Thermal Therapy for the Treatment of Depression in Cancer Survivors, the S-WARM Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Survivor Warming to Alter Mood (S-WARM)

Conditions
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Hematopoietic and Lymphoid Cell Neoplasm, Malignant Solid Neoplasm

Intervention / Treatment
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* Other: Quality-of-Life Assessment
* Other: Questionnaire Administration
* Procedure: Thermotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who have had therapy for malignancy Age >= 18 years Have an Eastern Cooperative Oncology Group (ECOG) performance status of =< 2 Patient or legal representative must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure Patient denies current pregnancy Patients who screen positive on the depression/anxiety domain will be given the Hamilton Depression Rating Scale. Those with a score of 16 or more on this scale will be eligible for intervention Exclusion Criteria: History of prior myocardial infarction. These patients may be allowed with clearance from a cardiologist History of any condition deemed by the principal investigator to be a contraindication to S-WARM therapy (e.g., skin reaction, dysregulation of thermoregulation, etc.) All patients with transdermal patches (e.g.; fentanyl, Lidoderm, scopolamine, etc.) Unwilling or unable to follow protocol requirements Any condition which in the Investigator's opinion deems the patient an unsuitable candidate to receive S-WARM Received an investigational agent within 30 days prior to enrollment Uncontrolled concurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements Patients on dialysis

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment of depression (thermal therapy)<br>Patients undergo thermal therapy over 2.5 hours. | Other: Quality-of-Life Assessment<br>* Ancillary studies<br>* Other names: Quality of Life Assessment;Other: Questionnaire Administration<br>* Ancillary studies<br>Procedure: Thermotherapy<br>* Undergo thermal therapy<br>* Other names: Heat Therapy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in depression | Measured by the Hamilton Depression Rating Scale. | Baseline to 1 or 2 weeks after completion of therapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | Baseline, up to 4 months |