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Sleep Education Program for Insomnia in Cancer Survivors
N/A
Recruiting
Led By Christopher Recklitis, PhD, MPH
Research Sponsored by Dana-Farber Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 13 weeks post-intervention
Awards & highlights
Study Summary
This trial is testing if a one-time, online education program can help cancer survivors get better sleep.
Who is the study for?
This trial is for cancer survivors aged 40-89 who have been cancer-free for at least a year, are not on active therapy, and suffer from significant insomnia. Participants need regular internet access and must be able to read/write in English. It's not suitable for those with bipolar or seizure disorders, untreated sleep apnea, irregular sleep patterns due to work, cognitive impairments that affect study participation, or recent involvement in other insomnia interventions.Check my eligibility
What is being tested?
The STEP-1 trial is testing if a single session online education program can improve the sleep of cancer survivors with insomnia. Participants will either receive this Sleep Treatment Education Program (STEP-1) or Enhanced Usual Care to compare effectiveness.See study design
What are the potential side effects?
Since the intervention involves educational content rather than medication, there are no direct side effects like you'd expect from drugs. However, participants may experience changes in their sleeping patterns as they apply new techniques learned.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at 16 weeks post-intervention
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 16 weeks post-intervention
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Insomnia Severity Change at 8 weeks
Secondary outcome measures
Change in Sleep Quality
Insomnia Severity Change at 4 weeks
Profile of Mood States Change at 4 Weeks
+2 moreOther outcome measures
Coaching Satisfaction Summary
Insomnia Symptoms at 16 Weeks (optional)
Intervention Satisfaction Summary
+1 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Sleep Treatment Education Program (STEP-1)Experimental Treatment1 Intervention
Prior to being randomized, all participants will complete health questionnaires.
Participants assigned to the Sleep Treatment Education Program (STEP-1) group will receive online instruction on making changes to sleep habits and health behaviors.
Participants will be contacted at 1 month and 2 months after the education session to complete follow up online questionnaires.
Group II: Enhanced Usual Care: Relaxation EducationActive Control1 Intervention
Prior to being randomized, all participants will complete health questionnaires.
Participants assigned to the Enhanced Usual Care group will receive information on relaxation techniques to improve sleep
Participants will be contacted at 1 month and 2 months after the education session to complete follow up online questionnaires.
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,660 Previous Clinical Trials
40,924,451 Total Patients Enrolled
10 Trials studying Insomnia
1,925 Patients Enrolled for Insomnia
Dana-Farber Cancer InstituteLead Sponsor
1,079 Previous Clinical Trials
340,878 Total Patients Enrolled
6 Trials studying Insomnia
494 Patients Enrolled for Insomnia
Christopher Recklitis, PhD, MPHPrincipal InvestigatorDana-Farber Cancer Insitute
2 Previous Clinical Trials
96 Total Patients Enrolled
1 Trials studying Insomnia
56 Patients Enrolled for Insomnia
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been in a study for insomnia that involved learning or behavior change.I plan to change my current medication for insomnia during the study.I have severe insomnia.I am between 40 and 89 years old.I do not have any impairments that prevent me from completing study tasks on my own.I have been diagnosed with Bipolar Disorder.I was diagnosed with cancer other than non-melanoma skin cancer over a year ago.I haven't had cancer treatment in the last 4 months and don't plan to have more.I have been diagnosed with a seizure disorder or had a seizure in the last year.My job involves irregular sleep patterns or could impact public safety.I have not participated in any formal insomnia programs in the last 2 years.
Research Study Groups:
This trial has the following groups:- Group 1: Sleep Treatment Education Program (STEP-1)
- Group 2: Enhanced Usual Care: Relaxation Education
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.
Insomnia Patient Testimony for trial: Trial Name: NCT05519982 — N/A
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is enrollment open to minors for this experiment?
"This clinical trial is geared towards patients aged 40 to 85. By contrast, there are 30 trials for younger participants and 204 studies focusing on the elderly population."
Answered by AI
Is it possible for me to join this clinical experiment?
"This medical trial is recruiting 60 individuals aged 40-85 who suffer from insomnia. In order to qualify, potential participants must have had a cancer diagnosis at least one year ago (excluding non-melanoma skin cancer), not received any active therapy in the past four months with no further treatment planned, present an Insomnia Severity Index score of 12 or higher, access the internet regularly on a daily basis and be able to read/write English fluently."
Answered by AI
Are there any available vacancies for participants in this experiment?
"According to the details on clinicaltrials.gov, this investigation is not accepting applicants at present. The trial was first shared online in January of 2023 and updated last August 26th. Nevertheless, there are 260 other experiments actively enrolling patients currently."
Answered by AI
Who else is applying?
What state do they live in?
New Hampshire
What site did they apply to?
Dana Farber Cancer Institute
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
3+
Why did patients apply to this trial?
I wake up as exhausted as I was before I went to sleep. I also wake up multiple times during the night. I am currently taking Trazodone and Nortriptyline for sleep, then Modafinil during the day to keep me awake. This is no way to live!
PatientReceived 1 prior treatment
How responsive is this trial?
Average response time
- < 2 Days
Typically responds via
Email
Most responsive sites:
- Dana Farber Cancer Institute: < 48 hours
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