InsomniaNCT05358951
Sleep Treatment Education Program for Young Adult Cancer Survivors (STEP-YA)
A study testing STEP-YA with Coaching and STEP-YA without Coaching in people with Insomnia and Insomnia Due to Medical Condition, run by Dana-Farber Cancer Institute at 1 site in United States.
Trial summary
The purpose of the study is to learn if a single online education session, with or without individualized coaching sessions, can help improve young adult cancer survivors' (YACS) sleep. The name of the study intervention is Sleep Treatment Education Program for Young Adult Cancer Survivors (STEP-YA). Read more about this study
- Who is it for?
- Ages 20 to 39 years
- Conditions the study is for
- Insomnia, Insomnia Due to Medical Condition, Cancer
- What is being tested?
- STEP-YA with Coaching and STEP-YA without Coaching
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Nov 2022to 28 Jul 2025
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 39 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- To be determined by patient self-report from eligibility screening with potential participants. (See Appendix A for eligibility screening materials). Participants must be screened for eligibility ≤2 weeks prior to study enrollment. Participants who are screened earlier must be rescreened within this period.
- Age 20-39
- History of a cancer diagnosis (except non-melanoma skin cancer) ≥ 1 year prior
- No active cancer therapy (excluding chemoprevention) in the past four months, and no further therapy planned
- Significant insomnia as evidenced by an Insomnia Severity Index score ≥12
- Able to read and write in English
Who cannot join
- Survivors who report ever being diagnosed with Bipolar Disorder.
- Survivors who report ever being diagnosed with a Seizure Disorder or have experienced a seizure in the past 12 months.
- Intention to adjust (decrease or increase) use of any prescribed or over-the-counter medications taken to decrease insomnia during the study period.
- Survivors who report being diagnosed with sleep apnea who are not receiving recommended medical treatment for their sleep apnea (as assessed by screening questions, see Appendix A).
- Survivors who report suspected sleep apnea who have not completed an evaluation by a sleep specialist (as assessed by screening questions, see Appendix A).
- Survivors who report their usual bedtime does not fall between 5:00 pm and 5:00 am.
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- Employment that involves irregular sleep patterns, such as shift-work or frequent long-distance travel across time zones, or employment in a position that could impact public safety (such as air traffic-controller, operating heavy machinery)
- Any impairment (e.g., hearing, visual, cognitive) that interferes with the ability to complete all study procedures independently.
- Prior participation in a research study which provided an educational or behavioral intervention for insomnia
- Prior participation in a behavioral treatment or patient education program for insomnia delivered at the Dana-Farber Cancer Institute, or at Boston Children's Hospital.
- Participation in behavioral or educational interventions for insomnia in the 2 years prior to enrollment. This includes in-person as well as synchronous and asynchronous online insomnia programs, but not independent use of books, workbooks or other written self-help materials addressing insomnia.
Trial locations and contacts
1 site in 1 country.
United States1 site
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
About this study
Official title: Sleep Treatment Education Program for Young Adult Cancer Survivors (STEP-YA): An Online Educational Intervention for Insomnia
The purpose of the study is to learn if a single online education session, with or without individualized coaching sessions, can help improve young adult cancer survivors' (YACS) sleep.
The name of the study intervention is Sleep Treatment Education Program for Young Adult Cancer Survivors (STEP-YA).
Read the detailed description
This study is a randomized controlled trial of young adult cancer survivors with clinically significant symptoms of insomnia to evaluate the cognitive-behavioral based Sleep Treatment Education Program for Young Adult Cancer Survivors (STEP-YA).
All participants will take part in a single STEP-YA session, during which they will complete baseline measures prior to randomization and then receive the STEP-YA intervention. Participants will then be randomly assigned to receive the STEP-YA intervention either, 1) alone (non-coaching condition), or 2) with the addition of 2 remote coaching sessions (coaching condition). Participants will also complete follow-up measures 4 and 8 weeks post-baseline.
