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Improving Sleep in Gynecologic Cancer Survivors

Primary Purpose

Sleep Disturbance, Gynecologic Cancer

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Sleep restriction
Stimulus control
Systematic light exposure
Sponsored by
University of Arizona
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Sleep Disturbance

Eligibility Criteria

18 Years - 74 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • history of Stage I, II, or III gynecologic cancer
  • age 18-74 years
  • English language proficiency
  • current sleep disturbance
  • 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
  • diagnosed and uncontrolled sleep apnea, narcolepsy, periodic limb movement disorder, or restless legs syndrome
  • use of medications that may be contraindications for study procedures
  • age ≥ 75 years
  • shift worker
  • severe physical or cognitive impairment
  • plans to travel across meridians during the study
  • history of a primary diagnosis of a distinct non-gynecologic or non-skin cancer
  • less than 30 days post-completion of primary gynecologic cancer treatment and/or less than 60 days post-surgery
  • Received CBT-I or systematic bright light therapy within the past 6 months

Sites / Locations

  • University of Arizona College of NursingRecruiting
  • Northwestern University Feinberg School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

No Intervention

Arm Label

Sleep restriction, Stimulus control, and Systematic light exposure

Sleep restriction and Stimulus control

Sleep restriction and Systematic light exposure

Stimulus control and Systematic light exposure

Sleep Restriction

Stimulus control

Systematic light exposure

Sleep tracking

Arm Description

Outcomes

Primary Outcome Measures

Changes in objectively-measured sleep outcomes from baseline to immediately after the intervention and 3-months post-intervention
Wrist actigraphy
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.
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.

Secondary Outcome Measures

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.
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.
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.
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.
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.

Full Information

First Posted
September 3, 2021
Last Updated
December 15, 2022
Sponsor
University of Arizona
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT05044975
Brief Title
Improving Sleep in Gynecologic Cancer Survivors
Official Title
Improving Sleep in Gynecologic Cancer Survivors
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 11, 2021 (Actual)
Primary Completion Date
January 31, 2026 (Anticipated)
Study Completion Date
January 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Arizona
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Disturbance, Gynecologic Cancer

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
95 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Sleep restriction, Stimulus control, and Systematic light exposure
Arm Type
Experimental
Arm Title
Sleep restriction and Stimulus control
Arm Type
Experimental
Arm Title
Sleep restriction and Systematic light exposure
Arm Type
Experimental
Arm Title
Stimulus control and Systematic light exposure
Arm Type
Experimental
Arm Title
Sleep Restriction
Arm Type
Experimental
Arm Title
Stimulus control
Arm Type
Experimental
Arm Title
Systematic light exposure
Arm Type
Experimental
Arm Title
Sleep tracking
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Sleep restriction
Intervention Description
Participants will receive sleep restriction intervention
Intervention Type
Behavioral
Intervention Name(s)
Stimulus control
Intervention Description
Participants will receive stimulus control intervention
Intervention Type
Behavioral
Intervention Name(s)
Systematic light exposure
Intervention Description
Participants will receive systematic light exposure intervention
Primary Outcome Measure Information:
Title
Changes in objectively-measured sleep outcomes from baseline to immediately after the intervention and 3-months post-intervention
Description
Wrist actigraphy
Time Frame
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)
Title
Changes in subjectively-reported sleep quality from baseline to immediately after the intervention and 3-months post-intervention
Description
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.
Time Frame
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)
Title
Changes in perceived impairment during wake associated with sleep problems from baseline to immediately after the intervention and 3-months post-intervention
Description
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.
Time Frame
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 Outcome Measure Information:
Title
Changes in health-related quality of life (HRQOL) from baseline to immediately after the intervention and 3-months post-intervention
Description
The 27-item Functional Assessment of Cancer Therapy - General (FACT-G) will measure HRQOL.
Time Frame
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)
Title
Changes in overall symptom burden from baseline to immediately after the intervention and 3-months post-intervention
Description
The 32-item Memorial Symptom Assessment Scale (MSAS) will evaluate symptom burden.
Time Frame
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)
Title
Changes in symptoms of depression from baseline to immediately after the intervention and 3-months post-intervention
Description
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.
Time Frame
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)
Title
Changes in symptoms of anxiety from baseline to immediately after the intervention and 3-months post-intervention
Description
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.
Time Frame
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)
Title
Changes in fatigue from baseline to immediately after the intervention and 3-months post-intervention
Description
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.
Time Frame
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 Pre-specified Outcome Measures:
Title
Changes in circadian activity rhythms from baseline to immediately after the intervention and 3-months post-intervention
Description
Wrist actigraphy
Time Frame
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)
Title
Changes in urinary 6-Sulfatoxymelatonin from baseline to immediately after the intervention and 3-months post-intervention
Description
The night prior to each assessment participants will collect overnight urine to enable analysis of urinary 6-Sulfatoxymelatonin
Time Frame
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)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: history of Stage I, II, or III gynecologic cancer age 18-74 years English language proficiency current sleep disturbance 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 diagnosed and uncontrolled sleep apnea, narcolepsy, periodic limb movement disorder, or restless legs syndrome use of medications that may be contraindications for study procedures age ≥ 75 years shift worker severe physical or cognitive impairment plans to travel across meridians during the study history of a primary diagnosis of a distinct non-gynecologic or non-skin cancer less than 30 days post-completion of primary gynecologic cancer treatment and/or less than 60 days post-surgery Received CBT-I or systematic bright light therapy within the past 6 months
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rina S Fox, PhD, MPH
Phone
(520) 626-3071
Email
rsfox@arizona.edu
Facility Information:
Facility Name
University of Arizona College of Nursing
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85721
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rina S Fox, PhD, MPH
Facility Name
Northwestern University Feinberg School of Medicine
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Individual Site Status
Active, not recruiting

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35310101
Citation
Fox RS, Gaumond JS, Zee PC, Kaiser K, Tanner EJ, Ancoli-Israel S, Siddique J, Penedo FJ, Wu LM, Reid KJ, Parthasarathy S, Badger TA, Rini C, Ong JC. Optimizing a Behavioral Sleep Intervention for Gynecologic Cancer Survivors: Study Design and Protocol. Front Neurosci. 2022 Mar 4;16:818718. doi: 10.3389/fnins.2022.818718. eCollection 2022.
Results Reference
derived

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Improving Sleep in Gynecologic Cancer Survivors

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