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NCT Number: NCT07253987

Cancer Survivors Program

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.

Recruiting

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Key information

Conditions

Prostate Cancer Patients Breast Cancer Patients Breast Diseases Breast Neoplasms Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Skin Diseases Skin and Connective Tissue Diseases Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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

Other

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.

Primary outcomes

  1. 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

  1. Comprehensibility of the questionnaire

    Time frame: Upon enrollment (baseline), six and twelve months after baseline

    Evaluation of the comprehensibility of the Questionnaire for the Assessment of Difficulties after Cancer Treatment.

  2. Usability of the questionnaire in routine clinical practice

    Time frame: Upon enrollment (baseline), six and twelve months after baseline

    Evaluation of the usability of the Questionnaire for the Assessment of Difficulties in routine clinical practice.

  3. Frequency of active intervention by a physician

    Time frame: Upon enrollment (baseline), six and twelve months after baseline

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Lenka Pavčíková, MUDr.

CONTACT

[email protected]

+420 543 136 136

Martina Lojová, Ph.D.

CONTACT

[email protected]

+420 543 136 232

Sponsors and collaborators

Lead sponsor

Masaryk Memorial Cancer Institute

Other

Registry information

Official study title

Cancer Survivors Program: Effectiveness of Monitoring Adverse Events After Completion of Curative Treatment for Breast and Prostate Cancer

Acronym: SURV-QoL

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Nov 28, 2025
Registry last updated
Jun 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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