Cancer Survivors Program

NCT ID: NCT07253987

Last Updated: 2025-11-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-05

Study Completion Date

2025-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Prostate Cancer Patients Breast Cancer Patients

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Interventional

screening of adverse effects of curative therapy + quality of life screening

Group Type EXPERIMENTAL

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

Intervention Type 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.

Control

quality of life screening

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Masaryk Memorial Cancer Institute

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Masaryk Memorial Cancer Institute

Brno, , Czechia

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Czechia

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Lenka Pavčíková, MUDr.

Role: CONTACT

+420 543 136 136

Martina Lojová, Ph.D.

Role: CONTACT

+420 543 136 232

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Martina Lojová, Ph.D.

Role: primary

+420 543 136 232

Iveta Selingerová, Ph.D.

Role: backup

+420 543 136 720

References

Explore related publications, articles, or registry entries linked to this study.

Vaz-Luis I, Masiero M, Cavaletti G, Cervantes A, Chlebowski RT, Curigliano G, Felip E, Ferreira AR, Ganz PA, Hegarty J, Jeon J, Johansen C, Joly F, Jordan K, Koczwara B, Lagergren P, Lambertini M, Lenihan D, Linardou H, Loprinzi C, Partridge AH, Rauh S, Steindorf K, van der Graaf W, van de Poll-Franse L, Pentheroudakis G, Peters S, Pravettoni G. ESMO Expert Consensus Statements on Cancer Survivorship: promoting high-quality survivorship care and research in Europe. Ann Oncol. 2022 Nov;33(11):1119-1133. doi: 10.1016/j.annonc.2022.07.1941. Epub 2022 Aug 10.

Reference Type BACKGROUND
PMID: 35963481 (View on PubMed)

Culbertson MG, Bennett K, Kelly CM, Sharp L, Cahir C. The psychosocial determinants of quality of life in breast cancer survivors: a scoping review. BMC Cancer. 2020 Oct 2;20(1):948. doi: 10.1186/s12885-020-07389-w.

Reference Type BACKGROUND
PMID: 33008323 (View on PubMed)

van Leeuwen M, Kieffer JM, Efficace F, Fossa SD, Bolla M, Collette L, Colombel M, De Giorgi U, Holzner B, van de Poll-Franse LV, van Poppel H, White J, de Wit R, Osanto S, Aaronson NK; European Organisation for Research and Treatment of Cancer Quality of Life Group; Genito-Urinary Cancers Group and Radiation Oncology Group; and the NCRN Testis Clinical Studies Group. International evaluation of the psychometrics of health-related quality of life questionnaires for use among long-term survivors of testicular and prostate cancer. Health Qual Life Outcomes. 2017 May 11;15(1):97. doi: 10.1186/s12955-017-0670-4.

Reference Type BACKGROUND
PMID: 28490338 (View on PubMed)

Allen I, Hassan H, Sofianopoulou E, Eccles D, Turnbull C, Tischkowitz M, Pharoah P, Antoniou AC. Risks of second non-breast primaries following breast cancer in women: a systematic review and meta-analysis. Breast Cancer Res. 2023 Feb 10;25(1):18. doi: 10.1186/s13058-023-01610-x.

Reference Type BACKGROUND
PMID: 36765408 (View on PubMed)

Lustberg MB, Reinbolt RE, Shapiro CL. Bone health in adult cancer survivorship. J Clin Oncol. 2012 Oct 20;30(30):3665-74. doi: 10.1200/JCO.2012.42.2097. Epub 2012 Sep 24.

Reference Type BACKGROUND
PMID: 23008309 (View on PubMed)

Mehta LS, Watson KE, Barac A, Beckie TM, Bittner V, Cruz-Flores S, Dent S, Kondapalli L, Ky B, Okwuosa T, Pina IL, Volgman AS; American Heart Association Cardiovascular Disease in Women and Special Populations Committee of the Council on Clinical Cardiology; Council on Cardiovascular and Stroke Nursing; and Council on Quality of Care and Outcomes Research. Cardiovascular Disease and Breast Cancer: Where These Entities Intersect: A Scientific Statement From the American Heart Association. Circulation. 2018 Feb 20;137(8):e30-e66. doi: 10.1161/CIR.0000000000000556. Epub 2018 Feb 1.

Reference Type BACKGROUND
PMID: 29437116 (View on PubMed)

Nardin S, Mora E, Varughese FM, D'Avanzo F, Vachanaram AR, Rossi V, Saggia C, Rubinelli S, Gennari A. Breast Cancer Survivorship, Quality of Life, and Late Toxicities. Front Oncol. 2020 Jun 16;10:864. doi: 10.3389/fonc.2020.00864. eCollection 2020.

Reference Type BACKGROUND
PMID: 32612947 (View on PubMed)

Mayer DK, Nasso SF, Earp JA. Defining cancer survivors, their needs, and perspectives on survivorship health care in the USA. Lancet Oncol. 2017 Jan;18(1):e11-e18. doi: 10.1016/S1470-2045(16)30573-3.

Reference Type BACKGROUND
PMID: 28049573 (View on PubMed)

van Leeuwen M, Husson O, Alberti P, Arraras JI, Chinot OL, Costantini A, Darlington AS, Dirven L, Eichler M, Hammerlid EB, Holzner B, Johnson CD, Kontogianni M, Kjaer TK, Morag O, Nolte S, Nordin A, Pace A, Pinto M, Polz K, Ramage J, Reijneveld JC, Serpentini S, Tomaszewski KA, Vassiliou V, Verdonck-de Leeuw IM, Vistad I, Young TE, Aaronson NK, van de Poll-Franse LV; EORTC QLG. Understanding the quality of life (QOL) issues in survivors of cancer: towards the development of an EORTC QOL cancer survivorship questionnaire. Health Qual Life Outcomes. 2018 Jun 4;16(1):114. doi: 10.1186/s12955-018-0920-0.

Reference Type BACKGROUND
PMID: 29866185 (View on PubMed)

Related Links

Access external resources that provide additional context or updates about the study.

https://www.uzis.cz/index-en.php

Institute of Health Information and Statistics of the Czech Republic

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

A8/25

Identifier Type: OTHER

Identifier Source: secondary_id

A8/25_SURV-QoL

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.