Ignite Creation Date:
2025-12-25 @ 1:45 AM
Ignite Modification Date:
2025-12-26 @ 2:13 AM
Study NCT ID:
NCT04069494
Status:
COMPLETED
Last Update Posted:
2020-07-17
First Post:
2019-08-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Descriptors and Predictors of Burden and Information Needs
Sponsor:
Organization:
Raw JSON
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Increasing physical activity and exercise in lung cancer: reviewing safety, benefits, and application. J Thorac Oncol. 2015 Jun;10(6):861-71. doi: 10.1097/JTO.0000000000000536.'}, {'pmid': '28210163', 'type': 'BACKGROUND', 'citation': 'Carnio S, Di Stefano RF, Novello S. Fatigue in lung cancer patients: symptom burden and management of challenges. Lung Cancer (Auckl). 2016 May 9;7:73-82. doi: 10.2147/LCTT.S85334. eCollection 2016.'}, {'pmid': '27112232', 'type': 'BACKGROUND', 'citation': 'Choi S, Ryu E. Effects of symptom clusters and depression on the quality of life in patients with advanced lung cancer. Eur J Cancer Care (Engl). 2018 Jan;27(1). doi: 10.1111/ecc.12508. Epub 2016 Apr 26.'}, {'pmid': '24292095', 'type': 'BACKGROUND', 'citation': 'Deshields TL, Potter P, Olsen S, Liu J. The persistence of symptom burden: symptom experience and quality of life of cancer patients across one year. Support Care Cancer. 2014 Apr;22(4):1089-96. doi: 10.1007/s00520-013-2049-3. Epub 2013 Dec 3.'}, {'pmid': '26860217', 'type': 'BACKGROUND', 'citation': "Dionne-Odom JN, Hull JG, Martin MY, Lyons KD, Prescott AT, Tosteson T, Li Z, Akyar I, Raju D, Bakitas MA. Associations between advanced cancer patients' survival and family caregiver presence and burden. Cancer Med. 2016 May;5(5):853-62. doi: 10.1002/cam4.653. Epub 2016 Feb 10."}, {'pmid': '28720267', 'type': 'BACKGROUND', 'citation': 'Kotronoulas G, Papadopoulou C, Burns-Cunningham K, Simpson M, Maguire R. A systematic review of the supportive care needs of people living with and beyond cancer of the colon and/or rectum. Eur J Oncol Nurs. 2017 Aug;29:60-70. doi: 10.1016/j.ejon.2017.05.004. Epub 2017 May 30.'}, {'pmid': '23893960', 'type': 'BACKGROUND', 'citation': 'Lee YH, Liao YC, Liao WY, Shun SC, Liu YC, Chan JC, Yu CJ, Yang PC, Lai YH. Anxiety, depression and related factors in family caregivers of newly diagnosed lung cancer patients before first treatment. Psychooncology. 2013 Nov;22(11):2617-23. doi: 10.1002/pon.3328. Epub 2013 Jul 28.'}, {'pmid': '27832984', 'type': 'BACKGROUND', 'citation': 'Lou VW, Chen EJ, Jian H, Zhou Z, Zhu J, Li G, He Y. Respiratory Symptoms, Sleep, and Quality of Life in Patients With Advanced Lung Cancer. J Pain Symptom Manage. 2017 Feb;53(2):250-256.e1. doi: 10.1016/j.jpainsymman.2016.09.006. Epub 2016 Nov 8.'}, {'pmid': '27776833', 'type': 'BACKGROUND', 'citation': 'Miaskowski C. Future Directions in Symptom Cluster Research. Semin Oncol Nurs. 2016 Nov;32(4):405-415. doi: 10.1016/j.soncn.2016.08.006. Epub 2016 Oct 21.'}, {'pmid': '28412094', 'type': 'BACKGROUND', 'citation': 'Morrison EJ, Novotny PJ, Sloan JA, Yang P, Patten CA, Ruddy KJ, Clark MM. Emotional Problems, Quality of Life, and Symptom Burden in Patients With Lung Cancer. Clin Lung Cancer. 2017 Sep;18(5):497-503. doi: 10.1016/j.cllc.2017.02.008. Epub 2017 Mar 2.'}, {'pmid': '21901689', 'type': 'BACKGROUND', 'citation': 'Rueda JR, Sola I, Pascual A, Subirana Casacuberta M. Non-invasive interventions for improving well-being and quality of life in patients with lung cancer. Cochrane Database Syst Rev. 2011 Sep 7;2011(9):CD004282. doi: 10.1002/14651858.CD004282.pub3.'}, {'pmid': '27787567', 'type': 'BACKGROUND', 'citation': "Schroder C, Engenhart-Cabillic R, Vorwerk H, Schmidt M, Huhnt W, Blank E, Sidow D, Buchali A. Patient's quality of life after high-dose radiation therapy for thoracic carcinomas : Changes over time and influence on clinical outcome. Strahlenther Onkol. 2017 Feb;193(2):132-140. doi: 10.1007/s00066-016-1068-7. Epub 2016 Oct 27."}, {'pmid': '27565917', 'type': 'BACKGROUND', 'citation': 'Shallwani SM, Simmonds MJ, Kasymjanova G, Spahija J. Quality of life, symptom status and physical performance in patients with advanced non-small cell lung cancer undergoing chemotherapy: an exploratory analysis of secondary data. Lung Cancer. 2016 Sep;99:69-75. doi: 10.1016/j.lungcan.2016.06.018. Epub 2016 Jun 23.'