Breast CancerPRIORITYNCT02821793
Expectations and Priorities of Elderly Patients for a First Medical Treatment for Cancer
An observational study of Breast Cancer and Colorectal Cancer, run by Institut Bergonié at 1 site in France.
Trial summary
The main objective of study is to describe the priorities of elderly patients (70 years and over) undergoing a first medical treatment for cancer, at initiation of treatment and after 3 months of treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Colorectal Cancer, Kidney Cancer
- What is being tested?
- Consultation, evaluation questionnaire and Geriatric consultation, evaluation questionnaire
- How many people
- 346 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2016to 31 Dec 2023
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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: 400 patients aged 70 years old or more and 100 patient between 18 and 69 years old.
Who may be able to join
- Male or female:
- Age ≥ 70 years
- Aged 18-69 years (case population)
- ECOG / performance status 0-3 (WHO).
- First line of medical oncology treatment (chemotherapy, targeted therapy, hormone therapy, combination):
- Neo-adjuvant setting,
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- Adjuvant setting: previous neo-adjuvant treatment is allowed,
- Metastatic setting: previous neo-adjuvant and/or adjuvant treatment are allowed,
- Solid tumors (breast, colorectal, kidney, lung, prostate, sarcoma, and ovarian) and lymphoma (indolent and aggressive).
- Life expectancy of more than 3 months.
- Patients potentially compliant with the rules of the follow-up study.
- Patients affiliated to a social security scheme.
- Patients who received clear information from the investigator on the study and had not refused to participate.
Who cannot join
- Exclusive surgery treatment.
- Exclusive radiotherapy treatment or in combination with oncological medical treatment (concomitant radio-chemotherapy or radio-hormonotherapy).
- Previous first line of oncological medical treatment in the same indication as the one concerned by the inclusion:
- Neo-adjuvant setting: previous line(s) of neo-adjuvant medical treatment,
- Adjuvant setting: previous line(s) of adjuvant medical treatment,
- Metastatic setting: previous line(s) of metastatic medical treatment,
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- Supportive care without specific medical treatment
- Previous or ongoing cancer under treatment at the time of inclusion.
- Patient already included in this study
- Patient who for psychological, psychiatric, social, family or geographical reasons could not be regularly monitored according to the criteria of the study; patient private of liberty or under guardianship.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Expectations and Priorities of Elderly Patients for a First Medical Treatment for Cancer : PRIORITY Study
The main objective of study is to describe the priorities of elderly patients (70 years and over) undergoing a first medical treatment for cancer, at initiation of treatment and after 3 months of treatment. The main criterion is a prioritization of 4 items per patient from a list of 8 expectations regarding the objectives of their treatment: treatment efficacy, life expectancy, autonomy, daily activities, social activities, heaviness of treatment, toxicity, economics.
Read the detailed description
For the primary endpoint assessment, this self-administered patient questionnaire will used an opinion scale (Not at all, A little, Moderately, Enough, Many) to explore the eight domains. Next to the completion of the expectations questionnaire, patients will have to order 4 of the different 8 items that they prioritized in regard of the first line treatment that has just been prescribed by their physician.
Secondary endpoint will focus on those 8 proposed expectations of patients at different periods of time since treatment initiation. Patients' priorities will be compared to physician's priorities (using the same prioritization grid) before medical treatment and after 3 months of treatment and to younger patients' priorities (18-69 years). Associations between elderly patients' characteristics (social, medical…) and their priorities will be search.
- Conditions
- Breast Cancer, Colorectal Cancer, Kidney Cancer, Lung Cancer, Prostate Cancer, Sarcoma
- Being tested
- Consultation, evaluation questionnaire, Geriatric consultation, evaluation questionnaire
- Medical subject headings
- Breast Neoplasms, Colorectal Neoplasms, Kidney Neoplasms, Lung Neoplasms, Prostatic Neoplasms, Sarcoma, Ovarian Neoplasms, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Consultation, evaluation questionnaireOther
Consultation, evaluation questionnaire
Geriatric consultation, evaluation questionnaireOther
Geriatric consultation, evaluation questionnaire
| Study group | Role | What they receive |
|---|---|---|
| Elderly patient (70 years and older) | Not described Receives: Other: Geriatric consultation, evaluation questionnaire | |
| Young patient (18 years - 69 years) | Not described Receives: Other: Consultation, evaluation questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Priorities of Patients Receiving First Medical Treatment for Cancer at Treatment Initiation
Prioritization among of the 4 items selected from a list of 8 expectations regarding the objectives of their treatment : treatment efficacy, life expectancy, autonomy, daily tasks, social activities, burden of treatment, toxicity and economic burden.
For each expectation, the number and rate of priorization are reported.
Measured: Day 0 initiation of treatment
Priorities of Patients Receiving First Medical Treatment for Cancer 3 Months After Initiation of Treatment
Prioritization among of the 4 items selected from a list of 8 expectations regarding the objectives of their treatment : treatment efficacy, life expectancy, autonomy, daily tasks, social activities, burden of treatment, toxicity and economic burden.
For each expectation, the number and rate of priorization are reported.
Measured: 3 months after initiation of treatment
Secondary outcomes (5)
Expectations of Patients at Initiation of Treatment
Patients had to rate on a 5-point Likert scale (not at all / a little / moderately / quite / a lot) their expectations for treatment efficacy, life expectancy, autonomy, daily tasks, social activities, burden of treatment, toxicity and economic burden
Measured: Day 0 initiation of treatment
Expectations of Patients 3 Months After Initiation of Treatment
Patients had to rate on a 5-point Likert scale (not at all / a little / moderately / quite / a lot) their expectations for treatment efficacy, life expectancy, autonomy, daily tasks, social activities, burden of treatment, toxicity and economic burden
Measured: 3 months after initiation of treatment
Stability of Patients in Their Priorities at 3 Months
For each expectation, stability is defined as the prioritization of the expectation at treatment initiation and 3 months after treatment initiation
Measured: 3 months after initiation of treatment
1-year Overall Survival
Overall survival is defined as the time between the date of inclusion and the date of death, whatever the cause.
The rate of overall survival is reported at 1 year
Measured: From inclusion to the end of study
Agreement Rate for Prioritization of Expectations Between Patients and Physicians
For each expectation, the agreement rate is defined by the same prioritization or non-prioritization by the patient-physician pairs.
Measured: Day 0 initiation of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2016 (estimated)
- Study startJan 2016
- Primary completion30 Jun 2022
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Breast CancerStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 346 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Bergonié
- Sponsor type
- University, hospital or other
- Collaborators
- Fondation Université de Bordeaux, AG2R La Mondiale
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02821793
- Sponsor's protocol ID
- IB 2015-06
- Acronym
- PRIORITY
- Status last verified
- Nov 2024
- First submitted
- 14 Jun 2016
- Last updated
- 1 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expectations and Priorities of Elderly Patients for a First Medical Treatment for Cancer : PRIORITY Study
- ClinicalTrials.gov ID
- NCT02821793
- Acronym / sponsor ID
- PRIORITY / IB 2015-06
- Conditions
- Breast Cancer, Colorectal Cancer, Kidney Cancer, Lung Cancer, Prostate Cancer, Sarcoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 346 participants (actual)
- Lead sponsor
- Institut BergoniéUniversity, hospital or other
- Collaborators
- Fondation Université de Bordeaux, AG2R La Mondiale
- Study start
- Jan 2016
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 4 Jul 2016 (estimated)
- Results
- Posted 1 Jul 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main objective of study is to describe the priorities of elderly patients (70 years and over) undergoing a first medical treatment for cancer, at initiation of treatment and after 3 months of treatment. The main criterion is a prioritization of 4 items per patient from a list of 8 expectations regarding the objectives of their treatment: treatment efficacy, life expectancy, autonomy, daily activities, social activities, heaviness of treatment, toxicity, economics.
