Prostate Cancer PatientsSURV-QoLNCT07253987
Cancer Survivors Program
A study testing active screening of adverse effects of anticancer therapy based on specific questionnaire + quality of life screening in people with Prostate Cancer Patients and Breast Cancer Patients, run by Masaryk Memorial Cancer Institute at 1 site in Czechia.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prostate Cancer Patients, Breast Cancer Patients
- What is being tested?
- active screening of adverse effects of anticancer therapy based on specific questionnaire + quality of life screening
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteCzechia
- Study dates
- 5 May 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Czechia1 site, 1 recruiting
- Recruiting
Masaryk Memorial Cancer Institute
Brno, 656 53
Martina Lojová, Ph.D., +420 543 136 232, martina.lojova@mou.cz
Iveta Selingerová, Ph.D., +420 543 136 720, iveta.selingerova@mou.cz
About this study
Official title: 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.
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.
- Conditions
- Prostate Cancer Patients, Breast Cancer Patients
- Being tested
- active screening of adverse effects of anticancer therapy based on specific questionnaire + quality of life screening
- Keywords
- cancer survivors, breast cancer, prostate cancer, neo-/adjuvant chemotherapy, quality of life
- Medical subject headings
- Breast Neoplasms, Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
active screening of adverse effects of anticancer therapy based on specific questionnaire + quality of life screeningOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Interventional | Experimental | screening of adverse effects of curative therapy + quality of life screening Receives: Other: active screening of adverse effects of anticancer therapy based on specific questionnaire + quality of life screening |
| Control | No intervention | quality of life screening |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Upon enrollment (baseline), six and twelve months after baseline
Secondary outcomes (3)
Comprehensibility of the questionnaire
Evaluation of the comprehensibility of the Questionnaire for the Assessment of Difficulties after Cancer Treatment.
Measured: Upon enrollment (baseline), six and twelve months after baseline
Usability of the questionnaire in routine clinical practice
Evaluation of the usability of the Questionnaire for the Assessment of Difficulties in routine clinical practice.
Measured: Upon enrollment (baseline), six and twelve months after baseline
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.
Measured: Upon enrollment (baseline), six and twelve months after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2025
- Study start5 May 2025
- Primary completion5 Sep 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Prostate Cancer PatientsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Masaryk Memorial Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07253987
- Sponsor's protocol ID
- A8/25_SURV-QoL
- Other IDs
- A8/25
- Acronym
- SURV-QoL
- Status last verified
- Jun 2026
- First submitted
- 19 Nov 2025
- Last updated
- 11 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD to be shared in pseudonymized form during the study. IPD to be published in anonymized form.
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 35963481Culbertson 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 33008323van 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 28490338Allen 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 36765408Lustberg 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 23008309Mehta 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 29437116Nardin 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 32612947Mayer 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 28049573van 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
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cancer Survivors Program: Effectiveness of Monitoring Adverse Events After Completion of Curative Treatment for Breast and Prostate Cancer
- ClinicalTrials.gov ID
- NCT07253987
- Acronym / sponsor ID
- SURV-QoL / A8/25_SURV-QoL
- Conditions
- Prostate Cancer Patients, Breast Cancer Patients
- Keywords
- cancer survivors, breast cancer, prostate cancer, neo-/adjuvant chemotherapy, quality of life
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Masaryk Memorial Cancer InstituteUniversity, hospital or other
- Study start
- 5 May 2025 (actual)
- Primary completion
- 5 Sep 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 28 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interventional | Experimental | Other: active screening of adverse effects of anticancer therapy based on specific questionnaire + quality of life screeningscreening of adverse effects of curative therapy + quality of life screening |
| Control | No intervention | –quality of life screening |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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:
- The patient is available for follow-up within 12 months of enrollment in the study.
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| active screening of adverse effects of anticancer therapy based on specific questionnaire + quality of life screeningBased 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. | Other | Interventional |
Primary outcome
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.
3 secondary outcomes
Comprehensibility of the questionnaire
Time frame: 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
Frequency of active intervention by a physician
Time frame: Upon enrollment (baseline), six and twelve months after baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2026.
- Background: PubMed 35963481Vaz-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.
- Background: PubMed 33008323Culbertson 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.
- Background: PubMed 28490338van 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.
- Background: PubMed 36765408Allen 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.
- Background: PubMed 23008309Lustberg 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.
- Background: PubMed 29437116Mehta 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.
- Background: PubMed 32612947Nardin 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.
- Background: PubMed 28049573Mayer 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.
- Background: PubMed 29866185van 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.
- Institute of Health Information and Statistics of the Czech RepublicLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. IPD to be shared in pseudonymized form during the study. IPD to be published in anonymized form.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing active screening of adverse effects of anticancer therapy based on specific questionnaire + quality of life screening in people with Prostate Cancer Patients and Breast Cancer Patients, run by Masaryk Memorial Cancer Institute at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lenka Pavčíková, MUDr. (+420 543 136 136, lenka.pavcikova@mou.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Impact of active monitoring of adverse effects on quality of life (time frame: Upon enrollment (baseline), six and twelve months after baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07253987, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2026.