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

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Stanford University

Status and phase

Completed
Phase 3

Conditions

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

Treatments

Behavioral: Videoconferencing support group

Study type

Interventional

Funder types

Other

Identifiers

NCT01108016
BRSADJ0019
SU-03012010-5082

Details and patient eligibility

About

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?

Enrollment

100 estimated patients

Sex

Female

Ages

21+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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