Cancer Survivor, Fatigue, Psychosocial Effects of Cancer and Its Treatment, Sleep Disorders
Conditions
Keywords
psychosocial effects of cancer and its treatment, fatigue, sleep disorders, cancer survivor
Brief summary
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.
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.
Interventions
BEHAVIORALHome-based sleep intervention
Participants will be asked to practice behaviors consistent with the stimulus control sheet and to read the sleep hygiene booklet.
Sponsors
National Cancer Institute (NCI)
Alliance for Clinical Trials in Oncology
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Baseline and 7 weeks | The primary analysis will compare the change in time (in minutes) to fall asleep from baseline to week 7 as reported by question 3 in the sleep diary: How long did it take you to get to sleep last night? and time to fall back asleep after awakening during the night as reported by question 6A on sleep dairy: When waking up after first falling asleep, how long did it take you to fall back to sleep? \> \> Data were analyzed as a percent change from baseline to week 7. The percent change were compared between arms using a Wilcoxon rank-sum test. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. | Baseline and 7 weeks | Overall efficacy was analyzed as a composite of 4 outcomes: 1. sleep difficulty, 2. sleep quality, 3. Number of awakenings, and 4. Sleep latency. These 4 outcomes were measured by the responses to the following questions, respectively:\> 1. How difficult was it to get to sleep last night? (scale 1-5, 5 meaning very easy)\> 2. How deeply did you sleep last night? (scale 1-5, 5 meaning very deeply)\> 3. How many times did you awaken last night?\> 4. How long did it take you to get to sleep last night?\> \> The 4 questions were analyzed as percent change from baseline after week 4 and after week 7. The percent change between arms was analyzed using a Wilcoxon test. |
| Comparing the Efficacy of Two Home-based Sleep Interventions as Therapy for Sleep-wake Disturbances as Measured by the Percent of People Who Show Improved Sleep Per the Pittsburgh Sleep Quality Index (PSQI) | Baseline and 7 weeks | The PSQI has 19 items and seven component scales: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep-wake disturbances, use of sleep medication, and daytime dysfunction. The scoring algorithm yields seven component scales on 0-3 scales which are summed to produce a global score on a 0-21 scale with higher values representing more severe sleep difficulty. The percentage of patients that showed improvement or worsening in sleep score from baseline to Week 7 were analyzed and compared using a Chi-squared test. |
| Total Mood Disturbance as Measured by Profiles of Mood States B (POMS-B) | At baseline and week 7 | The POMS-B is a shortened version of the original POMS with 30 items each asking the patient to select how he/she has been feeling during the past week with respect to an adjective such as tense, angry, worn out, etc., on a 0-4 scale (0=not at all; 4=extremely). The POMS-B consists of six identifiable mood states (tension/anxiety, depression/dejection, anger/hostility, vigor/activity, fatigue/inertia, and confusion/bewilderment) and measures the patient's total mood disturbance. This study analyzed total mood disturbance (total scale score) as a secondary endpoints. Possible weekly scores ranged from 0-120. Week 7 scores were analyzed as a percentage change from baseline with a negative score representing a worsening condition. A Wilcoxon rank-sum test was used to compare treatment arms. |
| Distress at Week 6 | From baseline to week 7 | The Distress Thermometer is a single-item tool which asks patients to describe how much distress he/she has been experiencing in the past week on a scale of 0 to 10 (0=no distress, 10=extreme distress). The Distress Thermometer was selected for this study due to its brevity. Week 7 distress measures were analyzed as percent change from baseline and analyzed between arms with a t-test. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 43 |
| 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. | 38 |
| Total | 81 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | ineligible | 1 | 0 |
| Overall Study | Withdrawal by Subject | 4 | 7 |
Baseline characteristics
| Characteristic | Arm A: Home-based Sleep Intervention With Device #1 | Arm B: Home-based Sleep Intervention With Device #2 | Total |
|---|---|---|---|
| Age, Continuous | 55 years | 59 years | 57 years |
| Region of Enrollment United States | 43 participants | 38 participants | 81 participants |
| Sex: Female, Male Female | 35 Participants | 32 Participants | 67 Participants |
| Sex: Female, Male Male | 8 Participants | 6 Participants | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 44 | 0 / 43 |
| other Total, other adverse events | 22 / 44 | 18 / 43 |
| serious Total, serious adverse events | 1 / 44 | 0 / 43 |
Outcome results
Primary
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
The primary analysis will compare the change in time (in minutes) to fall asleep from baseline to week 7 as reported by question 3 in the sleep diary: How long did it take you to get to sleep last night? and time to fall back asleep after awakening during the night as reported by question 6A on sleep dairy: When waking up after first falling asleep, how long did it take you to fall back to sleep? \> \> Data were analyzed as a percent change from baseline to week 7. The percent change were compared between arms using a Wilcoxon rank-sum test.
