Text Size

A Patient-Controlled Cognitive-Behavioral Intervention for Cancer Symptoms

This study has been completed.
Sponsor:
Collaborator:
National Institute of Nursing Research (NINR)
Information provided by:
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT00946803
First received: July 23, 2009
Last updated: May 24, 2011
Last verified: May 2011
History of Changes
  Purpose

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.


Condition Intervention
Pain
Fatigue
Sleep Disturbance
Cancer
 Behavioral: Patient-Controlled Cognitive-Behavioral Intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: A Patient-Controlled Cognitive-Behavioral Intervention for Cancer Symptoms

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:
  • symptom severity [ Time Frame: two weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • symptom interference with daily activities [ Time Frame: two weeks ] [ Designated as safety issue: No ]

Enrollment: 86
Study Start Date: July 2009
Study Completion Date: January 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00946803

Locations
United States, Wisconsin
University of Wisconsin Carbone Cancer Center
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
University of Wisconsin, Madison
National Institute of Nursing Research (NINR)
Investigators
Principal Investigator: Kristine Kwekkeboom, PhD University of Wisconsin, Madison
  More Information

Additional Information:
Investigator profile  This link exits the ClinicalTrials.gov site

No publications provided by University of Wisconsin, Madison

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Kristine Kwekkeboom, PhD, RN, University of Wisconsin - Madison
ClinicalTrials.gov Identifier: NCT00946803     History of Changes
Other Study ID Numbers: CO08316, 1R21NR010746
Study First Received: July 23, 2009
Last Updated: May 24, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of Wisconsin, Madison:
Pain
Fatigue
Sleep
Cancer
Complementary therapies

Additional relevant MeSH terms:
Fatigue
Sleep Disorders
Dyssomnias
Parasomnias
 Signs and Symptoms
Nervous System Diseases
Neurologic Manifestations
Mental Disorders

ClinicalTrials.gov processed this record on May 23, 2013