Know Cancer

forgot password

A Patient-Controlled Cognitive-Behavioral Intervention for Cancer Symptoms

18 Years
Not Enrolling
Pain, Fatigue, Sleep Disturbance, Cancer

Thank you

Trial Information

A Patient-Controlled Cognitive-Behavioral Intervention for Cancer Symptoms

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.

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.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

symptom severity

Outcome Time Frame:

two weeks

Safety Issue:


Principal Investigator

Kristine Kwekkeboom, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Wisconsin, Madison


United States: Institutional Review Board

Study ID:




Start Date:

July 2009

Completion Date:

January 2011

Related Keywords:

  • Pain
  • Fatigue
  • Sleep Disturbance
  • Cancer
  • Pain
  • Fatigue
  • Sleep
  • Cancer
  • Complementary therapies
  • Fatigue
  • Sleep Disorders
  • Dyssomnias
  • Parasomnias



University of Wisconsin Carbone Cancer Center Madison, Wisconsin  53792-5669