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

NCT ID: NCT01672684

Last Updated: 2014-10-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-10-31
• Study Completion Date: 2014-06-30

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

Detailed Description

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Arm I (experimental arm)

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

Group Type: EXPERIMENTAL

support group therapy

Intervention Type: PROCEDURE

Complete at-home group video calling support sessions

Arm II (control arm)

Participants receive an educational workbook journal.

Group Type: ACTIVE_COMPARATOR

educational intervention

Intervention Type: OTHER

Receive an educational workbook journal

Interventions

support group therapy

Complete at-home group video calling support sessions

Intervention Type: PROCEDURE

educational intervention

Receive an educational workbook journal

Intervention Type: OTHER

Other Intervention Names

intervention, educational

Eligibility Criteria

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
• 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

• Minimum Eligible Age: 21 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

California Breast Cancer Research Program

OTHER

Sponsor Role: collaborator

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Cheryl Koopman

Professor (Research) of Psychiatry and Behavioral Sciences

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Cheryl Koopman

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Sierra Streams Institute

Nevada City, California, United States

Stanford University Cancer Institute

Stanford, California, United States

Countries

United States

Other Identifiers

NCI-2012-01357

Identifier Type: REGISTRY

Identifier Source: secondary_id

21349

Identifier Type: OTHER

Identifier Source: secondary_id

BRSADJ0023

Identifier Type: -

Identifier Source: org_study_id