Clinical trial · Interventional
Improving Sleep, Fatigue, Activity & Quality of Life in Cancer Survivors Via a Transdiagnostic Intervention
Using a Transdiagnostic Sleep Health Intervention Approach to Improve Sleep Quality and Subsequent Daytime Fatigue, Physical Activity, and Quality of Life in Cancer Survivors
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer Survivors | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Transdiagnostic Sleep Health Intervention (TSHI) | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Sleep Health Intervention Arm
- description
- 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.
- interventionNames
- Behavioral: Transdiagnostic Sleep Health Intervention (TSHI)
Primary outcomes (4)
- measure
- Feasibility and acceptability of a videoconference-based Transdiagnostic Sleep Health Intervention
- timeFrame
- After study week 7
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available