AzTrials
AzTrials

Cancer SurvivorsSLEEP-CARENCT07023783

Improving Sleep, Fatigue, Activity & Quality of Life in Cancer Survivors Via a Transdiagnostic Intervention

A study testing Transdiagnostic Sleep Health Intervention (TSHI) in people with Cancer Survivors, run by University of Oklahoma at 1 site in United States.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

Poor sleep affects over half of U.S. cancer survivors, contributing to daytime fatigue, reduced physical activity, and diminished quality of life. Traditional sleep treatments often target diagnosed disorders, leaving many survivors with subclinical sleep issues underserved. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Cancer Survivors
What is being tested?
Transdiagnostic Sleep Health Intervention (TSHI)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
1 siteUnited States
Study dates
Aug 2026to Oct 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

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 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • ≥18 years old
  • ≤7 on RU-SATED questionnaire
  • ≥6 months removed from primary cancer treatment
  • able to speak/read English
  • can sign informed consent
  • have internet access via smartphone or computer

Who cannot join

  • ≥15 on Patent Health Questionnaire 8
  • ≥10 on Generalized Anxiety Disorder-7
  • self-reported current or recent history (≤2 years) of drug or alcohol abuse
  • history of nervous system disorder [e.g., stroke, Parkinson's disease, multiple sclerosis]
  • severe mental illness such as schizophrenia or bipolar disorder
  • current or recent history (≤5 years) of shift work
  • currently receiving a sleep intervention

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Rebecca M Ludwig, OT, PhD contact

405-271-2131 ext. 47150

rebecca-ludwig@ouhsc.edu

Zachary Pope, PhD, ACSM-EP contact

(405) 271-6872

zachary-pope@ouhsc.edu

United States1 site
  • University of Oklahoma College of Allied Health

    Oklahoma City, Oklahoma, 73117

    Rebecca Ludwig, OT, PhD, rebecca-ludwig@ouhsc.edu

Other trials in United States

About this study

Official title: Using a Transdiagnostic Sleep Health Intervention Approach to Improve Sleep Quality and Subsequent Daytime Fatigue, Physical Activity, and Quality of Life in Cancer Survivors

Poor sleep affects over half of U.S. cancer survivors, contributing to daytime fatigue, reduced physical activity, and diminished quality of life. Traditional sleep treatments often target diagnosed disorders, leaving many survivors with subclinical sleep issues underserved. Sleep health-a broader concept encompassing sleep regularity, satisfaction, alertness, timing, efficiency, and duration (RU-SATED)-offers a more inclusive framework for intervention. The TSHI is a modular, skills-based program designed to improve these dimensions of sleep health. Delivered via six weekly one-on-one Zoom sessions, TSHI emphasizes behavioral strategies like sleep hygiene, relaxation, and energy management.

This six-week, single-group quasi-experimental pilot study will enroll 10 cancer survivors to assess the feasibility, acceptability, and preliminary effectiveness of TSHI. Researchers will evaluate changes in sleep health, fatigue, physical activity, and quality of life using surveys, interviews, and ActiGraph data. By targeting sleep as a modifiable health behavior, this study aims to lay the groundwork for scalable interventions that enhance recovery and well-being in cancer survivors.

Read the detailed description

While cancer incidence remains steady, survivorship is rapidly increasing, with over 18 million cancer survivors (CS) in the U.S. as of 2022 and projections estimating 26 million by 2040. As survival rates improve, attention has shifted toward enhancing the quality of life (QoL) for survivors. One of the most prevalent and under-addressed issues affecting CS is poor sleep health. More than half of survivors report sleep disturbances, which can persist long after treatment ends and are linked to fatigue, reduced physical activity, and diminished health-related quality of life (HRQoL). Despite the high prevalence, many survivors do not meet diagnostic criteria for sleep disorders and are thus excluded from traditional interventions like cognitive behavioral therapy for insomnia (CBT-I).

Sleep health is increasingly recognized as a multidimensional construct encompassing regularity, satisfaction, alertness, timing, efficiency, and duration (RU-SATED). This broader framework allows for interventions that target sleep as a modifiable behavior rather than a binary clinical diagnosis. The Transdiagnostic Sleep Health Intervention (TSHI) was developed to address these six dimensions through a modular, skills-based approach. TSHI is designed to be flexible, accessible, and scalable-delivered via six weekly 50-minute one-on-one sessions with a sleep expert through a HIPAA-compliant Zoom platform.