It expected that about 74 people will take part in this study
- Conditions
- Insomnia, Insomnia Due to Medical Condition, Cancer
- Being tested
- STEP-YA with Coaching, STEP-YA without Coaching
- Keywords
- Insomnia, Insomnia Due to Medical Condition, Cancer
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STEP-YA with CoachingBehavioural
Online instruction on behavioral changes to improve sleep with 2 additional individually coached session
STEP-YA without CoachingBehavioural
Online instruction on behavioral changes to improve sleep without additional individually coached session
| Study group | Role | What they receive |
|---|---|---|
| NON-COACHING CONDITION STEP-YA | Active comparator | Participants will receive a single online education session and complete online questionnaires then be randomized to not receive additional coaching support sessions.
Participates will also complete follow up questionaires at 4 and 8 weeks post baseline. Receives: Behavioral: STEP-YA without Coaching |
| COACHING CONDITION STEP-YA | Experimental | Participants will receive a single online education session and complete online questionnaire then be randomized to receive 2 individualized remote coaching sessions.
Participates will also complete follow up questionaires at 4 and 8 weeks post baseline. Receives: Behavioral: STEP-YA with Coaching |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insomnia Severity Change at 8 Weeks
The Insomnia Severity Index (ISI) is a 7-item measure used to evaluate insomnia severity (e.g. dissatisfaction with sleep and worry about sleep problems). Item response values are totaled to calculate a total ISI score ranging from 0-28, with higher scores indicating more insomnia symptom burden.
Measured: Baseline to 8-weeks post-intervention session
Secondary outcomes (3)
Profile of Mood States Change at 8 Weeks
The Profile of Mood States-Short Form (POMS-SF) is a 35-item measure of mood. Items responses are totaled to calculate scores on 7 subscales: Anger-Hostility, Confusion-Bewilderment, Depression-Dejection, Fatigue-Inertia, Tension-Anxiety, Vigor-Activity, and Friendliness. The Total Mood Disturbance (TMD) score used in the study is calculated by adding together the scores of 5 subscales, Anger-Hostility, Confusion-Bewilderment, Depression-Dejection, Fatigue-Inertia, Tension-Anxiety, then subtracting the score from the Vigor-Activity subscale. TMD scores range from -20 to 100 with higher scores indicating greater impairment.
Measured: Baseline to 8-weeks post-intervention session
Profile of Mood States Change at 4 Weeks
The Profile of Mood States-Short Form (POMS-SF) is a 35-item measure of mood. Items responses are totaled to calculate scores on 7 subscales: Anger-Hostility, Confusion-Bewilderment, Depression-Dejection, Fatigue-Inertia, Tension-Anxiety, Vigor-Activity, and Friendliness. The Total Mood Disturbance (TMD) score used in the study is calculated by adding together the scores of 5 subscales, Anger-Hostility, Confusion-Bewilderment, Depression-Dejection, Fatigue-Inertia, Tension-Anxiety, then subtracting the score from the Vigor-Activity subscale. TMD scores range from -20 to 100 with higher scores indicating greater impairment.
Measured: Baseline to 4-weeks post-intervention session
Insomnia Severity Change at 4 Weeks
The Insomnia Severity Index (ISI) is a 7-item measure used to evaluate insomnia severity (e.g. dissatisfaction with sleep and worry about sleep problems). Item response values are totaled to calculate a total ISI score ranging from 0-28, with higher scores indicating more insomnia symptom burden.
Measured: Baseline to 4-weeks post-intervention session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2022
- Study start19 Nov 2022
- Primary completion28 Jul 2025
- Study completion28 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InsomniaStudies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Christopher Recklitis, PhD, Dana-Farber Cancer Institute
- Investigators
- Christopher J Recklitis, PhD, MPH, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05358951
- Sponsor's protocol ID
- 21-613
- Other IDs
- R21CA261863
- Status last verified
- Jan 2026
- First submitted
- 28 Apr 2022
- Last updated
- 27 Feb 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Publications
Michaud AL, Bice B, Miklos E, McCormick K, Medeiros-Nancarrow C, Zhou ES, Recklitis CJ. Sleep Treatment Education Program for Young Adult Cancer Survivors (STEP-YA): Protocol for an Efficacy Trial. JMIR Res Protoc. 2023 Nov 29;12:e52315. doi: 10.2196/52315.
PubMed 38019571