Breast Cancer, Prostate Cancer
Conditions
Brief summary
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.
Detailed 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.
Interventions
BEHAVIORALCognitive Behavioral therapy for insomnia (CBT-I)
Cognitive Behavioral Therapy for Insomnia includes evaluation and orientation; data acquisition and delivery of sleep restriction therapy & stimulus control instructions; review of sleep hygiene; cognitive therapy \[decatastrophization\]; managing nonadherence and relapse prevention), and, finally, the final sessions will be largely focused on time-in-bed titration.
Sponsors
Abramson Cancer Center at Penn Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fatigue | From enrollment to three months post-treatment | Fatigue, as measured by the Multidimensional Fatigue Symptom Inventory-Short Form and the FACIT-Fatigue scale. |
| Insomnia Severity | From enrollment to post-treatment, and 3 months post-treatment | As measured by the Insomnia Severity Index |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sleep Continuity | From enrollment to post-treatment, and 3 months post-treatment.] | As measured by the daily sleep diary, including sleep latency, number of awakenings, wake after sleep onset, total sleep time and sleep efficiency. |
Countries
United States
Outcome results
None listed