TSHI incorporates evidence-based strategies such as stimulus control, sleep restriction, relaxation techniques, energy management, cognitive restructuring, and sleep hygiene education. Each session builds on the last, guiding participants through personalized behavior change strategies aimed at improving sleep health and, by extension, daytime functioning and overall well-being.

To evaluate the feasibility and preliminary efficacy of TSHI in cancer survivors, the investigators are conducting a six-week, single-group, quasi-experimental pilot study with 10 participants. The study will assess both the acceptability of the intervention and its impact on key outcomes including sleep health, fatigue, physical activity, and HRQoL.

Participants will first complete baseline assessments, including validated surveys and one week of continuous monitoring using ActiGraph accelerometers to capture objective sleep and activity data. They will then engage in the six-session TSHI program. Following the intervention, participants will repeat the surveys and ActiGraph monitoring, and participate in semi-structured interviews to provide qualitative feedback on their experience.

Our primary aim is to determine whether TSHI is feasible and acceptable when delivered virtually to cancer survivors. The investigators hypothesize that participants will report high usability and satisfaction, with at least 80% retention and adherence.

Our secondary aim is to explore changes in RU-SATED sleep health dimensions, fatigue, physical activity, and HRQoL from pre- to post-intervention. The investigators expect to observe improvements across these domains, supported by both self-report and objective data.

Quantitative data will be analyzed using descriptive statistics and pre-post comparisons, while qualitative data from interviews will be thematically coded to identify common experiences and suggestions for refinement. This mixed-methods approach will provide a comprehensive understanding of TSHI's potential and inform future, larger-scale trials.

This project represents a critical step toward addressing the unmet sleep health needs of cancer survivors. By targeting sleep as a modifiable behavior and using a transdiagnostic framework, TSHI offers a promising, scalable solution to improve survivorship outcomes and enhance long-term quality of life.

Being tested
Transdiagnostic Sleep Health Intervention (TSHI)
Keywords
Sleep Health, Physical Activity, Cancer Related Fatigue
Medical subject headings
Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Transdiagnostic Sleep Health Intervention (TSHI)Behavioural

    A transdiagnostic sleep health intervention (TSHI) will be delivered across six weekly 50-minute one-on-one sessions with a sleep expert via a HIPAA-compliant videoconference link. The six weekly TSHI sessions are outlined as:

    Week 1: Consists of discussing sleep physiology and discussing appropriate bed and wake up times.

    Week 2: Consists of discussing how to set/importance of setting, a bedtime routine Week 3: Consists of discussing how to improve daytime function through energy management for daily and weekly tasks.

    Week 4: Consists of discussing the sleep beliefs the participant holds and possible corrections of any unhelpful sleep beliefs.

    Week 5: Consists of educating participants on sleep hygiene and how it is influenced by environmental, social, and physical factors.

    Week 6: Consists of discussing sleep behavior changes observed during the TSHI and collaborating with the participant on plans to maintain their new sleep pattern.

Study groups in NCT07023783
Study groupRoleWhat they receive
Sleep Health Intervention ArmExperimentalA transdiagnostic sleep health intervention (TSHI) will be delivered across six weekly 50-minute one-on-one sessions with a sleep expert via a HIPAA-compliant videoconference link. The six weekly TSHI sessions are outlined as: Week 1: Consists of discussing sleep physiology and discussing appropriate bed and wake up times. Week 2: Consists of discussing how to set/importance of setting, a bedtime routine Week 3: Consists of discussing how to improve daytime function through energy management for daily and weekly tasks. Week 4: Consists of discussing the sleep beliefs the participant holds and possible corrections of any unhelpful sleep beliefs. Week 5: Consists of educating participants on sleep hygiene and how it is influenced by environmental, social, and physical factors. Week 6: Consists of discussing sleep behavior changes observed during the TSHI and collaborating with the participant on plans to maintain their new sleep pattern.
Receives: Behavioral: Transdiagnostic Sleep Health Intervention (TSHI)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Feasibility and acceptability of a videoconference-based Transdiagnostic Sleep Health Intervention

    TSHI acceptability will be assessed qualitatively and quantitatively following the study. Qualitative assessments will involve semi-structured interviews with each participant, guided by a written list of questions. Quantitative assessments of TSHI acceptability, usability, and usefulness will use a modified System Usability Scale (SUS). scores range from 0-100 with a higher score indicating better perceived usability of the intervention.

