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Cancer Survivors Program (SURV-QoL)

M

Masaryk Memorial Cancer Institute

Status

Enrolling

Conditions

Breast Cancer Patients
Prostate Cancer Patients

Treatments

Other: active screening of adverse effects of anticancer therapy based on specific questionnaire + quality of life screening

Study type

Interventional

Funder types

Other

Identifiers

NCT07253987
A8/25_SURV-QoL
A8/25 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

200 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

200 participants in 2 patient groups

Interventional
Experimental group
Description:
screening of adverse effects of curative therapy + quality of life screening
Treatment:
Other: active screening of adverse effects of anticancer therapy based on specific questionnaire + quality of life screening
Control
No Intervention group
Description:
quality of life screening

Trial contacts and locations

1

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Central trial contact

Lenka Pavčíková, MUDr.; Martina Lojová, Ph.D.

Data sourced from clinicaltrials.gov

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