Online Sleep Program for Survivors of Gynecologic Cancers

Not currently recruiting at 1 trial location

Overseen By Rina S Fox, PhD, MPH

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Northwestern University

Must not be taking: Sedatives, Hypnotics

Disqualifiers: Stage IV cancer, Psychiatric conditions, others

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores ways to assist gynecologic cancer survivors who have trouble sleeping. It tests methods such as sleep restriction (limiting time in bed), stimulus control (regulating activities in bed), and systematic light exposure (using light to improve sleep). Participants may try one or a combination of these approaches. The trial suits those who have had Stage I, II, or III gynecologic cancer and currently experience sleep problems. Participants need reliable internet access and the ability to speak English. As an unphased trial, this study provides a unique opportunity to explore innovative sleep improvement methods tailored for cancer survivors.

Will I have to stop taking my current medications?

The trial may require you to stop taking certain medications, especially if they are sedatives or hypnotics, as these could interfere with the study. This will be determined on a case-by-case basis.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that the sleep treatments in this study, including sleep restriction, stimulus control, and light exposure, are generally safe for cancer survivors. Studies have found that these methods are well-tolerated, with most participants not experiencing serious side effects. Specifically, sleep restriction and stimulus control have been used with cancer survivors without causing significant problems.

For light exposure, research indicates it is easy to use and rarely causes issues. This method involves using bright light in the morning to help improve sleep. Most people find it safe and simple to follow. Overall, these sleep treatments are considered low-risk and are designed to be manageable for cancer survivors. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores innovative non-medical strategies to improve sleep for survivors of gynecologic cancers. Unlike traditional options like medication or cognitive behavioral therapy, these treatments focus on behavioral interventions such as sleep restriction, stimulus control, and systematic light exposure. These methods aim to reset the body's natural sleep-wake cycle and improve sleep quality without the side effects often associated with medication. By utilizing online platforms, this approach offers convenient access to interventions, potentially making it easier for participants to integrate into their daily lives. Ultimately, this trial could pave the way for more accessible and personalized sleep solutions for cancer survivors.

What evidence suggests that this trial's treatments could be effective for improving sleep in gynecologic cancer survivors?

Research has shown that limiting sleep time, known as Sleep Restriction, can greatly improve sleep quality for cancer survivors. Participants in studies reported sleeping more efficiently and spending less time awake during the night. In this trial, some participants will receive Sleep Restriction therapy. Others will receive Stimulus Control therapy, which involves using the bed only for sleep and has effectively reduced insomnia in cancer survivors. Another group will receive Systematic Light Exposure, which involves regular exposure to light, especially in the morning, and has shown promise in improving sleep quality and reducing tiredness. Together, these treatments offer a comprehensive approach to enhancing sleep for those who have survived gynecologic cancers. ^{1 3 4 5 6}

Are You a Good Fit for This Trial?

This trial is for English-speaking gynecologic cancer survivors aged 18-74 with sleep issues, who finished their primary cancer treatment at least 30 days ago. They must have internet and phone access, and typically go to bed between 9 PM and 3 AM. Those with severe health conditions or on certain medications, other major cancers, or recent CBT-I therapy cannot join.

Inclusion Criteria

I have trouble sleeping, as shown by my PSQI score being over 5.

I had Stage I, II, or III cancer of the female reproductive organs.

Usual sleep onset time between 9:00PM and 3:00AM

Exclusion Criteria

I finished my ovarian cancer treatment less than 2 years ago, or any other gynecologic cancer treatment less than 30 days ago.

I do not have any mental health or serious medical conditions that could affect my participation.

I have not had a non-skin, non-gynecologic cancer diagnosis in the last 5 years.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Part 1

15 gynecologic cancer survivors receive three intervention components for six weeks

6 weeks

Weekly visits (in-person or virtual)

Treatment Part 2

80 gynecologic cancer survivors randomized to one of eight six-week intervention conditions

6 weeks

Weekly visits (in-person or virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months

Monthly visits (in-person or virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Sleep restriction
• Stimulus control
• Systematic light exposure

Trial Overview The study tests three methods to improve sleep: limiting time in bed (sleep restriction), establishing a consistent sleep routine (stimulus control), and using light exposure strategically. The goal is to find effective treatments for sleep difficulties in women who've had gynecologic cancer.

