or
forgot password

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


Phase 3
21 Years
N/A
Not Enrolling
Female
Depression, Breast Cancer, Stress, Breast Cancer Non-invasive Breast Cancer, Breast Cancer Early Stage Breast Cancer (Stage 1-3), Breast Cancer Metastatic Breast Cancer

Thank you

Trial Information

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


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

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.

Outcome Time Frame:

after 8 weeks of the immediate group sessions

Safety Issue:

No

Principal Investigator

Cheryl Koopman

Investigator Role:

Principal Investigator

Investigator Affiliation:

Stanford University

Authority:

United States: Institutional Review Board

Study ID:

SU-03012010-5082

NCT ID:

NCT01108016

Start Date:

May 2008

Completion Date:

July 2010

Related Keywords:

  • Depression
  • Breast Cancer
  • Stress
  • Breast Cancer Non-invasive Breast Cancer
  • Breast Cancer Early Stage Breast Cancer (Stage 1-3)
  • Breast Cancer Metastatic Breast Cancer
  • Breast Neoplasms
  • Depression
  • Depressive Disorder
  • Neoplasms
  • Neoplasms, Second Primary

Name

Location

Stanford University School of Medicine Stanford, California  94305-5317