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

NCT ID: NCT03285633

Last Updated: 2019-08-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-03
• Study Completion Date: 2018-09-08

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.

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.

Conditions

Advanced Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: OTHER

Cognitive Behavioral Mutli-Symptom management(CBT)

Intervention Type: BEHAVIORAL

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

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Palliative Care Research Cooperative Group

NETWORK

Sponsor Role: collaborator

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jennifer Plumb Vilardaga

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

Duke University Medical Center

Durham, North Carolina, United States

Countries

United States

Other Identifiers

Pro00080262

Identifier Type: -

Identifier Source: org_study_id