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ICAN Symptoms Duke-NUS

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02787993
Recruitment Status : Completed
First Posted : June 2, 2016
Last Update Posted : August 19, 2019
Information provided by (Responsible Party):
Duke University

Brief 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 advanced stage breast cancer in Singapore and the US.

Condition or disease Intervention/treatment Phase
Breast Cancer Behavioral: Cognitive Behavioral Mult-Symptom management(CBT) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Feasibility and Acceptability of a Behavioral Symptom Management Program for Patients With Advanced Breast Cancer in Singapore and the US
Study Start Date : November 2016
Actual Primary Completion Date : August 2018
Actual Study Completion Date : August 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Palliative Care

Arm Intervention/treatment
Active Comparator: Cognitive Behavioral Mutli-Symptom management(CBT)
Learn to manage distress, fatigue, and/or pain via (Cognitive Behavioral Multi-Symptom management (CBT) four one hour sessions.
Behavioral: 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.

No Intervention: Treatment as usual
Treatment as usual

Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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)

  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

  5. 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.

Secondary Outcome Measures :
  1. Change in anxiety and depression [ Time Frame: Baseline and 6 weeks ]
    The Hospital Anxiety and Depression Scale14 will be used to assess distress (anxiety and depressive symptoms)

  2. Change in pain [ Time Frame: Baseline and 6 weeks ]
    Pain will be assessed with the Brief Pain Inventory (BPI)

  3. Change in fatigue [ Time Frame: Baseline and 6 weeks ]
    Fatigue will be assessed with the PROMIS Adult Fatigue Profile Short Form.

  4. Change in Pain [ Time Frame: Baseline and 6 weeks ]
    Pain will be assessed with the Pain Disability Index

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02787993

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United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27705
Sponsors and Collaborators
Duke University
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Principal Investigator: Tamara J Somers, Ph.D. Duke University
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Responsible Party: Duke University Identifier: NCT02787993    
Other Study ID Numbers: Pro00072023
First Posted: June 2, 2016    Key Record Dates
Last Update Posted: August 19, 2019
Last Verified: August 2019
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases