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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05226078
Other study ID # 850366
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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)
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