©2024 Stanford Medicine
Phase I: At-Home Support for Rural Women Using Group Video Calling
Not Recruiting
Trial ID: NCT01672684
Purpose
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
Official Title
At-Home Support for Rural Women Using Group Video Calling
Eligibility
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
Intervention(s):
procedure: support group therapy
other: educational intervention
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Cheryl Koopman
650-723-9081