Breast CancerPhase 2NCT00186511
Expanding Rural Access: Distance Delivery of Support
A Phase 2 study testing workbook/journal on coping with breast cancer and supportive expressive group therapy using videoconferencing in people with Breast Cancer and Stress Disorders, Post-Traumatic, run by Stanford University at 1 site in United States.
Trial summary
The major goal of this project is to test the feasibility and acceptability of using videoconferencing to provide support groups led by trained facilitators to rural women with breast cancer in northern California. Read more about this study
- Who is it for?
- Ages 21 years and older, women only
- Conditions the study is for
- Breast Cancer, Stress Disorders, Post-Traumatic, Depression
- What is being tested?
- workbook/journal on coping with breast cancer and supportive expressive group therapy using videoconferencing
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2004to Jun 2006
- Phase
- Phase 2
- 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
- 1) has been diagnosed with breast cancer, and 2) is a woman
Who cannot join
- 1) under 21 years of age, and 2) does not speak and read English
Trial locations and contacts
1 site in 1 country.
About this study
The major goal of this project is to test the feasibility and acceptability of using videoconferencing to provide support groups led by trained facilitators to rural women with breast cancer in northern California.
Read the detailed description
Women with breast cancer in rural areas are likely exhaust their usual sources of psychosocial support while still facing challenges posed by breast cancer, but are unlikely to have access to professionally-led support groups. In this community-based project, we assessed the feasibility and acceptability of providing support groups to women with breast cancer in a large rural area using videoconferencing and a workbook journal, and we assessed the intervention's potential to reduce distress and increase emotional expression and self-efficacy for coping with cancer. Twenty-seven women in the Intermountain Region of northeastern California participated in 8-session support groups led by an oncology social worker by going to nearby videoconferencing sites. Feasibility and acceptability were demonstrated. Older as well as younger women were comfortable using videoconferencing and said the groups were valuable because they promoted information sharing and emotional bonds with other women with breast cancer. They emphasized the importance of a professional facilitator and identified advantages of using videoconferencing for support groups. Pretest and posttest comparisons showed significant decreases in depression and posttraumatic stress disorder symptoms. The results suggest that the intervention has the potential to provide a valuable service that is not readily available in rural communities.
- Conditions
- Breast Cancer, Stress Disorders, Post-Traumatic, Depression
- Being tested
- workbook/journal on coping with breast cancer, supportive expressive group therapy using videoconferencing
- Medical subject headings
- Breast Neoplasms, Stress Disorders, Post-Traumatic, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
workbook/journal on coping with breast cancerBehavioural
supportive expressive group therapy using videoconferencingBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Center for Epidemiological Studies Depression Scale
Posttraumatic Stress Checklist
Secondary outcomes (2)
Cancer Behavior Inventory
Courtauld Emotional Control Scale
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startNov 2004
- Study completionJun 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, Berkeley
- Investigators
- Cheryl Koopman, Ph.D., Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00186511
- Sponsor's protocol ID
- 10AB-2801
- Status last verified
- Dec 2006
- First submitted
- 13 Sep 2005
- Last updated
- 5 Dec 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expanding Rural Access: Distance Delivery of Support
- ClinicalTrials.gov ID
- NCT00186511
- Acronym / sponsor ID
- 10AB-2801
- Conditions
- Breast Cancer, Stress Disorders, Post-Traumatic, Depression
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- University of California, Berkeley
- Study start
- Nov 2004
- Study completion
- Jun 2006
- First posted
- 16 Sep 2005 (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 major goal of this project is to test the feasibility and acceptability of using videoconferencing to provide support groups led by trained facilitators to rural women with breast cancer in northern California.
Detailed description
Women with breast cancer in rural areas are likely exhaust their usual sources of psychosocial support while still facing challenges posed by breast cancer, but are unlikely to have access to professionally-led support groups. In this community-based project, we assessed the feasibility and acceptability of providing support groups to women with breast cancer in a large rural area using videoconferencing and a workbook journal, and we assessed the intervention's potential to reduce distress and increase emotional expression and self-efficacy for coping with cancer. Twenty-seven women in the Intermountain Region of northeastern California participated in 8-session support groups led by an oncology social worker by going to nearby videoconferencing sites. Feasibility and acceptability were demonstrated. Older as well as younger women were comfortable using videoconferencing and said the groups were valuable because they promoted information sharing and emotional bonds with other women with breast cancer. They emphasized the importance of a professional facilitator and identified advantages of using videoconferencing for support groups. Pretest and posttest comparisons showed significant decreases in depression and posttraumatic stress disorder symptoms. The results suggest that the intervention has the potential to provide a valuable service that is not readily available in rural communities.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1) has been diagnosed with breast cancer, and 2) is a woman
Key exclusion criteria (1 listed)
- 1) under 21 years of age, and 2) does not speak and read English
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 |
|---|---|---|
| workbook/journal on coping with breast cancer | Behavioural | – |
| supportive expressive group therapy using videoconferencing | Behavioural | – |
Primary outcome
Center for Epidemiological Studies Depression Scale
Posttraumatic Stress Checklist
2 secondary outcomes
Cancer Behavior Inventory
Courtauld Emotional Control Scale
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 5 Dec 2006.
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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, Ph.D. 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 2 study testing workbook/journal on coping with breast cancer and supportive expressive group therapy using videoconferencing in people with Breast Cancer and Stress Disorders, Post-Traumatic, 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?
The sponsor lists 1 inclusion and 1 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 5 Dec 2006. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Center for Epidemiological Studies Depression Scale. 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 5 Dec 2006.