Understanding Shared Psychobiological Pathways

NCT00245219 | Completed Results DMC

• 2 other identifiers: 338P50HL065111
• Study Type: interventional
• Target: 245
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Breast Neoplasms

Outcome Measures

Primary Outcomes (3)

• Mental Health (as Measured With the SF-36) at 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).

  Baseline, Time 2 (2 weeks post-intervention) and Time 3 (6 months post-intervention)

• Perceived Physical Health (as Measured With the SF36) at 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).

  Baseline, Time 2 (2 weeks post-intervention) and Time 3 (6 months post-intervention)

• Depressive Symptoms (as Measured With the CES-D) at 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.

  Baseline, Time 2 (2 Weeks post-intervention) and Time 3 (6 months post-intervention)

Study Arms (3)

Health Tracking (control)

NO INTERVENTION

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

Peer support

EXPERIMENTAL

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.

Behavioral: Peer support

Education

EXPERIMENTAL

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.

Behavioral: Education

Interventions

Education 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.

Education

Peer support 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.

Peer support

Eligibility Criteria

• Age: 26 Years - 78 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Carnegie Mellon University: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Related Publications (2)

• 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.

  PMID: 1593914 BACKGROUND

• 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.

  PMID: 8037935 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics

Limitations and Caveats

The study was originally planned as a 2(early stage, late stage) X 3(education intervention, peer support intervention, control condition) design; however, the education condition for the late stage cancer group was dropped, due to slow recruitment.

Results Point of Contact

• Title: Michael F. Scheier, PhD
• Organization: Carnegie Mellon University

Scheier@cmu.edu

412-268-3791

Study Officials

• Michael Scheier

  Carnegie Mellon University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychology

Study Record Dates

• First Submitted: October 26, 2005
• First Posted: October 27, 2005
• Study Start: September 1, 1999
• Primary Completion: August 1, 2005
• Study Completion: August 1, 2005
• Last Updated: February 26, 2024
• Results First Posted: March 3, 2016

Record last verified: 2024-02