Understanding Shared Psychobiological Pathways

This study has been completed.
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Michael F. Scheier, Carnegie Mellon University
ClinicalTrials.gov Identifier:
NCT00245219
First received: October 26, 2005
Last updated: February 3, 2016
Last verified: December 2015
  Purpose
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.

Condition Intervention
Breast Neoplasms
Behavioral: Education
Behavioral: Peer support

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Understanding Shared Psychobiological Pathways--Project 4. Psychobiological Pathways: Breast Cancer Interventions

Resource links provided by NLM:


Further study details as provided by Carnegie Mellon University:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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).

  • 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) ] [ Designated as safety issue: No ]
    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.


Enrollment: 245
Study Start Date: September 1999
Study Completion Date: August 2005
Primary Completion Date: August 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Health Tracking (control)
Participants assigned to the health-tracking condition received usual care and did not attend any meetings.
Experimental: 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.
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.
Experimental: 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.
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.

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.

  Eligibility

Ages Eligible for Study:   25 Years and older   (Adult, Senior)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00245219

Sponsors and Collaborators
Carnegie Mellon University
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Principal Investigator: Michael Scheier Carnegie Mellon University
  More Information

Publications:
Responsible Party: Michael F. Scheier, Professor of Psychology, Carnegie Mellon University
ClinicalTrials.gov Identifier: NCT00245219     History of Changes
Other Study ID Numbers: 338  P50HL065111 
Study First Received: October 26, 2005
Results First Received: August 25, 2015
Last Updated: February 3, 2016
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on July 28, 2016