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A Patient-Controlled Cognitive-Behavioral Intervention for Cancer Symptoms

Primary Purpose

Pain, Fatigue, Sleep Disturbance

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Patient-Controlled Cognitive-Behavioral Intervention
Sponsored by
University of Wisconsin, Madison
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Pain focused on measuring Pain, Fatigue, Sleep, Cancer, Complementary therapies

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Wisconsin Carbone Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

PC-CB Intervention

Wait list

Arm Description

Patient-Controlled Cognitive-Behavioral Intervention

Wait list control group. Offered PC-CB Intervention after the study.

Outcomes

Primary Outcome Measures

symptom severity

Secondary Outcome Measures

symptom interference with daily activities

Full Information

First Posted
July 23, 2009
Last Updated
April 29, 2014
Sponsor
University of Wisconsin, Madison
Collaborators
National Institute of Nursing Research (NINR)
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1. Study Identification

Unique Protocol Identification Number
NCT00946803
Brief Title
A Patient-Controlled Cognitive-Behavioral Intervention for Cancer Symptoms
Official Title
A Patient-Controlled Cognitive-Behavioral Intervention for Cancer Symptoms
Study Type
Interventional

2. Study Status

Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
July 2009 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
January 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Wisconsin, Madison
Collaborators
National Institute of Nursing Research (NINR)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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 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. Secondary Aims 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Fatigue, Sleep Disturbance, Cancer
Keywords
Pain, Fatigue, Sleep, Cancer, Complementary therapies

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
86 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PC-CB Intervention
Arm Type
Experimental
Arm Description
Patient-Controlled Cognitive-Behavioral Intervention
Arm Title
Wait list
Arm Type
No Intervention
Arm Description
Wait list control group. Offered PC-CB Intervention after the study.
Intervention Type
Behavioral
Intervention Name(s)
Patient-Controlled Cognitive-Behavioral Intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
symptom severity
Time Frame
two weeks
Secondary Outcome Measure Information:
Title
symptom interference with daily activities
Time Frame
two weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kristine Kwekkeboom, PhD
Organizational Affiliation
University of Wisconsin, Madison
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Wisconsin Carbone Cancer Center
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
22771125
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.
Results Reference
derived

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A Patient-Controlled Cognitive-Behavioral Intervention for Cancer Symptoms

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