Time frame: Baseline and 7 weeks
Population: In Arm A, 4 went off treatment prior to week 7 and 2 had missing data. 23 patients were able to respond to question 6A. In Arm B, 7 did not finish 7 weeks of treatment and 1 patient had missing data. 16 patients responded to question 6A. Therefore, Q3 and Q6A are based on 37 and 23 patients in Arm A and 30 and 23 patients from Arm B, respectively.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Arm A: Home-based Sleep Intervention With Device #1 | 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 | Q3: Sleep Latency | -25 percentage change |
| Arm A: Home-based Sleep Intervention With Device #1 | 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 | Q6A: TIme to fall back Asleep | -17 percentage change |
| Arm B: Home-based Sleep Intervention With Device #2 | 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 | Q3: Sleep Latency | -45.6 percentage change |
| Arm B: Home-based Sleep Intervention With Device #2 | 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 | Q6A: TIme to fall back Asleep | -40 percentage change |
Comparison: Comparison of Q3: Percent change in sleep latency from baseline to week 7.p-value: 0.85Wilcoxon (Mann-Whitney)
Comparison: Comparison of Q6A: Percent change in time to fall back asleep from baseline to week 7.p-value: 0.86Wilcoxon (Mann-Whitney)
Secondary
Comparing the Efficacy of Two Home-based Sleep Interventions as Therapy for Sleep-wake Disturbances as Measured by the Percent of People Who Show Improved Sleep Per the Pittsburgh Sleep Quality Index (PSQI)
The PSQI has 19 items and seven component scales: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep-wake disturbances, use of sleep medication, and daytime dysfunction. The scoring algorithm yields seven component scales on 0-3 scales which are summed to produce a global score on a 0-21 scale with higher values representing more severe sleep difficulty. The percentage of patients that showed improvement or worsening in sleep score from baseline to Week 7 were analyzed and compared using a Chi-squared test.
Time frame: Baseline and 7 weeks
Population: Thirty-six patients from Arm A and 31 patients from Arm B had PSQI measurements available for analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm A: Home-based Sleep Intervention With Device #1 | Comparing the Efficacy of Two Home-based Sleep Interventions as Therapy for Sleep-wake Disturbances as Measured by the Percent of People Who Show Improved Sleep Per the Pittsburgh Sleep Quality Index (PSQI) | Improvement | 36 percentage of participants |
| Arm A: Home-based Sleep Intervention With Device #1 | Comparing the Efficacy of Two Home-based Sleep Interventions as Therapy for Sleep-wake Disturbances as Measured by the Percent of People Who Show Improved Sleep Per the Pittsburgh Sleep Quality Index (PSQI) | Worsening | 3 percentage of participants |
| Arm A: Home-based Sleep Intervention With Device #1 | Comparing the Efficacy of Two Home-based Sleep Interventions as Therapy for Sleep-wake Disturbances as Measured by the Percent of People Who Show Improved Sleep Per the Pittsburgh Sleep Quality Index (PSQI) | No Chanage | 61 percentage of participants |
| Arm B: Home-based Sleep Intervention With Device #2 | Comparing the Efficacy of Two Home-based Sleep Interventions as Therapy for Sleep-wake Disturbances as Measured by the Percent of People Who Show Improved Sleep Per the Pittsburgh Sleep Quality Index (PSQI) | Improvement | 48 percentage of participants |
| Arm B: Home-based Sleep Intervention With Device #2 | Comparing the Efficacy of Two Home-based Sleep Interventions as Therapy for Sleep-wake Disturbances as Measured by the Percent of People Who Show Improved Sleep Per the Pittsburgh Sleep Quality Index (PSQI) | Worsening | 0 percentage of participants |
| Arm B: Home-based Sleep Intervention With Device #2 | Comparing the Efficacy of Two Home-based Sleep Interventions as Therapy for Sleep-wake Disturbances as Measured by the Percent of People Who Show Improved Sleep Per the Pittsburgh Sleep Quality Index (PSQI) | No Chanage | 52 percentage of participants |
p-value: 0.42Chi-squared
Secondary
Distress at Week 6
The Distress Thermometer is a single-item tool which asks patients to describe how much distress he/she has been experiencing in the past week on a scale of 0 to 10 (0=no distress, 10=extreme distress). The Distress Thermometer was selected for this study due to its brevity. Week 7 distress measures were analyzed as percent change from baseline and analyzed between arms with a t-test.
