Trial Outcomes & Findings for Home-Based Programs for Improving Sleep in Cancer Survivors (NCT NCT00993928)
NCT ID: NCT00993928
Last Updated: 2019-12-03
Results Overview
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.
TERMINATED
PHASE2
93 participants
Baseline and 7 weeks
2019-12-03
Participant Flow
Participant milestones
| Measure |
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.
|
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.
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|---|---|---|
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Overall Study
STARTED
|
48
|
45
|
|
Overall Study
COMPLETED
|
43
|
38
|
|
Overall Study
NOT COMPLETED
|
5
|
7
|
Reasons for withdrawal
| Measure |
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.
|
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.
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|---|---|---|
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Overall Study
Withdrawal by Subject
|
4
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7
|
|
Overall Study
ineligible
|
1
|
0
|
Baseline Characteristics
Home-Based Programs for Improving Sleep in Cancer Survivors
Baseline characteristics by cohort
| Measure |
Arm A: Home-based Sleep Intervention With Device #1
n=43 Participants
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.
|
Arm B: Home-based Sleep Intervention With Device #2
n=38 Participants
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.
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Total
n=81 Participants
Total of all reporting groups
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|---|---|---|---|
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Age, Continuous
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55 years
n=93 Participants
|
59 years
n=4 Participants
|
57 years
n=27 Participants
|
|
Sex: Female, Male
Female
|
35 Participants
n=93 Participants
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32 Participants
n=4 Participants
|
67 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
14 Participants
n=27 Participants
|
|
Region of Enrollment
United States
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43 participants
n=93 Participants
|
38 participants
n=4 Participants
|
81 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Baseline and 7 weeksPopulation: 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.
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.
Outcome measures
| Measure |
Arm A: Home-based Sleep Intervention With Device #1
n=37 Participants
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.\>
\> Home-based sleep intervention: Participants will be asked to practice behaviors consistent with the stimulus control sheet and to read the sleep hygiene booklet.
|
Arm B: Home-based Sleep Intervention With Device #2
n=30 Participants
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.\>
\> Home-based sleep intervention: Participants will be asked to practice behaviors consistent with the stimulus control sheet and to read the sleep hygiene booklet.
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|---|---|---|
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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
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-17 percentage change
Interval -91.0 to 145.0
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-40 percentage change
Interval -86.0 to 350.0
|
|
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
Interval -90.0 to 157.0
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-45.6 percentage change
Interval -90.0 to 255.0
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SECONDARY outcome
Timeframe: Baseline and 7 weeksPopulation: 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.
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.
Outcome measures
| Measure |
Arm A: Home-based Sleep Intervention With Device #1
n=43 Participants
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.\>
\> Home-based sleep intervention: Participants will be asked to practice behaviors consistent with the stimulus control sheet and to read the sleep hygiene booklet.
|
Arm B: Home-based Sleep Intervention With Device #2
n=38 Participants
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.\>
\> Home-based sleep intervention: Participants will be asked to practice behaviors consistent with the stimulus control sheet and to read the sleep hygiene booklet.
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|---|---|---|
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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
Interval -55.0 to 200.0
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37.5 percentage of change
Interval -43.0 to 200.0
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|
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
Interval -46.0 to 333.0
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45 percentage of change
Interval -46.0 to 175.0
|
|
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
Interval -25.0 to 175.0
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20 percentage of change
Interval -30.0 to 267.0
|
|
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
Interval -71.0 to 200.0
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29 percentage of change
Interval -40.0 to 233.0
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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
Interval -100.0 to 150.0
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-44 percentage of change
Interval -100.0 to 600.0
|
|
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
Interval -91.0 to 400.0
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-48 percentage of change
Interval -100.0 to 900.0
|
|
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
Interval -83.0 to 250.0
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-48 percentage of change
Interval -92.0 to 127.0
|
|
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
Interval -95.0 to 700.0
|
-49 percentage of change
Interval -100.0 to 91.0
|
SECONDARY outcome
Timeframe: Baseline and 7 weeksPopulation: Thirty-six patients from Arm A and 31 patients from Arm B had PSQI measurements available for analysis.
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.
Outcome measures
| Measure |
Arm A: Home-based Sleep Intervention With Device #1
n=36 Participants
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.\>
\> Home-based sleep intervention: Participants will be asked to practice behaviors consistent with the stimulus control sheet and to read the sleep hygiene booklet.
|
Arm B: Home-based Sleep Intervention With Device #2
n=31 Participants
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.\>
\> Home-based sleep intervention: Participants will be asked to practice behaviors consistent with the stimulus control sheet and to read the sleep hygiene booklet.
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|---|---|---|
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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
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48 percentage of participants
|
|
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
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3 percentage of participants
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0 percentage of participants
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|
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
|
52 percentage of participants
|
SECONDARY outcome
Timeframe: At baseline and week 7Population: Patients that completed the POMS-B questionnaire at baseline and week 7 were used in this analysis.
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.
Outcome measures
| Measure |
Arm A: Home-based Sleep Intervention With Device #1
n=34 Participants
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.\>
\> Home-based sleep intervention: Participants will be asked to practice behaviors consistent with the stimulus control sheet and to read the sleep hygiene booklet.
|
Arm B: Home-based Sleep Intervention With Device #2
n=29 Participants
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.\>
\> Home-based sleep intervention: Participants will be asked to practice behaviors consistent with the stimulus control sheet and to read the sleep hygiene booklet.
|
|---|---|---|
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Total Mood Disturbance as Measured by Profiles of Mood States B (POMS-B)
|
7.8 percentage of change
Interval -40.0 to 168.0
|
7.8 percentage of change
Interval -15.0 to 88.0
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SECONDARY outcome
Timeframe: From baseline to week 7Population: All patients that completed a Distress Thermometer assessment at baseline and week 7 were included in the analysis.
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.
Outcome measures
| Measure |
Arm A: Home-based Sleep Intervention With Device #1
n=35 Participants
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.\>
\> Home-based sleep intervention: Participants will be asked to practice behaviors consistent with the stimulus control sheet and to read the sleep hygiene booklet.
|
Arm B: Home-based Sleep Intervention With Device #2
n=31 Participants
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.\>
\> Home-based sleep intervention: Participants will be asked to practice behaviors consistent with the stimulus control sheet and to read the sleep hygiene booklet.
|
|---|---|---|
|
Distress at Week 6
|
10 percentage of change
Interval -50.0 to 70.0
|
10 percentage of change
Interval -60.0 to 70.0
|
Adverse Events
Arm A: Home-based Sleep Intervention With Device #1
Arm B: Home-based Sleep Intervention With Device #2
Serious adverse events
| Measure |
Arm A: Home-based Sleep Intervention With Device #1
n=44 participants at risk
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.
|
Arm B: Home-based Sleep Intervention With Device #2
n=43 participants at risk
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.
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|---|---|---|
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Psychiatric disorders
Agitation
|
2.3%
1/44 • Number of events 2 • Adverse events were monitored weekly from week 1 to week 7.
Regardless of whether they completed study treatment or any endpoint, all patients that began intervention and were assessed for adverse events were included in the analysis.
|
0.00%
0/43 • Adverse events were monitored weekly from week 1 to week 7.
Regardless of whether they completed study treatment or any endpoint, all patients that began intervention and were assessed for adverse events were included in the analysis.
|
|
Psychiatric disorders
Anxiety
|
2.3%
1/44 • Number of events 2 • Adverse events were monitored weekly from week 1 to week 7.
Regardless of whether they completed study treatment or any endpoint, all patients that began intervention and were assessed for adverse events were included in the analysis.
|
0.00%
0/43 • Adverse events were monitored weekly from week 1 to week 7.
Regardless of whether they completed study treatment or any endpoint, all patients that began intervention and were assessed for adverse events were included in the analysis.
|
Other adverse events
| Measure |
Arm A: Home-based Sleep Intervention With Device #1
n=44 participants at risk
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.
|
Arm B: Home-based Sleep Intervention With Device #2
n=43 participants at risk
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.
|
|---|---|---|
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General disorders
Facial pain
|
2.3%
1/44 • Number of events 1 • Adverse events were monitored weekly from week 1 to week 7.
Regardless of whether they completed study treatment or any endpoint, all patients that began intervention and were assessed for adverse events were included in the analysis.
|
0.00%
0/43 • Adverse events were monitored weekly from week 1 to week 7.
Regardless of whether they completed study treatment or any endpoint, all patients that began intervention and were assessed for adverse events were included in the analysis.
|
|
Infections and infestations
Infections and infestations - Other, specify
|
0.00%
0/44 • Adverse events were monitored weekly from week 1 to week 7.
Regardless of whether they completed study treatment or any endpoint, all patients that began intervention and were assessed for adverse events were included in the analysis.
|
2.3%
1/43 • Number of events 1 • Adverse events were monitored weekly from week 1 to week 7.
Regardless of whether they completed study treatment or any endpoint, all patients that began intervention and were assessed for adverse events were included in the analysis.
|
|
Infections and infestations
Periorbital infection
|
2.3%
1/44 • Number of events 1 • Adverse events were monitored weekly from week 1 to week 7.
Regardless of whether they completed study treatment or any endpoint, all patients that began intervention and were assessed for adverse events were included in the analysis.
|
0.00%
0/43 • Adverse events were monitored weekly from week 1 to week 7.
Regardless of whether they completed study treatment or any endpoint, all patients that began intervention and were assessed for adverse events were included in the analysis.
|
|
Psychiatric disorders
Agitation
|
34.1%
15/44 • Number of events 29 • Adverse events were monitored weekly from week 1 to week 7.
Regardless of whether they completed study treatment or any endpoint, all patients that began intervention and were assessed for adverse events were included in the analysis.
|
23.3%
10/43 • Number of events 22 • Adverse events were monitored weekly from week 1 to week 7.
Regardless of whether they completed study treatment or any endpoint, all patients that began intervention and were assessed for adverse events were included in the analysis.
|
|
Psychiatric disorders
Anxiety
|
43.2%
19/44 • Number of events 49 • Adverse events were monitored weekly from week 1 to week 7.
Regardless of whether they completed study treatment or any endpoint, all patients that began intervention and were assessed for adverse events were included in the analysis.
|
34.9%
15/43 • Number of events 32 • Adverse events were monitored weekly from week 1 to week 7.
Regardless of whether they completed study treatment or any endpoint, all patients that began intervention and were assessed for adverse events were included in the analysis.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60