Clinical trial NCT01108016: Expanding Rural Access: Distance Delivery of Support Groups (Main Study)
Official title: Expanding Rural Access: Distance Delivery of Support Groups (Main Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
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
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: California Breast Cancer Research Program
First posted: 2010-04-21
Enrollment: 100
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief 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?


Eligibility 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.

Primary outcomes:
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.
timeFrame: after 8 weeks of the immediate group sessions
measure: 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)
timeFrame: after 8 weeks of the immediate group sessions
Secondary outcomes:
measure: Intensity and frequency of emotional control as assessed by the total score on the Courtauld Emotional Control Scale (CECS),
timeFrame: after 8 weeks of the immediate group sessions
measure: Level of self-efficacy for coping with breast cancer as assessed by the total score on the Cancer Behavior Inventory (CBI).
timeFrame: after 8 weeks of the immediate group sessions
measure: Satisfaction with social support as assessed by the total satisfaction score on the UCLA Social Support Inventory.
timeFrame: after 8 weeks of the immediate group sessions
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Cheryl Koopman
role: PRINCIPAL_INVESTIGATOR
References: