NCT02787993

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable breast-cancer

Timeline
Completed

Started Nov 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 24, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 2, 2016

Completed
5 months until next milestone

Study Start

First participant enrolled

November 1, 2016

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2018

Completed
Last Updated

August 19, 2019

Status Verified

August 1, 2019

Enrollment Period

1.7 years

First QC Date

May 24, 2016

Last Update Submit

August 15, 2019

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (5)

  • 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

  • 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

  • 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

  • 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

  • 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 Outcomes (4)

  • Change in anxiety and depression

    Baseline and 6 weeks

  • Change in pain

    Baseline and 6 weeks

  • Change in fatigue

    Baseline and 6 weeks

  • Change in Pain

    Baseline and 6 weeks

Study Arms (2)

Cognitive Behavioral Mutli-Symptom management(CBT)

ACTIVE COMPARATOR

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)

Treatment as usual

NO INTERVENTION

Treatment as usual

Interventions

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.

Cognitive Behavioral Mutli-Symptom management(CBT)

Eligibility Criteria

Age21 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27705, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Tamara J Somers, Ph.D.

    Duke University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 24, 2016

First Posted

June 2, 2016

Study Start

November 1, 2016

Primary Completion

August 1, 2018

Study Completion

August 1, 2018

Last Updated

August 19, 2019

Record last verified: 2019-08

Locations

US(1)