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

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

Condition	Intervention	Phase
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	Procedure: support group therapy Other: educational intervention	Phase 1


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Investigator) Primary Purpose: Supportive Care
Official Title:	At-Home Support for Rural Women Using Group Video Calling

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

U.S. FDA Resources

Further study details as provided by Cheryl Koopman, Stanford University:

Primary Outcome Measures:

Feasibility of the study protocol as determined primarily through qualitative analysis of the group sessions and the interview data [ Time Frame: At 1 week post-intervention ]
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.
Acceptability of the study protocol as determined primarily through qualitative analysis of the group sessions and the interview data [ Time Frame: At 1 week post-intervention ]
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.

Secondary Outcome Measures:

Changes in quality of life (posttraumatic stress, depression symptoms, perceived stress, and positive states of mind) [ Time Frame: From baseline to 1 week post-intervention ]
Treatment effect size will be estimated for each measure for the purpose of prescribing the sample size for a subsequent larger randomized clinical trial examining efficacy of the intervention. Will be analyzed using generalized linear mixed models.
Changes in satisfaction with social support [ Time Frame: From baseline to 1 week post-intervention ]
Treatment effect size will be estimated for each measure for the purpose of prescribing the sample size for a subsequent larger randomized clinical trial examining efficacy of the intervention. Will be analyzed using generalized linear mixed models.
Changes in self-efficacy for coping with cancer [ Time Frame: From baseline to 1 week post-intervention ]
Treatment effect size will be estimated for each measure for the purpose of prescribing the sample size for a subsequent larger randomized clinical trial examining efficacy of the intervention. Will be analyzed using generalized linear mixed models.


Enrollment:	34
Study Start Date:	October 2012
Study Completion Date:	June 2014
Primary Completion Date:	December 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Arm I (experimental arm) Participants complete at-home group video calling sessions for 1 1/2 hours once weekly for 8 weeks.	Procedure: support group therapy Complete at-home group video calling support sessions
Active Comparator: Arm II (control arm) Participants receive an educational workbook journal.	Other: educational intervention Receive an educational workbook journal Other Name: intervention, educational

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.

Eligibility


Ages Eligible for Study:	21 Years and older (Adult, Senior)
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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 Ã¢ 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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01672684

Locations


United States, California
Sierra Streams Institute
Nevada City, California, United States, 95959
Stanford University Cancer Institute
Stanford, California, United States, 94305

Sponsors and Collaborators

Stanford University

California Breast Cancer Research Program

Investigators


Principal Investigator:	Cheryl Koopman	Stanford University

More Information


Responsible Party:	Cheryl Koopman, Professor (Research) of Psychiatry and Behavioral Sciences, Stanford University
ClinicalTrials.gov Identifier:	NCT01672684 History of Changes
Other Study ID Numbers:	BRSADJ0023 NCI-2012-01357 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ) 21349 ( Other Identifier: Stanford University )
Study First Received:	August 20, 2012
Last Updated:	October 15, 2014

Keywords provided by Cheryl Koopman, Stanford University:


quality of life

Additional relevant MeSH terms:


Breast Neoplasms Stress Disorders, Traumatic Stress Disorders, Post-Traumatic Neoplasms by Site Neoplasms	Breast Diseases Skin Diseases Trauma and Stressor Related Disorders Mental Disorders

ClinicalTrials.gov processed this record on June 23, 2017