The Association Between CBT-I Dose, Sleep Duration, and Fatigue in Breast Cancer Patients

Chronic Insomnia Clinical Trial

Official title:

The Association Between CBT-I Dose, Sleep Duration, and Fatigue in Breast Cancer Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05226078
• Other study ID #: 850366
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2023
• Est. completion date: September 30, 2025

Study information

• Verified date: August 2023
• Source: Abramson Cancer Center at Penn Medicine
• Contact: Alexandria Muench
• Phone: 215-746-4378
• Email: amuench[@]pennmedicine.upenn.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: September 30, 2025
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 25 Years to 85 Years

Eligibility

Inclusion Criteria:

1. 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:

1. 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.

Related Conditions & MeSH terms

• Cancer-related Problem/Condition
• Cancer-Related Syndrome
• Chronic Insomnia
• Fatigue
• Neoplasms
• Sleep Initiation and Maintenance Disorders

Intervention

Behavioral:
• Cognitive Behavioral Therapy for Insomnia
Cognitive behavioral treatment of insomnia

Locations

Country	Name	City	State
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Abramson Cancer Center at Penn Medicine	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recruitment	Proportion of screened eligible subjects who: complete a screener; enroll; and accept randomization.	Baseline to End of Treatment (Up to 12 weeks)
Primary	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.	Baseline to End of Treatment (Up to 12 weeks)
Primary	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.	End of Treatment
Primary	Retention	Percent of subjects who complete the study, overall and by group.	Baseline to End of Treatment (Up to 12 weeks)