The Association Between CBT-I Dose, Sleep Duration, and Fatigue in Breast Cancer Patients
Primary Purpose
Chronic Insomnia, Cancer-related Problem/Condition, Cancer-Related Syndrome
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive Behavioral Therapy for Insomnia
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Insomnia focused on measuring Insomnia, Fatigue, CBT-I, Dose Response, Cancer-Related Fatigue
Eligibility Criteria
Inclusion Criteria:
- The diagnosis of organ-confined BC;
- Treatment with RT;
- Willingness and ability to provide informed consent;
- They endorse problems with both insomnia and CRF, as determined by a score within the significant ranges on the ISI, PROMIS 7a and FACIT-F;
- and/or they do not have any significant medical (e.g., OSA; COPD) and/or psychiatric diagnoses (e.g., PTSD).
Exclusion Criteria:
- History of untreated obstructive sleep apnea (OSA [defined as an apnea-hypopnea index ≥ 10]) or above threshold scores on the STOP-BANG;
- History of narcolepsy;
- Night shift work;
- Distant metastatic disease at presentation;
- Active alcohol and/or drug dependence;
- They do not have a diagnosis of BC;
- They do not endorse insomnia, CRF and/or do not score within the significant ranges on the ISI, PROMIS 7a and/or the FACIT;
- They have a current diagnosis of significant medical and/or psychiatric disorders;
- And/or they are not between the ages of 25-85 years.
Sites / Locations
- University of PennsylvaniaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
Four Sessions of CBT-I
Eight Sessions of CBT-I
Ten Sessions of CBT-I
Twelve Sessions of CBT-I
Arm Description
Outcomes
Primary Outcome Measures
Recruitment
Proportion of screened eligible subjects who: complete a screener; enroll; and accept randomization.
Adherence
Average adherence to Sleep Restriction Therapy (SRT) and Stimulus Control Therapy (SCT) [overall and by week] as measured by deviations between prescribed and actual times (from sleep diaries), overall and by group.
Treatment Acceptability
Average Insomnia Treatment Acceptability Scale (ITAS) scores, overall and by group.
Total score for each subscale is the average of the 8 items, with higher scores indicating greater willingness to utilize the treatment.
Retention
Percent of subjects who complete the study, overall and by group.
Secondary Outcome Measures
Full Information
NCT ID
NCT05226078
First Posted
December 7, 2021
Last Updated
August 29, 2023
Sponsor
Abramson Cancer Center at Penn Medicine
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT05226078
Brief Title
The Association Between CBT-I Dose, Sleep Duration, and Fatigue in Breast Cancer Patients
Official Title
The Association Between CBT-I Dose, Sleep Duration, and Fatigue in Breast Cancer Patients
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2023 (Actual)
Primary Completion Date
September 30, 2024 (Anticipated)
Study Completion Date
September 30, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Abramson Cancer Center at Penn Medicine
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
Data Monitoring Committee
No
5. Study Description
Brief Summary
Cancer-related fatigue (CRF) and insomnia are prevalent among cancer patients and have been linked to de-creases in quality of life and poorer overall survivorship. Currently, the mechanisms underlying CRF are not well understood, which has led to treatments that are only moderately effective. In addition, when compared to CBT-I in the general population, the treatment outcomes in CBT-I with cancer patients are subpar and, as such, this study will evaluate whether dose of CBT-I is effective in ameliorating CRF.
Detailed Description
Subjects will be randomized into one of four groups, four, eight, ten or twelve sessions. Sessions will be con-ducted weekly by Telehealth and will be modified based on the duration of treatment but all will include the following, evaluation and orientation; data acquisition and delivery of sleep restriction therapy & stimulus control instructions; review of sleep hygiene; cognitive therapy [decatastrophization]; managing non-adherence and relapse prevention), and, finally, the final sessions will be largely focused on time-in-bed titration. Treatment will be conducted by a master therapist via a HIPAA compliant video link.
