A Phase 1 interventional study of support group therapy and educational intervention in Depression, Post-traumatic Stress Disorder and Recurrent Breast Cancer, sponsored by Stanford University. Completed at 2 sites in United States. Open to female participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2014-10-17.
Sponsored by Stanford University · Phase 1, Interventional, and Supportive care
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
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.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 34 is below the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Stanford University is the lead sponsor of 2,117 studies on the registry; 425 are open to participants now.
Of its 259 completed or terminated interventional studies of FDA-regulated products, 197 (76%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants complete at-home group video calling sessions for 1 1/2 hours once weekly for 8 weeks.
Procedure: support group therapy
Participants receive an educational workbook journal.
Other: educational intervention
Complete at-home group video calling support sessions
Receive an educational workbook journal
Also known as: intervention, educational
Feasibility of the study protocol as determined primarily through qualitative analysis of the group sessions and the interview data
The major criterion for determining feasibility is to determine whether we can recruit rural women with breast cancer more rapidly using predominantly on-line procedures in this study than in our previous study that predominantly used face-to-face procedures. The qualitative data for determining the feasibility will be collected during the at-home group video calling sessions and from women's interviews conducted at the end of the study. Will be assessed using mixed methods.
Time frame: At 1 week post-intervention
Acceptability of the study protocol as determined primarily through qualitative analysis of the group sessions and the interview data
The qualitative data for determining the acceptability will be collected during the at-home group video calling sessions and from women's interviews conducted at the end of the study. Will be assessed using mixed methods.
Time frame: At 1 week post-intervention
Changes in quality of life (posttraumatic stress, depression symptoms, perceived stress, and positive states of mind)
Treatment effect size will be estimated for each measure for the purpose of prescribing the sample size for a subsequent larger randomized clinical trial examining efficacy of the intervention. Will be analyzed using generalized linear mixed models.
Time frame: From baseline to 1 week post-intervention
Changes in satisfaction with social support
Treatment effect size will be estimated for each measure for the purpose of prescribing the sample size for a subsequent larger randomized clinical trial examining efficacy of the intervention. Will be analyzed using generalized linear mixed models.
Time frame: From baseline to 1 week post-intervention
Changes in self-efficacy for coping with cancer
Treatment effect size will be estimated for each measure for the purpose of prescribing the sample size for a subsequent larger randomized clinical trial examining efficacy of the intervention. Will be analyzed using generalized linear mixed models.
Time frame: From baseline to 1 week post-intervention
This study is completed, as verified in Oct 2014. You cannot join it, but the record below documents what was studied.
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