Cancer Survivors Program (SURV-QoL)

April 16, 2026 updated by: Masaryk Memorial Cancer Institute

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Czechia
      • Brno, Czechia, 656 53
        • Recruiting
        • Masaryk Memorial Cancer Institute
        • Contact:
        • Contact:
        • Principal Investigator:
          • Lenka Pavčíková, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Interventional
screening of adverse effects of curative therapy + quality of life screening
Other: active screening of adverse effects of anticancer therapy based on specific questionnaire + quality of life screening
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.
No Intervention: Control
quality of life screening

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Upon enrollment (baseline), six and twelve months after baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Upon enrollment (baseline), six and twelve months after baseline
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.
Upon enrollment (baseline), six and twelve months after baseline
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.
Upon enrollment (baseline), six and twelve months after baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Masaryk Memorial Cancer Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 5, 2025

Primary Completion (Estimated)

May 5, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

November 19, 2025

First Submitted That Met QC Criteria

November 19, 2025

First Posted (Actual)

November 28, 2025

Study Record Updates

Last Update Posted (Actual)

April 17, 2026

Last Update Submitted That Met QC Criteria

April 16, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A8/25_SURV-QoL
  • A8/25 (Other Identifier: Masaryk Memorial Cancer Institute)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

IPD to be shared in pseudonymized form during the study. IPD to be published in anonymized form.

IPD Sharing Time Frame

after study completion

IPD Sharing Access Criteria

During the study, data will be managed in pseudonymized form in a protected database environment, available only for study team.

After completion of the study, the data will be fully anonymized for publication purposes. All publication outputs of the study will be carried out by a team of researchers led by the principal investigator. The submission of each publication is subject to the approval of the principal investigator.

The results of this study may be published or presented at scientific meetings after approval by the PI and always after anonymization of the subjects' personal data in accordance with Act No. 101/2000 Coll., on the protection of personal data.

IPD Sharing Supporting Information Type

  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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