Home-Based Programs for Improving Sleep in Cancer Survivors
The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2011 by National Cancer Institute (NCI).
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
North Central Cancer Treatment Group
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00993928
First received: October 13, 2009
Last updated: May 11, 2011
Last verified: May 2011
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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: compliance monitoring Other: educational intervention Other: questionnaire administration Procedure: fatigue assessment and management Procedure: psychosocial assessment and care Procedure: quality-of-life assessment Procedure: sleep disorder therapy Procedure: stress management therapy |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized 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 National Cancer Institute (NCI):
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 [ 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 [ Designated as safety issue: No ]
- Percentage of participants in each group who have improved sleep per the PSQI [ Designated as safety issue: No ]
- Side effects [ Designated as safety issue: Yes ]
- Overall adherence rate [ Designated as safety issue: No ]
| Estimated Enrollment: | 168 |
| Study Start Date: | April 2010 |
| Estimated Primary Completion Date: | May 2011 (Final data collection date for primary outcome measure) |
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.
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)
- Concurrent hormonal therapy (e.g., tamoxifen or aromatase inhibitors) allowed
- 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)
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00993928
Show 111 Study Locations
Show 111 Study LocationsSponsors and Collaborators
North Central Cancer Treatment Group
Investigators
| Study Chair: | Debra Barton, RN, PhD, AOCN, FAAN | Mayo Clinic |
| Study Chair: | Teri Pipe, PhD, RN | Mayo Clinic |
More Information
Additional Information:
No publications provided
| Responsible Party: | Jan C. Buckner, North Central Cancer Treatment Group |
| ClinicalTrials.gov Identifier: | NCT00993928 History of Changes |
| Other Study ID Numbers: | CDR0000656564, NCCTG-N07C4 |
| Study First Received: | October 13, 2009 |
| Last Updated: | May 11, 2011 |
| Health Authority: | Unspecified |
Keywords provided by National Cancer Institute (NCI):
|
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 June 18, 2013