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

NCT07023783 | Not Yet Recruiting DMC

• 1 other identifier: 776250
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer Survivors

Keywords

Sleep Health; Physical Activity; Cancer Related Fatigue

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (7)

• Changes in Sleep Health constructs

  Baseline and After study week 6

• Sleep Regularity

  Baseline and After Study week 6

• Sleep Satisfaction

  Baseline and After Study week 6

• Alertness

  Baseline and After Study week 6

• Timeing

  Baseline and After Study week 6

Study Arms (1)

Sleep Health Intervention Arm

EXPERIMENTAL

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)

Interventions

Transdiagnostic Sleep Health Intervention (TSHI) 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.

Sleep Health Intervention Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥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

You may not qualify if:

• ≥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

Sponsors & Collaborators

• University of Oklahoma: lead

Study Sites (1)

University of Oklahoma College of Allied Health

Oklahoma City, Oklahoma, 73117, United States

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Central Study Contacts

Rebecca M Ludwig, OT, PhD

CONTACT

405-271-2131; rebecca-ludwig@ouhsc.edu

Zachary Pope, PhD, ACSM-EP

CONTACT

(405) 271-6872; zachary-pope@ouhsc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2025
• First Posted: June 17, 2025
• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: February 6, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)