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

Completed · Phase 1

Conditions studied: Depression, Post-traumatic Stress Disorder, Recurrent Breast Cancer, Stage IA Breast Cancer, Stage IB Breast Cancer, Stage II Breast Cancer, Stage IIIA Breast Cancer, Stage IIIB Breast Cancer, Stage IIIC Breast Cancer, Stage IV Breast Cancer

In brief

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

Key facts

Study ID

NCT01672684

Run by

Stanford University

People needed

34

Starts

2012-10-01

Expected to finish

2014-06-01

Last updated by the study team

2014-10-17

Who can join

Age: 21 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Sierra Streams Institute — Nevada City, California, United States
• Stanford University Cancer Institute — Stanford, California, United States

Full record on ClinicalTrials.gov

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