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

NCT ID: NCT07023783

Last Updated: 2025-07-24

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-31
• Study Completion Date: 2025-10-31

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.

Conditions

Cancer Survivors

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Transdiagnostic Sleep Health Intervention (TSHI)

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Oklahoma

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of Oklahoma College of Allied Health

Oklahoma City, Oklahoma, United States

Countries

United States

Central Contacts

Rebecca M Ludwig, OT, PhD

Role: CONTACT

rebecca-ludwig@ouhsc.edu

405-271-2131 ext. 47150

Zachary Pope, PhD, ACSM-EP

Role: CONTACT

zachary-pope@ouhsc.edu

(405) 271-6872

Facility Contacts

Rebecca Ludwig, OT, PhD

Role: primary

rebecca-ludwig@ouhsc.edu

Other Identifiers

776250

Identifier Type: -

Identifier Source: org_study_id