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

Part of paid clinical trials in Oklahoma City, Oklahoma.

Sponsor
University of Oklahoma
Study ID
NCT07023783
Status
Not Yet Recruiting

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Conditions

  • Cancer Survivors

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

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.

Study Details

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.

Key Dates

Start date
Aug 31, 2026
Status verified
Feb 2026
Primary completion
Oct 31, 2026
Completion
Oct 31, 2026

Study Design

Enrollment
12 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE

Arms

  • 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.

Primary Outcome Measure

Feasibility and acceptability of a videoconference-based Transdiagnostic Sleep Health Intervention [ Time Frame: After study week 7 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Oklahoma College of Allied HealthOklahoma CityOklahoma73117
Rebecca Ludwig, OT, PhD
[email protected]

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By research site
University of Oklahoma College of Allied Health· Oklahoma City, OK

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