The Association Between CBT-I Dose, Sleep Duration, and Fatigue in Breast Cancer Patients
Purpose
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.
Conditions
- Chronic Insomnia
- Cancer-related Problem/Condition
- Cancer-Related Syndrome
Eligibility
- Eligible Ages
- Between 25 Years and 85 Years
- Eligible Genders
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- The diagnosis of organ-confined BC; 2. Treatment with RT; 3. Willingness and ability to provide informed consent; 4. 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; 5. 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; 2. History of narcolepsy; 3. Night shift work; 4. Distant metastatic disease at presentation; 5. Active alcohol and/or drug dependence; 6. They do not have a diagnosis of BC; 7. They do not endorse insomnia, CRF and/or do not score within the significant ranges on the ISI, PROMIS 7a and/or the FACIT; 8. They have a current diagnosis of significant medical and/or psychiatric disorders; 9. And/or they are not between the ages of 25-85 years.
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Four Sessions of CBT-I |
|
|
|
Experimental Eight Sessions of CBT-I |
|
|
|
Experimental Ten Sessions of CBT-I |
|
|
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Experimental Twelve Sessions of CBT-I |
|
Recruiting Locations
Philadelphia, Pennsylvania 19104
More Details
- NCT ID
- NCT05226078
- Status
- Recruiting
- Sponsor
- Abramson Cancer Center at Penn Medicine
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.