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

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.

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.