Sleep Health Intervention for Cancer Survivors

(SLEEP-CARE Trial)

Overseen By Rebecca M Ludwig, OT, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Oklahoma

Disqualifiers: Drug abuse, Nervous system disorder, Severe mental illness, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 9

Duration: 6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new sleep health program, the Transdiagnostic Sleep Health Intervention (TSHI), designed to help cancer survivors improve sleep quality and overall well-being. The program includes six weekly Zoom sessions that focus on better sleep tips, such as setting routines and managing energy. Researchers aim to determine if this approach enhances sleep, reduces fatigue, boosts activity, and improves life quality. The trial seeks cancer survivors who completed treatment over six months ago and have trouble sleeping but do not have a diagnosed sleep disorder. Participants need internet access and should not currently receive treatment for sleep issues. As an unphased trial, this study offers a unique opportunity for participants to contribute to innovative research aimed at enhancing the quality of life for cancer survivors.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this sleep health intervention is safe for cancer survivors?

Research has shown that the Transdiagnostic Sleep Health Intervention (TSHI) is generally safe and well-tolerated. Similar sleep programs in past studies have improved sleep problems without causing major negative effects. Although this trial for cancer survivors is new, TSHI uses proven methods like cognitive behavioral therapy for insomnia (CBT-I). CBT-I has reduced tiredness and improved sleep without serious side effects.

TSHI includes practical strategies like sleep hygiene (healthy sleep habits) and relaxation, which are safe and non-invasive. Similar treatments have not reported serious negative effects, making TSHI a promising option for those looking to improve their sleep health. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the transdiagnostic sleep health intervention (TSHI) because it offers a personalized approach to improving sleep for cancer survivors. Unlike standard treatments that might rely on medication or generalized advice, TSHI provides tailored, one-on-one sessions with a sleep expert through secure videoconferencing. This method focuses on educating participants about sleep physiology, establishing routines, managing energy, and addressing unhelpful sleep beliefs, offering a comprehensive strategy to enhance sleep health. This personalized, educational approach could lead to lasting sleep improvements and better overall well-being for participants.

What evidence suggests that the Transdiagnostic Sleep Health Intervention (TSHI) might be an effective treatment for sleep issues in cancer survivors?

Research shows that the Transdiagnostic Sleep Health Intervention (TSHI), which participants in this trial will receive, can help cancer survivors sleep better and improve their overall quality of life. Studies have found that TSHI teaches skills such as good sleep habits, relaxation, and managing daytime energy. By focusing on these areas, TSHI can reduce daytime tiredness and boost physical activity. Research also indicates that better sleep can lower anxiety and depression. Overall, TSHI offers a promising way to help cancer survivors feel better and more active. ^{1 2 4 6 7}

Are You a Good Fit for This Trial?

This trial is for U.S. cancer survivors struggling with poor sleep, which may lead to fatigue and reduced quality of life. Participants should be interested in improving their sleep through a program delivered via Zoom.

Inclusion Criteria

I am 18 years old or older.

≤7 on RU-SATED questionnaire

able to speak/read English

Exclusion Criteria

severe mental illness such as schizophrenia or bipolar disorder

current or recent history (≤5 years) of shift work

≥15 on Patent Health Questionnaire 8

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (virtual)

Baseline Assessment

Participants complete baseline assessments including surveys and one week of ActiGraph monitoring

1 week

1 visit (virtual)

Treatment

Participants engage in the Transdiagnostic Sleep Health Intervention (TSHI) through six weekly one-on-one Zoom sessions

6 weeks

6 visits (virtual)

Follow-up

Participants repeat surveys and ActiGraph monitoring, and participate in semi-structured interviews

1 week

1 visit (virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Transdiagnostic Sleep Health Intervention (TSHI)

Trial Overview The study tests a Transdiagnostic Sleep Health Intervention (TSHI) designed to improve various aspects of sleep health over six weeks through one-on-one online sessions focusing on behavioral strategies.

How Is the Trial Designed?

Group I: Sleep Health Intervention Arm Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

University of Oklahoma

Lead Sponsor

Trials

484

Recruited

95,900+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07023783

Improving Sleep, Fatigue, Activity & Quality of Life in ... By targeting sleep as a modifiable behavior and using a transdiagnostic framework, TSHI offers a promising, scalable solution to improve survivorship outcomes ...

2. withpower.com withpower.com/trial/phase-motor-activity-7-2025-15dd4

Sleep Health Intervention for Cancer Survivors Researchers will evaluate changes in sleep health, fatigue, physical activity, and quality of life using surveys, interviews, and ActiGraph data.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10635358

The Transdiagnostic Intervention for Sleep and Circadian ... Building on this past research, the overall goal of the three-phase randomized controlled trial is to compare the implementation and effectiveness outcomes of ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S1077722922000773

The Transdiagnostic Intervention for Sleep and Circadian ... Results indicated that most participants (>85.0%) had full diagnoses or subdiagnostic symptoms of two or more sleep and circadian problems. Further, ...

5. mghpsychnews.org mghpsychnews.org/the-survivorship-sleep-program-invertention-for-sleep-in-cancer-survivors/

The Survivorship Sleep Program: Enhancing Sleep Health ... With better sleep quality, survivors are likely to experience reductions in anxiety, depression, and fatigue, which can significantly impact ...

6. academic.oup.com academic.oup.com/sleep/article/48/6/zsaf014/7960093

Impact and mechanisms of cognitive behavioral therapy for ... CBT-I resulted in significant improvement in fatigue, and these effects were largely accounted for by changes in insomnia. CBT-I is a robust intervention with ...

7. link.springer.com link.springer.com/article/10.1007/s10488-024-01410-1

Interviews with Community Providers on Treating Clients ... The aim of the present study was to assess CMHC providers' perspectives on delivering a transdiagnostic treatment – the Transdiagnostic Intervention for Sleep ...