Understanding Shared Psychobiological Pathways

Carnegie Mellon University

Status: Completed

Conditions: Breast Neoplasms

Treatments: Behavioral: Peer support; Behavioral: Education

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00245219

P50HL065111 (U.S. NIH Grant/Contract)

338

Details and patient eligibility

About

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.

Full 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:

1. implement and evaluate two psychosocial interventions, a peer support intervention and an education intervention, to enhance psychological adjustment and well-being among women with early- vs. late-stage breast cancer
2. determine the psychological, behavioral, and biological mechanisms through which the interventions operate
3. assess whether the two interventions were differentially effective for women with different characteristics, most importantly early- vs. late-stage disease
4. use the baseline data collected prior to the intervention to determine the nature and extent of difficulties faced by early- vs. late-stage breast cancer patients
5. determine how participants in the intervention differed from those who choose to participate.

Participants included 180 patients with early stage (I or II) and 65 patients with late stage (IV) breast cancer. The interventions were conducted in groups of 6-9 women, and groups met once a week for 8 weeks. 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. The peer support group meetings focused on fostering purpose in life by providing participants with opportunities to support and care for one another. Participants were asked to share experiences and problems in group meetings and the group facilitator encouraged participants to help one another with these issues, and share how they had dealt with similar problems. Participants in the control condition received care as usual, and did not attend any group meetings.

Hypothesized predictors, mediators, and relevant outcome measures were assessed prior to the intervention. Mediators and outcomes were then reassessed, 2-weeks after intervention completion and 6-months later.

Enrollment: 245 patients

Sex: Female

Ages: 26 to 78 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Eligible participants were:

1. English speaking women,
2. 25 years of age or older,
3. Living within a 60 mile radius of Pittsburgh, Pennsylvania,
4. 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,
5. Patients with early stage cancer must have been diagnosed within the past 6 months,
6. There was no window for enrollment for patients with late stage cancer.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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245 participants in 3 patient groups

Health Tracking (control)

No Intervention group

Description:

Participants assigned to the health-tracking condition received usual care and did not attend any meetings.

Peer support

Experimental group

Description:

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.

Treatment:

Behavioral: Peer support

Education

Experimental group

Description:

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.

Treatment:

Behavioral: Education