An interventional study of Cognitive Behavioral Mutli-Symptom management(CBT) in Advanced Cancer, sponsored by Duke University. Completed at 1 site in United States. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2019-08-19.
Sponsored by Duke University · Not applicable, Interventional, and Treatment
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.
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.
Exclusion Criteria:
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.
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.
Time frame: 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
Time frame: 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.
Time frame: 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)
Time frame: 8 weeks
Change in pain
Pain will be assessed with the Brief Pain Inventory (BPI)
Time frame: Baseline and 8 weeks
Change in fatigue
Fatigue will be assessed with the PROMIS Adult Fatigue Profile Short Form.
Time frame: Baseline and 8 weeks
Change in depression
The Hospital Anxiety and Depression Scale will be used to assess distress (anxiety and depressive symptoms)
Time frame: 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.
Time frame: Baseline and 8 weeks
Change in anxiety
The Hospital Anxiety and Depression Scale will be used to assess distress (anxiety and depressive symptoms)
Time frame: 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.
Time frame: Baseline and 8 weeks
This study is completed, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.
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Duke University