    Measured: After study week 7

  2. Recruitment

    The investigators will assess program feasibility via recruitment. Recruitment rates will be: # of cancer survivors enrolled ÷ # of cancer survivors who complete the screening survey. With a higher number indicating ease, practicality, and efficiency of the recruitment process.

    Measured: After study week 7

  3. Study Retention

    We will assess program feasibility via study retention. Study retention will be: # of cancer survivors completing the TSHI ÷ # of cancer survivors who began the TSHI. A high retention rate indicates the ability to keep participants committed over time, suggesting that the project is feasible and likely to succeed.

    Measured: After study week 7

  4. Adherence Rates

    We will assess program feasibility via protocol adherence rates. Adherence will be: # of weekly videoconference-based TSHI sessions attended ÷ six (total number of TSHI sessions). A high adherence rate indicates that the study design is viable and participants are able and willing to follow the protocol.

    Measured: After study week 7

Secondary outcomes (7)
  1. Changes in Sleep Health constructs

    Means and standard deviations will be calculated to evaluate the pre/post difference in the Regularity, Satisfaction, Alertness, Timing, Efficiency, and duration sleep health scale ( RU-SATED constructs). During the Baseline and Post-Study Testing Sessions, participants will complete the RU-SATED scale. This validated six-item scale assesses sleep regularity, satisfaction, alertness, timing, efficiency, and duration (i.e., RU-SATED). A scores range from 0-12 with a higher score indicating healthier sleep health.

    Measured: Baseline and After study week 6

  2. Sleep Regularity

    We will supplement RU-SATED construct measurements with sleep measurements made via the ActiGraph. Using the ActiGraph, Regularity will be assessed by the standard deviation of sleep midpoint, which is calculated as [sleep onset+(wake-sleep inset/2)]. The cut off for good sleep health is <60 minutes

    Measured: Baseline and After Study week 6

  3. Sleep Satisfaction

    Using the sleep log, satisfaction will be assessed. The sleep log includes an item to rate "restedness upon awakening" with 0= " not at all", 1 "somewhat"., 2= "moderately", 3= " quite a bit", and 4 = " extremely". Satisfaction will be operationalized as the average "restedness" score. the cut off for good sleep ehalth is an average of ≥3

    Measured: Baseline and After Study week 6

  4. Alertness

    Using the Epworth Sleepiness Scale, Alertness will be measured. The Epworth Sleepiness Scale consists of 8-items of various activities (ie. Sitting and reading, watching TV, etc) answered using a 4-point Likert scale with 0+ " would never nod off" to 3= "high chance of nodding off". The cut off for food sleep health is ≤ 10.

    Measured: Baseline and After Study week 6

  5. Timeing

    Using Actigraphy timing will be assessed. The Actigraphy measure of the average sleep midpoint will be used. The cut off for good sleep health is 2-4 AM.

    Measured: Baseline and After Study week 6

  6. Sleep Effiency

    To measure Efficiency Actigraphy will be used. The average total minutes of sleep divided by the time in bed multiplied by 100. A higher percentage indicates high sleep efficiency. The cut off for good sleep health is ≥ 85%

    Measured: Baseline and After Study week 6

  7. Sleep Duration

    To measure Duration Actigraphy will be used based on the average total minutes of sleep. the cut off for good sleep health is 6-8 hours

    Measured: Baseline and After Study week 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jun 2025
  2. Study startAug 2026 (estimated)
  3. Primary completionOct 2026 (estimated)
  4. Study completionOct 2026 (estimated)

Resources

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
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
12 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07023783
Sponsor's protocol ID
776250
Acronym
SLEEP-CARE
Status last verified
Feb 2026
First submitted
29 May 2025
Last updated
6 Feb 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Transdiagnostic Sleep Health Intervention (TSHI) in people with Cancer Survivors, run by University of Oklahoma 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 7 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: opening soon, as of the sponsor's last update on 6 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Rebecca M Ludwig, OT, PhD (405-271-2131 ext. 47150, rebecca-ludwig@ouhsc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility and acceptability of a videoconference-based Transdiagnostic Sleep Health Intervention (time frame: After study week 7). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 6 Feb 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in