Improving Sleep in Gynecologic Cancer Survivors

Sleep Disturbance Clinical Trial

Official title:

Improving Sleep in Gynecologic Cancer Survivors

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05044975
• Other study ID #: STU00213356
• Secondary ID: K08CA247973
• Status: Recruiting
• Phase: N/A
• Start date: October 11, 2021
• Est. completion date: January 31, 2026

Study information

• Verified date: December 2023
• Source: University of Arizona
• Contact: Rina S Fox, PhD, MPH
• Phone: (520) 626-3071
• Email: rsfox[@]arizona.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This purpose of this study is to learn about how to provide treatment to gynecologic cancer survivors who have difficulty sleeping.

Description:

This study has two parts.

In Part 1, 15 gynecologic cancer survivors will receive three candidate intervention components known to reduce sleep disturbance (i.e., sleep restriction, stimulus control, systematic light exposure) simultaneously for six weeks. Participants will then complete semi-structured individual interviews to provide feedback about barriers to and facilitators of intervention adherence. Results of Part 1 will inform the design and delivery of the candidate components in Part 2.

In Part 2, a 2^3 full factorial design will be followed to randomize 80 gynecologic cancer survivors to one of eight six-week intervention conditions reflecting all possible combinations of the three candidate intervention components.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 95
• Est. completion date: January 31, 2026
• Est. primary completion date: January 31, 2026
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• History of Stage I, II, or III gynecologic cancer

• Age 18+ years

• English language proficiency

• Current sleep disturbance demonstrated by a Pittsburgh Sleep Quality Index (PSQI) score > 5

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

• Reliable telephone and Internet access

Exclusion Criteria:

• Stage IV disease

• Diagnosed or suspected psychiatric or medical condition that may interfere with participation (e.g., psychosis, dementia, bipolar disorder, abuse of alcohol or illicit substances within the past 6 months, narrow angle glaucoma, retinal disorders, epilepsy or a similar condition)

• Diagnosed sleep apnea, narcolepsy, periodic limb movement disorder, or restless legs syndrome unless well controlled

• Use of medications that may be contraindications for study procedures due to safety concerns or due to potential impact on intervention efficacy or assessment validity (e.g., sedatives/hypnotics), to be identified on a case-by-case basis

• Shift worker

• Severe physical or cognitive impairment (= 2 errors on a brief six-item version of the Mini Mental State Exam [MMSE] or Patient Reported Functional Status [PRFS] score > 2, which is based on the Eastern Cooperative Oncology Group [ECOG]but has been modified to be in lay language)

• Plans to travel across 3 or more meridians/time zones during the 6 intervention weeks or plans to cross any meridians/time zones during the 2 weeks leading up to wearing an actiwatch.

• History of a primary diagnosis of a distinct non-gynecologic or non-skin cancer other than a non-melanoma skin cancer within the 5 years prior to enrollment

• For participants with Stage III ovarian cancer: less than 2 years post-completion of primary gynecologic cancer treatment and/or less than 60 days post-surgery. For patients with any other gynecologic cancer/stage: less than 30 days post-completion of primary gynecologic cancer treatment and/or less than 60 days post-surgical intervention (e.g., hysterectomy)

• Male

• Have received CBT-I or systematic bright light therapy within the past 6 months

Related Conditions & MeSH terms

• Dyssomnias
• Gynecologic Cancer
• Parasomnias
• Sleep Disturbance

Intervention

Behavioral:
• Sleep restriction
Participants will receive sleep restriction intervention
• Stimulus control
Participants will receive stimulus control intervention
• Systematic light exposure
Participants will receive systematic light exposure intervention

