingness/inability to drive to group meeting site (37.2%) and being too busy (29.4%).
Participant milestones
| Measure |
Health Tracking (Control)
Participants assigned to the health-tracking condition received usual care and did not attend any meetings.
|
Peer Support
The peer support group meetings focused on fostering purpose in life by providing participants with opportunities to support and care for one another. Patients completed a weekly diary of critical experiences or current life problems as homework, and were then encouraged to share these experiences in the group meetings. The group facilitator encouraged participants to help one another with these issues, and share how they had dealt with similar problems.
|
Education
The education group meetings focused on providing patients with information about their disease as well as methods to manage their illness and its side effects. Facilitators emphasized the theme of perceived control during all sessions, discussing how participants are in control of their illness experience and can have more control of their lives. A different topic was addressed in each session. Weekly homework assignments asked patients to write down something new they had learned from the session regarding how to take control of their lives. Meeting topics were as follows: Overview of breast cancer, treatment types and side effects, nutrition and diet management, exercise, body image, communication issues, relationships, and sexuality.
|
|---|---|---|---|
|
Overall Study
STARTED
|
91
|
94
|
60
|
|
Overall Study
COMPLETED
|
85
|
88
|
58
|
|
Overall Study
NOT COMPLETED
|
6
|
6
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Understanding Shared Psychobiological Pathways
Baseline characteristics by cohort
| Measure |
Health Tracking (Control)
n=91 Participants
Participants assigned to the health-tracking condition received usual care and did not attend any meetings.
|
Peer Support
n=94 Participants
The peer support group meetings focused on fostering purpose in life by providing participants with opportunities to support and care for one another. Patients completed a weekly diary of critical experiences or current life problems as homework, and were then encouraged to share these experiences in the group meetings. The group facilitator encouraged participants to help one another with these issues, and share how they had dealt with similar problems.
|
Education
n=60 Participants
The education group meetings focused on providing patients with information about their disease as well as methods to manage their illness and its side effects. Facilitators emphasized the theme of perceived control during all sessions, discussing how participants are in control of their illness experience and can have more control of their lives. A different topic was addressed in each session. Weekly homework assignments asked patients to write down something new they had learned from the session regarding how to take control of their lives. Meeting topics were as follows: Overview of breast cancer, treatment types and side effects, nutrition and diet management, exercise, body image, communication issues, relationships, and sexuality.
|
Total
n=245 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
51.26 years
STANDARD_DEVIATION 9.56 • n=99 Participants
|
51.40 years
STANDARD_DEVIATION 10.19 • n=107 Participants
|
49.68 years
STANDARD_DEVIATION 8.64 • n=206 Participants
|
50.96 years
STANDARD_DEVIATION 9.61 • n=7 Participants
|
|
Sex: Female, Male
Female
|
91 Participants
n=99 Participants
|
94 Participants
n=107 Participants
|
60 Participants
n=206 Participants
|
245 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
White, Caucasian
|
84 participants
n=99 Participants
|
80 participants
n=107 Participants
|
56 participants
n=206 Participants
|
220 participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Black, African-American
|
6 participants
n=99 Participants
|
12 participants
n=107 Participants
|
4 participants
n=206 Participants
|
22 participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 participants
n=99 Participants
|
2 participants
n=107 Participants
|
0 participants
n=206 Participants
|
3 participants
n=7 Participants
|
PRIMARY outcome
Timeframe: Baseline, Time 2 (2 weeks post-intervention) and Time 3 (6 months post-intervention)Population: The intention-to-treat principle was followed, all participants were included in the analyses regardless of number of meetings attended.
The Mental Health Component Scale of the Medical Outcomes Study Short Form 36(SF-36) consists of a norm-based weighted average of the following subscales: Vitality, Social Functioning, Role Limitations due to Emotional Problems and Mental health. In the present study, scores ranged from a maximum of 72 (high levels of mental health) to a minimum of 12 (low levels of mental health).
Outcome measures
| Measure |
Health Tracking (Control)
n=85 Participants
Participants assigned to the health-tracking condition received usual care and did not attend any meetings.
|
Peer Support
n=62 Participants
The peer support group meetings focused on fostering purpose in life by providing participants with opportunities to support and care for one another. Patients completed a weekly diary of critical experiences or current life problems as homework, and were then encouraged to share these experiences in the group meetings. The group facilitator encouraged participants to help one another with these issues, and share how they had dealt with similar problems.
|
Education
n=46 Participants
The education group meetings focused on providing patients with information about their disease as well as methods to manage their illness and its side effects. Facilitators emphasized the theme of perceived control during all sessions, discussing how participants are in control of their illness experience and can have more control of their lives. A different topic was addressed in each session. Weekly homework assignments asked patients to write down something new they had learned from the session regarding how to take control of their lives. Meeting topics were as follows: Overview of breast cancer, treatment types and side effects, nutrition and diet management, exercise, body image, communication issues, relationships, and sexuality.
|
|---|---|---|---|
|
Mental Health (as Measured With the SF-36) at Baseline, Time 2 (2 Weeks Post-intervention) and Time 3 (6 Months Post-intervention)
Baseline
|
46.55 units on a scale
Standard Deviation 11.61
|
47.63 units on a scale
Standard Deviation 11.25
|
47.12 units on a scale
Standard Deviation 11.27
|
|
Mental Health (as Measured With the SF-36) at Baseline, Time 2 (2 Weeks Post-intervention) and Time 3 (6 Months Post-intervention)
Time 2
|
47.03 units on a scale
Standard Deviation 10.40
|
49.25 units on a scale
Standard Deviation 10.64
|
50.67 units on a scale
Standard Deviation 11.22
|
|
Mental Health (as Measured With the SF-36) at Baseline, Time 2 (2 Weeks Post-intervention) and Time 3 (6 Months Post-intervention)
Time 3
|
50.28 units on a scale
Standard Deviation 9.88
|
50.03 units on a scale
Standard Deviation 11.18
|
48.02 units on a scale
Standard Deviation 13.10
|
PRIMARY outcome
Timeframe: Baseline, Time 2 (2 weeks post-intervention) and Time 3 (6 months post-intervention)Population: The intention-to-treat principle was followed, all participants were included in the analyses regardless of number of meetings attended.
