Clinical trial · Interventional
Cancer Survivors Program
Cancer Survivors Program: Effectiveness of Monitoring Adverse Events After Completion of Curative Treatment for Breast and Prostate Cancer
NCT07253987CI-TRIAL-00114487SURV-QoLrecruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer Patients | — | UNRESOLVED | — |
| Prostate Cancer Patients | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| active screening of adverse effects of anticancer therapy based on specific questionnaire + quality of life screening | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Interventional
- description
- screening of adverse effects of curative therapy + quality of life screening
- interventionNames
- Other: active screening of adverse effects of anticancer therapy based on specific questionnaire + quality of life screening
- type
- NO_INTERVENTION
- label
- Control
- description
- quality of life screening
Primary outcomes (1)
- measure
- Impact of active monitoring of adverse effects on quality of life
- timeFrame
- Upon enrollment (baseline), six and twelve months after baseline
- description
- Compare the quality of life of breast and prostate cancer survivors between the interventional group, in which adverse effects are actively monitored using the Questionnaire for the Assessment of Difficulties after Cancer Treatment, and the control group.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: * 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)
References
Publications (9)
- BACKGROUNDVaz-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. PMID 35963481
- BACKGROUNDCulbertson 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
- BACKGROUNDvan 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. PMID 28490338
- BACKGROUNDAllen 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
- BACKGROUNDLustberg 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: 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.