How Is the Trial Designed?

Group I: Systematic light exposure Experimental Treatment 1 Intervention

Group II: Stimulus control and Systematic light exposure Experimental Treatment 2 Interventions

Group III: Stimulus control Experimental Treatment 1 Intervention

Group IV: Sleep restriction, Stimulus control, and Systematic light exposure Experimental Treatment 3 Interventions

Group V: Sleep restriction and Systematic light exposure Experimental Treatment 2 Interventions

Group VI: Sleep restriction and Stimulus control Experimental Treatment 2 Interventions

Group VII: Sleep Restriction Experimental Treatment 1 Intervention

Group VIII: Sleep tracking Active Control 1 Intervention

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials

1,674

Recruited

989,000+

University of Arizona

Lead Sponsor

Trials

545

Recruited

161,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

In a randomized-controlled trial involving 219 breast cancer patients, behavioral therapy (BT) significantly improved sleep quality during chemotherapy, as measured by the Pittsburgh Sleep Quality Index (PSQI).

Despite improvements in sleep quality reported by the BT group, there was no significant reduction in fatigue levels compared to the control group, indicating that better sleep does not always correlate with lower fatigue.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavioral therapy intervention trial to improve sleep quality and cancer-related fatigue. Berger, AM., Kuhn, BR., Farr, LA., et al.[2022]

Cognitive Behavioral Therapy for insomnia and pain (CBTi.p.) significantly improved sleep outcomes in women with gynecologic cancers, showing better subjective sleep efficiency and reduced sleep onset latency compared to psychoeducation.

The study involved 35 women and demonstrated that CBTi.p. led to clinically meaningful improvements in sleep efficiency and total wake time, indicating its potential as an effective treatment for insomnia in cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impacts of Cognitive Behavioral Therapy for Insomnia and Pain on Sleep in Women with Gynecologic Malignancies: A Randomized Controlled Trial. Padron, A., McCrae, CS., Robinson, ME., et al.[2023]

Gynecologic cancer survivors often experience significant sleep difficulties, which can negatively impact their quality of life, highlighting the need for effective sleep interventions tailored to this population.

This study aims to optimize a behavioral sleep intervention using the Multiphase Optimization Strategy (MOST) framework, evaluating components like sleep restriction and bright light exposure to find the most effective combination for improving sleep quality among survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optimizing a Behavioral Sleep Intervention for Gynecologic Cancer Survivors: Study Design and Protocol. Fox, RS., Gaumond, JS., Zee, PC., et al.[2022]

In a study of 114 endometrial cancer survivors, sleep disorders were prevalent, with 54.9% affected, and sleep quality was significantly impacted by treatment methods, particularly in those receiving combined chemotherapy and radiation therapy.

The Pittsburgh Sleep Quality Index (PSQI) scores indicated that sleep quality worsened during treatment, peaking at 3 months post-treatment, highlighting the need for tailored care plans to address sleep issues in cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sleep quality of endometrial cancer survivors and the effect of treatments. Tuyan İlhan, T., Uçar, MG., Gül, A., et al.[2022]

The Survivorship Sleep Program (SSP), a synchronous virtual cognitive behavioral therapy for insomnia (CBT-I) tailored for cancer survivors, demonstrated high feasibility and acceptability, with 90% retention and 100% attendance among participants.

The SSP led to significant reductions in insomnia severity compared to enhanced usual care, with a large effect size (Cohen d = 1.19) that was maintained at a 1-month follow-up, indicating its potential effectiveness for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Survivorship Sleep Program (SSP): A synchronous, virtual cognitive behavioral therapy for insomnia pilot program among cancer survivors. Hall, DL., Arditte Hall, KA., Gorman, MJ., et al.[2023]

In a study of 44 fatigued cancer survivors, morning exposure to bright white light significantly improved sleep efficiency compared to dim red light, with results showing normal sleep efficiency levels by the end of the 4-week intervention.

Participants in the bright light group also experienced medium to large improvements in sleep quality, total sleep time, and reduced wake time after sleep onset, indicating that bright light exposure may be an effective strategy for enhancing sleep in cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effect of Systematic Light Exposure on Sleep in a Mixed Group of Fatigued Cancer Survivors. Wu, LM., Amidi, A., Valdimarsdottir, H., et al.[2019]

Pre-radiotherapy sleep disorders were found in 46.8% of patients with gynecological malignancies, indicating a high prevalence of this issue before treatment begins.

Significant risk factors for sleep disorders included a Charlson comorbidity index of 3 or higher, a greater number of physical problems, and advanced tumor stage, suggesting that these patients may benefit from early psychological support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sleep Disorders Prior to Adjuvant Radiation Therapy for Gynecological Malignancies. Rades, D., Kopelke, S., Soror, T., et al.[2021]

A study involving 101 women undergoing chemotherapy for breast cancer found that combined cognitive behavioral therapy for insomnia and bright light therapy (CBT-I + Light) significantly improved insomnia symptoms compared to standard treatment with relaxation audio (TAU+), with a moderate effect size (ES = 0.69).

CBT-I + Light also led to greater improvements in sleep efficiency, fatigue, and daytime sleep-related impairment immediately after the intervention, suggesting it is an effective approach to manage sleep issues and fatigue during chemotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Light enhanced cognitive behavioral therapy for insomnia and fatigue during chemotherapy for breast cancer: a randomized controlled trial. Bean, HR., Diggens, J., Ftanou, M., et al.[2022]

Bright light (BL) therapy appears to be a feasible and potentially effective non-drug treatment for reducing sleep disturbances in ovarian and endometrial cancer survivors, based on a pilot study with 18 participants.

Participants receiving BL therapy showed trends toward improved sleep quality and reduced nighttime awakenings compared to those receiving dim light, although these improvements returned to baseline after three months.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and Preliminary Efficacy of a Bright Light Intervention in Ovarian and Endometrial Cancer Survivors. Fox, RS., Baik, SH., McGinty, H., et al.[2022]

The study aims to evaluate the effectiveness of digital cognitive behavioral therapy for insomnia (dCBT-I) compared to sleep hygiene education (SHE) in 308 women with cancer experiencing insomnia, with assessments at 12 and 24 weeks.

The primary outcome will measure changes in sleep quality using the Sleep Condition Indicator (SCI) score, helping to determine if dCBT-I provides better management of insomnia than SHE in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Sleepio after cancer (SAC) study. Digital cognitive behavioural therapy for insomnia (dCBT-I) in women cancer patients - Trial protocol of a randomised controlled trial. Treacy, T., O'Meara, Y., Galligan, MC., et al.[2023]

Bright blue-green light therapy significantly reduced fatigue and improved sleep quality in female breast cancer survivors 1-3 years post-treatment, as evidenced by self-reported measures after 14 days of therapy.

Interestingly, the control group receiving dim red light also experienced unexpected improvements in sleep metrics, suggesting that light exposure, regardless of type, may have beneficial effects on sleep disturbances.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating chronotypically tailored light therapy for breast cancer survivors: Preliminary findings on fatigue and disrupted sleep. Wu, HS., Gao, F., Yan, L., et al.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05044975

NCT05044975 | Improving Sleep in Gynecologic Cancer ... This purpose of this study is to learn about how to provide treatment to gynecologic cancer survivors who have difficulty sleeping. Detailed Description. This ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8931410/

Optimizing a Behavioral Sleep Intervention for Gynecologic ... Although leading behavioral sleep interventions have demonstrated efficacy among cancer survivors, up to 50% of survivors are non-adherent ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8669057/

Impacts of cognitive behavioral therapy for insomnia and ... A significant main effect of time revealed that all participants reported improved SE across timepoints as assessed by both sleep diaries.

4. sciencedirect.com sciencedirect.com/science/article/pii/S1048891X24009897

Sleep and gynecological cancer outcomes Poor sleep can lead to increased pain, depression, anxiety, and worse outcomes.5, 35 Conversely, good sleep in survivors is linked with a more positive affect ...

5. withpower.com withpower.com/trial/phase-dyssomnias-8-2021-81ff0

Online Sleep Program for Survivors of Gynecologic Cancers The study involved 35 women and demonstrated that CBTi.p. led to clinically meaningful improvements in sleep efficiency and total wake time, indicating its ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12064597/

Recording and reporting of adverse events during a ... CBT-I is a safe treatment that is well-tolerated by cancer survivors. The majority of participants did not experience AEs that could be attributed to the ...