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

NCT01108016 | Completed Phase 3

• 2 other identifiers: SU-03012010-5082BRSADJ0019
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

1. 1.Will they find this support group format utilizing videoconferencing acceptable and rewarding?
2. 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?

Conditions

Depression; Breast Cancer; Stress; Breast Cancer Non-invasive Breast Cancer; Breast Cancer Early Stage Breast Cancer (Stage 1-3); Breast Cancer Metastatic Breast Cancer

Outcome Measures

Primary Outcomes (2)

• 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.

  after 8 weeks of the immediate group sessions

• 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)

  after 8 weeks of the immediate group sessions

Secondary Outcomes (3)

• Intensity and frequency of emotional control as assessed by the total score on the Courtauld Emotional Control Scale (CECS),

  after 8 weeks of the immediate group sessions

• Level of self-efficacy for coping with breast cancer as assessed by the total score on the Cancer Behavior Inventory (CBI).

  after 8 weeks of the immediate group sessions

• Satisfaction with social support as assessed by the total satisfaction score on the UCLA Social Support Inventory.

  after 8 weeks of the immediate group sessions

Interventions

Videoconferencing support group BEHAVIORAL

Eligibility Criteria

• Age: 21 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• be a resident of one of nine rural counties in northeastern California (Modoc, Plumas, Siskiyou, Shasta, Lassen, Trinity, Sierra, Nevada, and Tehama),
• be able to travel to a rural health facility included in the Northern Sierra Rural Health Network to participate in videoconferencing meetings;
• be able to speak and read English well enough to be able to read, discuss, and comprehend the consent form;
• be 21 years of age or older;
• have been diagnosed with breast cancer by a physician; and
• 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.

Sponsors & Collaborators

• Stanford University: lead
• California Breast Cancer Research Program: collaborator

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Depression; Breast Neoplasms

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Cheryl Koopman

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 14, 2010
• First Posted: April 21, 2010
• Study Start: May 1, 2008
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2010
• Last Updated: December 6, 2010

Record last verified: 2010-12

Locations

US (1)