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
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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.
Show all 11Show fewer
- 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
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep Treatment Education Program for Young Adult Cancer Survivors (STEP-YA): An Online Educational Intervention for Insomnia
- ClinicalTrials.gov ID
- NCT05358951
- Acronym / sponsor ID
- 21-613
- Conditions
- Insomnia, Insomnia Due to Medical Condition, Cancer
- Keywords
- Insomnia, Insomnia Due to Medical Condition, Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 19 Nov 2022 (actual)
- Primary completion
- 28 Jul 2025 (actual)
- Study completion
- 28 Jul 2025 (actual)
- First posted
- 3 May 2022 (actual)
- Results
- Posted 27 Feb 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NON-COACHING CONDITION STEP-YA | Active comparator | Behavioral: STEP-YA without CoachingParticipants 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. |
| COACHING CONDITION STEP-YA | Experimental | Behavioral: STEP-YA with CoachingParticipants 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. |
Who may qualify
- Ages
- 20 to 39 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (11 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| STEP-YA with CoachingOnline instruction on behavioral changes to improve sleep with 2 additional individually coached session | Behavioural | COACHING CONDITION STEP-YA |
| STEP-YA without CoachingOnline instruction on behavioral changes to improve sleep without additional individually coached session | Behavioural | NON-COACHING CONDITION STEP-YA |
Primary outcome
Insomnia Severity Change at 8 Weeks
Time frame: Baseline to 8-weeks post-intervention session
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.
3 secondary outcomes
Profile of Mood States Change at 8 Weeks
Time frame: Baseline to 8-weeks post-intervention session
Profile of Mood States Change at 4 Weeks
Time frame: Baseline to 4-weeks post-intervention session
Insomnia Severity Change at 4 Weeks
Time frame: Baseline to 4-weeks post-intervention session
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38019571Michaud 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.
- Individual participant dataSharing planned: 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.
Related trials for Insomnia
Recruiting
Addressing Nocturia in Older Women Utilizing Behavioral Sleep Intervention and Brief Mindfulness
Nocturia, Insomnia
Not yet recruiting
A Transdiagnostic Sleep Health Intervention for Veterans With PTSD
Stress Disorders, Post-Traumatic, Sleep Initiation and Maintenance Disorders
Recruiting
Effect of Cyclic Sighing Breathing Exercise on CRBD, Pain, and Sleep Quality in Patients Undergoing TUR
Transurethral Resection of Bladder Tumor, Transurethral Resection of the Prostate (TURP)
Recruiting
Evaluation of Cognitive Behavioral Therapy for Insomnia (CBT-I) in Individuals With Mild Traumatic Brain Injury (mTBI)
Sleep Architecture, Mild Traumatic Brain Injury
RecruitingPhase 3
A Trial to See if Daridorexant Can Help Adults and Elderly People With Insomnia Sleep Better During the Night and Function Better During the Day
Insomia Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christopher J Recklitis, PhD, MPH principal investigator
Dana-Farber Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Feb 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insomnia Severity Change at 8 Weeks (time frame: Baseline to 8-weeks post-intervention session). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05358951, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.