Clinical trial · Interventional
Telephone-Based Mindfulness CBT for Patients in Community Settings With Advanced Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cognitive Behavioral Mutli-Symptom management(CBT) | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Cognitive Behavioral Mutli-Symptom management(CBT)
- description
- 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.
- interventionNames
- Behavioral: Cognitive Behavioral Mutli-Symptom management(CBT)
Primary outcomes (4)
- measure
- Feasibility as measured by study attrition which will be assessed by patients who do not complete the post-assessment.
- timeFrame
- 8 weeks
- description
- Feasibility will be shown by no more than 20% study attrition.
- measure
- Acceptability, as measured by Client Satisfaction Questionnaire 10-item version
- timeFrame
- 8 weeks
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 21 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available