Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-31 @ 4:39 AM
Study NCT ID:
NCT07433660
Status:
RECRUITING
Last Update Posted:
2026-03-02
First Post:
2026-02-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
WellSpan-THRIVE Cancer QOL Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010051', 'term': 'Ovarian Neoplasms'}], 'ancestors': [{'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}, 'targetDuration': '24 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2026-02', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2031-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-26', 'studyFirstSubmitDate': '2026-02-19', 'studyFirstSubmitQcDate': '2026-02-19', 'lastUpdatePostDateStruct': {'date': '2026-03-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2031-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Quality of Life Differences based on Race or Ethnicity or Gender', 'timeFrame': 'Baseline, 6-12-18-24 months', 'description': 'Quality of Life Differences based on Race or Ethnicity or Gender based on Quality-of-life questionnaire. We will look for changes in each question on Quality-of-life from baseline to 6-12-18-24 months.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cancer', 'Quality of Life', 'QOL', 'Registry', 'Patient'], 'conditions': ['Cancer (Active Cancer, Meaning Not Being Cancer Free), of Any Stage and Involving Any Treatment/Care Regimen; i.e. Curative, Life-extending, or Palliative', 'Cancer (Solid Tumors)', 'Cancer (With or Without Metastasis)', 'Cancer - Ovarian', 'Cancer Abdomen', 'Cancer (Advanced Stage)']}, 'referencesModule': {'references': [{'pmid': '8445433', 'type': 'BACKGROUND', 'citation': 'Cella DF, Tulsky DS, Gray G, Sarafian B, Linn E, Bonomi A, Silberman M, Yellen SB, Winicour P, Brannon J, et al. The Functional Assessment of Cancer Therapy scale: development and validation of the general measure. J Clin Oncol. 1993 Mar;11(3):570-9. doi: 10.1200/JCO.1993.11.3.570.'}, {'pmid': '11338755', 'type': 'BACKGROUND', 'citation': 'Dodd MJ, Miaskowski C, Paul SM. Symptom clusters and their effect on the functional status of patients with cancer. Oncol Nurs Forum. 2001 Apr;28(3):465-70.'}, {'pmid': '29158371', 'type': 'BACKGROUND', 'citation': 'Yennurajalingam S, Rodrigues LF, Shamieh O, Tricou C, Filbet M, Naing K, Ramaswamy A, Perez-Cruz PE, Bautista MJS, Bunge S, Muckaden MA, Sewram V, Fakrooden S, Noguera-Tejedor A, Rao SS, Liu D, Park M, Williams JL, Lu Z, Cantu H, Hui D, Reddy SK, Bruera E. Perception of Curability Among Advanced Cancer Patients: An International Collaborative Study. Oncologist. 2018 Apr;23(4):501-506. doi: 10.1634/theoncologist.2017-0264. Epub 2017 Nov 20.'}, {'pmid': '33843600', 'type': 'BACKGROUND', 'citation': 'Grabner M, Molife C, Wang L, Winfree KB, Cui ZL, Cuyun Carter G, Hess LM. Data Integration to Improve Real-world Health Outcomes Research for Non-Small Cell Lung Cancer in the United States: Descriptive and Qualitative Exploration. JMIR Cancer. 2021 Apr 12;7(2):e23161. doi: 10.2196/23161.'}, {'pmid': '33538338', 'type': 'BACKGROUND', 'citation': 'Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4.'}]}, 'descriptionModule': {'briefSummary': "Cancer affects millions of people worldwide and can significantly impact not only survival, but also day-to-day quality of life. Treatments such as surgery, chemotherapy, and radiation can cause side effects like fatigue, pain, and neuropathy, which may affect physical function, emotional well-being, and social relationships. While many studies have examined factors that influence quality of life; such as age, type and stage of cancer, and treatment-related symptoms; there is still a need for tools that more fully reflect patients' lived experiences.\n\nThis study aims to develop and implement a patient-centered quality of life (QOL) survey designed specifically for individuals with cancer. By directly involving patients in sharing what matters most to them, the survey seeks to provide a more complete and accurate understanding of how cancer and its treatment affect daily life. The results will help patients, families, and healthcare providers better identify needs, guide supportive care, and improve overall well-being throughout the cancer journey.", 'detailedDescription': "Cancer is a leading cause of morbidity and mortality worldwide. With more than 10 million deaths in 2020, it is imposing a significant burden on individuals, families, and healthcare systems. Cancer treatment often involves a combination of therapies, such as surgery, chemotherapy, and radiation therapy, which can lead to a range of physical and psychological side effects. Side effects such as fatigue, pain, and neuropathy can greatly affect a cancer patient's quality of life, impacting their ability to function, their emotional health, and their social relationships. Research into cancer-related quality of life (QOL) has become increasingly important, as it helps us understand how cancer impacts every part of a patient's life, not just survival. Involving patients in their own care is a powerful way to boost engagement and gain deeper insight into the factors that influence quality of life during the cancer journey.\n\nMany studies have looked at what affects quality of life (QOL) in cancer patients. Factors such as age, stage of disease, type of cancer, education, income, and treatment side effects all play a role. For example, older age, advanced cancer, and certain types like lung or pancreatic cancer can lower QOL, while treatment side effects such as fatigue, pain, and neuropathy can make it harder for patients to do daily activities and enjoy life. Research has made important progress in understanding how physical, emotional, and social issues impact well-being, but challenges remain in fully capturing all the factors that influence QOL for people living with cancer.\n\nThe goal is to bridge this gap by developing and implementing a patient-centered quality of life (QOL) survey tailored specifically for cancer patients and aims to capture a more accurate and comprehensive picture of the factors that affect their quality of life."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Newly diagnosed with a- primary cancer within the past six months from WellSpan cancer centers.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 years and above\n* Primary cancer diagnosis (newly diagnosed within the past 6 months)\n* Able to sign informed consent.\n\nExclusion Criteria:\n\n* Patients with age\\<18 years,\n* Patients with primary non-melanoma skin, neurological malignancies (Brain or brain metastases), and primary hematological malignancies.\n* Patients with severe cognitive impairment, unable to sign informed consent or unable to complete quality of life questionnaire.\n* Patients with life expectancy of \\<90 days, in the opinion of treating investigator.'}, 'identificationModule': {'nctId': 'NCT07433660', 'acronym': 'THRIVE', 'briefTitle': 'WellSpan-THRIVE Cancer QOL Study', 'organization': {'class': 'OTHER', 'fullName': 'WellSpan Health'}, 'officialTitle': 'WellSpan Study of Tracking Health and Resilience to Improve the Vitality of Individuals Experiencing Cancer [WellSpan-THRIVE]', 'orgStudyIdInfo': {'id': '2226965-1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients Diagnosed with primary cancer in past 6 months', 'description': 'Patients Diagnosed with primary cancer in past 6 months will be divided into Race, ethnicity and gender and will be looked for differences in quality of life based on these subsets.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '17201', 'city': 'Chambersburg', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Tara Reed, RN, OCN', 'role': 'CONTACT', 'email': 'Treed5@wellspan.org', 'phone': '717-217-6017'}], 'facility': 'WellSpan Medical Oncology & Hematology', 'geoPoint': {'lat': 39.93759, 'lon': -77.6611}}, {'zip': '17522', 'city': 'Ephrata', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Karen Comerford, RN, OCN', 'role': 'CONTACT', 'email': 'kcomerford@wellspan.org', 'phone': '717- 721-4838'}], 'facility': 'WellSpan Ephrata Cancer Center', 'geoPoint': {'lat': 40.17982, 'lon': -76.17884}}, {'zip': '17325', 'city': 'Gettysburg', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Erin Hill, RN, OCN', 'role': 'CONTACT', 'email': 'Ehill4@wellspan.org', 'phone': '717-339-2638'}], 'facility': 'WellSpan Adams Cancer Center', 'geoPoint': {'lat': 39.83093, 'lon': -77.2311}}, {'zip': '17042', 'city': 'Lebanon', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Lauren Adams, RN', 'role': 'CONTACT', 'email': 'Ladams10@wellspan.org', 'phone': '717-639-3924'}], 'facility': 'WellSpan Sechler Family Cancer Center', 'geoPoint': {'lat': 40.34093, 'lon': -76.41135}}, {'zip': '17403', 'city': 'York', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Joan K Moore, MSN, RN, OCN, CCRP', 'role': 'CONTACT', 'email': 'jmoore@wellspan.org', 'phone': '717-741-8124'}, {'name': 'Rahul Kashyap, MBBS, MBA, FCCM', 'role': 'CONTACT', 'email': 'rkashyap@wellspan.org', 'phone': '717-851-4611'}], 'facility': 'WellSpan York Cancer Center', 'geoPoint': {'lat': 39.9626, 'lon': -76.72774}}], 'centralContacts': [{'name': 'Joan K Moore, MSN, RN, OCN, CCRP', 'role': 'CONTACT', 'email': 'jmoore@wellspan.org', 'phone': '717-741-8124'}, {'name': 'Rahul Kashyap, MBBS, MBA, FCCM', 'role': 'CONTACT', 'email': 'rkashyap@wellspan.org', 'phone': '717-851-4611'}], 'overallOfficials': [{'name': 'Navesh Sharma, DO, PhD, FACRO', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'WellSpan Health'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': "We don't have patient and institution permission to share individual participant data (IPD)."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'WellSpan Health', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical Director Research', 'investigatorFullName': 'Rahul Kashyap', 'investigatorAffiliation': 'WellSpan Health'}}}}