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

Advanced Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03285633
• Other study ID #: Pro00080262
• Status: Completed
• Phase: N/A
• Start date: January 3, 2018
• Est. completion date: September 8, 2018

Study information

• Verified date: August 2019
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: September 8, 2018
• Est. primary completion date: September 8, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Advanced Cancer
• Neoplasms

Intervention

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.

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	Palliative Care Research Cooperative Group

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	Change in pain	Pain will be assessed with the Brief Pain Inventory (BPI)	Baseline and 8 weeks
Secondary	Change in fatigue	Fatigue will be assessed with the PROMIS Adult Fatigue Profile Short Form.	Baseline and 8 weeks
Secondary	Change in depression	The Hospital Anxiety and Depression Scale will be used to assess distress (anxiety and depressive symptoms)	Baseline and 8 weeks
Secondary	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
Secondary	Change in anxiety	The Hospital Anxiety and Depression Scale will be used to assess distress (anxiety and depressive symptoms)	Baseline and 8 weeks
Secondary	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