NCT01672684

Phase I: At-Home Support for Rural Women Using Group Video Calling

At-Home Support for Rural Women Using Group Video Calling

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: Stanford University · Academic / Other
• Sex: Female
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

This randomized phase I trial studies at-home group video calling sessions in quality of life in rural patients with breast cancer. At-home group video calling support sessions may improve the well-being and quality of life of women who have breast cancer

Detailed description

PRIMARY OBJECTIVES: I. To examine whether delivering at-home professionally-led breast cancer support using group video calling is feasible, acceptable and satisfactory for women in rural northern California. II. To evaluate the feasibility of using on-line tools to recruit, screen, treat, and assess this population for a subsequent randomized clinical trial. III. Assess whether the rate of recruitment of women in this region in this study using predominantly on-line means of recruitment can be improved over that of the previous study using predominantly face-to-face means of recruitment. SECONDARY OBJECTIVES: I. Estimate effect size changes in measures of quality of life (post-traumatic stress disorder symptoms, depression symptoms, perceived stress, and positive states of mind), satisfaction with social support, and self-efficacy for coping with cancer. II. Prescribe sample size. III. Perform I and II for all of these outcomes. OUTLINE: Participants are randomized to 1 of 2 treatment arms. ARM I (experimental arm): Participants complete at-home group video calling sessions for 1 1/2 hours once weekly for 8 weeks. ARM II (control arm): Participants receive an educational workbook journal. After completion of study treatment, participants are followed up for 1 week.

Conditions

• Depression
• Post-traumatic Stress Disorder
• Recurrent Breast Cancer
• Stage IA Breast Cancer
• Stage IB Breast Cancer
• Stage II Breast Cancer
• Stage IIIA Breast Cancer
• Stage IIIB Breast Cancer
• Stage IIIC Breast Cancer
• Stage IV Breast Cancer

Interventions

Type	Name	Description
PROCEDURE	support group therapy	Complete at-home group video calling support sessions
OTHER	educational intervention	Receive an educational workbook journal

Timeline

• Start date: 2012-10-01
• Primary completion: 2013-12-01
• Completion: 2014-06-01
• First posted: 2012-08-27
• Last updated: 2014-10-17

Locations

2 sites across 1 country: United States