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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01108016
• Other study ID #: SU-03012010-5082
• Secondary ID: BRSADJ0019
• Status: Completed
• Phase: Phase 3
• First received: April 14, 2010
• Last updated: December 2, 2010
• Start date: May 2008
• Est. completion date: July 2010

Study information

• Verified date: December 2010
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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?

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: July 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

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

Intervention

Behavioral:
• Videoconferencing support group

Locations

Country	Name	City	State
United States	Stanford University School of Medicine	Stanford	California

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	California Breast Cancer Research Program

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No