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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01954420
Other study ID # 2013-0733
Secondary ID OS11322R01NR0134
Status Completed
Phase N/A
First received
Last updated
Start date December 2013
Est. completion date January 31, 2017

Study information

Verified date February 2017
Source University of Wisconsin, Madison
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of the research is to test the efficacy of a patient-controlled cognitive-behavioral intervention for pain, fatigue, and sleep disturbance during cancer treatment, and to evaluate moderators and mediators of intervention effects. The intervention uses guided imagery, relaxation exercises, and nature sound recordings, self-administered via an MP3 player. The study will determine (1) if the intervention helps to control symptoms during chemotherapy, (2) if personal and clinical characteristics influence how well the intervention works, and (3) if the cognitive-behavioral strategies reduce markers of stress and inflammation found in blood and saliva.


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, 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.


Recruitment information / eligibility

Status Completed
Enrollment 188
Est. completion date January 31, 2017
Est. primary completion date January 31, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- 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.

- Be receiving outpatient chemotherapy.

- 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 -

Exclusion Criteria:

- Pain that is post-operative (< 3 months since surgery) or severe neuropathic pain.

- Hospitalized for psychiatric reasons within the past 3 months.

- Unable to read, write, or understand English, or otherwise unable to complete study procedures.

Study Design


Intervention

Behavioral:
Cognitive-Behavioral Intervention
Standard care + Selection of 12 recorded imagery- and non imagery-based cognitive-behavioral coping strategies provided on an MP3 player.
Other:
Attention Control
Standard care + Cancer education

Locations

Country Name City State
United States Mercy Health System Janesville Wisconsin
United States University of Wisconsin Madison Wisconsin
United States SwedishAmerican Regional Cancer Center Rockford Illinois
United States ProHealth Care Waukesha Wisconsin

Sponsors (2)

Lead Sponsor Collaborator
University of Wisconsin, Madison National Institute of Nursing Research (NINR)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Quality of Life 3-, 6-, 9-weeks
Primary Symptom Cluster Severity 3-weeks
Primary Symptom Cluster Distress 3-weeks
Primary Symptom Cluster Interference with Daily Life 3-weeks
Secondary Symptom Cluster Severity 6- and 9-weeks
Secondary Symptom Cluster Distress 6- and 9-weeks
Secondary Symptom Cluster Interference with Daily Life 6- and 9-weeks
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