Breast CancerNCT02787993
ICAN Symptoms Duke-NUS
A study testing Cognitive Behavioral Mult-Symptom management(CBT) in people with Breast Cancer, run by Duke University at 1 site in United States.
Trial summary
The purpose of this study is to conduct a pilot randomized controlled trial (RCT) to examine the feasibility, acceptability, and cultural sensitivity of a cross-cultural cognitive behavioral therapy (CBT) multi-symptom management protocol targeting distress (anxiety, depression), pain, and fatigue in women with… Read more about this study
- Who is it for?
- Ages 21 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Cognitive Behavioral Mult-Symptom management(CBT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2016to Aug 2018
- Phase
- Interventional
- 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
- being at least 21 years of age
- a diagnosis of stage IV breast cancer
- being able and willing to attend study appointments
- being able to speak/read English
- estimated survival of at least 3 months.
Who cannot join
- they have an active serious mental illness (e.g., schizophrenia, bipolar disorder) as indicated by medical records
- if visual, hearing, or cognitive impairment will interfere with intervention.
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27705
About this study
Official title: Feasibility and Acceptability of a Behavioral Symptom Management Program for Patients With Advanced Breast Cancer in Singapore and the US
The purpose of this study is to conduct a pilot randomized controlled trial (RCT) to examine the feasibility, acceptability, and cultural sensitivity of a cross-cultural cognitive behavioral therapy (CBT) multi-symptom management protocol targeting distress (anxiety, depression), pain, and fatigue in women with advanced stage breast cancer in Singapore and the US.
Read the detailed description
Up to two-thirds of women with advanced breast cancer experience significant symptom burden (e.g., distress, pain, fatigue), yet these symptoms are not adequately addressed. Cognitive behavioral therapy (CBT) protocols designed to teach patients strategies to improve their symptom management may be helpful in alleviating multiple symptoms. The efficacy of CBT protocols for reducing distinct symptoms in early-stage breast cancer has been shown in Western countries; however, the role of CBT protocols for multiple symptoms in late-stage cancer is less clear. This study aims to investigate the feasibility and acceptability and obtain estimates of efficacy of a novel, cross-cultural multi-symptom (i.e., anxiety and depression, pain, fatigue) CBT protocol in advanced breast cancer patients. A randomized controlled design will compare patients receiving the CBT protocol to a waitlist control condition in both Singapore and United States patients. The goal of this collaborative effort is to determine the scalability of the cross- cultural intervention. This IRB protocol only represents the Duke US portion of the project; Duke-NUS will obtain their own IRB approvals.
- Conditions
- Breast Cancer
- Being tested
- Cognitive Behavioral Mult-Symptom management(CBT)
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral Mult-Symptom management(CBT)Behavioural
Learn to manage distress, fatigue, and/or pain via Cognitive Behavioral Multi-Symptom Management(CBT). Four sessions will be conducted each session is approximately one hour.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Behavioral Mutli-Symptom management(CBT) | Active comparator | Learn to manage distress, fatigue, and/or pain via (Cognitive Behavioral Multi-Symptom management (CBT) four one hour sessions. Receives: Behavioral: Cognitive Behavioral Mult-Symptom management(CBT) |
| Treatment as usual | No intervention | Treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility as measured by study accrual by meeting recruitment goal
Feasibility will be shown by meeting targeted study accrual (N=40) in the 12-month study period.
Measured: 6 weeks
Feasibility as measured by study attrition which will be assessed by patients who do not complete the post-assessment.
Feasibility will be shown by no more than 20% study attrition.
Measured: 6 weeks
Feasibility as measured by adherence to the study protocol by number of intervention sessions completed by the participant
Feasibility will be shown by adherence to at least 75% of the intervention sessions (3/4)
Measured: 6 weeks
Acceptability, as measured by Client Satisfaction Questionnaire 10-item version
Acceptability will be indicated by at least 80% of the participants reporting satisfaction with the CBT protocol (mean score of 7) on the CSQ
Measured: 6 weeks
Cultural Sensitivity
Quantitative data will be collected with a 5-minute verbal interview to the participant inquiring about cultural relevance and sensitivity.
Measured: 6 weeks
Secondary outcomes (4)
Change in anxiety and depression
The Hospital Anxiety and Depression Scale14 will be used to assess distress (anxiety and depressive symptoms)
Measured: Baseline and 6 weeks
Change in pain
Pain will be assessed with the Brief Pain Inventory (BPI)
Measured: Baseline and 6 weeks
Change in fatigue
Fatigue will be assessed with the PROMIS Adult Fatigue Profile Short Form.
