NCT00946803

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
86

participants targeted

Target at P50-P75 for not_applicable pain

Timeline
Completed

Started Jul 2009

Typical duration for not_applicable pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2009

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

July 23, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 27, 2009

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
Last Updated

April 30, 2014

Status Verified

April 1, 2014

Enrollment Period

1.4 years

First QC Date

July 23, 2009

Last Update Submit

April 29, 2014

Conditions

PainFatigueSleep DisturbanceCancer

Keywords

PainFatigueSleepCancerComplementary therapies

Outcome Measures

Primary Outcomes (1)

  • symptom severity

    two weeks

Secondary Outcomes (1)

  • symptom interference with daily activities

    two weeks

Study Arms (2)

PC-CB Intervention

EXPERIMENTAL

Patient-Controlled Cognitive-Behavioral Intervention

Behavioral: Patient-Controlled Cognitive-Behavioral Intervention

Wait list

NO INTERVENTION

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

Interventions

Patient-Controlled Cognitive-Behavioral InterventionBEHAVIORAL

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.

PC-CB Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Wisconsin Carbone Cancer Center

Madison, Wisconsin, 53792, United States

Location

Related Publications (1)

  • 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.

    PMID: 22771125DERIVED

MeSH Terms

Conditions

PainFatigueParasomniasNeoplasms

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsSleep Wake DisordersNervous System DiseasesMental Disorders

Study Officials

  • Kristine Kwekkeboom, PhD

    University of Wisconsin, Madison

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 23, 2009

First Posted

July 27, 2009

Study Start

July 1, 2009

Primary Completion

December 1, 2010

Study Completion

January 1, 2011

Last Updated

April 30, 2014

Record last verified: 2014-04

Locations

US(1)