Recruitment

Recruitment Status
Completed
Estimated Enrollment
160

Inclusion Criterias

Report all three symptoms (pain, fatigue, and sleep disturbance) as present in the past week with worst severity rating ≥ 3 (0-10 scale) for at least two of the three symptoms -
Be receiving outpatient chemotherapy.
Be 18 years of age or older.
...
Report all three symptoms (pain, fatigue, and sleep disturbance) as present in the past week with worst severity rating ≥ 3 (0-10 scale) for at least two of the three symptoms -
Be receiving outpatient chemotherapy.
Be 18 years of age or older.
Have a diagnosis of advanced (metastatic or recurrent) lung, breast, colorectal, prostate, gynecologic or other solid tumor cancer.

Exclusion Criterias

Unable to read, write, or understand English, or otherwise unable to complete study procedures.
Hospitalized for psychiatric reasons within the past 3 months.
Pain that is post-operative (< 3 months since surgery) or severe neuropathic pain.
Unable to read, write, or understand English, or otherwise unable to complete study procedures.
Hospitalized for psychiatric reasons within the past 3 months.
Pain that is post-operative (< 3 months since surgery) or severe neuropathic pain.

Summary

Conditions
  • Cancer
  • Fatigue
  • Pain
  • Sleep Disturbance
Type
Interventional
Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: None (Open Label)
  • Primary Purpose: Supportive Care

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Description

Co-occuring pain, fatigue, and sleep disturbance is a common symptom cluster among patients with advanced cancer, diminishing functional status and quality of life. Cognitive-behavioral (CB) strategies (e.g., relaxation, distraction, and imagery) are effective treatments for each of these symptoms, ...

Co-occuring pain, fatigue, and sleep disturbance is a common symptom cluster among patients with advanced cancer, diminishing functional status and quality of life. Cognitive-behavioral (CB) strategies (e.g., relaxation, distraction, and imagery) are effective treatments for each of these symptoms, and provide a logical choice in managing all three co-occurring symptoms. CB strategies are thought to work psychologically by reducing anxiety and stress, improving expectations for symptom outcomes, and enhancing perceptions of personal control. Recent research also suggests a physiologic pathway, in which CB strategies attenuate dysregulation in stress hormones and reduce proinflammatory cytokines that contribute to symptom exacerbation. CB strategies are not equally effective for all patients, with differences based on individual preferences and skills and concurrent symptoms. Thus, training in a single strategy is not sufficient. Our previous work demonstrates feasibility and initial efficacy of a patient-controlled cognitive-behavioral (PC-CB) intervention in which patients receive information about their symptoms and rationale for CB strategies, then self-administer their selection of various relaxation, distraction, and imagery strategies via MP3 player, using the CB strategies at whatever time and place they are needed. This brief intervention was designed to be mindful of the high symptom burden, unpredictable treatment course, and often short life expectancy of persons with advanced cancer. The purpose of this study is to test efficacy of the PC-CB intervention in a randomized controlled trial and to test moderators and mediators of intervention effects. The specific aims are (1) to test efficacy of the PC-CB intervention on severity, distress, and interference with daily life from the pain, fatigue, sleep disturbance symptom cluster, (2) to test proposed moderators (imaging ability, concurrent symptoms) of PC-CB intervention effects, (3) to test psychological mediators (anxiety, stress, outcome expectancy, perceived control) of PC-CB intervention effects, and (4) to explore two types of physiological mediators (neuroendocrine stress hormones and indices of inflammation) of PC-CB intervention effects. A sample of 198 adults receiving chemotherapy for advanced breast, lung, colorectal, prostate, gynecologic or other solid tumor cancers and experiencing pain, fatigue, and sleep disturbance will be recruited. Patients randomized to the PC-CB intervention will receive a brief training session and instructions to use the recorded CB strategies during 9-weeks of cancer treatment. Patients randomized to attention control will receive instructions to use cancer educational recordings over the same period. Measures of symptom severity and distress, symptom interference with daily life, and proposed psychological and physiologic mediating variables will be completed at baseline and the 3-week (primary) time point. Symptom outcome measures will be repeated at 6- and 9-week (secondary) time points to evaluate longer term treatment effects.

Inclusion Criterias

Report all three symptoms (pain, fatigue, and sleep disturbance) as present in the past week with worst severity rating ≥ 3 (0-10 scale) for at least two of the three symptoms -
Be receiving outpatient chemotherapy.
Be 18 years of age or older.
...
Report all three symptoms (pain, fatigue, and sleep disturbance) as present in the past week with worst severity rating ≥ 3 (0-10 scale) for at least two of the three symptoms -
Be receiving outpatient chemotherapy.
Be 18 years of age or older.
Have a diagnosis of advanced (metastatic or recurrent) lung, breast, colorectal, prostate, gynecologic or other solid tumor cancer.

Exclusion Criterias

Unable to read, write, or understand English, or otherwise unable to complete study procedures.
Hospitalized for psychiatric reasons within the past 3 months.
Pain that is post-operative (< 3 months since surgery) or severe neuropathic pain.
Unable to read, write, or understand English, or otherwise unable to complete study procedures.
Hospitalized for psychiatric reasons within the past 3 months.
Pain that is post-operative (< 3 months since surgery) or severe neuropathic pain.

Locations

Madison, Wisconsin, 53792
Waukesha, Wisconsin, 53188
Rockford, Illinois, 61104
Janesville, Wisconsin, 53547-5003
...
Madison, Wisconsin, 53792
Waukesha, Wisconsin, 53188
Rockford, Illinois, 61104
Janesville, Wisconsin, 53547-5003

Tracking Information

NCT #
NCT01954420
Collaborators
National Institute of Nursing Research (NINR)
Investigators
  • Principal Investigator: Kristine Kwekkeboom, PhD., RN University of Wisconsin, Madison
  • Kristine Kwekkeboom, PhD., RN University of Wisconsin, Madison