Measured: Baseline and 6 weeks
Change in Pain
Pain will be assessed with the Pain Disability Index
Measured: Baseline and 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2016 (estimated)
- Study startNov 2016
- Primary completionAug 2018
- Study completionAug 2018
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 Duke 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tamara J Somers, Ph.D., Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02787993
- Sponsor's protocol ID
- Pro00072023
- Status last verified
- Aug 2019
- First submitted
- 24 May 2016
- Last updated
- 19 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Acceptability of a Behavioral Symptom Management Program for Patients With Advanced Breast Cancer in Singapore and the US
- ClinicalTrials.gov ID
- NCT02787993
- Acronym / sponsor ID
- Pro00072023
- Conditions
- Breast Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- Nov 2016
- Primary completion
- Aug 2018 (actual)
- Study completion
- Aug 2018 (actual)
- First posted
- 2 Jun 2016 (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 purpose of this study is to conduct a pilot randomized controlled trial (RCT) to examine the feasibility, acceptability, and cultural sensitivity of a cross-cultural cognitive behavioral therapy (CBT) multi-symptom management protocol targeting distress (anxiety, depression), pain, and fatigue in women with advanced stage breast cancer in Singapore and the US.
Detailed description
Up to two-thirds of women with advanced breast cancer experience significant symptom burden (e.g., distress, pain, fatigue), yet these symptoms are not adequately addressed. Cognitive behavioral therapy (CBT) protocols designed to teach patients strategies to improve their symptom management may be helpful in alleviating multiple symptoms. The efficacy of CBT protocols for reducing distinct symptoms in early-stage breast cancer has been shown in Western countries; however, the role of CBT protocols for multiple symptoms in late-stage cancer is less clear. This study aims to investigate the feasibility and acceptability and obtain estimates of efficacy of a novel, cross-cultural multi-symptom (i.e., anxiety and depression, pain, fatigue) CBT protocol in advanced breast cancer patients. A randomized controlled design will compare patients receiving the CBT protocol to a waitlist control condition in both Singapore and United States patients. The goal of this collaborative effort is to determine the scalability of the cross- cultural intervention. This IRB protocol only represents the Duke US portion of the project; Duke-NUS will obtain their own IRB approvals.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive Behavioral Mutli-Symptom management(CBT) | Active comparator | Behavioral: Cognitive Behavioral Mult-Symptom management(CBT)Learn to manage distress, fatigue, and/or pain via (Cognitive Behavioral Multi-Symptom management (CBT) four one hour sessions. |
| Treatment as usual | No intervention | –Treatment as usual |
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- being at least 21 years of age
- a diagnosis of stage IV breast cancer
- being able and willing to attend study appointments
- being able to speak/read English
- estimated survival of at least 3 months.
Key exclusion criteria (2 listed)
- they have an active serious mental illness (e.g., schizophrenia, bipolar disorder) as indicated by medical records
- if visual, hearing, or cognitive impairment will interfere with intervention.
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 |
|---|---|---|
| Cognitive Behavioral Mult-Symptom management(CBT)Learn to manage distress, fatigue, and/or pain via Cognitive Behavioral Multi-Symptom Management(CBT). Four sessions will be conducted each session is approximately one hour. | Behavioural | Cognitive Behavioral Mutli-Symptom management(CBT) |
Primary outcome
Feasibility as measured by study accrual by meeting recruitment goal
Time frame: 6 weeks
Feasibility will be shown by meeting targeted study accrual (N=40) in the 12-month study period.
Feasibility as measured by study attrition which will be assessed by patients who do not complete the post-assessment.
Time frame: 6 weeks
Feasibility will be shown by no more than 20% study attrition.
Feasibility as measured by adherence to the study protocol by number of intervention sessions completed by the participant
Time frame: 6 weeks
Feasibility will be shown by adherence to at least 75% of the intervention sessions (3/4)
Acceptability, as measured by Client Satisfaction Questionnaire 10-item version
Time frame: 6 weeks
Acceptability will be indicated by at least 80% of the participants reporting satisfaction with the CBT protocol (mean score of 7) on the CSQ
Cultural Sensitivity
Time frame: 6 weeks
Quantitative data will be collected with a 5-minute verbal interview to the participant inquiring about cultural relevance and sensitivity.
4 secondary outcomes
Change in anxiety and depression
Time frame: Baseline and 6 weeks
Change in pain
Time frame: Baseline and 6 weeks
Change in fatigue
Time frame: Baseline and 6 weeks
Change in Pain
Time frame: Baseline and 6 weeks
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 19 Aug 2019.
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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.
Tamara J Somers, Ph.D. principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavioral Mult-Symptom management(CBT) in people with Breast Cancer, run by Duke 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 5 inclusion and 2 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 19 Aug 2019. 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.
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 as measured by study accrual by meeting recruitment goal (time frame: 6 weeks). The study lists 5 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 19 Aug 2019.