NCT03285633

Brief Summary

This study examines the feasibility and acceptability of an open trial of mindfulness-based Cognitive Behavioral Therapy intervention delivered via telephone to men and women age 21 and older with a diagnosis of advanced cancer. Potential participants (N=35) will be recruited via letter from their oncologist at community-based clinics (N=18) and those served at the Duke Cancer Institute in Durham who live more than 60 miles away (N=17). Following informed consent, participants will be asked to complete assessments (e..g., examining their pain, anxiety, depression, fatigue, and engagement in valued activity). They will then receive 4 weekly 50-minute telephone sessions with a study therapist and practice skills learned in session at home. After completing the 4 sessions, they will complete a post-treatment assessment. Data analyses will examine the feasibility and acceptability of the study by assessing participant engagement, and will examine changes in key psychological variables (e.g., pain, anxiety, depression, fatigue, and valued activity) from baseline to post-treatment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2018

Shorter than P25 for not_applicable

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

September 14, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 18, 2017

Completed
4 months until next milestone

Study Start

First participant enrolled

January 3, 2018

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 8, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 8, 2018

Completed
Last Updated

August 19, 2019

Status Verified

August 1, 2019

Enrollment Period

8 months

First QC Date

September 14, 2017

Last Update Submit

August 15, 2019

Conditions

Advanced Cancer

Outcome Measures

Primary Outcomes (4)

  • 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.

    8 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

    8 weeks

  • Feasibility as measured by study accrual by meeting recruitment goal

    Feasibility will be shown by meeting targeted study accrual (N=35) in the 12-month study period.

    8 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)

    8 weeks

Secondary Outcomes (6)

  • Change in pain

    Baseline and 8 weeks

  • Change in fatigue

    Baseline and 8 weeks

  • Change in depression

    Baseline and 8 weeks

  • Change in Mindfulness

    Baseline and 8 weeks

  • Change in anxiety

    Baseline and 8 weeks

  • +1 more secondary outcomes

Study Arms (1)

Cognitive Behavioral Mutli-Symptom management(CBT)

OTHER

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.

Behavioral: Cognitive Behavioral Mutli-Symptom management(CBT)

Interventions

Cognitive Behavioral Mutli-Symptom management(CBT)BEHAVIORAL

Learn to manage distress, fatigue, and/or pain via (Cognitive Behavioral Multi-Symptom management (CBT) four one hour sessions.

Cognitive Behavioral Mutli-Symptom management(CBT)

Eligibility Criteria

Age21 Years+
Sexall
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 cancer in the past 3 years
  • being able to speak/read English

You may not qualify if:

  • visual or hearing impairment that would prevent ability to engage in the telephone session or study materials
  • presence of a severe unmanaged psychiatric condition (i.e., psychotic disorder or episode) or a psychiatric condition (e.g., suicidal intent) that would contraindicate safe participation in the study as indicated by the medical chart, treating oncologist, or interactions with the medical/study staff.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27705, United States

Location

Study Officials

  • Jennifer Plumb Vilardaga

    Duke University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 14, 2017

First Posted

September 18, 2017

Study Start

January 3, 2018

Primary Completion

September 8, 2018

Study Completion

September 8, 2018

Last Updated

August 19, 2019

Record last verified: 2019-08

Locations

US(1)