Clinical trial NCT07023783: Improving Sleep, Fatigue, Activity & Quality of Life in Cancer Survivors Via a Transdiagnostic Intervention
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cancer Survivors
Keywords: Sleep Health
Physical Activity
Cancer Related Fatigue
Lead sponsor: University of Oklahoma
Sponsor class: OTHER
First posted: 2025-06-17
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief 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. 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Feasibility and acceptability of a videoconference-based Transdiagnostic Sleep Health Intervention
timeFrame: After study week 7
measure: Recruitment
timeFrame: After study week 7
measure: Study Retention
timeFrame: After study week 7
measure: Adherence Rates
timeFrame: After study week 7
Secondary outcomes:
measure: Changes in Sleep Health constructs
timeFrame: Baseline and After study week 6
measure: Sleep Regularity
timeFrame: Baseline and After Study week 6
measure: Sleep Satisfaction
timeFrame: Baseline and After Study week 6
measure: Alertness
timeFrame: Baseline and After Study week 6
measure: Timeing
timeFrame: Baseline and After Study week 6
measure: Sleep Effiency
timeFrame: Baseline and After Study week 6
measure: Sleep Duration
timeFrame: Baseline and After Study week 6
Other outcomes:
Locations:
city: Oklahoma City
country: United States
facility: University of Oklahoma College of Allied Health
state: Oklahoma
Study officials:
References: