ICAN Symptoms Duke-NUS

Breast Cancer Clinical Trial

Official title:

Feasibility and Acceptability of a Behavioral Symptom Management Program for Patients With Advanced Breast Cancer in Singapore and the US

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02787993
• Other study ID #: Pro00072023
• Status: Completed
• Phase: N/A
• Start date: November 2016
• Est. completion date: August 2018

Study information

• Verified date: August 2019
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 advanced stage breast cancer in Singapore and the US.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: August 2018
• Est. primary completion date: August 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

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.

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	6 weeks
Primary	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.	6 weeks
Primary	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)	6 weeks
Primary	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	6 weeks
Primary	Cultural Sensitivity	Quantitative data will be collected with a 5-minute verbal interview to the participant inquiring about cultural relevance and sensitivity.	6 weeks
Secondary	Change in anxiety and depression	The Hospital Anxiety and Depression Scale14 will be used to assess distress (anxiety and depressive symptoms)	Baseline and 6 weeks
Secondary	Change in pain	Pain will be assessed with the Brief Pain Inventory (BPI)	Baseline and 6 weeks
Secondary	Change in fatigue	Fatigue will be assessed with the PROMIS Adult Fatigue Profile Short Form.	Baseline and 6 weeks
Secondary	Change in Pain	Pain will be assessed with the Pain Disability Index	Baseline and 6 weeks