Trial record 1 of 1 for:    NCT00993928
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Home-Based Programs for Improving Sleep in Cancer Survivors

This study is currently recruiting participants.
Verified October 2012 by Alliance for Clinical Trials in Oncology
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology ( North Central Cancer Treatment Group )
ClinicalTrials.gov Identifier:
NCT00993928
First received: October 13, 2009
Last updated: August 8, 2013
Last verified: October 2012
  Purpose

RATIONALE: Following a program that uses written materials and pre-recorded mp3 devices may help improve the sleep of cancer survivors. It is not yet known which home-based program is more effective in improving the sleep of cancer survivors.

PURPOSE: This randomized phase II trial is comparing two home-based programs for improving sleep in cancer survivors.


Condition Intervention Phase
Cancer Survivor
Fatigue
Psychosocial Effects of Cancer and Its Treatment
Sleep Disorders
Behavioral: Home-based sleep intervention
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: A Randomized Phase II Trial Evaluating Two Non-pharmacologic Interventions in Cancer Survivors for the Treatment of Sleep-wake Disturbances

Resource links provided by NLM:


Further study details as provided by Alliance for Clinical Trials in Oncology:

Primary Outcome Measures:
  • Change of the (3 day) sleep latency time and time to fall back asleep after awakening during the night from baseline to the end of study at week 7 [ Time Frame: Up to 7 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Efficacy of home-based interventions on the number of awakenings after sleep, sleep quality, sleep difficulty, and sleep latency at baseline and weeks 4 and 7 [ Time Frame: Up to 7 weeks ] [ Designated as safety issue: No ]
  • The proportion of poor and good sleepers according to the two cutoff points of the PSQI total score at week 6 [ Time Frame: Up to 6 weeks ] [ Designated as safety issue: No ]
  • Side effects [ Time Frame: Up to 6 weeks ] [ Designated as safety issue: Yes ]
  • Overall adherence rate [ Time Frame: Up to 7 weeks ] [ Designated as safety issue: No ]
  • The proportion of patients reporting an improvement in sleep at week 6 [ Time Frame: Up to 6 weeks ] [ Designated as safety issue: No ]
  • Total mood disturbance and each of the subscale measured by POMS-B [ Time Frame: Up to 7 weeks ] [ Designated as safety issue: No ]
  • The proportion of patients reporting mild to moderate distress at week 6 [ Time Frame: Up to 6 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 168
Study Start Date: April 2010
Estimated Primary Completion Date: April 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm A: Home-based sleep intervention with Device #1
Participants listen to a pre-recorded mp3 device #1 before retiring to sleep. Only patients in Arm A will have assigned bed and wake times based on their baseline diary.
Behavioral: Home-based sleep intervention
Participants will be asked to practice behaviors consistent with the stimulus control sheet and to read the sleep hygiene booklet.
Active Comparator: Arm B: Home-based sleep intervention with Device #2
Participants will listen to a pre-recorded mp3 device #2 before retiring to sleep. At the end of the study, participants assigned to pre-recorded mp3 device #2 will be offered pre-recorded mp3 device #1 for their own use.
Behavioral: Home-based sleep intervention
Participants will be asked to practice behaviors consistent with the stimulus control sheet and to read the sleep hygiene booklet.

Detailed Description:

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 sleep behavior record.
  • 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 Behavior Record 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Prior diagnosis of cancer
  • At least 2 months and ≤ 24 months since completed curative-intent treatment (chemotherapy, surgery, and/or radiotherapy)

    • Ongoing hormonal therapy (i.e., tamoxifen, aromatase inhibitors, casodex)
    • Concurrent trastuzumab and maintenance rituximab allowed
  • Sleep difficulty defined as self report of sleep latency of ≥ 30 minutes on 3 out of 7 nights in a week and wishing therapeutic intervention, and/or self report of waking up after first falling asleep and not being able to fall back asleep for ≥ 30 minutes on 3 out of 7 nights in a week
  • No history of diagnosis of primary insomnia (patient medical record, defined by having had behavioral, cognitive, or pharmacologic treatment) for > 30 consecutive days in the year before cancer diagnosis
  • No active cancer (i.e., not considered no evidence of disease)
  • No concurrent CNS malignancy
  • No history of diagnosed sleep disorder (i.e., obstructive sleep apnea, restless legs, or periodic leg movement disorder)

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-1
  • Availability of a CD player and head or earphones
  • Ability to complete questionnaires
  • No uncontrolled chronic pain (i.e., pain score of ≥ 4 on Numeric Analogue Sleep and Pain Scale)
  • No diagnosis of major depression disorder, acute anxiety disorder, or schizophrenia per medical record
  • No hot flashes that interrupt sleep
  • Not working overnight hours and unable to change schedule
  • No emotional, psychological, or physical state that, according to physician and/or study personnel evaluation, would preclude adherence to daily home intervention implementation

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • More than 4 days since prior corticosteroid, including inhaled steroids, of any dose for > 2 days
  • No prior experience with guided imagery or cognitive behavioral therapy for insomnia
  • No concurrent new herbal therapies

    • Stable dose of daily herbal supplements started ≥ 8 weeks before study intervention allowed
    • Herbal teas or herbs in various drink products allowed
  • No concurrent treatment with variable doses of any of the following:

    • Antidepressants
    • Anxiolytics
    • Pain medication (not including over the counter ad anti-inflammatory pain relievers)
  • Pharmacologic treatment for sleep/wake disturbances is allowed, but must be used for 4 weeks before study entry, and can be used daily or intermittently
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00993928

  Show 193 Study Locations
Sponsors and Collaborators
North Central Cancer Treatment Group
Investigators
Study Chair: Debra Barton, RN, PhD, AOCN, FAAN Mayo Clinic
  More Information

Additional Information:
No publications provided

Responsible Party: Alliance for Clinical Trials in Oncology ( North Central Cancer Treatment Group )
ClinicalTrials.gov Identifier: NCT00993928     History of Changes
Other Study ID Numbers: NCCTG-N07C4, NCI-2011-01978, CDR0000656564
Study First Received: October 13, 2009
Last Updated: August 8, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Alliance for Clinical Trials in Oncology:
psychosocial effects of cancer and its treatment
fatigue
sleep disorders
cancer survivor

Additional relevant MeSH terms:
Fatigue
Sleep Disorders
Parasomnias
Signs and Symptoms
Nervous System Diseases
Neurologic Manifestations
Mental Disorders

ClinicalTrials.gov processed this record on April 16, 2014