Cancer Survivors Program

Официальное название

Cancer Survivors Program: Effectiveness of Monitoring Adverse Events After Completion of Curative Treatment for Breast and Prostate Cancer

Обзор

The questionnaire for assessment of adverse events after completion of cancer treatment, which is being piloted at the Masaryk Memorial Cancer Institute, aims to detect a wide range of adverse effects early on, thus facilitating adequate intervention and planning of follow-up care for all cancer survivors.

Подробное описание

According to the current recommendations of the European Society for Medical Oncology (ESMO), comprehensive care for cancer survivors should focus on five main areas: 1) the physical effects of the disease and subsequent treatment, 2) the psychological effects of the disease and treatment, 3) the social, occupational, and financial impacts of the disease and treatment, 4) early detection of recurrence or subsequent primary malignancies, and last but not least, 5) prevention of cancer and promotion of healthy lifestyles.

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.

Вмешательства

• Другое 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.

Первичные конечные точки

• Impact of active monitoring of adverse effects on quality of life [Срок оценки: Upon enrollment (baseline), six and twelve months after baseline]

Вторичные конечные точки (3)

• Comprehensibility of the questionnaire [Срок оценки: Upon enrollment (baseline), six and twelve months after baseline]
• Usability of the questionnaire in routine clinical practice [Срок оценки: Upon enrollment (baseline), six and twelve months after baseline]
• Frequency of active intervention by a physician [Срок оценки: Upon enrollment (baseline), six and twelve months after baseline]

Критерии участия

Критерии включения

• The patient understands the information provided and agrees to participate in the study.
• 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.

Критерии исключения

• Active ongoing oncological therapy (except for (i) adjuvant hormone therapy, (ii) adjuvant targeted therapy (anti-HER2 therapy, CDK4/6i, PARPi, T-DM1), (iii) adjuvant immunotherapy)
• 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

Чехия · 1 центр

• Masaryk Memorial Cancer Institute — Brno

Публикации

• 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 Survivors PMID 35963481
• 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. PMID 33008323
• 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 th PMID 28490338
• 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. PMID 36765408
• 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. PMID 23008309
• 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: PMID 29437116
• 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. PMID 32612947
• 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. PMID 28049573

Идентификаторы

NCT: NCT07253987 · A8/25_SURV-QoL · A8/25

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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