A Brief Patient-Controlled Intervention for a Symptom Cluster in Advanced Cancer

Completed · Not applicable

Conditions studied: Pain, Fatigue, Sleep Disturbance, Cancer

In brief

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.

Key facts

Study ID

NCT01954420

Run by

University of Wisconsin, Madison

People needed

188

Starts

2013-12-01

Expected to finish

2017-01-31

Last updated by the study team

2019-11-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 -

You may not qualify if…

• 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.

Where it is running

• SwedishAmerican Regional Cancer Center — Rockford, Illinois, United States
• Mercy Health System — Janesville, Wisconsin, United States
• University of Wisconsin — Madison, Wisconsin, United States
• ProHealth Care — Waukesha, Wisconsin, United States

Full record on ClinicalTrials.gov

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