Online Sleep Program for Survivors of Gynecologic Cancers
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Northwestern University
Must not be taking: Sedatives, Hypnotics
Disqualifiers: Stage IV cancer, Psychiatric conditions, others
No Placebo Group
Trial Summary
What is the purpose of this trial?This purpose of this study is to learn about how to provide treatment to gynecologic cancer survivors who have difficulty sleeping.
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.
What data supports the effectiveness of this treatment for improving sleep in survivors of gynecologic cancers?
Research shows that behavioral sleep interventions, including sleep restriction, stimulus control, and bright light therapy, have been effective in reducing sleep disturbances in cancer survivors. These treatments have been shown to improve sleep quality and reduce fatigue, which are common issues for gynecologic cancer survivors.
12345Is the online sleep program safe for gynecologic cancer survivors?
Research on sleep interventions like sleep restriction, stimulus control, and bright light therapy suggests they are generally safe for cancer survivors, though adherence can be challenging due to lifestyle changes required.
24678How does the online sleep program for gynecologic cancer survivors differ from other treatments?
This online sleep program is unique because it combines sleep restriction, stimulus control, and systematic light exposure to improve sleep in gynecologic cancer survivors, focusing on making the treatment more efficient and easier to adhere to compared to traditional behavioral sleep interventions.
2391011Eligibility Criteria
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
+3 more
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.
+8 more
Trial Timeline
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)
Participant Groups
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.
8Treatment groups
Experimental Treatment
Active Control
Group I: Systematic light exposureExperimental Treatment1 Intervention
Group II: Stimulus control and Systematic light exposureExperimental Treatment2 Interventions
Group III: Stimulus controlExperimental Treatment1 Intervention
Group IV: Sleep restriction, Stimulus control, and Systematic light exposureExperimental Treatment3 Interventions
Group V: Sleep restriction and Systematic light exposureExperimental Treatment2 Interventions
Group VI: Sleep restriction and Stimulus controlExperimental Treatment2 Interventions
Group VII: Sleep RestrictionExperimental Treatment1 Intervention
Group VIII: Sleep trackingActive Control1 Intervention
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of Arizona College of NursingTucson, AZ
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Who Is Running the Clinical Trial?
Northwestern UniversityLead Sponsor
University of ArizonaLead Sponsor
National Cancer Institute (NCI)Collaborator
References
Evaluating chronotypically tailored light therapy for breast cancer survivors: Preliminary findings on fatigue and disrupted sleep. [2023]More than one-third of cancer survivors experience significant residual symptoms after treatment completion. Fatigue and sleep disruption often co-occur and exacerbate each other. The purpose of this preliminary analysis was to examine the effect of a chronotypically tailored light therapy on fatigue and sleep disruption in female survivors 1-3 years post-completion of chemotherapy and/or radiation for stage I to III breast cancer. The data for this analysis were collected as part of an ongoing two-group randomized controlled trial (NCT03304587). Participants were randomized to receive either bright blue-green light (experimental) or dim red light (control). Light therapy was self-administered using a light visor cap at home. Both groups received 30-min daily light therapy for 14 consecutive days either between 19:00 and 20:00 h (for morning chronotypes) or within 30 min of waking in the morning (for evening chronotypes). Fatigue and sleep quality were self-reported using the Patient-Reported Outcomes Measurement Information System (PROMIS)-Fatigue, PROMIS-Sleep Disturbance, Pittsburgh Sleep Quality Index, and a daily log before (pre-test) and following the light intervention (post-test). Linear mixed model analysis or generalized estimating equations examined group difference overtime adjusting for pre-test scores. No between-group differences were found. However, after adjusting for the baseline fatigue, the experimental group reported significant decreases in fatigue (p < .001) and sleep disturbance (p = .024) overtime. The experimental group also reported significantly better subjective sleep quality after 14 d of light therapy (p = .017). Positive trends in sleep latency, sleep duration, night-time awakenings, and early morning awakenings were also observed. Unexpectedly, sleep disturbance significantly decreased in the control group (p = .030). Those who received dim light control reported significantly shorter sleep latency (p = .002), longer total sleep time (p = .042), and greater habitual sleep efficiency (p = .042). These findings suggest that bright light therapy significantly improved post-treatment fatigue and subjective sleep quality in breast cancer survivors. Although it remains to be confirmed, the findings additionally show unexpected benefits of dim light on sleep. Properly timed light exposure may optimize the therapeutic effect and can be the key for successful light therapy. How the administration timing coupled with wavelengths (short vs. long) and intensity of light affecting fatigue and disrupted sleep requires further investigation.
Optimizing a Behavioral Sleep Intervention for Gynecologic Cancer Survivors: Study Design and Protocol. [2022]Sleep difficulties, particularly symptoms of insomnia and circadian disruption, are among the primary complaints of gynecologic cancer survivors before, during, and after treatment. Moreover, difficulty sleeping has been linked to poorer health-related quality of life and elevated symptom burden in this population. Although leading behavioral sleep interventions have demonstrated efficacy among cancer survivors, up to 50% of survivors are non-adherent to these treatments, likely because these interventions require labor-intensive behavior and lifestyle changes. Therefore, there is a need for more effective and acceptable approaches to diminish sleep disturbance among cancer survivors. This manuscript describes the methodology of a two-part study guided by the Multiphase Optimization Strategy (MOST) framework to identify a streamlined behavioral sleep intervention for gynecologic cancer survivors. Three candidate intervention components previously shown to decrease sleep disturbance will be evaluated, including sleep restriction, stimulus control, and systematic bright light exposure. Participants will be adult women with a history of non-metastatic gynecologic cancer who have completed primary treatment and who report current poor sleep quality. Fifteen participants will be recruited for Part 1 of the study, which will utilize qualitative methods to identify barriers to and facilitators of intervention adherence. Results will inform changes to the delivery of the candidate intervention components to promote adherence in Part 2, where 80 participants will be recruited and randomized to one of eight conditions reflecting every possible combination of the three candidate intervention components in a full factorial design. Participants will complete assessments at baseline, post-intervention, and 3-months post-intervention. Part 2 results will identify the combination of candidate intervention components that yields the most efficacious yet efficient 6-week intervention for diminishing sleep disturbance. This is the first known study to apply the MOST framework to optimize a behavioral sleep intervention and will yield a resource-efficient treatment to diminish sleep disturbance, improve health-related quality of life, and decrease symptom burden among gynecologic cancer survivors. ClinicalTrials.gov Identifier: NCT05044975.
Impacts of Cognitive Behavioral Therapy for Insomnia and Pain on Sleep in Women with Gynecologic Malignancies: A Randomized Controlled Trial. [2023]Insomnia is an adverse cancer outcome impacting mood, pain, quality of life, and mortality in cancer patients. Cognitive Behavioral Therapy (CBT) is an evidence-based treatment for diverse psychophysiological disorders, including pain and insomnia. Primarily studied in breast cancer, there is limited research on CBT within gynecology oncology. This study examined CBT effects on subjective and behavioral sleep outcomes: Sleep Efficiency (SE), Sleep Quality (SQ), Total Wake Time (TWT), Sleep Onset Latency (SOL), and Wake After Sleep Onset (WASO). Thirty-five women with insomnia status/post-surgery for gynecologic cancer were randomized to CBT for insomnia and pain (CBTi.p., N = 18) or Psychoeducation (N = 17). Sleep was assessed via sleep diaries and wrist-worn actigraphy at baseline (T1), post-intervention (T2), and two-month follow-up (T3). Intent-to-treat analyses utilizing mixed linear modeling examined longitudinal group differences on sleep controlling for age and advanced cancer. All participants demonstrated improved (1) subjective SE (0.5, p < .01), SOL (-1.2, p < .01), TWT (-1.2, p < .01), and (2) behavioral SE (0.1, p = .02), TWT (-1.2, p = .03), WASO (-0.8, p < .01) across time. Group-level time trends were indicative of higher subjective SE (6.8, p = .02), lower TWT (-40.3, p = .01), and lower SOL (-13.0, p = .05) in CBTi.p. compared to Psychoeducation. Supplemental analyses examining clinical significance and acute treatment effects demonstrated clinical improvements in SE (T1), TWT (T2, T3), and SOL (T3). Remaining effects were not significant. Despite lacking power to detect interaction effects, CBTi.p. clinically improved sleep in women with gynecologic cancers and insomnia during the active treatment phase. Future research will focus on developing larger trials within underserved populations.
The Effect of Systematic Light Exposure on Sleep in a Mixed Group of Fatigued Cancer Survivors. [2019]Sleep disturbances are commonly reported by cancer survivors. Systematic light exposure using bright light has been used to improve sleep in other populations. In this secondary data analysis, the effect of morning administration of bright light on sleep and sleep quality was examined in a mixed group of fatigued cancer survivors.
Behavioral therapy intervention trial to improve sleep quality and cancer-related fatigue. [2022]To determine whether sleep quality and fatigue associated with breast cancer adjuvant chemotherapy treatments can be improved with behavioral therapy (BT) [Individualized Sleep Promotion Plan (ISPP)] including modified stimulus control, modified sleep restriction, relaxation therapy, and sleep hygiene.
Light enhanced cognitive behavioral therapy for insomnia and fatigue during chemotherapy for breast cancer: a randomized controlled trial. [2022]Sleep problems are common during chemotherapy for breast cancer (BC). We evaluated whether combined brief cognitive behavioral and bright light therapy (CBT-I + Light) is superior to treatment as usual with relaxation audio (TAU+) for insomnia symptoms and sleep efficiency (primary outcomes).
Feasibility and Preliminary Efficacy of a Bright Light Intervention in Ovarian and Endometrial Cancer Survivors. [2022]Cancer-related sleep disturbance is common and can adversely affect physical and mental health. Bright light (BL) therapy is a novel intervention that targets sleep by promoting circadian regulation. Emerging evidence suggests BL can improve sleep disturbance, symptom burden, and health-related quality of life in cancer and other populations; however, this research is limited. The present two-phase pilot study assessed the feasibility and preliminary intended effects of BL therapy on sleep in ovarian and endometrial cancer survivors, and explored biologic and chronobiologic factors that may underlie intervention effects.
Sleep Disorders Prior to Adjuvant Radiation Therapy for Gynecological Malignancies. [2021]Many patients with gynecological malignancies receive postoperative radiotherapy, which can lead to fear and sleep disorders. We aimed to identify the prevalence of and risk factors for sleep disorders.
The Survivorship Sleep Program (SSP): A synchronous, virtual cognitive behavioral therapy for insomnia pilot program among cancer survivors. [2023]For cancer survivors, insomnia is prevalent, distressing, and persists for years if unmanaged. Cognitive behavioral therapy for insomnia (CBT-I) is an effective treatment yet can be difficult to access and may require modification to address survivorship-specific barriers to sleep. In this 2-phase study, the authors adapted and assessed the feasibility, acceptability, and preliminary effects of synchronous, virtual CBT-I adapted for cancer survivors (the Survivorship Sleep Program [SSP]).
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. [2023]This study will assess the efficacy of digital CBT for insomnia (dCBT-I) compared to sleep hygiene education (SHE) for the management of insomnia in women with cancer.
Sleep quality of endometrial cancer survivors and the effect of treatments. [2022]Sleep disorders affect 54.9% of gynaecologic cancer survivors. The effect of treatment methods on sleep quality is not clear. This study evaluated the sleep quality of survivors of endometrial cancer and compared the effects of different treatments on sleep quality.