DepressionPhase 3NCT01108016
Expanding Rural Access: Distance Delivery of Support Groups (Main Study)
A Phase 3 study testing Videoconferencing support group in people with Depression and Breast Cancer, run by Stanford University at 1 site in United States.
Trial summary
The study will answer two questions about women with breast cancer in rural communities: 1. Will they find this support group format utilizing videoconferencing acceptable and rewarding? 2. Read more about this study
- Who is it for?
- Ages 21 years and older, women only
- Conditions the study is for
- Depression, Breast Cancer, Stress
- What is being tested?
- Videoconferencing support group
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- May 2008to Jul 2010
- Phase
- Phase 3
- 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
Inclusion Criteria:To be eligible to participate, a woman must meet all of the following criteria:
- be a resident of one of nine rural counties in northeastern California (Modoc, Plumas, Siskiyou, Shasta, Lassen, Trinity, Sierra, Nevada, and Tehama),
- be able to travel to a rural health facility included in the Northern Sierra Rural Health Network to participate in videoconferencing meetings;
- be able to speak and read English well enough to be able to read, discuss, and comprehend the consent form;
- be 21 years of age or older;
- have been diagnosed with breast cancer by a physician; and
- who (in the judgment of the Local Coordinator) is not unduly distressed or otherwise not able to participate effectively in a support group.
Women will be included with any stage of breast cancer as our pilot study demonstrated that in these rural communities, women wanted to include women with any stage of breast cancer in their groups. Also, our pilot study results showed that it worked fine to include women regardless of the period elapsing since they received their diagnosis, as our pilot study results showed that some women with a long period of time elapsing since receiving their diagnosis were still in need of a source of social support for coping with having had this experience and felt that they had a lot of help to offer women who had more recently received a breast cancer diagnosis. The 9 counties were selected because they are among the most remote counties in California, yet they have strong primary care systems in place, and most patients receive specialty care in-state, as opposed to out-of-state. Every effort will be made to include women of ethnic minority groups.
The support group facilitator, community advisory board (CAB) members, and the local community coordinators will also be recruited for the interviews, with informed consent, identified by having played one of these roles for this study.
Exclusion Criteria:Potential participants who do not meet all of the inclusion criteria listed above will be excluded.
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University School of Medicine
Stanford, California, 94305
About this study
The study will answer two questions about women with breast cancer in rural communities:
- Will they find this support group format utilizing videoconferencing acceptable and rewarding?
- Will they report a greater sense of emotional and informational support, and less depression and traumatic stress, than the control groups of women who wait to participate until after the first groups have ended?
- Conditions
- Depression, Breast Cancer, Stress, Breast Cancer Non-invasive Breast Cancer, Breast Cancer Early Stage Breast Cancer (Stage 1-3), Breast Cancer Metastatic Breast Cancer
- Being tested
- Videoconferencing support group
- Medical subject headings
- Depression, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Videoconferencing support groupBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Intensity and frequency of posttraumatic stress symptoms in the past month as assessed by total score on the Posttraumatic Check List - Specific version (PCL-S) for breast cancer.
Measured: after 8 weeks of the immediate group sessions
Intensity and frequency of depression symptoms in the past week as assessed by total score on the Center for Epidemiological Studies Depression scale (CES-D)
Measured: after 8 weeks of the immediate group sessions
Secondary outcomes (3)
Intensity and frequency of emotional control as assessed by the total score on the Courtauld Emotional Control Scale (CECS),
Measured: after 8 weeks of the immediate group sessions
Level of self-efficacy for coping with breast cancer as assessed by the total score on the Cancer Behavior Inventory (CBI).
Measured: after 8 weeks of the immediate group sessions
Satisfaction with social support as assessed by the total satisfaction score on the UCLA Social Support Inventory.
Measured: after 8 weeks of the immediate group sessions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2010 (estimated)
- Study startMay 2008
- Primary completionJul 2010
- Study completionJul 2010
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 3
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- California Breast Cancer Research Program
- Investigators
- Cheryl Koopman, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01108016
- Sponsor's protocol ID
- SU-03012010-5082
- Other IDs
- BRSADJ0019
- Status last verified
- Dec 2010
- First submitted
- 14 Apr 2010
- Last updated
- 6 Dec 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expanding Rural Access: Distance Delivery of Support Groups (Main Study)
- ClinicalTrials.gov ID
- NCT01108016
- Acronym / sponsor ID
- SU-03012010-5082
- Conditions
- Depression, Breast Cancer, Stress, Breast Cancer Non-invasive Breast Cancer, Breast Cancer Early Stage Breast Cancer (Stage 1-3), Breast Cancer Metastatic Breast Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- California Breast Cancer Research Program
- Study start
- May 2008
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 21 Apr 2010 (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.
The study will answer two questions about women with breast cancer in rural communities:
- Will they find this support group format utilizing videoconferencing acceptable and rewarding?
- Will they report a greater sense of emotional and informational support, and less depression and traumatic stress, than the control groups of women who wait to participate until after the first groups have ended?
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Videoconferencing support group | Behavioural | – |
Primary outcome
Intensity and frequency of posttraumatic stress symptoms in the past month as assessed by total score on the Posttraumatic Check List - Specific version (PCL-S) for breast cancer.
Time frame: after 8 weeks of the immediate group sessions
Intensity and frequency of depression symptoms in the past week as assessed by total score on the Center for Epidemiological Studies Depression scale (CES-D)
Time frame: after 8 weeks of the immediate group sessions
3 secondary outcomes
Intensity and frequency of emotional control as assessed by the total score on the Courtauld Emotional Control Scale (CECS),
Time frame: after 8 weeks of the immediate group sessions
Level of self-efficacy for coping with breast cancer as assessed by the total score on the Cancer Behavior Inventory (CBI).
Time frame: after 8 weeks of the immediate group sessions
Satisfaction with social support as assessed by the total satisfaction score on the UCLA Social Support Inventory.
Time frame: after 8 weeks of the immediate group sessions
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 6 Dec 2010.
Related trials for Depression
Recruiting
Unified Protocol in Penitentiary Facilities
Depression Disorders, Anxiety
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Not yet recruitingObservational study
Functional Impact of Psychological Symptoms in Patients With Superior Semicircular Canal Dehiscence Syndrome (SSCD): a National Cross-sectional Study
Superior Semicircular Canal Dehiscence
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Recruiting
Cultural Adaptation of an Online Parenting Intervention to Reduce the Risk of Depression and Anxiety in Adolescents
Risk of Depression and Anxiety
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Videoconferencing support group in people with Depression and Breast Cancer, run by Stanford University at 1 site 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?
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 6 Dec 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Intensity and frequency of posttraumatic stress symptoms in the past month as assessed by total score on the Posttraumatic Check List - Specific version (PCL-S) for breast cancer. (time frame: after 8 weeks of the immediate group sessions). 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 6 Dec 2010.