Telephone-Based Mindfulness CBT for Patients in Community Settings With Advanced Cancer

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.

Study Overview

• Status: Completed
• Conditions: Advanced Cancer
• Intervention / Treatment: Behavioral: Cognitive Behavioral Mutli-Symptom management(CBT)

Detailed Description

Individuals with advanced cancers often experience significant symptom burden including pain, fatigue, and psychological distress, all while facing acceptance of the meaning of their advanced disease. Evidence-based behavioral interventions have been developed to alleviate this multiple symptom burden but are understudied and the treatments that are available are often not easily accessed by patients most in need in community-based settings. The current 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. There is minimal risk related to confidentiality of data and the possibility of feeling uncomfortable in the study. All study contacts will be conducted by trained study staff and supervised by the PI; a licensed clinical psychologist. Participant tracking data will be stored online via REDCAP and accessed only by study staff, participant assessment data will be collected and stored online via REDCap, and audio recordings of study telephone sessions will be stored on Duke servers.

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• being at least 21 years of age
• a diagnosis of stage IV cancer in the past 3 years
• being able to speak/read English

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: Cognitive Behavioral Mutli-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.	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in pain	Pain will be assessed with the Brief Pain Inventory (BPI)	Baseline and 8 weeks
Change in fatigue	Fatigue will be assessed with the PROMIS Adult Fatigue Profile Short Form.	Baseline and 8 weeks
Change in depression	The Hospital Anxiety and Depression Scale will be used to assess distress (anxiety and depressive symptoms)	Baseline and 8 weeks
Change in Mindfulness	Acceptance and mindfulness will be assessed using the Acceptance and Action Questionnaire-II, the most widely used measure of mechanism of change in ACT-based medical treatment studies.	Baseline and 8 weeks
Change in anxiety	The Hospital Anxiety and Depression Scale will be used to assess distress (anxiety and depressive symptoms)	Baseline and 8 weeks
Change in Acceptance	Acceptance and mindfulness will be assessed using the Acceptance and Action Questionnaire-II, the most widely used measure of mechanism of change in ACT-based medical treatment studies.	Baseline and 8 weeks

Collaborators and Investigators

• Sponsor: Duke University
• Collaborators: Palliative Care Research Cooperative Group
• Investigators: Principal Investigator: Jennifer Plumb Vilardaga, Duke University

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 3, 2018
• Primary Completion (ACTUAL): September 8, 2018
• Study Completion (ACTUAL): September 8, 2018

Study Registration Dates

• First Submitted: September 14, 2017
• First Submitted That Met QC Criteria: September 14, 2017
• First Posted (ACTUAL): September 18, 2017

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: Neoplasms
• Other Study ID Numbers: Pro00080262

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No