Locations

Country	Name	City	State
United States	Northwestern University Feinberg School of Medicine	Chicago	Illinois
United States	University of Arizona College of Nursing	Tucson	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
University of Arizona	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Changes in circadian activity rhythms from baseline to immediately after the intervention and 3-months post-intervention	Wrist actigraphy	Baseline (Part 1 and Part 2 participants), immediately after the intervention (Part 1 and Part 2 participants), 3-months post-intervention (Part 2 participants only)
Other	Changes in urinary 6-Sulfatoxymelatonin from baseline to immediately after the intervention and 3-months post-intervention	The night prior to each assessment participants will collect overnight urine to enable analysis of urinary 6-Sulfatoxymelatonin	Baseline (Part 1 and Part 2 participants), immediately after the intervention (Part 1 and Part 2 participants), 3-months post-intervention (Part 2 participants only)
Primary	Changes in objectively-measured sleep outcomes from baseline to immediately after the intervention and 3-months post-intervention	Wrist actigraphy	Baseline (Part 1 and Part 2 participants), immediately after the intervention (Part 1 and Part 2 participants), 3-months post-intervention (Part 2 participants only)
Primary	Changes in subjectively-reported sleep quality from baseline to immediately after the intervention and 3-months post-intervention	Subjectively-reported sleep quality over the past 7 days will be measured with the Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance questionnaire. Raw scores will be converted to T-scores with a mean of 50 and a standard deviation of 10. Higher scores indicate more of the underlying construct.	Baseline (Part 1 and Part 2 participants), immediately after the intervention (Part 1 and Part 2 participants), 3-months post-intervention (Part 2 participants only)
Primary	Changes in perceived impairment during wake associated with sleep problems from baseline to immediately after the intervention and 3-months post-intervention	Perceived impairment during wake associated with sleep problems over the past seven days will be measured with the PROMIS Sleep-Related Impairment questionnaire. Raw scores will be converted to T-scores with a mean of 50 and a standard deviation of 10. Higher scores indicate more of the underlying construct.	Baseline (Part 1 and Part 2 participants), immediately after the intervention (Part 1 and Part 2 participants), 3-months post-intervention (Part 2 participants only)
Secondary	Changes in health-related quality of life (HRQOL) from baseline to immediately after the intervention and 3-months post-intervention	The 27-item Functional Assessment of Cancer Therapy - General (FACT-G) will measure HRQOL.	Baseline (Part 1 and Part 2 participants), immediately after the intervention (Part 1 and Part 2 participants), 3-months post-intervention (Part 2 participants only)
Secondary	Changes in overall symptom burden from baseline to immediately after the intervention and 3-months post-intervention	The 32-item Memorial Symptom Assessment Scale (MSAS) will evaluate symptom burden.	Baseline (Part 1 and Part 2 participants), immediately after the intervention (Part 1 and Part 2 participants), 3-months post-intervention (Part 2 participants only)
Secondary	Changes in symptoms of depression from baseline to immediately after the intervention and 3-months post-intervention	Symptoms of depression over the past seven days with be measured with the PROMIS Depression questionnaire. Raw scores will be converted to T-scores with a mean of 50 and a standard deviation of 10. Higher scores indicate more of the underlying construct.	Baseline (Part 1 and Part 2 participants), immediately after the intervention (Part 1 and Part 2 participants), 3-months post-intervention (Part 2 participants only)
Secondary	Changes in symptoms of anxiety from baseline to immediately after the intervention and 3-months post-intervention	Symptoms of anxiety over the past seven days with be measured with the PROMIS Anxiety questionnaire. Raw scores will be converted to T-scores with a mean of 50 and a standard deviation of 10. Higher scores indicate more of the underlying construct.	Baseline (Part 1 and Part 2 participants), immediately after the intervention (Part 1 and Part 2 participants), 3-months post-intervention (Part 2 participants only)
Secondary	Changes in fatigue from baseline to immediately after the intervention and 3-months post-intervention	Fatigue over the past seven days with be measured with the PROMIS Fatigue questionnaire. Raw scores will be converted to T-scores with a mean of 50 and a standard deviation of 10. Higher scores indicate more of the underlying construct.	Baseline (Part 1 and Part 2 participants), immediately after the intervention (Part 1 and Part 2 participants), 3-months post-intervention (Part 2 participants only)