MedTrace Logo

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

NCT05226078 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2025-05-20

No results posted yet for this study

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.

Conditions

  • Chronic Insomnia
  • Cancer-related Problem/Condition
  • Cancer-Related Syndrome

Interventions

BEHAVIORAL

Cognitive Behavioral Therapy for Insomnia

Cognitive behavioral treatment of insomnia

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Abramson Cancer Center at Penn Medicine

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
25 Years
Max Age
85 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-01
Primary Completion
2026-08-31
Completion
2026-11-30

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05226078 on ClinicalTrials.gov