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Completed

NCT Number: NCT02787993

ICAN Symptoms Duke-NUS

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

21 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Duke University Medical Center

Durham, North Carolina, 27705, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cognitive Behavioral Mult-Symptom management(CBT)

Behavioral

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.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Jun 2, 2016
Registry last updated
Aug 19, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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