A Patient-Controlled Cognitive-Behavioral Intervention for Cancer Symptoms
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|ClinicalTrials.gov Identifier: NCT00946803|
Recruitment Status : Completed
First Posted : July 27, 2009
Last Update Posted : April 30, 2014
|Condition or disease||Intervention/treatment||Phase|
|Pain Fatigue Sleep Disturbance Cancer||Behavioral: Patient-Controlled Cognitive-Behavioral Intervention||Not Applicable|
Patients undergoing treatment for advanced cancer often experience the combination of pain, fatigue, and sleep disturbance as symptoms that co-occur or "cluster" within patients. Medications may be effective in reducing some of these symptoms; however, they often have side effects that exacerbate the other symptoms. Practice guidelines and research evidence suggest that cognitive-behavioral (CB) strategies may be effective treatments with few, if any, side effects for each of these symptoms. However, investigators have not yet explored the effect of CB strategies on co-occuring pain, fatigue, and sleep disturbance. It is possible that an intervention that is effective for one symptom may also have beneficial effects on the other co-occuring symptoms. For example, controlling pain may permit better sleep and subsequently reduce fatigue. Cognitive-behavioral strategies, however, are not equally effective for all patients, and training in just one strategy may not be sufficient. Providing multiple CB strategies may be more efficacious, but is complicated by the fact that oncology nurses report having insufficient time and equipment to deliver the interventions in practice. And given patient-care demands, providing CB strategies exactly when patients experience increased symptom intensity is usually not feasible. A patient-centered approach to symptom management would allow patients to select from a variety of CB strategies based on their personal preferences, skills, and interests and permit the use of those strategies at whatever time and place the symptoms occur. The use of MP3 technology to deliver the intervention would allow patients to control delivery of the CB strategies without increasing burden on nursing staff and could potentially improve all symptoms in the cluster. The purpose of this study is to conduct a pilot test of a 2-week patient-controlled cognitive-behavioral intervention (PC-CB intervention), using an MP3 player to deliver recorded CB strategies for co-occurring pain, fatigue, and sleep disturbance during cancer treatment.
- To explore the acceptability and patterns of use of recorded CB strategies delivered via MP3 player among patients receiving treatment for advanced cancer.
- To pilot test efficacy of a 2-week PC-CB intervention on symptom outcomes during cancer treatment compared to a waitlist control condition.
- To determine if changes in perceived control over symptoms and outcome expectancy mediate the effect of the PC-CB intervention on symptom outcomes.
- To determine if gender, age, imaging ability, and concurrent symptoms moderate the impact of the PC-CB intervention on symptom outcomes.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||86 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||A Patient-Controlled Cognitive-Behavioral Intervention for Cancer Symptoms|
|Study Start Date :||July 2009|
|Actual Primary Completion Date :||December 2010|
|Actual Study Completion Date :||January 2011|
Experimental: PC-CB Intervention
Patient-Controlled Cognitive-Behavioral Intervention
Behavioral: Patient-Controlled Cognitive-Behavioral Intervention
Selection of 12 recorded imagery- and non imagery-based cognitive-behavioral coping strategies provided on an MP3 player to be used at least once per day or more frequently, as needed for pain, fatigue, and sleep disturbance.
No Intervention: Wait list
Wait list control group. Offered PC-CB Intervention after the study.
- symptom severity [ Time Frame: two weeks ]
- symptom interference with daily activities [ Time Frame: two weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00946803
|United States, Wisconsin|
|University of Wisconsin Carbone Cancer Center|
|Madison, Wisconsin, United States, 53792|
|Principal Investigator:||Kristine Kwekkeboom, PhD||University of Wisconsin, Madison|