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Not yet recruiting NCT07023783

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

No phase Interventional Cancer Survivors

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Transdiagnostic Sleep Health Intervention (TSHI).
Who it may be relevant to
Registry conditions: Cancer Survivors. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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

Overview

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.

Interventions

  • 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 f

Primary outcome measures

  • Feasibility and acceptability of a videoconference-based Transdiagnostic Sleep Health Intervention [Time frame: After study week 7]
  • Recruitment [Time frame: After study week 7]
  • Study Retention [Time frame: After study week 7]
  • Adherence Rates [Time frame: After study week 7]
Secondary outcome measures (7)
  • Changes in Sleep Health constructs [Time frame: Baseline and After study week 6]
  • Sleep Regularity [Time frame: Baseline and After Study week 6]
  • Sleep Satisfaction [Time frame: Baseline and After Study week 6]
  • Alertness [Time frame: Baseline and After Study week 6]
  • Timeing [Time frame: Baseline and After Study week 6]
  • Sleep Effiency [Time frame: Baseline and After Study week 6]
  • Sleep Duration [Time frame: Baseline and After Study week 6]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Supportive care

Study locations

United States · 1 center
  • University of Oklahoma College of Allied Health — Oklahoma City

Identifiers

NCT: NCT07023783 · 776250

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