Understanding Shared Psychobiological Pathways--Project 4. Psychobiological Pathways: Breast Cancer Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Carnegie Mellon University
- Enrollment
- 245
- Primary Endpoint
- Depressive Symptoms (as Measured With the CES-D) at Baseline, Time 2 (2 Weeks Post-intervention) and Time 3 (6 Months Post-intervention)
Study Overview
Brief Summary
The present study sought to investigate the efficacy of two psychosocial interventions for breast cancer patients, a peer support intervention and an education intervention. The present study also sought to identify mechanisms underlying the benefits of these interventions, and to determine if the efficacy of these interventions is moderated by cancer severity.
Detailed Description
BACKGROUND:
The study was a subproject within a Mind-Body Center on Understanding Shared Psychobiological Pathways. The Center was in response to a Request for Applications issued by the Office of the Director, NIH. Dr. Scheier was the Co-Director of the Center as well as the subproject principal investigator. The major objective of the Center was to to identify, measure, and understand the shared psychological, behavioral, and psychobiological pathways that contributed to the onset of and recovery from diverse physical illnesses, which included infections, arthritis, cancer, and cardiovascular disease.
The subproject studied an important area of psychosocial research in cancer, specially the relative effectiveness of different psychosocial interventions for women with breast cancer, and the mechanisms that underlie the benefits of these interventions.
DESIGN NARRATIVE:
The specific aims of the project were to:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 26 Years to 78 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Eligible participants were:
- •English speaking women,
- •25 years of age or older,
- •Living within a 60 mile radius of Pittsburgh, Pennsylvania,
- •either: a first time diagnosis of stage I or II breast cancer or if they had received an initial diagnosis of stage IV cancer or a distant recurrence of breast cancer,
- •Patients with early stage cancer must have been diagnosed within the past 6 months,
- •There was no window for enrollment for patients with late stage cancer.
Exclusion Criteria
- Not provided
Arms & Interventions
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.
Intervention: Peer support (Behavioral)
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.
Intervention: Education (Behavioral)
Outcomes
Primary Outcomes
Depressive Symptoms (as Measured With the CES-D) at Baseline, Time 2 (2 Weeks Post-intervention) and Time 3 (6 Months Post-intervention)
Time Frame: Baseline, Time 2 (2 Weeks post-intervention) and Time 3 (6 months post-intervention)
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.
Mental Health (as Measured With the SF-36) at Baseline, Time 2 (2 Weeks Post-intervention) and Time 3 (6 Months Post-intervention)
Time Frame: Baseline, Time 2 (2 weeks post-intervention) and Time 3 (6 months post-intervention)
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).
Perceived Physical Health (as Measured With the SF36) at Baseline, Time 2 (2 Weeks Post-intervention) and Time 3 (6 Months Post-intervention)
Time Frame: Baseline, Time 2 (2 weeks post-intervention) and Time 3 (6 months post-intervention)
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).
Secondary Outcomes
No secondary outcomes reported
Investigators
Michael F. Scheier
Professor of Psychology
Carnegie Mellon University