Cancer Survivors Program
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMasaryk Memorial Cancer Institute
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
for breast cancer: curative surgery performed + completed neoadjuvant/adjuvant chemotherapy and completed adjuvant radiotherapy, if indicated
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
active screening of adverse effects of anticancer therapy based on specific questionnaire + quality of life screening
Other interventionBased 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.
Treatment groups
200 Participants
are divided into 2 treatment groupsGroup A: InterventionalExperimental treatment 1 intervention
Group B: ControlNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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 baselineSecondary outcomes
1
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 baseline2
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 baseline3
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 baselineSponsors and contacts
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Source ClinicalTrials.gov