Cancer Survivors Program: Effectiveness of Monitoring Adverse Events After Completion of Curative Treatment for Breast and Prostate Cancer
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Impact of active monitoring of adverse effects on quality of life
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
Arms & Interventions
Interventional
screening of adverse effects of curative therapy + quality of life screening
Intervention: active screening of adverse effects of anticancer therapy based on specific questionnaire + quality of life screening (Other)
Control
quality of life screening
Outcomes
Primary Outcomes
Impact of active monitoring of adverse effects on quality of life
Time Frame: Upon enrollment (baseline), six and twelve months after baseline
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.
Secondary Outcomes
- Comprehensibility of the questionnaire(Upon enrollment (baseline), six and twelve months after baseline)
- Usability of the questionnaire in routine clinical practice(Upon enrollment (baseline), six and twelve months after baseline)
- Frequency of active intervention by a physician(Upon enrollment (baseline), six and twelve months after baseline)