The Association Between CBT-I Dose and Innate Immunity in Insomnia and Fatigue in Prostate Cancer Patients

Abramson Cancer Center at Penn Medicine

Status: Completed

Conditions: Breast Cancer; Prostate Cancer

Treatments: Behavioral: Cognitive Behavioral therapy for insomnia (CBT-I)

Study type: Interventional

Funder types: Other

Identifiers

NCT06604247

834620

Details and patient eligibility

About

The objective of this project is to test the association between Cognitive Behavioral Therapy for Insomnia dose (number of sessions), severity of cancer related fatigue, and levels of innate immunity biomarkers. Ultimately, this research will help to develop a better understanding of the underlying mechanisms of cancer related fatigue.

Full description

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. Currently, the mechanisms underlying CRF are not well understood, which has led to treatments that are only moderately effective. In addition, when compared to Cognitive Behavioral Therapy for Insomnia (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.

Enrollment: 18 patients

Sex: All

Ages: 40 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of organ-confined breast cancer or prostate cancer
• Received radiation treatment
• Willing and able to provide informed consent
• Endorse problem with both insomnia and cancer-related fatigue, as measured by the insomnia severity index, Multidimensional Fatigue Symptom Inventory (short form) and the Brief Fatigue Inventory

Exclusion criteria

• History of obstructive Sleep Apnea
• History of narcolepsy
• Night shift work
• Distant metastatic disease at presentation
• Active drug/alcohol dependence

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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18 participants in 4 patient groups

4-session

Experimental group

Description:

Participants randomized to this condition received 4 weekly CBT-I sessions.

Treatment:

Behavioral: Cognitive Behavioral therapy for insomnia (CBT-I)

8-session

Experimental group

Description:

Participants randomized to this condition received 8 weekly CBT-I sessions.

Treatment:

Behavioral: Cognitive Behavioral therapy for insomnia (CBT-I)

10-session

Experimental group

Description:

Participants randomized to this condition received 10 weekly CBT-I sessions.

Treatment:

Behavioral: Cognitive Behavioral therapy for insomnia (CBT-I)

12-session

Experimental group

Description:

Participants randomized to this condition received 12 weekly CBT-I sessions.

Treatment:

Behavioral: Cognitive Behavioral therapy for insomnia (CBT-I)