Clinical trial · Interventional
A Patient-Controlled Cognitive-Behavioral Intervention for Cancer Symptoms
- 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)
Patients receiving treatment for advanced cancer often experience co-occuring pain, fatigue, and sleep disturbance that are not relieved with medications. Brief cognitive-behavioral coping strategies such as relaxation or imagery have been shown to be useful for these symptoms individually and may be effective for the cluster of co-occuring pain, fatigue, and sleep disturbance. Because single cognitive-behavioral strategies don't work equally well for all persons, providing training in multiple cognitive-behavioral strategies is necessary. However, oncology nurses report having insufficient time and are often not available to deliver the interventions exactly when patients experience symptom exacerbation. This application proposes a patient-controlled cognitive-behavioral (PC-CB) intervention, using an MP3 player to deliver recorded cognitive-behavioral strategies. The PC-CB intervention would allow patients to select from a variety of cognitive-behavioral strategies based on their personal preferences, and facilitate self-administration of those strategies at whatever time and place the symptoms occur, without increasing burden on nursing staff. Primary aims are (1) to explore acceptability and patterns of use of the recorded cognitive-behavioral strategies and (2) to pilot test efficacy of the PC-CB intervention compared to a waitlist control.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Fatigue | — | UNRESOLVED | — |
| Pain | — | UNRESOLVED | — |
| Sleep Disturbance | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Patient-Controlled Cognitive-Behavioral Intervention | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- PC-CB Intervention
- description
- Patient-Controlled Cognitive-Behavioral Intervention
- interventionNames
- Behavioral: Patient-Controlled Cognitive-Behavioral Intervention
- type
- NO_INTERVENTION
- label
- Wait list
- description
- Wait list control group. Offered PC-CB Intervention after the study.
Primary outcomes (1)
- measure
- symptom severity
- timeFrame
- two weeks
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Advanced (metastatic/recurrent) lung, prostate, colorectal, or GYN cancer. * Currently receiving chemotherapy or radiation treatments. * Worst pain, fatigue, sleep disturbance rated 3 or greater on 0 - 10 scale. Exclusion Criteria: * Pain that is post-operative (\< 3 months since surgery) or neuropathic in etiology. * Hospitalized for psychiatric reasons within the last 3 months. * Unable to read, write, or understand English. * Diagnosis of confusion or cognitive impairment that would preclude completion of study procedures.
References
Publications (1)
- DERIVEDKwekkeboom KL, Abbott-Anderson K, Cherwin C, Roiland R, Serlin RC, Ward SE. Pilot randomized controlled trial of a patient-controlled cognitive-behavioral intervention for the pain, fatigue, and sleep disturbance symptom cluster in cancer. J Pain Symptom Manage. 2012 Dec;44(6):810-22. doi: 10.1016/j.jpainsymman.2011.12.281. Epub 2012 Jul 7. PMID 22771125