Expectations and Priorities of Elderly Patients for a First Medical Treatment for Cancer (PRIORITY)

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.

Study Overview

• Status: Completed
• Conditions: Sarcoma; Lymphoma; Kidney Cancer; Breast Cancer; Colorectal Cancer; Ovarian Cancer; Lung Cancer; Prostate Cancer
• Intervention / Treatment: Other: Geriatric consultation, evaluation questionnaire; Other: Consultation, evaluation questionnaire

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 Type: Observational
• Enrollment (Actual): 346

Contacts and Locations

Study Locations

• France
  • Bordeaux, France, 33076
    • Institut Bergonie

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

400 patients aged 70 years old or more and 100 patient between 18 and 69 years old.

Description

Inclusion Criteria:

1. Male or female:

   1. Age ≥ 70 years
   2. Aged 18-69 years (case population)
2. ECOG / performance status 0-3 (WHO).

3. First line of medical oncology treatment (chemotherapy, targeted therapy, hormone therapy, combination):

   1. Neo-adjuvant setting,
   2. Adjuvant setting: previous neo-adjuvant treatment is allowed,
   3. Metastatic setting: previous neo-adjuvant and/or adjuvant treatment are allowed,
4. Solid tumors (breast, colorectal, kidney, lung, prostate, sarcoma, and ovarian) and lymphoma (indolent and aggressive).
5. Life expectancy of more than 3 months.
6. Patients potentially compliant with the rules of the follow-up study.
7. Patients affiliated to a social security scheme.
8. Patients who received clear information from the investigator on the study and had not refused to participate.

Exclusion Criteria:

1. Exclusive surgery treatment.
2. Exclusive radiotherapy treatment or in combination with oncological medical treatment (concomitant radio-chemotherapy or radio-hormonotherapy).

3. Previous first line of oncological medical treatment in the same indication as the one concerned by the inclusion:

   1. Neo-adjuvant setting: previous line(s) of neo-adjuvant medical treatment,
   2. Adjuvant setting: previous line(s) of adjuvant medical treatment,
   3. Metastatic setting: previous line(s) of metastatic medical treatment,
4. Supportive care without specific medical treatment
5. Previous or ongoing cancer under treatment at the time of inclusion.
6. Patient already included in this study
7. 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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Elderly patient (70 years and older)	Other: Geriatric consultation, evaluation questionnaire; Geriatric consultation, evaluation questionnaire
Young patient (18 years - 69 years)	Other: Consultation, evaluation questionnaire; Consultation, evaluation questionnaire

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: Institut Bergonié
• Collaborators: Fondation Université de Bordeaux; AG2R La Mondiale

Study record dates

Study Major Dates

• Study Start: January 1, 2016
• Primary Completion (Actual): June 30, 2022
• Study Completion (Actual): December 31, 2023

Study Registration Dates

• First Submitted: June 14, 2016
• First Submitted That Met QC Criteria: June 29, 2016
• First Posted (Estimated): July 4, 2016

Study Record Updates

• Last Update Posted (Estimated): July 1, 2025
• Last Update Submitted That Met QC Criteria: June 10, 2025
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urologic Neoplasms; Kidney Neoplasms
• Other Study ID Numbers: IB 2015-06

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO