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

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.

Inclusion Criteria:

- To be eligible for this study, the participant must have been diagnosed with breast
cancer within the previous 5 years prior to study entry; individuals who have been
diagnosed with any stage of breast cancer are eligible

- There are no limitations regarding allowable type and amount of prior therapy

- There are no race/ethnic restrictions

- There are no life expectancy restrictions

- Neither Eastern Cooperative Oncology Group (ECOG) nor Karnofsky performance status
will be employed

- There are no requirements for organ and marrow function

- Ability to understand and the willingness to sign a written informed consent
document; this will be assessed in the telephone screen conducted by Lisa Frankel as
she will review each section of the consent form with the participant and ask if she
has any questions about it; this telephone screen will have been approved by the
Stanford University Institutional Review Board (IRB), and Lisa Frankel will conduct
the interviews in a private location to ensure confidentiality

- Eligibility for this study requires that a woman be a resident of one of 27 rural
counties in California (Alpine, Amador, Butte, Calaveras, Colusa, Del Norte, El
Dorado, Glenn, Imperial, Inyo, Lake, Lassen, Madera, Mariposa, Modoc, Mono, Nevada,
Placer, Plumas, Shasta, Sierra, Siskiyou, Sutter, Tehama, Trinity, Tuolumne, or Yuba,
except we will not include women living within the following cities: Chico, Madera,
Redding, Rocklin, Roseville or Yuba City, due to this study's more rural focus)

- Eligibility for this study requires that a woman has sufficient hearing to be able to
engage in conversation over the phone

- Eligibility for this study requires that a woman has a private place available where
she can access the internet

- Eligibility for this study requires that a woman is potentially available to meet at
the day of the week and time of the day that the group intervention is scheduled â
in the event that she is randomly assigned to receive the at-home group calling
intervention

- Eligibility for this study requires that women have broadband or digital subscriber
line (DSL) internet access

- Eligibility for this study requires that women have a computer with a webcam and
either a microphone or a phone available to call into the video conference

Exclusion Criteria:

- There are no therapy restrictions

- There are no restrictions regarding use of other investigational agents

- There are no exclusion requirements due to co-morbid disease or incurrent illness

- Requirements regarding history of allergic reactions attributed to compounds of
similar chemical or biologic composition to investigational agent or device are not
applicable to this study

- There are no exclusion criteria relating to concomitant medications or substances
that have the potential to affect the activity or pharmacokinetics of the study agent

- There are no other agent-specific exclusion criteria

- Pregnancy or nursing patients will not be excluded from the study

- Patients who are cancer survivors or those who are human immunodeficiency virus
(HIV)-positive will not be excluded from the study