Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
200 participants
INTERVENTIONAL
2025-05-05
2025-12-31
Brief Summary
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Detailed Description
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The proposed questionnaire should effectively and comprehensively reflect both the physical problems typically associated with a given diagnosis and the psychological, social, occupational, and financial impacts. It should also focus the physician's attention on interventions aimed at healthy lifestyles (smoking cessation, obesity prevention, sufficient physical activity) to maintain the health of cancer survivors.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Interventional
screening of adverse effects of curative therapy + quality of life screening
active screening of adverse effects of anticancer therapy based on specific questionnaire + quality of life screening
Based on the Questionnaire for the Assessment of Difficulties after the completion of cancer treatment, the attending physician will assess the need for intervention and respond appropriately to the reported problems. Intervention is assessed as education by the physician, the use of medication, or referral of the patient to a specialized outpatient clinic.
Control
quality of life screening
No interventions assigned to this group
Interventions
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active screening of adverse effects of anticancer therapy based on specific questionnaire + quality of life screening
Based on the Questionnaire for the Assessment of Difficulties after the completion of cancer treatment, the attending physician will assess the need for intervention and respond appropriately to the reported problems. Intervention is assessed as education by the physician, the use of medication, or referral of the patient to a specialized outpatient clinic.
Eligibility Criteria
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Inclusion Criteria
* Age 18 years or older.
* Histologically confirmed invasive breast cancer or invasive prostate cancer.
* Completion of the acute phase of curative oncological therapy:
* for breast cancer: curative surgery performed + completed neoadjuvant/adjuvant chemotherapy and completed adjuvant radiotherapy, if indicated
* for prostate cancer: completed radiotherapy with curative intent or radical prostatectomy performed (open, laparoscopic, robotic) or completed adjuvant radiotherapy after prostatectomy
* The patient is available for follow-up within 12 months of enrollment in the study.
Exclusion Criteria
* Neoadjuvant/adjuvant therapy did not include chemotherapy (breast cancer).
* Recurrence of cancer
* Metastatic disease
* History of other primary malignancy (except for non-melanoma skin cancer)
18 Years
ALL
No
Sponsors
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Masaryk Memorial Cancer Institute
OTHER
Responsible Party
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Locations
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Masaryk Memorial Cancer Institute
Brno, , Czechia
Countries
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Central Contacts
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Facility Contacts
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References
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Vaz-Luis I, Masiero M, Cavaletti G, Cervantes A, Chlebowski RT, Curigliano G, Felip E, Ferreira AR, Ganz PA, Hegarty J, Jeon J, Johansen C, Joly F, Jordan K, Koczwara B, Lagergren P, Lambertini M, Lenihan D, Linardou H, Loprinzi C, Partridge AH, Rauh S, Steindorf K, van der Graaf W, van de Poll-Franse L, Pentheroudakis G, Peters S, Pravettoni G. ESMO Expert Consensus Statements on Cancer Survivorship: promoting high-quality survivorship care and research in Europe. Ann Oncol. 2022 Nov;33(11):1119-1133. doi: 10.1016/j.annonc.2022.07.1941. Epub 2022 Aug 10.
Culbertson MG, Bennett K, Kelly CM, Sharp L, Cahir C. The psychosocial determinants of quality of life in breast cancer survivors: a scoping review. BMC Cancer. 2020 Oct 2;20(1):948. doi: 10.1186/s12885-020-07389-w.
van Leeuwen M, Kieffer JM, Efficace F, Fossa SD, Bolla M, Collette L, Colombel M, De Giorgi U, Holzner B, van de Poll-Franse LV, van Poppel H, White J, de Wit R, Osanto S, Aaronson NK; European Organisation for Research and Treatment of Cancer Quality of Life Group; Genito-Urinary Cancers Group and Radiation Oncology Group; and the NCRN Testis Clinical Studies Group. International evaluation of the psychometrics of health-related quality of life questionnaires for use among long-term survivors of testicular and prostate cancer. Health Qual Life Outcomes. 2017 May 11;15(1):97. doi: 10.1186/s12955-017-0670-4.
Allen I, Hassan H, Sofianopoulou E, Eccles D, Turnbull C, Tischkowitz M, Pharoah P, Antoniou AC. Risks of second non-breast primaries following breast cancer in women: a systematic review and meta-analysis. Breast Cancer Res. 2023 Feb 10;25(1):18. doi: 10.1186/s13058-023-01610-x.
Lustberg MB, Reinbolt RE, Shapiro CL. Bone health in adult cancer survivorship. J Clin Oncol. 2012 Oct 20;30(30):3665-74. doi: 10.1200/JCO.2012.42.2097. Epub 2012 Sep 24.
Mehta LS, Watson KE, Barac A, Beckie TM, Bittner V, Cruz-Flores S, Dent S, Kondapalli L, Ky B, Okwuosa T, Pina IL, Volgman AS; American Heart Association Cardiovascular Disease in Women and Special Populations Committee of the Council on Clinical Cardiology; Council on Cardiovascular and Stroke Nursing; and Council on Quality of Care and Outcomes Research. Cardiovascular Disease and Breast Cancer: Where These Entities Intersect: A Scientific Statement From the American Heart Association. Circulation. 2018 Feb 20;137(8):e30-e66. doi: 10.1161/CIR.0000000000000556. Epub 2018 Feb 1.
Nardin S, Mora E, Varughese FM, D'Avanzo F, Vachanaram AR, Rossi V, Saggia C, Rubinelli S, Gennari A. Breast Cancer Survivorship, Quality of Life, and Late Toxicities. Front Oncol. 2020 Jun 16;10:864. doi: 10.3389/fonc.2020.00864. eCollection 2020.
Mayer DK, Nasso SF, Earp JA. Defining cancer survivors, their needs, and perspectives on survivorship health care in the USA. Lancet Oncol. 2017 Jan;18(1):e11-e18. doi: 10.1016/S1470-2045(16)30573-3.
van Leeuwen M, Husson O, Alberti P, Arraras JI, Chinot OL, Costantini A, Darlington AS, Dirven L, Eichler M, Hammerlid EB, Holzner B, Johnson CD, Kontogianni M, Kjaer TK, Morag O, Nolte S, Nordin A, Pace A, Pinto M, Polz K, Ramage J, Reijneveld JC, Serpentini S, Tomaszewski KA, Vassiliou V, Verdonck-de Leeuw IM, Vistad I, Young TE, Aaronson NK, van de Poll-Franse LV; EORTC QLG. Understanding the quality of life (QOL) issues in survivors of cancer: towards the development of an EORTC QOL cancer survivorship questionnaire. Health Qual Life Outcomes. 2018 Jun 4;16(1):114. doi: 10.1186/s12955-018-0920-0.
Related Links
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Institute of Health Information and Statistics of the Czech Republic
Other Identifiers
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A8/25
Identifier Type: OTHER
Identifier Source: secondary_id
A8/25_SURV-QoL
Identifier Type: -
Identifier Source: org_study_id
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