DepressionPhase 1NCT01672684
Phase I: At-Home Support for Rural Women Using Group Video Calling
A Phase 1 study testing support group therapy and educational intervention in people with Depression and Post-traumatic Stress Disorder, run by Stanford University at 2 sites in United States.
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 Read more about this study
- Who is it for?
- Ages 21 years and older, women only
- Conditions the study is for
- Depression, Post-traumatic Stress Disorder, Recurrent Breast Cancer
- What is being tested?
- support group therapy and educational intervention
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 2 sitesUnited States
- Study dates
- Oct 2012to Jun 2014
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Sierra Streams Institute
Nevada City, California, 95959
Stanford University Cancer Institute
Stanford, California, 94305
About this study
Official title: At-Home Support for Rural Women Using Group Video Calling
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
Read the detailed description
PRIMARY OBJECTIVES:
- 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:
- 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
- Being tested
- support group therapy, educational intervention
- Keywords
- quality of life
- Medical subject headings
- Depression, Stress Disorders, Post-Traumatic, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
support group therapyProcedure or surgery
Complete at-home group video calling support sessions
educational interventionOther
Also called intervention, educational
Receive an educational workbook journal
| Study group | Role | What they receive |
|---|---|---|
| Arm I (experimental arm) | Experimental | Participants complete at-home group video calling sessions for 1 1/2 hours once weekly for 8 weeks. Receives: Procedure: support group therapy |
| Arm II (control arm) | Active comparator | Participants receive an educational workbook journal. Receives: Other: educational intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At 1 week post-intervention
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.
Measured: At 1 week post-intervention
Secondary outcomes (3)
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.
Measured: From baseline to 1 week post-intervention
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.
Measured: From baseline to 1 week post-intervention
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.
Measured: From baseline to 1 week post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2012 (estimated)
- Study startOct 2012
- Primary completionDec 2013
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- California Breast Cancer Research Program
- Responsible party
- Principal investigator, Cheryl Koopman, Stanford University
- Investigators
- Cheryl Koopman, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01672684
- Sponsor's protocol ID
- BRSADJ0023
- Other IDs
- NCI-2012-01357, 21349
- Status last verified
- Oct 2014
- First submitted
- 20 Aug 2012
- Last updated
- 17 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- At-Home Support for Rural Women Using Group Video Calling
- ClinicalTrials.gov ID
- NCT01672684
- Acronym / sponsor ID
- BRSADJ0023
- Conditions
- Depression, Post-traumatic Stress Disorder, Recurrent Breast Cancer, Stage IA Breast Cancer, Stage IB Breast Cancer, Stage II Breast Cancer
- Keywords
- quality of life
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- California Breast Cancer Research Program
- Study start
- Oct 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 27 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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:
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (experimental arm) | Experimental | Procedure: support group therapyParticipants complete at-home group video calling sessions for 1 1/2 hours once weekly for 8 weeks. |
| Arm II (control arm) | Active comparator | Other: educational interventionParticipants receive an educational workbook journal. |
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| support group therapyComplete at-home group video calling support sessions | Procedure or surgery | Arm I (experimental arm) |
| educational interventionAlso: intervention, educationalReceive an educational workbook journal | Other | Arm II (control arm) |
Primary outcome
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.
3 secondary outcomes
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
Changes in satisfaction with social support
Time frame: From baseline to 1 week post-intervention
Changes in self-efficacy for coping with cancer
Time frame: From baseline to 1 week post-intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cheryl Koopman principal investigator
Stanford University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing support group therapy and educational intervention in people with Depression and Post-traumatic Stress Disorder, run by Stanford University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2014.