Clinical Trials

OBJECTIVES:

     Primary

       -  To compare the efficacy of two home-based sleep interventions as therapy for sleep-wake disturbances,as measured by sleep latency or time to fall back asleep after initial sleep onset per sleep diaries, at baseline (week 1) and at the end of week 7 in cancer survivors.

     Secondary

       -  To compare the efficacy of these interventions as therapy for sleep-wake disturbances as measured by the number of awakenings after sleep, sleep quality, sleep difficulty, and sleep latency at baseline (week 1) and weeks 4 and 7 in these participants.

       -  To compare the efficacy of these interventions as therapy for sleep-wake disturbances as measured by the percentage of participants in each group who show improved sleep per the Pittsburgh Sleep Quality Index.

       -  To compare the effects of these interventions on fatigue, mood disturbance, sleep, benefit, and distress in this patient population.

       -  To describe the side effects associated with these interventions in these patients.

       -  To describe patient practice habits and adherence measured via a practice diary.

       -  To explore symptom clusters in this patient population and look at distress as a mediating variable. (Exploratory)

       -  To explore predictors of sleep quality. (Exploratory)

     OUTLINE: This is a multicenter study. Patients are stratified according to current (≥ 1 per week in the past 4 weeks) pharmacological treatment, including anxiolytics, for insomnia or mood (yes vs no), current pharmacologic treatment for pain (yes vs no), sleep difficulty period (≤ 1 month vs > 1 month), and age (≤ 50 vs 51-70 vs > 70 years). Patients are randomized to 1 of 2 intervention groups.

       -  Group 1: Participants receive a home-based sleep intervention comprising a Sleep Hygiene Education booklet, printed stimulus-control guidelines, instructions on sleeping restrictions, and a guided-imagery pre-recorded mp3 device. Participants meet with study personnel for intervention refinement and are asked to practice behaviors consistent with the stimulus-control sheet, to read the sleep hygiene booklet one chapter per day for 7 days during the first week, and then as needed during study. They are also instructed to use the CD, with or without headphones, in a quiet and comfortable place without lights for up to 30 minutes every day for 6 weeks before bedtime. Participants are instructed to go to sleep and wake at the same time every day during study intervention.

       -  Group 2: Participants receive a home-based sleep intervention comprising a Sleep Hygiene Education booklet, printed stimulus-control guidelines, and a pre-recorded mp3 device containing short stories and essays. Participants meet with study personnel and are instructed to practice behaviors consistent with the stimulus control sheet, to read the sleep hygiene booklet, and use the CD as in group 1. Participants are not instructed about sleeping restrictions. They are offered the guided-imagery CD after study completion.

     Patients complete a Three-Day Sleep Diary for 3 consecutive days at baseline and during weeks 4 and 7 of study intervention. Patients also complete questionnaires on Numeric Analog Sleep for Pain Scale, daily use of CD, Sleep Hygiene Practice, Pittsburgh Sleep Quality Index, Profile of Mood States, Brief Fatigue Inventory, Distress Thermometer, Side-Effect Questionnaire, and a Subject Global Impression of Change at baseline, during weeks 2 and 6, and after completion of study intervention.

The overall aim of this protocol is to examine patient and care-giver outcomes and acceptance of a new 6 week intervention in Arizona for our transplant patients and their care-givers, designed to improve quality of life, decrease perceived stress, and improve medical outcomes, that has been approved as a pilot clinical program at Mayo Clinic in Arizona.

PRIMARY OBJECTIVES:

     I. To assess the safety and feasibility of short-term fasting prior to administration of chemotherapy.

     SECONDARY OBJECTIVES:

     I. To evaluate weight changes in patients who are exposed to short-term fasting prior to chemotherapy.

     II. To get a preliminary estimate of the longest feasible fasting period prior to chemotherapy.

     III. To evaluate the toxicity profile of systemic chemotherapy treatment in patients who undergo short-term fasting prior to treatment.

     IV. To investigate changes in plasma glucose, insulin, IGF-1 and IGF-1BP in patients who undertake short-term fasting.

     OUTLINE:

     COHORT I: Patients fast 24 hours before day 1 of course 2 of chemotherapy. If fast is well tolerated, patients may escalate fasting by 12 hours for each subsequent course of chemotherapy for up to 3 courses in the absence of unacceptable toxicity.

     COHORT II: Patients fast at the longest fasting regimen found to be safe and tolerable in cohort I before day 1 of each course of course of chemotherapy for up to 4 courses in the absence of unacceptable toxicity.