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Online Sleep Program for Survivors of Gynecologic Cancers
N/A
Recruiting
Research Sponsored by Northwestern University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Current sleep disturbance demonstrated by a Pittsburgh Sleep Quality Index (PSQI) score > 5
History of Stage I, II, or III gynecologic cancer
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (part 1 and part 2 participants), immediately after the intervention (part 1 and part 2 participants), 3-months post-intervention (part 2 participants only)
Awards & highlights
Study Summary
This trial is testing whether an online program can help gynecologic cancer survivors with insomnia.
Who is the study for?
This trial is for English-speaking gynecologic cancer survivors aged 18-74 with sleep issues, who finished their primary cancer treatment at least 30 days ago. They must have internet and phone access, and typically go to bed between 9 PM and 3 AM. Those with severe health conditions or on certain medications, other major cancers, or recent CBT-I therapy cannot join.Check my eligibility
What is being tested?
The study tests three methods to improve sleep: limiting time in bed (sleep restriction), establishing a consistent sleep routine (stimulus control), and using light exposure strategically. The goal is to find effective treatments for sleep difficulties in women who've had gynecologic cancer.See study design
What are the potential side effects?
Potential side effects are not specified but may include tiredness due to sleep restriction or discomfort adjusting to new routines. Light therapy can sometimes cause eye strain or headache.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have trouble sleeping, as shown by my PSQI score being over 5.
Select...
I had Stage I, II, or III cancer of the female reproductive organs.
Select...
I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline (part 1 and part 2 participants), immediately after the intervention (part 1 and part 2 participants), 3-months post-intervention (part 2 participants only)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (part 1 and part 2 participants), immediately after the intervention (part 1 and part 2 participants), 3-months post-intervention (part 2 participants only)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Changes in objectively-measured sleep outcomes from baseline to immediately after the intervention and 3-months post-intervention
Changes in perceived impairment during wake associated with sleep problems from baseline to immediately after the intervention and 3-months post-intervention
Changes in subjectively-reported sleep quality from baseline to immediately after the intervention and 3-months post-intervention
Secondary outcome measures
Changes in fatigue from baseline to immediately after the intervention and 3-months post-intervention
Changes in health-related quality of life (HRQOL) from baseline to immediately after the intervention and 3-months post-intervention
Changes in overall symptom burden from baseline to immediately after the intervention and 3-months post-intervention
+2 moreOther outcome measures
Changes in circadian activity rhythms from baseline to immediately after the intervention and 3-months post-intervention
Changes in urinary 6-Sulfatoxymelatonin from baseline to immediately after the intervention and 3-months post-intervention
Trial Design
8Treatment groups
Experimental Treatment
Active Control
Group I: Systematic light exposureExperimental Treatment1 Intervention
Group II: Stimulus control and Systematic light exposureExperimental Treatment2 Interventions
Group III: Stimulus controlExperimental Treatment1 Intervention
Group IV: Sleep restriction, Stimulus control, and Systematic light exposureExperimental Treatment3 Interventions
Group V: Sleep restriction and Systematic light exposureExperimental Treatment2 Interventions
Group VI: Sleep restriction and Stimulus controlExperimental Treatment2 Interventions
Group VII: Sleep RestrictionExperimental Treatment1 Intervention
Group VIII: Sleep trackingActive Control1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sleep restriction
2005
Completed Phase 1
~450
Find a Location
Who is running the clinical trial?
Northwestern UniversityLead Sponsor
1,589 Previous Clinical Trials
917,031 Total Patients Enrolled
University of ArizonaLead Sponsor
514 Previous Clinical Trials
148,499 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,667 Previous Clinical Trials
40,926,037 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I finished my ovarian cancer treatment less than 2 years ago, or any other gynecologic cancer treatment less than 30 days ago.I do not have any mental health or serious medical conditions that could affect my participation.I have trouble sleeping, as shown by my PSQI score being over 5.I had Stage I, II, or III cancer of the female reproductive organs.I have not had a non-skin, non-gynecologic cancer diagnosis in the last 5 years.I am not on medications that could interfere with the study.I plan to travel across different time zones soon.I have undergone CBT-I or bright light therapy in the last 6 months.I am male.I am 18 years old or older.I have a sleep disorder that is well managed.I have significant difficulty thinking or doing physical activities.My condition is at stage IV.
Research Study Groups:
This trial has the following groups:- Group 1: Stimulus control
- Group 2: Sleep Restriction
- Group 3: Sleep tracking
- Group 4: Sleep restriction, Stimulus control, and Systematic light exposure
- Group 5: Sleep restriction and Stimulus control
- Group 6: Sleep restriction and Systematic light exposure
- Group 7: Stimulus control and Systematic light exposure
- Group 8: Systematic light exposure
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is there still capacity for people to enroll in this research?
"Per the latest information on clinicaltrials.gov, this trial has opened for recruitment and is actively seeking applicants. First posted in October 2021, the study was most recently updated in November 2022."
Answered by AI
Is the inclusion criteria for this clinical trial limited to individuals fifty years or younger?
"For this medical trial, participants must be higher than 18 years and under 74 years of age."
Answered by AI
What are the eligibility criteria for participating in this experiment?
"Eligibility criteria for this trial are patients with dyssomnias aged between 18 and 74 years old. The study is aiming to recruit 95 participants in total."
Answered by AI
How many participants is this research team inviting to join?
"Indeed, clinicaltrials.gov data suggests that this medical trial is currently recruiting participants after being first advertised on October 11th 2021 and last updated November 23rd 2022. 95 individuals are needed at 1 site for the study to be complete."
Answered by AI
What are the fundamental goals of this research endeavor?
"This clinical trial is set to track changes in impairments associated with sleep problems, fatigue, symptom burden and anxiety from Baseline (Part 1 & Part 2 participants), immediately post-intervention (Part 1 & Part 2) and 3 months after the intervention (Part 2 only). This will be done through PROMIS Fatigue Questionnaire with T-scores calculated using a mean of 50 and standard deviation of 10. Additionally, Memorial Symptom Assessment Scale (MSAS) will evaluate overall symptoms while PROMIS Anxiety questionnaire will measure levels of stress."
Answered by AI
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