An interventional study of active screening of adverse effects of anticancer therapy based on specific questionnaire + quality of life screening in Prostate Cancer Patients and Breast Cancer Patients, sponsored by Masaryk Memorial Cancer Institute. Recruiting at 1 site in Czechia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-11.
Sponsored by Masaryk Memorial Cancer Institute · Not applicable, Interventional, and Supportive care
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.
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.
Completion of the acute phase of curative oncological therapy:
Exclusion Criteria:
screening of adverse effects of curative therapy + quality of life screening
Other: active screening of adverse effects of anticancer therapy based on specific questionnaire + quality of life screening
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.
Impact of active monitoring of adverse effects on quality of life
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.
Time frame: Upon enrollment (baseline), six and twelve months after baseline
Comprehensibility of the questionnaire
Evaluation of the comprehensibility of the Questionnaire for the Assessment of Difficulties after Cancer Treatment.
Time frame: Upon enrollment (baseline), six and twelve months after baseline
Usability of the questionnaire in routine clinical practice
Evaluation of the usability of the Questionnaire for the Assessment of Difficulties in routine clinical practice.
Time frame: Upon enrollment (baseline), six and twelve months after baseline
Frequency of active intervention by a physician
Assessment of the impact of active monitoring of adverse effects, based on the Questionnaire for the Assessment of Difficulties after Cancer Treatment, on the frequency of active physician interventions in the interventional group.
Time frame: Upon enrollment (baseline), six and twelve months after baseline
Plan to share: Yes — IPD to be shared in pseudonymized form during the study. IPD to be published in anonymized form.
Supporting information: Csr
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Masaryk Memorial Cancer Institute