Trial Information

A Randomized Phase II Trial Evaluating Two Non-pharmacologic Interventions in Cancer Survivors for the Treatment of Sleep-wake Disturbances

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.