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

This study has been terminated.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier:
NCT00993928
First received: October 13, 2009
Last updated: January 11, 2017
Last verified: January 2017
Results First Received: January 11, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Supportive Care
Conditions: Cancer Survivor
Fatigue
Psychosocial Effects of Cancer and Its Treatment
Sleep Disorders
Intervention: Behavioral: Home-based sleep intervention

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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.

Participant Flow:   Overall Study
    Arm A: Home-based Sleep Intervention With Device #1   Arm B: Home-based Sleep Intervention With Device #2
STARTED   48   45 
COMPLETED   43   38 
NOT COMPLETED   5   7 
Withdrawal by Subject                4                7 
ineligible                1                0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All eligible patients that started protocol treatment were included in baseline analysis.

Reporting Groups
  Description
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.
Total Total of all reporting groups

Baseline Measures
   Arm A: Home-based Sleep Intervention With Device #1   Arm B: Home-based Sleep Intervention With Device #2   Total 
Overall Participants Analyzed 
[Units: Participants]
 43   38   81 
Age 
[Units: Years]
Median (Full Range)
 55 
 (36 to 78) 
 59 
 (31 to 77) 
 57 
 (31 to 78) 
Gender 
[Units: Participants]
Count of Participants
     
Female      35  81.4%      32  84.2%      67  82.7% 
Male      8  18.6%      6  15.8%      14  17.3% 
Region of Enrollment 
[Units: Participants]
     
United States   43   38   81 


  Outcome Measures
  Show All Outcome Measures

1.  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   [ Time Frame: Up to 7 weeks ]

2.  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.   [ Time Frame: Up to 7 weeks ]

3.  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)   [ Time Frame: 7 weeks ]

4.  Secondary:   Total Mood Disturbance as Measured by Profiles of Mood States B (POMS-B)   [ Time Frame: At baseline and week 7 ]

5.  Secondary:   Distress at Week 6   [ Time Frame: From baseline to week 7 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Charles Lawrence Loprinzi, M.D.
Organization: Mayo Clinic
e-mail: cloprinzi@mayo.edu



Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT00993928     History of Changes
Other Study ID Numbers: NCCTG-N07C4
NCI-2011-01978 ( Registry Identifier: CTRP (Clinical Trials Reporting System) )
CDR0000656564 ( Registry Identifier: PDQ (Physician Data Query) )
Study First Received: October 13, 2009
Results First Received: January 11, 2017
Last Updated: January 11, 2017