[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100570692":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":38,"locations":47,"responsibleParty":140,"collaborators":143,"id":147,"slug":148,"hasResults":149,"nctId":150,"briefTitle":151,"officialTitle":152,"acronym":26,"eligibilityCriteria":153,"healthyVolunteers":149,"sex":154,"minAge":155,"maxAge":26,"enrollmentInfo":156,"targetDuration":26,"studyType":159,"phases":160,"briefSummary":162,"conditions":163,"keywords":171,"overallStatus":50,"whyStopped":26,"lastUpdateSubmitDate":176,"lastUpdatePostDateStruct":177,"startDateStruct":180,"completionDateStruct":182,"leadSponsor":184,"locationsCount":185},{"fullName":5,"class":6},"Dana-Farber Cancer Institute","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"ARM 1: REVITALIZE Intervention","EXPERIMENTAL","120 participants will be randomized in a 1:1 fashion stratified by PARP inhibitor type and study site and will complete the following:\n\n1. Questionnaire upon enrollment.\n2. Use of a wireless pill bottle for PARP inhibitor medication.\n3. Eight weekly one-on-one intervention sessions with a coach via Zoom.\n4. Two booster sessions to reinforce intervention with a coach via Zoom.\n5. Questionnaires at 8, 13, 20, and 28 weeks.",[13],"Behavioral: REVITALIZE Intervention",{"label":15,"type":16,"description":17,"interventionNames":18},"ARM 2: Educational Materials","ACTIVE_COMPARATOR","120 participants will be randomized in a 1:1 fashion stratified by PARP inhibitor type and study site and will complete the following:\n\n1. Questionnaire upon enrollment.\n2. Use of wireless pill bottle for PARP inhibitor medication.\n3. Educational information on cancer survivorship, including management of fatigue.\n4. Questionnaires at 8, 13, 20, and 28 weeks.",[19],"Behavioral: Educational Materials",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"BEHAVIORAL","REVITALIZE Intervention","A remotely delivered tele-health intervention to address cancer fatigue that is based on an acceptance-based approach. The intervention includes 8 one-on-one weekly sessions and 2 booster sessions with trained psychology doctoral students based at University of Colorado. Sessions will focus on fatigue education, Acceptance and Commitment Therapy (ACT) skills, and behavior changes. Wi-Fi enabled tablets and keyboards will be provided to participants if needed. All sessions will be conducted via the Zoom platform and will either be videotaped or audiotaped.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Educational Materials","The educational materials arm will receive specialized cancer survivorship educational materials created by the National Cancer Institute",[15],[32,35],{"name":33,"affiliation":5,"role":34},"Alexi A Wright, MD, MPH","PRINCIPAL_INVESTIGATOR",{"name":36,"affiliation":37,"role":34},"Joanna J Arch, PhD","University of Colorado, Boulder",[39,44],{"name":40,"role":41,"phone":42,"phoneExt":26,"email":43},"Hannah Park, BS","CONTACT","857.215.4936","revitalize@dfci.harvard.edu",{"name":45,"role":41,"phone":46,"phoneExt":26,"email":43},"Irene Wang, MPH","617.582.7238",[48,69,86,101,112,123],{"facility":49,"status":50,"city":51,"state":52,"zip":53,"country":54,"countryCode":55,"cosmosGeoPoint":56,"geoPoint":61,"contacts":62},"University of Colorado Cancer Center-Anschutz","RECRUITING","Aurora","Colorado","80045","United States","US",{"type":57,"coordinates":58},"Point",[59,60],-104.83192,39.72943,{"lat":60,"lon":59},[63,67],{"name":64,"role":41,"phone":65,"phoneExt":26,"email":66},"Evamaria Bravo, MS","303-724-0131","evamaria.kentbravo@cuanschutz.edu",{"name":68,"role":34,"phone":26,"phoneExt":26,"email":26},"Carolyn Lefkowits, MD, MPH, MS",{"facility":70,"status":50,"city":71,"state":52,"zip":72,"country":54,"countryCode":55,"cosmosGeoPoint":73,"geoPoint":77,"contacts":78},"University of Colorado Boulder","Boulder","80309",{"type":57,"coordinates":74},[75,76],-105.27055,40.01499,{"lat":76,"lon":75},[79,83,85],{"name":80,"role":41,"phone":81,"phoneExt":26,"email":82},"Madeline Nealis, MPH","720-515-9461","revitalize@colorado.edu",{"name":84,"role":41,"phone":81,"phoneExt":26,"email":82},"Sarah Genung, BA MSc",{"name":36,"role":34,"phone":26,"phoneExt":26,"email":26},{"facility":87,"status":50,"city":88,"state":89,"zip":90,"country":54,"countryCode":55,"cosmosGeoPoint":91,"geoPoint":95,"contacts":96},"Massachusetts General Hospital-Cancer Center","Boston","Massachusetts","02114",{"type":57,"coordinates":92},[93,94],-71.05977,42.35843,{"lat":94,"lon":93},[97],{"name":98,"role":41,"phone":99,"phoneExt":26,"email":100},"Richard Penson, MBBS","617-724-4800","rpenson@mgb.org",{"facility":102,"status":50,"city":88,"state":89,"zip":103,"country":54,"countryCode":55,"cosmosGeoPoint":104,"geoPoint":106,"contacts":107},"Beth Israel Deaconess Medical Center","02115",{"type":57,"coordinates":105},[93,94],{"lat":94,"lon":93},[108],{"name":109,"role":41,"phone":110,"phoneExt":26,"email":111},"Page Widick, MD","617-667-2100","pwidick@bidmc.harvard.edu",{"facility":5,"status":50,"city":88,"state":89,"zip":113,"country":54,"countryCode":55,"cosmosGeoPoint":114,"geoPoint":116,"contacts":117},"02215",{"type":57,"coordinates":115},[93,94],{"lat":94,"lon":93},[118,122],{"name":119,"role":41,"phone":120,"phoneExt":26,"email":121},"Alexi Wright, MD, MPH","617-632-2334","Alexi_Wright@dfci.harvard.edu",{"name":119,"role":34,"phone":26,"phoneExt":26,"email":26},{"facility":124,"status":50,"city":125,"state":126,"zip":127,"country":54,"countryCode":55,"cosmosGeoPoint":128,"geoPoint":132,"contacts":133},"Duke Cancer Center","Durham","North Carolina","27710",{"type":57,"coordinates":129},[130,131],-78.89862,35.99403,{"lat":131,"lon":130},[134,138],{"name":135,"role":41,"phone":136,"phoneExt":26,"email":137},"Amelia Scott","919-613-4584","amelia.lorenzo@duke.edu",{"name":139,"role":34,"phone":26,"phoneExt":26,"email":26},"Laura Havrilesky, MD, MHSc",{"type":34,"investigatorFullName":141,"investigatorTitle":142,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Alexi A. Wright, MD","Principal Investigator",[144],{"name":145,"class":146},"National Cancer Institute (NCI)","NIH","100570692","revitalize-rct-to-reduce-fatigue-in-adults-with-ovarian-cancer-on-parp-inhibitors-100570692",false,"NCT06710548","REVITALIZE: RCT to Reduce Fatigue in Adults With Ovarian Cancer on PARP Inhibitors","Randomized Trial of REVITALIZE: A Telehealth Intervention to Reduce Fatigue Interference Among Adults With Advanced Ovarian Cancer on PARP Inhibitors","Inclusion Criteria:\n\n* Adult patients (age ≥ 18 years) with ovarian, fallopian tube, or primary peritoneal cancers (hereafter ovarian cancer) who have completed primary therapy (surgery and chemotherapy).\n* Treated with a PARP inhibitor as maintenance therapy for ≥2 months and plan to continue for at least 7 months.\n* English-speaking.\n* Mean fatigue severity level ≥4 on the first three items of the Fatigue Symptom Inventory.\n* ECOG performance status of 0-2.\n* Willing to use a wireless pill bottle for PARP inhibitor medication.\n\nExclusion Criteria:\n\n* Untreated clinical condition or comorbid condition that pre-dates PARP inhibitor use and could explain fatigue, as evaluated by their treating oncologist.\n* Patients with severe psychiatric conditions (e.g. untreated trauma unrelated to cancer, high or imminent suicidality) as evaluated by their treating oncologist, which require more intensive psychiatric treatment than the study can provide.\n* Patients with cognitive conditions (e.g. dementia), determined by their treating oncologist, such that they could not provide informed consent or complete the study procedures.\n* Inability to complete the first questionnaire within one week of consent.","FEMALE","18 Years",{"count":157,"type":158},240,"ESTIMATED","INTERVENTIONAL",[161],"NA","The purpose of this study is to see whether a supportive intervention (REVITALIZE) reduces fatigue and its impact on daily life and activities for participants with ovarian cancer taking PARP inhibitors.\n\nThe name of the study groups in this research study are:\n\n1. REVITALIZE\n2. Educational Materials",[164,165,166,167,168,169,170],"Ovarian Cancer","Advanced Ovarian Carcinoma","Fallopian Tube Carcinoma","Primary Peritoneal Cancer","PARP Inhibitor","Fatigue Related to Cancer Treatment","Fatigue in Cancer Survivors",[164,165,172,167,173,174,170,175],"Advanced Ovarian Cancer","Fallopian Tube Cancer","Fatigue related to cancer treatment","PARP inhibitor","2026-04-07",{"date":178,"type":179},"2026-04-13","ACTUAL",{"date":181,"type":179},"2025-03-17",{"date":183,"type":158},"2029-01-31",{"name":5,"class":6},6]