Clinical trial · Interventional
A Brief Patient-Controlled Intervention for a Symptom Cluster in 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)
The purpose of the research is to test the efficacy of a patient-controlled cognitive-behavioral intervention for pain, fatigue, and sleep disturbance during cancer treatment, and to evaluate moderators and mediators of intervention effects. The intervention uses guided imagery, relaxation exercises, and nature sound recordings, self-administered via an MP3 player. The study will determine (1) if the intervention helps to control symptoms during chemotherapy, (2) if personal and clinical characteristics influence how well the intervention works, and (3) if the cognitive-behavioral strategies reduce markers of stress and inflammation found in blood and saliva.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Attention Control | Other | — | UNRESOLVED |
| Cognitive-Behavioral Intervention | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- Attention Control
- description
- Standard care + cancer education Participants receive a single session with a research nurse to discuss the importance of understanding cancer and cancer treatment strategies, and to introduce educational recordings available on an MP3 player. The educational recordings provide a selection of publicly available American Cancer Society patient information materials addressing topics related to cancer and cancer treatment strategies. Participants are asked to listen to at least one recording per day, or more frequently as desired.
- interventionNames
- Other: Attention Control
- type
- EXPERIMENTAL
- label
- Cognitive-Behavioral Intervention
- description
- Standard care + Patient-Controlled Cognitive Behavioral Intervention Participants will receive a single training session with a research nurse including: 1) Information about the causes of cancer-related pain, fatigue, and sleep disturbance. 2) An explanation of how cognitive-behavioral interventions may affect symptoms. 3) Review of the specific cognitive-behavioral strategies provided on the MP3 player. 4) Individualized recommendations for using the cognitive-behavioral strategies. The nurse interventionist and patient will develop a written plan for practicing the strategies with recommendations to use a strategy at least once a day, or more frequently as needed.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Be 18 years of age or older. * Have a diagnosis of advanced (metastatic or recurrent) lung, breast, colorectal, prostate, gynecologic or other solid tumor cancer. * Be receiving outpatient chemotherapy. * Report all three symptoms (pain, fatigue, and sleep disturbance) as present in the past week with worst severity rating ≥ 3 (0-10 scale) for at least two of the three symptoms - Exclusion Criteria: * Pain that is post-operative (\< 3 months since surgery) or severe neuropathic pain. * Hospitalized for psychiatric reasons within the past 3 months. * Unable to read, write, or understand English, or otherwise unable to complete study procedures.
References
Publications (0)
Data not yet available