Detailed description
For the primary endpoint assessment, this self-administered patient questionnaire will used an opinion scale (Not at all, A little, Moderately, Enough, Many) to explore the eight domains. Next to the completion of the expectations questionnaire, patients will have to order 4 of the different 8 items that they prioritized in regard of the first line treatment that has just been prescribed by their physician.
Secondary endpoint will focus on those 8 proposed expectations of patients at different periods of time since treatment initiation. Patients' priorities will be compared to physician's priorities (using the same prioritization grid) before medical treatment and after 3 months of treatment and to younger patients' priorities (18-69 years). Associations between elderly patients' characteristics (social, medical…) and their priorities will be search.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Elderly patient (70 years and older) | – | Other: Geriatric consultation, evaluation questionnaire |
| Young patient (18 years - 69 years) | – | Other: Consultation, evaluation questionnaire |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 400 patients aged 70 years old or more and 100 patient between 18 and 69 years old.
Key inclusion criteria (13 listed)
- Male or female:
- ECOG / performance status 0-3 (WHO).
- First line of medical oncology treatment (chemotherapy, targeted therapy, hormone therapy, combination):
- Solid tumors (breast, colorectal, kidney, lung, prostate, sarcoma, and ovarian) and lymphoma (indolent and aggressive).
- Life expectancy of more than 3 months.
Key exclusion criteria (10 listed)
- Exclusive surgery treatment.
- Exclusive radiotherapy treatment or in combination with oncological medical treatment (concomitant radio-chemotherapy or radio-hormonotherapy).
- Previous first line of oncological medical treatment in the same indication as the one concerned by the inclusion:
- Supportive care without specific medical treatment
- Previous or ongoing cancer under treatment at the time of inclusion.
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 |
|---|---|---|
| Consultation, evaluation questionnaireConsultation, evaluation questionnaire | Other | Young patient (18 years - 69 years) |
| Geriatric consultation, evaluation questionnaireGeriatric consultation, evaluation questionnaire | Other | Elderly patient (70 years and older) |
Primary outcome
Priorities of Patients Receiving First Medical Treatment for Cancer at Treatment Initiation
Time frame: Day 0 initiation of treatment
Prioritization among of the 4 items selected from a list of 8 expectations regarding the objectives of their treatment : treatment efficacy, life expectancy, autonomy, daily tasks, social activities, burden of treatment, toxicity and economic burden. For each expectation, the number and rate of priorization are reported.
Priorities of Patients Receiving First Medical Treatment for Cancer 3 Months After Initiation of Treatment
Time frame: 3 months after initiation of treatment
Prioritization among of the 4 items selected from a list of 8 expectations regarding the objectives of their treatment : treatment efficacy, life expectancy, autonomy, daily tasks, social activities, burden of treatment, toxicity and economic burden. For each expectation, the number and rate of priorization are reported.
5 secondary outcomes
Expectations of Patients at Initiation of Treatment
Time frame: Day 0 initiation of treatment
Expectations of Patients 3 Months After Initiation of Treatment
Time frame: 3 months after initiation of treatment
Stability of Patients in Their Priorities at 3 Months
Time frame: 3 months after initiation of treatment
1-year Overall Survival
Time frame: From inclusion to the end of study
Agreement Rate for Prioritization of Expectations Between Patients and Physicians
Time frame: Day 0 initiation of treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and Colorectal Cancer, run by Institut Bergonié at 1 site in France.
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 13 inclusion and 10 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: finished, as of the sponsor's last update on 1 Jul 2025. 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 France. 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?
Yes. Results are posted in the registry (first posted 1 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Priorities of Patients Receiving First Medical Treatment for Cancer at Treatment Initiation (time frame: Day 0 initiation of treatment). The study lists 2 primary outcomes in all. 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 1 Jul 2025.