Clinical trial NCT03285633: Telephone-Based Mindfulness CBT for Patients in Community Settings With Advanced Cancer
Official title: Telephone-Based Mindfulness CBT for Patients in Community Settings With Advanced Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Advanced Cancer
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: Palliative Care Research Cooperative Group
First posted: 2017-09-18
Enrollment: 24
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Feasibility as measured by study attrition which will be assessed by patients who do not complete the post-assessment.
timeFrame: 8 weeks
measure: Acceptability, as measured by Client Satisfaction Questionnaire 10-item version
timeFrame: 8 weeks
measure: Feasibility as measured by study accrual by meeting recruitment goal
timeFrame: 8 weeks
measure: Feasibility as measured by adherence to the study protocol by number of intervention sessions completed by the participant
timeFrame: 8 weeks
Secondary outcomes:
measure: Change in pain
timeFrame: Baseline and 8 weeks
measure: Change in fatigue
timeFrame: Baseline and 8 weeks
measure: Change in depression
timeFrame: Baseline and 8 weeks
measure: Change in Mindfulness
timeFrame: Baseline and 8 weeks
measure: Change in anxiety
timeFrame: Baseline and 8 weeks
measure: Change in Acceptance
timeFrame: Baseline and 8 weeks
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Jennifer Plumb Vilardaga
role: PRINCIPAL_INVESTIGATOR
References: