Grant Number:	1K08CA247973-01A1 Interpret this number
Primary Investigator:	Fox, Rina
Organization:	Northwestern University At Chicago
Project Title:	Improving Sleep in Gynecologic Cancer Survivors
Fiscal Year:	2021

PROJECT SUMMARY Sleep disturbance is one of the primary complaints of gynecologic cancer survivors, with more than 80% of survivors reporting sleep difficulties. Sleep disturbance also contributes to worsened health-related quality of life (HRQOL) and increased symptom burden. Although non-pharmacological interventions for sleep disturbance have been explored among cancer populations, up to 50% of survivors do not adhere to treatment recommendations, possibly due to the behaviorally labor-intensive nature thereof. Therefore, there is a need for more effective and acceptable approaches to improve sleep outcomes in cancer. This application proposes a career development plan to support Dr. Rina Fox in establishing an independent research program focused on examining strategies to improve HRQOL and reduce symptom burden among cancer survivors, with particular consideration for the role of sleep and circadian rhythms in the overall disease experience. Her career development will be supported by a multidisciplinary group of researchers. Her mentors, Drs. Ong, Rini, and Zee, are recognized scholars in behavioral sleep medicine, cancer control and survivorship, and circadian rhythms and biology, respectively. They have lengthy histories of federal funding, multidisciplinary collaboration, and successful mentorship of trainees who go on to achieve independence. Dr. Fox’s training will be enhanced by expert consultants who will provide guidance in clinical gynecologic oncology (Dr. Tanner), biostatistics and optimization methodology (Dr. Siddique), qualitative research methods (Dr. Kaiser), circadian activity rhythms and execution of sleep-focused research among cancer survivors (Dr. Ancoli-Israel), and biobehavioral mechanisms of intervention efficacy and psychosocial intervention development specifically among gynecologic cancer survivors (Dr. Penedo). The aim of this application is to optimize a behavioral intervention to decrease sleep disturbance (primary outcome), and improve HRQOL and reduce symptom burden (secondary outcomes) among gynecologic cancer survivors. In Phase I, 15 participants will simultaneously receive three candidate intervention components known to reduce sleep disturbance (i.e., sleep restriction, stimulus control, and bright light), and will subsequently complete semi-structured individual interviews to provide feedback regarding barriers and facilitators to intervention adherence. In Phase II, 80 participants will be randomized to evaluate these intervention components within a 23 full factorial trial design, as guided by the Multiphase Optimization Strategy (MOST) framework, to identify the optimal combination of candidate intervention components, enhanced to promote adherence, that best affect the study’s primary and secondary outcomes. Sleep disturbance and circadian markers will also be evaluated as potential mechanisms underlying the candidate intervention components’ effects on study outcomes. Results of this innovative research will directly lead to an R01 application and an independent and programmatic line of research for Dr. Fox focused on HRQOL, symptom burden, and sleep and circadian disturbance among cancer survivors.

Error Notice