NCT02821793

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
346

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 14, 2016

Completed
20 days until next milestone

First Posted

Study publicly available on registry

July 4, 2016

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

July 1, 2025

Completed
Last Updated

July 1, 2025

Status Verified

November 1, 2024

Enrollment Period

6.5 years

First QC Date

June 14, 2016

Results QC Date

June 10, 2025

Last Update Submit

June 10, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (5)

  • Expectations of Patients at Initiation of Treatment

    Day 0 initiation of treatment

  • Expectations of Patients 3 Months After Initiation of Treatment

    3 months after initiation of treatment

  • Stability of Patients in Their Priorities at 3 Months

    3 months after initiation of treatment

  • 1-year Overall Survival

    From inclusion to the end of study

  • Agreement Rate for Prioritization of Expectations Between Patients and Physicians

    Day 0 initiation of treatment

Study Arms (2)

Elderly patient (70 years and older)

Other: Geriatric consultation, evaluation questionnaire

Young patient (18 years - 69 years)

Other: Consultation, evaluation questionnaire

Interventions

Consultation, evaluation questionnaire

Young patient (18 years - 69 years)

Geriatric consultation, evaluation questionnaire

Elderly patient (70 years and older)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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,
  • 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.

You may not qualify if:

  • Exclusive surgery treatment.
  • Exclusive radiotherapy treatment or in combination with oncological medical treatment (concomitant radio-chemotherapy or radio-hormonotherapy).
  • 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,
  • Supportive care without specific medical treatment
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut Bergonié

Bordeaux, 33076, France

Location

MeSH Terms

Conditions

Breast NeoplasmsColorectal NeoplasmsKidney NeoplasmsLung NeoplasmsProstatic NeoplasmsSarcomaOvarian NeoplasmsLymphoma

Interventions

Referral and Consultation

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesUrologic NeoplasmsUrogenital NeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital DiseasesRespiratory Tract NeoplasmsThoracic NeoplasmsLung DiseasesRespiratory Tract DiseasesGenital Neoplasms, MaleGenital Diseases, MaleGenital DiseasesProstatic DiseasesNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeEndocrine Gland NeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleGenital Neoplasms, FemaleEndocrine System DiseasesGonadal DisordersLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

Professional PracticeOrganization and AdministrationHealth Services Administration

Results Point of Contact

Title
Pr Simone Mathoulin-Pelissier
Organization
Institut Bergonié

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 14, 2016

First Posted

July 4, 2016

Study Start

January 1, 2016

Primary Completion

June 30, 2022

Study Completion

December 31, 2023

Last Updated

July 1, 2025

Results First Posted

July 1, 2025

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations