Understanding Shared Psychobiological Pathways

NCT ID: NCT00245219

Last Updated: 2024-02-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 245 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1999-09-30
• Study Completion Date: 2005-08-31

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:

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.

Conditions

Breast Neoplasms

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Health Tracking (control)

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

Peer support

Intervention Type: BEHAVIORAL

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.

Group Type: EXPERIMENTAL

Education

Intervention Type: BEHAVIORAL

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.

Interventions

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 Type: BEHAVIORAL

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 Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

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.

• Minimum Eligible Age: 26 Years
• Maximum Eligible Age: 78 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

Carnegie Mellon University

OTHER

Sponsor Role: lead

Responsible Party

Michael F. Scheier

Professor of Psychology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michael Scheier

Role: PRINCIPAL_INVESTIGATOR

Carnegie Mellon University

References

Ware JE Jr, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care. 1992 Jun;30(6):473-83.

Reference Type: BACKGROUND

PMID: 1593914 (View on PubMed)

Andresen EM, Malmgren JA, Carter WB, Patrick DL. Screening for depression in well older adults: evaluation of a short form of the CES-D (Center for Epidemiologic Studies Depression Scale). Am J Prev Med. 1994 Mar-Apr;10(2):77-84.

Reference Type: BACKGROUND

PMID: 8037935 (View on PubMed)

Other Identifiers

P50HL065111

Identifier Type: NIH

Identifier Source: secondary_id

View Link

338

Identifier Type: -

Identifier Source: org_study_id