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| Name | Class |
|---|---|
| Fondation Université de Bordeaux | UNKNOWN |
| AG2R La Mondiale | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Elderly patient (70 years and older) |
| ||
| Young patient (18 years - 69 years) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Consultation, evaluation questionnaire | Other | Consultation, evaluation questionnaire |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 3 months after initiation of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Day 0 initiation of treatment |
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Inclusion Criteria:
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.
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.
Exclusion Criteria:
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.
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.
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400 patients aged 70 years old or more and 100 patient between 18 and 69 years old.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut Bergonié | Bordeaux | 33076 | France |
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Elderly patients (≥ 70 years of age) were recruited by the investigating oncologists or geriatricians at organ-specific multidisciplinary consultation meetings (RCP) or during consultations.
Younger patients were identified and recruited in the same way, mainly through RCP or specialized consultation by oncologists.
Recruitment from January 2016 to January 2022 in 8 centers.
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| ID | Title | Description |
|---|---|---|
| FG000 | Elderly Patient (70 Years and Older) | Geriatric consultation, evaluation questionnaire: Geriatric consultation, evaluation questionnaire |
| FG001 | Young Patient (18 Years - 69 Years) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 17, 2021 |
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| Geriatric consultation, evaluation questionnaire | Other | Geriatric consultation, evaluation questionnaire |
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| 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 |
| 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 | 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 | 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. | Day 0 initiation of treatment |
Consultation, evaluation questionnaire: Consultation, evaluation questionnaire
| Major Deviation From Protocol |
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| Major Deviation on Eligibility Criteria |
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| COMPLETED |
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| NOT COMPLETED |
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Eligible population : Patients without major deviation on study protocol and eligibility criteria
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| ID | Title | Description |
|---|---|---|
| BG000 | Elderly Patient (70 Years and Older) | Geriatric consultation, evaluation questionnaire: Geriatric consultation, evaluation questionnaire |
| BG001 | Young Patient (18 Years - 69 Years) | Consultation, evaluation questionnaire: Consultation, evaluation questionnaire |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Inter-Quartile Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Patients without major deviation on study protocol and eligibility criteria who indicated at least one priority in the prioritization grid at the initiation of treatment | Posted | Count of Participants | Participants | Day 0 initiation of treatment |
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| Primary | 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. | Patients without major deviation on study protocol and eligibility criteria who indicated at least one priority in the prioritization grid 3 months after initiation of treatment | Posted | Count of Participants | Participants | 3 months after initiation of treatment |
|
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| Secondary | 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 | Patients without major deviation on study protocol and eligibility criteria who indicated at least one priority in the prioritization grid at the initiation of treatment | Posted | Count of Participants | Participants | Day 0 initiation of treatment |
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| Secondary | 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 | Patients without major deviation on study protocol and eligibility criteria who indicated at least one priority in the prioritization grid 3 months after initiation of treatment | Posted | Count of Participants | Participants | 3 months after initiation of treatment |
|
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| Secondary | 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 | Patients without major deviation on study protocol and eligibility criteria who indicated at least one priority in the prioritization grid at the initiation of treatment and 3 months after treatment initiation | Posted | Count of Participants | Participants | 3 months after initiation of treatment |
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| Secondary | 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 | Patients without major deviation on study protocol and eligibility criteria who indicated at least one priority in the prioritization grid at the initiation of treatment | Posted | Number | 95% Confidence Interval | percentage of patient | From inclusion to the end of study |
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| Secondary | 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. | Patients without major deviations from study protocol and eligibility criteria who indicated at least one priority in the prioritization grid at treatment initiation and whose physician also indicated at least one priority in the prioritization grid. | Posted | Count of Participants | Participants | Day 0 initiation of treatment |
|
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1 year from inclusion.
Only death were assessed on study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Elderly Patient (70 Years and Older) | Geriatric consultation, evaluation questionnaire: Geriatric consultation, evaluation questionnaire | 47 | 211 | 0 | 0 | 0 | 0 |
| EG001 | Young Patient (18 Years - 69 Years) | Consultation, evaluation questionnaire: Consultation, evaluation questionnaire | 17 | 97 | 0 | 0 | 0 | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pr Simone Mathoulin-Pelissier | Institut Bergonié | 0556333333 | S.Mathoulin@bordeaux.unicancer.fr |
| Jun 10, 2025 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D015179 | Colorectal Neoplasms |
| D007680 | Kidney Neoplasms |
| D008175 | Lung Neoplasms |
| D011471 | Prostatic Neoplasms |
| D012509 | Sarcoma |
| D010051 | Ovarian Neoplasms |
| D008223 | Lymphoma |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D005834 | Genital Neoplasms, Male |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D011469 | Prostatic Diseases |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D004701 | Endocrine Gland Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D005833 | Genital Neoplasms, Female |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D012017 | Referral and Consultation |
| ID | Term |
|---|---|
| D011364 | Professional Practice |
| D009934 | Organization and Administration |
| D006298 | Health Services Administration |
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| Autonomy |
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