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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
California Breast Cancer Research Program
Information provided by (Responsible Party):
Stanford University
ClinicalTrials.gov Identifier:
NCT01672684
First received: August 20, 2012
Last updated: April 1, 2014
Last verified: April 2014
  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
Endpoint Classification: Efficacy Study
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:


Further study details as provided by 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 32
Study Start Date: October 2012
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: April 2014 (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
Genders 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 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
  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

Additional Information:
No publications provided

Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT01672684     History of Changes
Other Study ID Numbers: BRSADJ0023, NCI-2012-01357, 21349
Study First Received: August 20, 2012
Last Updated: April 1, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Stanford University:
quality of life

Additional relevant MeSH terms:
Depression
Breast Neoplasms
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Behavioral Symptoms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on September 18, 2014