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.|
|ClinicalTrials.gov Identifier: NCT02787993|
Recruitment Status : Completed
First Posted : June 2, 2016
Last Update Posted : August 19, 2019
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Behavioral: Cognitive Behavioral Mult-Symptom management(CBT)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|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|
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
- 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.
- 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)
- Change in pain [ Time Frame: Baseline and 6 weeks ]Pain will be assessed with the Brief Pain Inventory (BPI)
- Change in fatigue [ Time Frame: Baseline and 6 weeks ]Fatigue will be assessed with the PROMIS Adult Fatigue Profile Short Form.
- Change in Pain [ Time Frame: Baseline and 6 weeks ]Pain will be assessed with the Pain Disability Index
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 ClinicalTrials.gov identifier (NCT number): NCT02787993
|United States, North Carolina|
|Duke University Medical Center|
|Durham, North Carolina, United States, 27705|
|Principal Investigator:||Tamara J Somers, Ph.D.||Duke University|