Expanding Rural Access: Distance Delivery of Support Groups (Main Study)

This study has been completed.
Sponsor:
Collaborator:
California Breast Cancer Research Program
Information provided by:
Stanford University
ClinicalTrials.gov Identifier:
NCT01108016
First received: April 14, 2010
Last updated: December 2, 2010
Last verified: December 2010
  Purpose

The study will answer two questions about women with breast cancer in rural communities:

  1. Will they find this support group format utilizing videoconferencing acceptable and rewarding?
  2. Will they report a greater sense of emotional and informational support, and less depression and traumatic stress, than the control groups of women who wait to participate until after the first groups have ended?

Condition Intervention Phase
Depression
Breast Cancer
Stress
Breast Cancer Non-invasive Breast Cancer
Breast Cancer Early Stage Breast Cancer (Stage 1-3)
Breast Cancer Metastatic Breast Cancer
Behavioral: Videoconferencing support group
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: Expanding Rural Access: Distance Delivery of Support Groups (Main Study)

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Intensity and frequency of posttraumatic stress symptoms in the past month as assessed by total score on the Posttraumatic Check List - Specific version (PCL-S) for breast cancer. [ Time Frame: after 8 weeks of the immediate group sessions ] [ Designated as safety issue: No ]
  • Intensity and frequency of depression symptoms in the past week as assessed by total score on the Center for Epidemiological Studies Depression scale (CES-D) [ Time Frame: after 8 weeks of the immediate group sessions ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Intensity and frequency of emotional control as assessed by the total score on the Courtauld Emotional Control Scale (CECS), [ Time Frame: after 8 weeks of the immediate group sessions ] [ Designated as safety issue: No ]
  • Level of self-efficacy for coping with breast cancer as assessed by the total score on the Cancer Behavior Inventory (CBI). [ Time Frame: after 8 weeks of the immediate group sessions ] [ Designated as safety issue: No ]
  • Satisfaction with social support as assessed by the total satisfaction score on the UCLA Social Support Inventory. [ Time Frame: after 8 weeks of the immediate group sessions ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: May 2008
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:To be eligible to participate, a woman must meet all of the following criteria:

  1. be a resident of one of nine rural counties in northeastern California (Modoc, Plumas, Siskiyou, Shasta, Lassen, Trinity, Sierra, Nevada, and Tehama),
  2. be able to travel to a rural health facility included in the Northern Sierra Rural Health Network to participate in videoconferencing meetings;
  3. be able to speak and read English well enough to be able to read, discuss, and comprehend the consent form;
  4. be 21 years of age or older;
  5. have been diagnosed with breast cancer by a physician; and
  6. who (in the judgment of the Local Coordinator) is not unduly distressed or otherwise not able to participate effectively in a support group.

Women will be included with any stage of breast cancer as our pilot study demonstrated that in these rural communities, women wanted to include women with any stage of breast cancer in their groups. Also, our pilot study results showed that it worked fine to include women regardless of the period elapsing since they received their diagnosis, as our pilot study results showed that some women with a long period of time elapsing since receiving their diagnosis were still in need of a source of social support for coping with having had this experience and felt that they had a lot of help to offer women who had more recently received a breast cancer diagnosis. The 9 counties were selected because they are among the most remote counties in California, yet they have strong primary care systems in place, and most patients receive specialty care in-state, as opposed to out-of-state. Every effort will be made to include women of ethnic minority groups.

The support group facilitator, community advisory board (CAB) members, and the local community coordinators will also be recruited for the interviews, with informed consent, identified by having played one of these roles for this study.

Exclusion Criteria:Potential participants who do not meet all of the inclusion criteria listed above will be excluded.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01108016

Locations
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
California Breast Cancer Research Program
Investigators
Principal Investigator: Cheryl Koopman Stanford University
  More Information

No publications provided

Responsible Party: Cheryl Koopman, Stanford University School of Medicine
ClinicalTrials.gov Identifier: NCT01108016     History of Changes
Other Study ID Numbers: SU-03012010-5082, BRSADJ0019
Study First Received: April 14, 2010
Last Updated: December 2, 2010
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Depression
Breast Neoplasms
Behavioral Symptoms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on September 30, 2014