Clinical trial NCT00946803: A Patient-Controlled Cognitive-Behavioral Intervention for Cancer Symptoms
Official title: A Patient-Controlled Cognitive-Behavioral Intervention for Cancer Symptoms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Fatigue
Sleep Disturbance
Cancer
Keywords: Pain
Fatigue
Sleep
Cancer
Complementary therapies
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2009-07-27
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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.

Primary Aims

1. To explore the acceptability and patterns of use of recorded CB strategies delivered via MP3 player among patients receiving treatment for advanced cancer.
2. To pilot test efficacy of a 2-week PC-CB intervention on symptom outcomes during cancer treatment compared to a waitlist control condition.

Secondary Aims

1. To determine if changes in perceived control over symptoms and outcome expectancy mediate the effect of the PC-CB intervention on symptom outcomes.
2. To determine if gender, age, imaging ability, and concurrent symptoms moderate the impact of the PC-CB intervention on symptom outcomes.

Eligibility criteria: 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.

Primary outcomes:
measure: symptom severity
timeFrame: two weeks
Secondary outcomes:
measure: symptom interference with daily activities
timeFrame: two weeks
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin Carbone Cancer Center
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Kristine Kwekkeboom, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kwekkeboom 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.