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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
34
Complete at-home group video calling support sessions
Receive an educational workbook journal
Sierra Streams Institute
Nevada City, California, United States
Stanford University Cancer Institute
Stanford, California, United States
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
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