All CBT-I related data will be obtained via dedicated internet websites built with RedCap, where subjects will be asked to complete weekly and monthly questionnaires. One website will be for use by subjects. One website will be for use by the therapist. The patient and therapist website will have a landing page (password entry), a login page, and an activities page (what questionnaires are due when). For an example of such a website, please see our pilot study, https://redcap.med.upenn.edu/surveys/?s=RXLLA7C4KJ (access using password "sleepstudy"). The patient website will contain daily sleep diaries, weekly severity measures of insomnia (ISI), sleepiness (ESS), fatigue (PROMIS 7a, Brief Fatigue Inventory, and FACIT-F), depression (PHQ-9), anxiety (GAD-7), a medical symptoms checklist.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Insomnia, Cancer-related Problem/Condition, Cancer-Related Syndrome
Keywords
Insomnia, Fatigue, CBT-I, Dose Response, Cancer-Related Fatigue
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
70 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Four Sessions of CBT-I
Arm Type
Experimental
Arm Title
Eight Sessions of CBT-I
Arm Type
Experimental
Arm Title
Ten Sessions of CBT-I
Arm Type
Experimental
Arm Title
Twelve Sessions of CBT-I
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioral Therapy for Insomnia
Other Intervention Name(s)
CBT-I
Intervention Description
Cognitive behavioral treatment of insomnia
Primary Outcome Measure Information:
Title
Recruitment
Description
Proportion of screened eligible subjects who: complete a screener; enroll; and accept randomization.
Time Frame
Baseline to End of Treatment (Up to 12 weeks)
Title
Adherence
Description
Average adherence to Sleep Restriction Therapy (SRT) and Stimulus Control Therapy (SCT) [overall and by week] as measured by deviations between prescribed and actual times (from sleep diaries), overall and by group.
Time Frame
Baseline to End of Treatment (Up to 12 weeks)
Title
Treatment Acceptability
Description
Average Insomnia Treatment Acceptability Scale (ITAS) scores, overall and by group.
Total score for each subscale is the average of the 8 items, with higher scores indicating greater willingness to utilize the treatment.
Time Frame
End of Treatment
Title
Retention
Description
Percent of subjects who complete the study, overall and by group.
Time Frame
Baseline to End of Treatment (Up to 12 weeks)
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
The diagnosis of organ-confined BC;
Treatment with RT;
Willingness and ability to provide informed consent;
They endorse problems with both insomnia and CRF, as determined by a score within the significant ranges on the ISI, PROMIS 7a, BFI, and FACIT-F;
and/or they do not have any significant medical (e.g., OSA; COPD) and/or psychiatric diagnoses (e.g., PTSD).
Exclusion Criteria:
History of untreated obstructive sleep apnea (OSA [defined as an apnea-hypopnea index ≥ 10]) or above threshold scores on the STOP-BANG;
History of narcolepsy;
Night shift work;
Distant metastatic disease at presentation;
Active alcohol and/or drug dependence;
They do not have a diagnosis of BC;
They do not endorse insomnia, CRF and/or do not score within the significant ranges on the ISI, PROMIS 7a and/or the FACIT;
They have a current diagnosis of significant medical and/or psychiatric disorders;
And/or they are not between the ages of 25-85 years.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alexandria Muench
Phone
215-746-4378
Email
amuench@pennmedicine.upenn.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Mark Seewald
Phone
4848888952
Email
mark.seewald@pennmedicine.upenn.edu
Facility Information:
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexandria Muench, PsyD
Phone
215-421-4491
Email
amuench@pennmedicine.upenn.edu
First Name & Middle Initial & Last Name & Degree
Mark Seewald, BS
Phone
215-746-4378
Email
mark.seewald@pennmedicine.upenn.edu
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Association Between CBT-I Dose, Sleep Duration, and Fatigue in Breast Cancer Patients
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