TumorNCT06109896
Clinical Stories and Psychological Experiences of Cancer Patients
An observational study of Tumor, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS.
Trial summary
The purpose of the study is to collect and analyze information from the multidimensional assessment of cancer patients (medical, psychological, psychometric, biological, etc.) treated at the Fondazione Policlinico Universitario Agostino Gemelli IRCCS. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tumor
- What is being tested?
- Self Report Questionaires
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 31 Oct 2023to 31 Dec 2028
- Phase
- Observational
- 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
Study population: Adult patients who have been diagnosed with cancer. Patients who access the services of: Gynecology Oncology Unit, Internal Medicine and Gastroenterology Unit, Digestive Surgery Unit, Radiotherapy Oncology Unit, Senology Surgery Unit, Medical Oncology Unit, Hematology Unit, Medicine Unit will be considered. Neurosurgery and at the same time as psychological consultation with the operators belonging to the Clinical Psychology Unit of Fondazione Policlinico Universitario A. Gemelli IRCSS.
Who may be able to join
- Individuals between 18 and 99 years old;
- Individuals with a diagnosis of current oncologic disease and in active oncologic treatment at the hospital where the study is conducted;
- Individuals with a history of oncologic disease who have completed oncologic treatment or in follow-up at the hospital where the study is conducted;
Who cannot join
- Non-signing of informed consent;
- Non-signing of consent/assent by patient/legal guardian;
- Patients with cognitive impairment or legal disqualification;
- Clinical/medical or psychological condition that does not allow completion of self-report questionnaires;
About this study
Official title: ONCO_STORIES. Stress, Trauma, Origins, Psychological Responses, Interpersonal Relationships and Experiences in the Clinical History of Cancer Patients
The purpose of the study is to collect and analyze information from the multidimensional assessment of cancer patients (medical, psychological, psychometric, biological, etc.) treated at the Fondazione Policlinico Universitario Agostino Gemelli IRCCS. The collection of information will allow to investigate the possible presence of correlations between psychological aspects and clinical medical conditions of the person during the course/treatment of cancer.
In the course of the study, the possible presence of previous stressful and/or traumatic events, and the presence of psychological, post-traumatic and/or dissociative symptoms during treatment will be explored. Any correlations between medical conditions and psychological, emotional and behavioral characteristics will also be explored. Finally, it will be possible to investigate the effectiveness of psychological interventions that are carried out according to clinical practice.
- Conditions
- Tumor
- Being tested
- Self Report Questionaires
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self Report QuestionairesOther
Collection and analysis of information from patient self-report assessments and integration with clinical information from assessments performed routinely during cancer treatment.
What is being measured
The primary outcome is the main question the study is designed to answer.
Collect and analyze information from the multidimensional assessment of cancer patients
Descriptive and statistical analysis of data collected on the clinical and psychological conditions of the cancer patient through routine assessments and self-report questionnaires.
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2023
- Study start31 Oct 2023 (estimated)
- Primary completion31 Oct 2025 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TumorStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06109896
- Sponsor's protocol ID
- 5913
- Status last verified
- Oct 2023
- First submitted
- 26 Oct 2023
- Last updated
- 31 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ONCO_STORIES. Stress, Trauma, Origins, Psychological Responses, Interpersonal Relationships and Experiences in the Clinical History of Cancer Patients
- ClinicalTrials.gov ID
- NCT06109896
- Acronym / sponsor ID
- 5913
- Conditions
- Tumor
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 31 Oct 2023 (estimated)
- Primary completion
- 31 Oct 2025 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 31 Oct 2023 (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 purpose of the study is to collect and analyze information from the multidimensional assessment of cancer patients (medical, psychological, psychometric, biological, etc.) treated at the Fondazione Policlinico Universitario Agostino Gemelli IRCCS. The collection of information will allow to investigate the possible presence of correlations between psychological aspects and clinical medical conditions of the person during the course/treatment of cancer.
In the course of the study, the possible presence of previous stressful and/or traumatic events, and the presence of psychological, post-traumatic and/or dissociative symptoms during treatment will be explored. Any correlations between medical conditions and psychological, emotional and behavioral characteristics will also be explored. Finally, it will be possible to investigate the effectiveness of psychological interventions that are carried out according to clinical practice.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients who have been diagnosed with cancer. Patients who access the services of: Gynecology Oncology Unit, Internal Medicine and Gastroenterology Unit, Digestive Surgery Unit, Radiotherapy Oncology Unit, Senology Surgery Unit, Medical Oncology Unit, Hematology Unit, Medicine Unit will be considered. Neurosurgery and at the same time as psychological consultation with the operators belonging to the Clinical Psychology Unit of Fondazione Policlinico Universitario A. Gemelli IRCSS.
Key inclusion criteria (3 listed)
- Individuals between 18 and 99 years old;
- Individuals with a diagnosis of current oncologic disease and in active oncologic treatment at the hospital where the study is conducted;
- Individuals with a history of oncologic disease who have completed oncologic treatment or in follow-up at the hospital where the study is conducted;
Key exclusion criteria (4 listed)
- Non-signing of informed consent;
- Non-signing of consent/assent by patient/legal guardian;
- Patients with cognitive impairment or legal disqualification;
- Clinical/medical or psychological condition that does not allow completion of self-report questionnaires;
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 |
|---|---|---|
| Self Report QuestionairesCollection and analysis of information from patient self-report assessments and integration with clinical information from assessments performed routinely during cancer treatment. | Other | – |
Primary outcome
Collect and analyze information from the multidimensional assessment of cancer patients
Time frame: 1 hour
Descriptive and statistical analysis of data collected on the clinical and psychological conditions of the cancer patient through routine assessments and self-report questionnaires.
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 31 Oct 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Tumor, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS.
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 3 inclusion and 4 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: opening soon, as of the sponsor's last update on 31 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Collect and analyze information from the multidimensional assessment of cancer patients (time frame: 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Oct 2023; AzTrials last refreshed its copy on 8 Nov 2026.