CBT-I for the Treatment of Insomnia and Cancer-related Fatigue in Patients with Breast Cancer

Status: closed to accrual

This clinical trial evaluates the effect of the number of cognitive behavior therapy for insomnia(CBT-I) sessions for the treatment of insomnia and cancer-related fatigue in patients with breast cancer. Cancer-related fatigue (CRF) and insomnia are prevalent among cancer patients and have been linked to decreases in quality of life and poorer overall survivorship. Cancer treatments such as chemotherapy and radiation can cause several of unwanted side effects including insomnia and CRF. CBT-I is a behavioral treatment for insomnia and is currently considered the first line treatment. Behavioral treatments such as CBT-I may provide some relief to patients who are experiencing the effects of insomnia and/or fatigue. This study may help researchers learn how CBT-I may improve insomnia and cancer-related fatigue in patients with breast cancer.

Inclusion Criteria

The diagnosis of organ-confined breast cancer (BC)
Treatment with radiation therapy (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 Insomnia Severity Index (ISI), Patient Reported Outcomes Measurement Information System (PROMIS) 7a and Brief Fatigue Inventory (BFI)
And/or they do not have any significant medical (e.g., obstructive sleep apnea [OSA]; chronic obstructive pulmonary disease [COPD]) and/or psychiatric diagnoses (e.g., post-traumatic stress disorder [PTSD])

Exclusion Criteria

History of untreated obstructive sleep apnea (OSA [defined as an apnea-hypopnea index >=10]) or above threshold scores on the; snoring, tiredness, observed apnea, high blood pressure (BP), body mass index (BMI), age, neck circumference, and male gender (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 BFI
They have a current diagnosis of significant medical and/or psychiatric disorders
And/or they are not between the ages of 25-85 years

PRIMARY OBJECTIVE:

I. To test the association between CBT-I dose and how it relates to CRF, the incidence and/or severity of sleep continuity disturbance, reduced total sleep time, or all of these factors.

OUTLINE: Patients are randomized to 1 of 4 arms.

ARM I: Patients attend 4 weekly CBT-I telehealth sessions on study.

ARM II: Patients attend 8 weekly CBT-I telehealth sessions on study.

ARM III: Patients attend 10 weekly CBT-I telehealth sessions on study.

ARM IV: Patients attend 12 weekly CBT-I telehealth sessions on study.

After completion of study intervention, patients are followed up at 3, 6, 9, and 12 months.

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CBT-I for the Treatment of Insomnia and Cancer-related Fatigue in Patients with Breast Cancer

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