Time frame: From baseline to week 7
Population: All patients that completed a Distress Thermometer assessment at baseline and week 7 were included in the analysis.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Arm A: Home-based Sleep Intervention With Device #1 | Distress at Week 6 | 10 percentage of change |
| Arm B: Home-based Sleep Intervention With Device #2 | Distress at Week 6 | 10 percentage of change |
Comparison: Compare percent change from baseline to week 7 Distress Thermometer score.p-value: 0.64t-test, 2 sided
Secondary
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.
Overall efficacy was analyzed as a composite of 4 outcomes: 1. sleep difficulty, 2. sleep quality, 3. Number of awakenings, and 4. Sleep latency. These 4 outcomes were measured by the responses to the following questions, respectively:\> 1. How difficult was it to get to sleep last night? (scale 1-5, 5 meaning very easy)\> 2. How deeply did you sleep last night? (scale 1-5, 5 meaning very deeply)\> 3. How many times did you awaken last night?\> 4. How long did it take you to get to sleep last night?\> \> The 4 questions were analyzed as percent change from baseline after week 4 and after week 7. The percent change between arms was analyzed using a Wilcoxon test.
Time frame: Baseline and 7 weeks
Population: In Arm A, 38 patients responded to questions during week 4 and 37 responded during week 7. In Arm B, 31 patients responded during week 4 and 30 responded during week 7.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Arm A: Home-based Sleep Intervention With Device #1 | 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. | Sleep Difficulty: Week 4 | 18 percentage of change |
| Arm A: Home-based Sleep Intervention With Device #1 | 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. | Sleep Difficulty: Week 7 | 20 percentage of change |
| Arm A: Home-based Sleep Intervention With Device #1 | 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. | Sleep Quality: Week 4 | 13 percentage of change |
| Arm A: Home-based Sleep Intervention With Device #1 | 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. | Sleep Quality: Week 7 | 22 percentage of change |
| Arm A: Home-based Sleep Intervention With Device #1 | 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. | Number of Awakenings: Week 4 | -40 percentage of change |
| Arm A: Home-based Sleep Intervention With Device #1 | 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. | Number of Awakenings: Week 7 | -50 percentage of change |
| Arm A: Home-based Sleep Intervention With Device #1 | 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. | Sleep Latency: Week 4 | -37 percentage of change |
| Arm A: Home-based Sleep Intervention With Device #1 | 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. | Sleep Latency: Week 7 | -24 percentage of change |
| Arm B: Home-based Sleep Intervention With Device #2 | 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. | Sleep Latency: Week 7 | -49 percentage of change |
| Arm B: Home-based Sleep Intervention With Device #2 | 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. | Sleep Difficulty: Week 4 | 37.5 percentage of change |
| Arm B: Home-based Sleep Intervention With Device #2 | 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. | Number of Awakenings: Week 4 | -44 percentage of change |
| Arm B: Home-based Sleep Intervention With Device #2 | 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. | Sleep Difficulty: Week 7 | 45 percentage of change |
| Arm B: Home-based Sleep Intervention With Device #2 | 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. | Sleep Latency: Week 4 | -48 percentage of change |
| Arm B: Home-based Sleep Intervention With Device #2 | 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. | Sleep Quality: Week 4 | 20 percentage of change |
| Arm B: Home-based Sleep Intervention With Device #2 | 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. | Number of Awakenings: Week 7 | -48 percentage of change |
| Arm B: Home-based Sleep Intervention With Device #2 | 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. | Sleep Quality: Week 7 | 29 percentage of change |
Secondary
Total Mood Disturbance as Measured by Profiles of Mood States B (POMS-B)
The POMS-B is a shortened version of the original POMS with 30 items each asking the patient to select how he/she has been feeling during the past week with respect to an adjective such as tense, angry, worn out, etc., on a 0-4 scale (0=not at all; 4=extremely). The POMS-B consists of six identifiable mood states (tension/anxiety, depression/dejection, anger/hostility, vigor/activity, fatigue/inertia, and confusion/bewilderment) and measures the patient's total mood disturbance. This study analyzed total mood disturbance (total scale score) as a secondary endpoints. Possible weekly scores ranged from 0-120. Week 7 scores were analyzed as a percentage change from baseline with a negative score representing a worsening condition. A Wilcoxon rank-sum test was used to compare treatment arms.
Time frame: At baseline and week 7
Population: Patients that completed the POMS-B questionnaire at baseline and week 7 were used in this analysis.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Arm A: Home-based Sleep Intervention With Device #1 | Total Mood Disturbance as Measured by Profiles of Mood States B (POMS-B) | 7.8 percentage of change |
| Arm B: Home-based Sleep Intervention With Device #2 | Total Mood Disturbance as Measured by Profiles of Mood States B (POMS-B) | 7.8 percentage of change |