CClinicalTrials.gg
RecruitingNCT07253987SURV-QoLUpdated Jun 11, 2026

Cancer Survivors Program

An interventional study of active screening of adverse effects of anticancer therapy based on specific questionnaire + quality of life screening in Prostate Cancer Patients and Breast Cancer Patients, sponsored by Masaryk Memorial Cancer Institute. Recruiting at 1 site in Czechia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-11.

Sponsored by Masaryk Memorial Cancer Institute · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
200
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Prostate Cancer Patients
  • Breast Cancer Patients

Keywords

  • cancer survivors
  • breast cancer
  • prostate cancer
  • neo-/adjuvant chemotherapy
  • quality of life
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

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)
04

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
200 participants (estimated)

Study arms

  • 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

  • No intervention
    Control

    quality of life screening

Interventions

  • Otheractive 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.

05

What researchers measure

Primary outcomes

  1. Impact of active monitoring of adverse effects on quality of life

    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.

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

Secondary outcomes

  1. Comprehensibility of the questionnaire

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

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

  2. Usability of the questionnaire in routine clinical practice

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

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

  3. Frequency of active intervention by a physician

    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.

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

06

Study locations

1 of 1 sites recruiting
  • Masaryk Memorial Cancer Institute
    Brno, 656 53, Czechia
    Recruiting
07

References and documents

Publications

  • 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. PubMed 35963481 ↗
  • 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. PubMed 33008323 ↗
  • 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. PubMed 28490338 ↗
  • 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. PubMed 36765408 ↗
  • 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. PubMed 23008309 ↗
  • 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. PubMed 29437116 ↗
  • 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. PubMed 32612947 ↗
  • 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. PubMed 28049573 ↗
  • 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. PubMed 29866185 ↗

Individual participant data

Plan to share: Yes — IPD to be shared in pseudonymized form during the study. IPD to be published in anonymized form.

Supporting information: Csr

08

Registry details

Key details

Study ID
NCT07253987
Lead sponsor
Masaryk Memorial Cancer Institute
Responsible party
Sponsor
First posted
Nov 28, 2025
Start date
May 5, 2025
Primary completion
Sep 5, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Jun 11, 2026

Study contacts

Lenka Pavčíková, MUDr.
Contact
lenka.pavcikova@mou.cz
+420 543 136 136
Martina Lojová, Ph.D.
Contact
martina.lojova@mou.cz
+420 543 136 232

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion