An interventional study of Cognitive Behavioral therapy for insomnia (CBT-I) in Breast Cancer and Prostate Cancer, sponsored by Abramson Cancer Center at Penn Medicine. Completed at 1 site in United States. Open to participants aged 40 Years to 85 Years. Per ClinicalTrials.gov, last updated 2024-09-19.
Sponsored by Abramson Cancer Center at Penn Medicine · Not applicable, Interventional, and Treatment
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.
12,815 studies on the registry are indexed under Breast Neoplasms; 2,920 are open to participants now.
This study's enrollment of 18 is below the median of 72 across 9,494 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Abramson Cancer Center at Penn Medicine is the lead sponsor of 457 studies on the registry; 84 are open to participants now.
Of its 33 completed or terminated interventional studies of FDA-regulated products, 14 (42%) have results posted.
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Exclusion Criteria:
Participants randomized to this condition received 4 weekly CBT-I sessions.
Behavioral: Cognitive Behavioral therapy for insomnia (CBT-I)
Participants randomized to this condition received 8 weekly CBT-I sessions.
Behavioral: Cognitive Behavioral therapy for insomnia (CBT-I)
Participants randomized to this condition received 10 weekly CBT-I sessions.
Behavioral: Cognitive Behavioral therapy for insomnia (CBT-I)
Participants randomized to this condition received 12 weekly CBT-I sessions.
Behavioral: Cognitive 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.
Fatigue
Fatigue, as measured by the Multidimensional Fatigue Symptom Inventory-Short Form and the FACIT-Fatigue scale.
Time frame: From enrollment to three months post-treatment
Insomnia Severity
As measured by the Insomnia Severity Index
Time frame: From enrollment to post-treatment, and 3 months post-treatment
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.
Time frame: From enrollment to post-treatment, and 3 months post-treatment.]
Plan to share: Undecided
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This study is completed, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.
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Abramson Cancer Center at Penn Medicine →