The Perceived Physical Health Component scale of the Medical Outcomes Study Short Form 36(SF-36) consists of a norm-based weighted average of the following subscales: Physical Functioning, Bodily Pain, Role Limitations due to Physical Problems and General Health. In the present study, scores ranged from a maximum of 70 (high levels of perceived health) to a minimum of 12 (low levels of perceived health).
Outcome measures
| Measure |
Health Tracking (Control)
n=85 Participants
Participants assigned to the health-tracking condition received usual care and did not attend any meetings.
|
Peer Support
n=62 Participants
The peer support group meetings focused on fostering purpose in life by providing participants with opportunities to support and care for one another. Patients completed a weekly diary of critical experiences or current life problems as homework, and were then encouraged to share these experiences in the group meetings. The group facilitator encouraged participants to help one another with these issues, and share how they had dealt with similar problems.
|
Education
n=46 Participants
The education group meetings focused on providing patients with information about their disease as well as methods to manage their illness and its side effects. Facilitators emphasized the theme of perceived control during all sessions, discussing how participants are in control of their illness experience and can have more control of their lives. A different topic was addressed in each session. Weekly homework assignments asked patients to write down something new they had learned from the session regarding how to take control of their lives. Meeting topics were as follows: Overview of breast cancer, treatment types and side effects, nutrition and diet management, exercise, body image, communication issues, relationships, and sexuality.
|
|---|---|---|---|
|
Perceived Physical Health (as Measured With the SF36) at Baseline, Time 2 (2 Weeks Post-intervention) and Time 3 (6 Months Post-intervention)
Baseline
|
42.43 units on a scale
Standard Deviation 9.39
|
44.40 units on a scale
Standard Deviation 8.93
|
47.62 units on a scale
Standard Deviation 8.81
|
|
Perceived Physical Health (as Measured With the SF36) at Baseline, Time 2 (2 Weeks Post-intervention) and Time 3 (6 Months Post-intervention)
Time 2
|
43.46 units on a scale
Standard Deviation 11.23
|
46.49 units on a scale
Standard Deviation 11.02
|
50.47 units on a scale
Standard Deviation 7.56
|
|
Perceived Physical Health (as Measured With the SF36) at Baseline, Time 2 (2 Weeks Post-intervention) and Time 3 (6 Months Post-intervention)
Time 3
|
46.02 units on a scale
Standard Deviation 11.53
|
47.36 units on a scale
Standard Deviation 11.43
|
51.96 units on a scale
Standard Deviation 8.96
|
PRIMARY outcome
Timeframe: Baseline, Time 2 (2 Weeks post-intervention) and Time 3 (6 months post-intervention)Population: The intention-to-treat principle was followed, all participants were included in the analyses regardless of number of meetings attended.
Scores for the shortened form of the Center for Epidemiologic Studies Depression scale(CES-D) ranged from 0 (no depressive symptoms) to 29 (high levels of depressives symptoms) in the present sample. For the sake of analyses, CES-D scores were dichotomized (cutoff score of 8), because scores exhibited marked positive skew in the present sample.
Outcome measures
| Measure |
Health Tracking (Control)
n=85 Participants
Participants assigned to the health-tracking condition received usual care and did not attend any meetings.
|
Peer Support
n=62 Participants
The peer support group meetings focused on fostering purpose in life by providing participants with opportunities to support and care for one another. Patients completed a weekly diary of critical experiences or current life problems as homework, and were then encouraged to share these experiences in the group meetings. The group facilitator encouraged participants to help one another with these issues, and share how they had dealt with similar problems.
|
Education
n=46 Participants
The education group meetings focused on providing patients with information about their disease as well as methods to manage their illness and its side effects. Facilitators emphasized the theme of perceived control during all sessions, discussing how participants are in control of their illness experience and can have more control of their lives. A different topic was addressed in each session. Weekly homework assignments asked patients to write down something new they had learned from the session regarding how to take control of their lives. Meeting topics were as follows: Overview of breast cancer, treatment types and side effects, nutrition and diet management, exercise, body image, communication issues, relationships, and sexuality.
|
|---|---|---|---|
|
Depressive Symptoms (as Measured With the CES-D) at Baseline, Time 2 (2 Weeks Post-intervention) and Time 3 (6 Months Post-intervention)
Baseline
|
7.78 units on a scale
Standard Deviation 6.05
|
6.14 units on a scale
Standard Deviation 5.15
|
7.37 units on a scale
Standard Deviation 6.61
|
|
Depressive Symptoms (as Measured With the CES-D) at Baseline, Time 2 (2 Weeks Post-intervention) and Time 3 (6 Months Post-intervention)
Time 2
|
8.53 units on a scale
Standard Deviation 5.80
|
6.75 units on a scale
Standard Deviation 5.89
|
6.37 units on a scale
Standard Deviation 6.02
|
|
Depressive Symptoms (as Measured With the CES-D) at Baseline, Time 2 (2 Weeks Post-intervention) and Time 3 (6 Months Post-intervention)
Time 3
|
6.94 units on a scale
Standard Deviation 5.45
|
6.19 units on a scale
Standard Deviation 5.92
|
6.60 units on a scale
Standard Deviation 6.55
|
Adverse Events
Health Tracking (Control)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Peer Support
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Education
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place