This early phase I trial evaluates the effect of thermal therapy on depression with or without sleep disturbance in cancer survivors. Thermal therapy may help improve quality of life, physical capacity, fatigue, and enhance positive mood and sleep quality. The purpose of this study is to evaluate the potential of thermal therapy to improve patient's quality of life by reducing symptoms of depression, sleep disruption, fatigue and anxiety in cancer survivors.
PRIMARY OBJECTIVE: I. To evaluate the potential of thermal therapy to improve quality of life by reducing symptoms of depression in cancer survivors. SECONDARY OBJECTIVE: I. To evaluate the potential of thermal therapy to improve quality of life by reducing symptoms of sleep disruption in cancer survivors. EXPLORATORY OBJECTIVE: I. To evaluate the potential of thermal therapy to improve quality of life by reducing symptoms of fatigue, anxiety and other generally debilitating aspects of increased stress in cancer survivors. OUTLINE: Patients undergo thermal therapy over 2.5 hours. After completion of study treatment, patients are followed up at weeks 1 or 2, 3 or 4, and then monthly for months 2-4.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Roswell Park Cancer Institute
Buffalo, New York, United States
Change in depression
Measured by the Hamilton Depression Rating Scale.
Time frame: Baseline to 1 or 2 weeks after completion of therapy
Durability of and variability in the response over time
Hypothesis tests of mixed effect model fixed effect slope parameters representing the population averaged changes in HDRS over time will be used to investigate whether the thermal intervention effects are durable over the course of the study.
Time frame: Up to 4 months after completion of therapy
Change in Pittsburgh Sleep Quality Index scores
A 19 self-rated questionnaire. Each item is weighted on a 0-3 interval scale where lower scores denote a healthier sleep quality.
Time frame: Baseline, up to 4 months
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