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

• Feasibility of the study protocol as determined primarily through qualitative analysis of the group sessions and the interview data [ Time Frame: At 1 week post-intervention ] [ Designated as safety issue: No ]
  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.
  
  
• Acceptability of the study protocol as determined primarily through qualitative analysis of the group sessions and the interview data [ Time Frame: At 1 week post-intervention ] [ Designated as safety issue: No ]
  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.
  
  

• Changes in quality of life (posttraumatic stress, depression symptoms, perceived stress, and positive states of mind) [ Time Frame: From baseline to 1 week post-intervention ] [ Designated as safety issue: No ]
  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.
  
  
• Changes in satisfaction with social support [ Time Frame: From baseline to 1 week post-intervention ] [ Designated as safety issue: No ]
  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.
  
  
• Changes in self-efficacy for coping with cancer [ Time Frame: From baseline to 1 week post-intervention ] [ Designated as safety issue: No ]
  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.
  
  

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.