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

Primary Purpose

Depression, Post-traumatic Stress Disorder, Recurrent Breast Cancer

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
support group therapy
educational intervention
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Depression focused on measuring quality of life

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Sierra Streams Institute
  • Stanford University Cancer Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm I (experimental arm)

Arm II (control arm)

Arm Description

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

Participants receive an educational workbook journal.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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

Full Information

First Posted
August 20, 2012
Last Updated
October 15, 2014
Sponsor
Stanford University
Collaborators
California Breast Cancer Research Program
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1. Study Identification

Unique Protocol Identification Number
NCT01672684
Brief Title
Phase I: At-Home Support for Rural Women Using Group Video Calling
Official Title
At-Home Support for Rural Women Using Group Video Calling
Study Type
Interventional

2. Study Status

Record Verification Date
October 2014
Overall Recruitment Status
Completed
Study Start Date
October 2012 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
Collaborators
California Breast Cancer Research Program

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm I (experimental arm)
Arm Type
Experimental
Arm Description
Participants complete at-home group video calling sessions for 1 1/2 hours once weekly for 8 weeks.
Arm Title
Arm II (control arm)
Arm Type
Active Comparator
Arm Description
Participants receive an educational workbook journal.
Intervention Type
Procedure
Intervention Name(s)
support group therapy
Intervention Description
Complete at-home group video calling support sessions
Intervention Type
Other
Intervention Name(s)
educational intervention
Other Intervention Name(s)
intervention, educational
Intervention Description
Receive an educational workbook journal
Primary Outcome Measure Information:
Title
Feasibility of the study protocol as determined primarily through qualitative analysis of the group sessions and the interview data
Description
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.
Time Frame
At 1 week post-intervention
Title
Acceptability of the study protocol as determined primarily through qualitative analysis of the group sessions and the interview data
Description
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.
Time Frame
At 1 week post-intervention
Secondary Outcome Measure Information:
Title
Changes in quality of life (posttraumatic stress, depression symptoms, perceived stress, and positive states of mind)
Description
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.
Time Frame
From baseline to 1 week post-intervention
Title
Changes in satisfaction with social support
Description
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.
Time Frame
From baseline to 1 week post-intervention
Title
Changes in self-efficacy for coping with cancer
Description
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.
Time Frame
From baseline to 1 week post-intervention

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cheryl Koopman
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sierra Streams Institute
City
Nevada City
State/Province
California
ZIP/Postal Code
95959
Country
United States
Facility Name
Stanford University Cancer Institute
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States

12. IPD Sharing Statement

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

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