Improving Sleep, Fatigue, Activity & Quality of Life in Cancer Survivors Via a Transdiagnostic Intervention (SLEEP-CARE)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Cancer Survivors
• Intervention / Treatment: Behavioral: Transdiagnostic Sleep Health Intervention (TSHI)

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.

• Study Type: Interventional
• Enrollment (Estimated): 12
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rebecca M Ludwig, OT, PhD; Phone Number: 47150 405-271-2131; Email: rebecca-ludwig@ouhsc.edu
• Study Contact Backup: Name: Zachary Pope, PhD, ACSM-EP; Phone Number: (405) 271-6872; Email: zachary-pope@ouhsc.edu

Study Locations

• United States
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73117
      • University of Oklahoma College of Allied Health
      • Contact: Rebecca Ludwig, OT, PhD; Email: rebecca-ludwig@ouhsc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• ≥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

Exclusion Criteria:

• ≥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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Sleep Health Intervention Arm; 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.

Behavioral: Transdiagnostic Sleep Health Intervention (TSHI); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	After study week 7
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.	After study week 7
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.	After study week 7
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.	After study week 7

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline and After study week 6
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	Baseline and After Study week 6
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	Baseline and After Study week 6
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.	Baseline and After Study week 6
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.	Baseline and After Study week 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%	Baseline and After Study week 6
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	Baseline and After Study week 6

Collaborators and Investigators

• Sponsor: University of Oklahoma

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026

Study Registration Dates

• First Submitted: May 29, 2025
• First Submitted That Met QC Criteria: June 13, 2025
• First Posted (Actual): June 17, 2025

Study Record Updates

• Last Update Posted (Actual): February 6, 2026
• Last Update Submitted That Met QC Criteria: February 4, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Physical Activity; Sleep Health; Cancer Related Fatigue
• Additional Relevant MeSH Terms: Behavior; Motor Activity
• Other Study ID Numbers: 776250

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No