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

NCT01672684 | Completed Phase 1

• 3 other identifiers: BRSADJ0023NCI-2012-0135721349
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

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

Keywords

quality of life

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  At 1 week post-intervention

Secondary Outcomes (3)

• Changes in quality of life (posttraumatic stress, depression symptoms, perceived stress, and positive states of mind)

  From baseline to 1 week post-intervention

• Changes in satisfaction with social support

  From baseline to 1 week post-intervention

• Changes in self-efficacy for coping with cancer

  From baseline to 1 week post-intervention

Study Arms (2)

Arm I (experimental arm)

EXPERIMENTAL

Participants complete at-home group video calling sessions for 1 1/2 hours once weekly for 8 weeks.

Procedure: support group therapy

Arm II (control arm)

ACTIVE COMPARATOR

Participants receive an educational workbook journal.

Other: educational intervention

Interventions

support group therapy PROCEDURE

Complete at-home group video calling support sessions

Arm I (experimental arm)

educational intervention OTHER

Receive an educational workbook journal

Also known as: intervention, educational

Arm II (control arm)

Eligibility Criteria

• Age: 21 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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
• 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
• 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

Sponsors & Collaborators

• Stanford University: lead
• California Breast Cancer Research Program: collaborator

Study Sites (2)

Sierra Streams Institute

Nevada City, California, 95959, United States

Location

Stanford University Cancer Institute

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Depression; Stress Disorders, Post-Traumatic; Breast Neoplasms

Interventions

Early Intervention, Educational; Methods

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Child Health Services; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Preventive Health Services; Investigative Techniques

Study Officials

• Cheryl Koopman

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor (Research) of Psychiatry and Behavioral Sciences

Study Record Dates

• First Submitted: August 20, 2012
• First Posted: August 27, 2012
• Study Start: October 1, 2012
• Primary Completion: December 1, 2013
• Study Completion: June 1, 2014
• Last Updated: October 17, 2014

Record last verified: 2014-10

Locations

US (2)