ICAN Symptoms Duke-NUS

August 15, 2019 updated by: Duke University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27705
        • Duke University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Treatment as usual
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 weeks
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.
6 weeks
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)
6 weeks
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
6 weeks
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.
6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Baseline and 6 weeks
Change in pain
Time Frame: Baseline and 6 weeks
Pain will be assessed with the Brief Pain Inventory (BPI)
Baseline and 6 weeks
Change in fatigue
Time Frame: Baseline and 6 weeks
Fatigue will be assessed with the PROMIS Adult Fatigue Profile Short Form.
Baseline and 6 weeks
Change in Pain
Time Frame: Baseline and 6 weeks
Pain will be assessed with the Pain Disability Index
Baseline and 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Investigators

  • Principal Investigator: Tamara J Somers, Ph.D., Duke University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2016

Primary Completion (Actual)

August 1, 2018

Study Completion (Actual)

August 1, 2018

Study Registration Dates

First Submitted

May 24, 2016

First Submitted That Met QC Criteria

May 26, 2016

First Posted (Estimate)

June 2, 2016

Study Record Updates

Last Update Posted (Actual)

August 19, 2019

Last Update Submitted That Met QC Criteria

August 15, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00072023

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Breast Cancer

Clinical Trials on Cognitive Behavioral Mult-Symptom management(CBT)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Egypt

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe