Breast CancerPhase 1/2NCT01335152
Online Stress Management and Coping Skills Training for Women With Breast Cancer
A Phase 1/2 study testing Coping with Breast Cancer web-based workbook in people with Breast Cancer, run by Talaria, Inc at 1 site in United States.
Trial summary
Stress Management interventions have been shown to decrease cancer-related distress, foster emotional growth and improve immune functioning during treatment for breast cancer. This study will evaluate an online version of a stress management intervention for women with early stage breast cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Coping with Breast Cancer web-based workbook
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2010to Aug 2011
- Phase
- Phase 1/2
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of stage 0, I, II or III breast cancer within past 18 months
- Elevated stress, distress or negative mood
- Access at least 1.5 - 2 hours per week to a computer with audio capabilities that is connected to the internet
- Ability to read, write, and speak English at a sixth grade level
- Access to a telephone and an active e-mail account
Who cannot join
- Cancer diagnosis is a recurrence
- Diagnosis of schizophrenia
- Use of anti-psychotic medication
- Diagnosis of bipolar disorder without use of mood stabilizing medication
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Coping With Breast Cancer and Treatment: An E-Learning Course for Skills and Strategies
Stress Management interventions have been shown to decrease cancer-related distress, foster emotional growth and improve immune functioning during treatment for breast cancer.
This study will evaluate an online version of a stress management intervention for women with early stage breast cancer. Each chapter of the 10-week intervention include self-assessment and targeted feedback, education, interactive learning exercises -- all tailored to the needs of women with early stage breast cancer. In addition, guided writing exercises will promote emotional expression and a discussion board will encourage group support.
The web-based intervention is being evaluated in a randomized clinical trial with a sample of 120 women with early stage breast cancer. Women will be randomly assigned to use the 10-week intervention with biweekly telephone assessments or to the telephone assessments alone.
Read the detailed description
Stress Management interventions have been shown to decrease cancer-related distress, foster emotional growth and improve immune functioning during treatment for breast cancer.
This study will evaluate an online version of a stress management intervention for women with early stage breast cancer. Each chapter of the 10-week intervention include self-assessment and targeted feedback, education, interactive learning exercises -- all tailored to the needs of women with early stage breast cancer. In addition, guided writing exercises will promote emotional expression and a discussion board will encourage group support.
The web-based intervention is being evaluated in a randomized clinical trial with a sample of 120 women with early stage breast cancer. Women will be randomly assigned to use the 10-week intervention with biweekly telephone assessments or to the telephone assessments alone.
- Conditions
- Breast Cancer
- Being tested
- Coping with Breast Cancer web-based workbook
- Keywords
- stress, depression, anxiety, web, internet, coping
- Medical subject headings
- Breast Neoplasms, Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coping with Breast Cancer web-based workbookBehavioural
Also called Stress management, Coping with Cancer, Cancer Coping, Online workbook
10 chapter web-based workbook that teaches stress management, cognitive behavioral coping skills and relaxation training.
| Study group | Role | What they receive |
|---|---|---|
| Web-based workbook | Experimental | Participants will use one chapter of the web-based workbook each week for 10 weeks. The workbook consists of stress management education, cognitive behavioral interventions and relaxation training exercises. Receives: Behavioral: Coping with Breast Cancer web-based workbook |
| Waitlist control group | No intervention | Participants will no intervention for the first 10 weeks of the study and then will receive the web-based intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
PHQ GAD-7 - Anxiety
7-item self-report questionnaire measureing anxiety.
Measured: baseline, post-intervention, follow-up
CES-D 10
10 item self-report measure of depression.
Measured: baseline, post-intervention, follow-up
FACT-B: Functional Assessment of Cancer Therapy - Breast
44 item self-report measure of health related quality of life for breast cancer patients.
Measured: baseline, post-intervention, follow-up
Secondary outcomes (3)
Revised Impact of Event Scale
22 item self-report measure of intrusive thoughts and avoidance of cancer-related thoughts.
Measured: baseline, post-intervention, follow-up
Benefit Finding Scale for breast cancer
17-item self-report measure of finding positive impact of negative events.
Measured: baseline, post-intervention, follow-up
CANCER BEHAVIOR INVENTORY (CBI-B)
16-item self-report measure of self-efficacy for coping with cancer and cancer treatment.
