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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 4-session | Experimental | Participants randomized to this condition received 4 weekly CBT-I sessions. |
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| 8-session | Experimental | Participants randomized to this condition received 8 weekly CBT-I sessions. |
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| 10-session | Experimental | Participants randomized to this condition received 10 weekly CBT-I sessions. |
|
| 12-session | Experimental | Participants randomized to this condition received 12 weekly CBT-I sessions. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive Behavioral therapy for insomnia (CBT-I) | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Fatigue | Fatigue, as measured by the Multidimensional Fatigue Symptom Inventory-Short Form and the FACIT-Fatigue scale. | From enrollment to three months post-treatment |
| Insomnia Severity | As measured by the Insomnia Severity Index | From enrollment to post-treatment, and 3 months post-treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Sleep Continuity | As measured by the daily sleep diary, including sleep latency, number of awakenings, wake after sleep onset, total sleep time and sleep efficiency. | From enrollment to post-treatment, and 3 months post-treatment.] |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Of Pennsylvania, Behavioral Sleep Medicine Program | Philadelphia | Pennsylvania | 19104 | United States |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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|
| D017437 |
| Skin and Connective Tissue Diseases |
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |