ESMO Expert Consensus Statements on Cancer Survivorship: promoting high-quality survivorship care and research in Europe.
I Vaz-Luis, M Masiero, G Cavaletti...
https://pubmed.ncbi.nlm.nih.gov/35963481Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
ID07253987
Cancer Survivors Program: Effectiveness of Monitoring Adverse Events After Completion of Curative Treatment for Breast and Prostate Cancer
Led by Masaryk Memorial Cancer Institute · Updated on 2026-04-17
200
Participants Needed
1
Research Sites
34 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a program to monitor adverse effects after completion of curative treatment for breast and prostate cancer. The study aims to detect a broad range of side effects early, helping doctors provide timely care and plan follow-up for cancer survivors. The focus is on physical, psychological, social, occupational, and financial impacts, as well as promoting healthy lifestyles and preventing recurrence or new cancers. Participants are randomly assigned to one of two groups: an experimental group receiving active screening for adverse effects using a specific questionnaire alongside quality of life assessments, or a control group receiving only quality of life screening. The active screening involves physicians assessing reported problems and providing interventions such as education, medication, or referrals to specialist clinics when needed. During the study, participants complete questionnaires at baseline, six months, and twelve months to measure the impact of monitoring on their quality of life. The study also evaluates how understandable and usable the questionnaire is in clinical practice and how often physicians actively intervene. Follow-up care and participant availability are tracked for up to twelve months after enrollment to ensure thorough monitoring and support.
CONDITIONS
Brief Title
Cancer Survivors Program
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- 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 plus completed neoadjuvant/adjuvant chemotherapy and completed adjuvant radiotherapy if indicated; for prostate cancer, completed radiotherapy with curative intent or radical prostatectomy performed or completed adjuvant radiotherapy after prostatectomy.
- The patient is available for follow-up within 12 months of enrollment in the study.
You will not qualify if you...
- Active ongoing oncological therapy except for adjuvant hormone therapy, adjuvant targeted therapy (anti-HER2 therapy, CDK4/6i, PARPi, T-DM1), or adjuvant immunotherapy.
- Neoadjuvant/adjuvant therapy did not include chemotherapy for breast cancer.
- Recurrence of cancer.
- Metastatic disease.
- History of other primary malignancy except for non-melanoma skin cancer.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Monitoring
Duration - 12 months
Participants complete questionnaires assessing adverse effects of cancer therapy and quality of life. The attending physician evaluates the need for interventions such as education, medication, or specialist referral based on these assessments.
3 visits: baseline, 6 months, and 12 months (in-person or remote)
Trial Site Locations
Total: 1 location
1
Masaryk Memorial Cancer Institute
Brno, Czechia, 656 53
Actively Recruiting
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Research Team
L
Lenka Pavčíková, MUDr.
M
Martina Lojová, Ph.D.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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Michael G Culbertson, Kathleen Bennett, Catherine M Kelly...
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Marieke van Leeuwen, Jacobien M Kieffer, Fabio Efficace...
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https://pubmed.ncbi.nlm.nih.gov/32612947Defining cancer survivors, their needs, and perspectives on survivorship health care in the USA.
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https://pubmed.ncbi.nlm.nih.gov/29866185