Measured: baseline, post-intervention, follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2011 (estimated)
- Study startApr 2010
- Primary completionApr 2011
- Study completionAug 2011
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.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Talaria, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Kelly M Carpenter, PhD, Principal investigator, Talaria, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01335152
- Sponsor's protocol ID
- CA106154
- Other IDs
- 5R44CA106154-03
- Status last verified
- May 2014
- First submitted
- 12 Apr 2011
- Last updated
- 7 May 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coping With Breast Cancer and Treatment: An E-Learning Course for Skills and Strategies
- ClinicalTrials.gov ID
- NCT01335152
- Acronym / sponsor ID
- CA106154
- Conditions
- Breast Cancer
- Keywords
- stress, depression, anxiety, web, internet, coping
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Talaria, IncIndustry (pharma, biotech, devices)
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Apr 2010
- Primary completion
- Apr 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 14 Apr 2011 (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.
Stress Management interventions have been shown to decrease cancer-related distress, foster emotional growth and improve immune functioning during treatment for breast cancer.
This study will evaluate an online version of a stress management intervention for women with early stage breast cancer. Each chapter of the 10-week intervention include self-assessment and targeted feedback, education, interactive learning exercises -- all tailored to the needs of women with early stage breast cancer. In addition, guided writing exercises will promote emotional expression and a discussion board will encourage group support.
The web-based intervention is being evaluated in a randomized clinical trial with a sample of 120 women with early stage breast cancer. Women will be randomly assigned to use the 10-week intervention with biweekly telephone assessments or to the telephone assessments alone.
Detailed description
Stress Management interventions have been shown to decrease cancer-related distress, foster emotional growth and improve immune functioning during treatment for breast cancer.
This study will evaluate an online version of a stress management intervention for women with early stage breast cancer. Each chapter of the 10-week intervention include self-assessment and targeted feedback, education, interactive learning exercises -- all tailored to the needs of women with early stage breast cancer. In addition, guided writing exercises will promote emotional expression and a discussion board will encourage group support.
The web-based intervention is being evaluated in a randomized clinical trial with a sample of 120 women with early stage breast cancer. Women will be randomly assigned to use the 10-week intervention with biweekly telephone assessments or to the telephone assessments alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Web-based workbook | Experimental | Behavioral: Coping with Breast Cancer web-based workbookParticipants will use one chapter of the web-based workbook each week for 10 weeks. The workbook consists of stress management education, cognitive behavioral interventions and relaxation training exercises. |
| Waitlist control group | No intervention | –Participants will no intervention for the first 10 weeks of the study and then will receive the web-based intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosis of stage 0, I, II or III breast cancer within past 18 months
- Elevated stress, distress or negative mood
- Access at least 1.5 - 2 hours per week to a computer with audio capabilities that is connected to the internet
- Ability to read, write, and speak English at a sixth grade level
- Access to a telephone and an active e-mail account
Key exclusion criteria (4 listed)
- Cancer diagnosis is a recurrence
- Diagnosis of schizophrenia
- Use of anti-psychotic medication
- Diagnosis of bipolar disorder without use of mood stabilizing medication
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 |
|---|---|---|
| Coping with Breast Cancer web-based workbookAlso: Stress management, Coping with Cancer, Cancer Coping, Online workbook10 chapter web-based workbook that teaches stress management, cognitive behavioral coping skills and relaxation training. | Behavioural | Web-based workbook |
Primary outcome
PHQ GAD-7 - Anxiety
Time frame: baseline, post-intervention, follow-up
7-item self-report questionnaire measureing anxiety.
CES-D 10
Time frame: baseline, post-intervention, follow-up
10 item self-report measure of depression.
FACT-B: Functional Assessment of Cancer Therapy - Breast
Time frame: baseline, post-intervention, follow-up
44 item self-report measure of health related quality of life for breast cancer patients.
3 secondary outcomes
Revised Impact of Event Scale
Time frame: baseline, post-intervention, follow-up
Benefit Finding Scale for breast cancer
Time frame: baseline, post-intervention, follow-up
CANCER BEHAVIOR INVENTORY (CBI-B)
Time frame: baseline, post-intervention, follow-up
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 7 May 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.
Kelly M Carpenter, PhD principal investigator
Talaria, Inc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Coping with Breast Cancer web-based workbook in people with Breast Cancer, run by Talaria, Inc 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 5 inclusion and 4 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 7 May 2014. 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 combined 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.
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?
PHQ GAD-7 - Anxiety (time frame: baseline, post-intervention, follow-up). The study lists 3 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 7 May 2014.