}, {'pmid': '26252436', 'type': 'BACKGROUND', 'citation': 'Stapleton SJ, Holden J, Epstein J, Wilkie DJ. A Systematic Review of the Symptom Distress Scale in Advanced Cancer Studies. Cancer Nurs. 2016 Jul-Aug;39(4):E9-E23. doi: 10.1097/NCC.0000000000000292.'}, {'pmid': '26150131', 'type': 'BACKGROUND', 'citation': 'Sun V, Grant M, Koczywas M, Freeman B, Zachariah F, Fujinami R, Del Ferraro C, Uman G, Ferrell B. Effectiveness of an interdisciplinary palliative care intervention for family caregivers in lung cancer. Cancer. 2015 Oct 15;121(20):3737-45. doi: 10.1002/cncr.29567. Epub 2015 Jul 6.'}, {'pmid': '28417550', 'type': 'BACKGROUND', 'citation': 'Tan JY, Molassiotis A, Lloyd-Williams M, Yorke J. Burden, emotional distress and quality of life among informal caregivers of lung cancer patients: An exploratory study. Eur J Cancer Care (Engl). 2018 Jan;27(1). doi: 10.1111/ecc.12691. Epub 2017 Apr 18.'}, {'pmid': '25651787', 'type': 'BACKGROUND', 'citation': 'Torre LA, Bray F, Siegel RL, Ferlay J, Lortet-Tieulent J, Jemal A. Global cancer statistics, 2012. CA Cancer J Clin. 2015 Mar;65(2):87-108. doi: 10.3322/caac.21262. Epub 2015 Feb 4.'}, {'pmid': '28533161', 'type': 'BACKGROUND', 'citation': 'Wong ML, Cooper BA, Paul SM, Levine JD, Conley YP, Wright F, Hammer M, Miaskowski C. Differences in Symptom Clusters Identified Using Ratings of Symptom Occurrence vs. Severity in Lung Cancer Patients Receiving Chemotherapy. J Pain Symptom Manage. 2017 Aug;54(2):194-203. doi: 10.1016/j.jpainsymman.2017.04.005. Epub 2017 May 19.'}, {'pmid': '28160076', 'type': 'BACKGROUND', 'citation': 'Wong ML, Paul SM, Cooper BA, Dunn LB, Hammer MJ, Conley YP, Wright F, Levine JD, Walter LC, Cartwright F, Miaskowski C. Predictors of the multidimensional symptom experience of lung cancer patients receiving chemotherapy. Support Care Cancer. 2017 Jun;25(6):1931-1939. doi: 10.1007/s00520-017-3593-z. Epub 2017 Feb 3.'}, {'pmid': '26111954', 'type': 'BACKGROUND', 'citation': 'Yorke J, Lloyd-Williams M, Smith J, Blackhall F, Harle A, Warden J, Ellis J, Pilling M, Haines J, Luker K, Molassiotis A. Management of the respiratory distress symptom cluster in lung cancer: a randomised controlled feasibility trial. Support Care Cancer. 2015 Nov;23(11):3373-84. doi: 10.1007/s00520-015-2810-x. Epub 2015 Jun 26.'}, {'pmid': '24641382', 'type': 'RESULT', 'citation': 'Chindaprasirt J, Limpawattana P, Pakkaratho P, Wirasorn K, Sookprasert A, Kongbunkiat K, Sawanyawisuth K. Burdens among caregivers of older adults with advanced cancer and risk factors. Asian Pac J Cancer Prev. 2014;15(4):1643-8. doi: 10.7314/apjcp.2014.15.4.1643.'}, {'pmid': '28573475', 'type': 'RESULT', 'citation': 'Korner P, Ehrmann K, Hartmannsgruber J, Metz M, Steigerwald S, Flentje M, van Oorschot B. Patient-reported symptoms during radiotherapy : Clinically relevant symptom burden in patients treated with palliative and curative intent. Strahlenther Onkol. 2017 Jul;193(7):570-577. doi: 10.1007/s00066-017-1146-5. Epub 2017 Jun 1.'}, {'pmid': '22888384', 'type': 'RESULT', 'citation': 'Mohile SG, Heckler C, Fan L, Mustian K, Jean-Pierre P, Usuki K, Sprod L, Janelsins M, Purnell J, Peppone L, Palesh O, Devine KA, Morrow G. Age-related Differences in Symptoms and Their Interference with Quality of Life in 903 Cancer Patients Undergoing Radiation Therapy. J Geriatr Oncol. 2011 Oct;2(4):225-232. doi: 10.1016/j.jgo.2011.08.002.'}, {'pmid': '25376224', 'type': 'RESULT', 'citation': 'Reinke LF, Feemster LC, Backhus LM, Gylys-Colwell I, Au DH. Assessment and Management of Symptoms for Outpatients Newly Diagnosed With Lung Cancer. Am J Hosp Palliat Care. 2016 Mar;33(2):178-83. doi: 10.1177/1049909114557635. Epub 2014 Nov 5.'}, {'pmid': '21538097', 'type': 'RESULT', 'citation': 'Zeng L, Koo K, Zhang L, Jon F, Dennis K, Holden L, Nguyen J, Tsao M, Barnes E, Danjoux C, Sahgal A, Chow E. Fatigue in advanced cancer patients attending an outpatient palliative radiotherapy clinic as screened by the Edmonton Symptom Assessment System. Support Care Cancer. 2012 May;20(5):1037-42. doi: 10.1007/s00520-011-1179-8. Epub 2011 May 4.'}]}, 'descriptionModule': {'briefSummary': "the purpose of this study is to investigate over time patients' symptom burden, caregiving burden, and patients and caregivers' need for information on patient symptom self-management at home during palliative radiotherapy(RT) for lung cancer. Repeatedly assessing burden and information needs on symptom self-management at home can help healthcare professionals to design a bespoke service and plan of care for both patients and family caregivers. In addition, I will explore psycho-social and clinical predictors of burden and information needs in patients and caregivers. These predictors can help health professionals to identify patients and caregivers at risk for distress during palliative radiotherapy for lung cancer.", 'detailedDescription': 'Eligible patients will be invited to take part in the study via a patient information sheet. They will also be asked to nominate their primary caregiver, who will also be invited to take part in the study. We will give patients and caregivers 24 hours to decide whether they want to take part or not. If they do decide to take part, all research participants will be involved in the study on four consecutive occasions before, during and after their treatment. These four time points will be the following:\n\n* before first fraction of RT\n* 1st week of RT (1st-5th faction)\n* 2nd week of RT (6th-10th fraction)\n* 1 month after the last fraction of RT The principal researcher, i.e. Saengrawee Thanthong, will endeavour to collect questionnaires in the hospital. If participants cannot come to the hospital to receive radiotherapy or for their follow up appointment and complete the questionnaire, then the principal researcher will call them and offer to complete the questionnaires over the phone so as to minimise missing data due to attrition.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'People diagnosed with advanced lung cancer and scheduled to receive palliative RT and their carer will be invited to participate between 1st september 2019 and 29 Febuary 2020.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:• Inclusion criteria for patients:\n\n* Histological diagnosis of Lung cancer with stage III-IV(TNM)\n* Age: 18 years or over\n* Planning for palliative RT\n* Scheduled to receive up to 10 fractions of palliative radiotherapy (Stevens, Macbeth, Toy, Coles, \\& Lester, 2015)\n\n • Exclusion criteria for patients:\n* Non-English, Non-Thai speaking\n* Diagnosis of severe cognitive or mental illness that affects communication\n\nPatients' family caregivers will also be invited to participate as per below:\n\n* Inclusion criteria for caregivers:\n\n * Family member of the care recipient can be spouse, child, parent, friend etc.\n * Age: 18 years or over\n * Only one family member if the patient presents with more than one.\n * Same person in every time point\n* Exclusion criteria for caregivers:\n\n * Non-English, Non-Thai speaking"}, 'identificationModule': {'nctId': 'NCT04069494', 'briefTitle': 'Descriptors and Predictors of Burden and Information Needs', 'organization': {'class': 'OTHER', 'fullName': 'Chulabhorn Cancer Center'}, 'officialTitle': 'Descriptors and Predictors of Burden and Information Needs on Symptom Self-management in Thai Patients With Lung Cancer and Their Family Caregivers During Palliative Radiotherapy', 'orgStudyIdInfo': {'id': '200180015'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'patients', 'description': 'People diagnosed with advanced lung cancer and scheduled to receive palliative RT will be invited to participate between 1st July 2019 and 31st January 2020.', 'interventionNames': ['Other: questionnaires']}, {'label': 'care giver', 'description': "Patients' family caregivers will also be invited to participate", 'interventionNames': ['Other: questionnaires']}], 'interventions': [{'name': 'questionnaires', 'type': 'OTHER', 'description': 'Two questionnaires in patients and another two questionnaires in carer.', 'armGroupLabels': ['care giver', 'patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10210', 'city': 'Bangkok', 'country': 'Thailand', 'facility': 'ChulaBhorn Hospital', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}], 'overallOfficials': [{'name': 'Saengrawee Thanthong', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mrs'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chulabhorn Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Glasgow', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Saengrawee Thanthong', 'investigatorAffiliation': 'Chulabhorn Cancer Center'}}}}