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

Depression Clinical Trial

Official title:

At-Home Support for Rural Women Using Group Video Calling

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01672684
• Other study ID #: BRSADJ0023
• Secondary ID: NCI-2012-0135721
• Status: Completed
• Phase: Phase 1
• First received: August 20, 2012
• Last updated: October 15, 2014
• Start date: October 2012
• Est. completion date: June 2014

Study information

• Verified date: October 2014
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: June 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Breast Neoplasms
• 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
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Procedure:
• support group therapy
Complete at-home group video calling support sessions

Other:
• educational intervention
Receive an educational workbook journal

Locations

Country	Name	City	State
United States	Sierra Streams Institute	Nevada City	California
United States	Stanford University Cancer Institute	Stanford	California

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	California Breast Cancer Research Program

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	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.	From baseline to 1 week post-intervention	No
Secondary	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.	From baseline to 1 week post-intervention	No
Secondary	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.	From baseline to 1 week post-intervention	No

External Links

•   Study information with link to be screened for eligibility