Elderly CAncer Patient: Qualitative and Quantitative Factors of Inclusion Failure in Clinical Trials (Quali-SAGE)

November 19, 2020 updated by: Assistance Publique - Hôpitaux de Paris

The transposition of the results of biomedical research to medical management of patients in real-life setting depends highly from patient's selection. In Europe and the United States, the majority of cancers occur after 65 years. In France, 45% of cancers diagnosed in 2012 were after 70 years or 158,722 in absolute value. In this context, the median age at diagnosis was 72 years old. Disease particularly affecting the elderly, cancer is also characterized by the importance of biomedical research devoted to it. Despite the dynamism of the research activity in oncology and therefore the number of affected patients, the elderly are paradoxically sparsely included in clinical trials. Numerous studies have focused in recent years, to identify possible causes of under-representation of elderly patients in clinical trials but most of them focused on eligibility criteria and few on barriers related to non-invitation or non-inclusion in eligible patients.

The investigator postulate that a qualitative survey based on an structured epidemiological device will able to objective evidences of reasons related to the patient, participant familial caregivers, participant physician and the clinical center organization for participating or not to a clinical trial and the interrelations between the identified reasons.

The main objective is to assess reasons of non-participation of older patients with cancer in clinical trials, from the physicians, patients and family caregivers' perspectives using qualitative and quantitative methods.

The secondary objectives are:

To investigate the social representation and construction of being "aged" from the patient, physician and family caregiver perspective (qualitative part).

To compare the reasons of non-participation regarding age class (old and very old), localized versus metastatic disease and tumor site (quantitative part).

To characterize the profiles of participants and non-participants to clinical trial among older patients with cancer thanks to qualitative and quantitative data.

Method Quali SAGE is a French, socio-epidemiologic, multicenter prospective study that includes patients aged 70 years or over, with solid tumor (irrespective of the stage) in French hospitals.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

313

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Creteil, France, 94010
        • Henri Mondor Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

70 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Population: all patients aged 70 years or more with a solid cancer and pre-screened/screened for at least one clinical trial ongoing in the center

Description

Inclusion Criteria:

  • Aged 70 years or over
  • With solid cancer irrespective of the stage
  • Pre-screened or screened for at least one ongoing clinical trial in the center
  • Informed oral consent (patient, his/her legal representant, trustworthy person or family member)
  • Social security affiliation

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Elderly cancer patient cohort
  • Aged 70 years or over
  • With solid cancer irrespective of the stage
  • Pre-screened or screened for at least one ongoing clinical trial in the center
  • Informed oral consent (patient, his/her legal representant, trustworthy person or family member)
  • Social security affiliation
Other: Ethnographic interview

If a patient is invited to participate in the a clinical trial, inclusion's status (included or/not) will be sought.

  • If included: an ethnographic interview will be held with patient (or his representant) who agreed to participate in the clinical trial, his family caregivers, his physician(s) in charge of him and the trial and, and clinical studies technician responsible for management.
  • If not included, an ethnographic interview has offered to him, his caregivers, his physician(s) in charge of him and the trial and clinical studies technician responsible for management. In parallel, the reasons for non-inclusion are collected from a pre-established epidemiological questionnaire.

If a patient is not invited to participate,an ethnographic interview will be held with his physician(s) in charge of him and the clinical trial and with clinical studies technician responsible for management.The reasons for non-invitation will be collected from an epidemiological survey multiple choices.

Other Names:
  • Socio-demographic interview

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Invitation to participate in at least one clinical trial currently ongoing
Time Frame: one year follow up
one year follow up

Secondary Outcome Measures

Outcome Measure
Time Frame
Inclusion in at least one clinical trial currently ongoing
Time Frame: one year follow up
one year follow up
Secondary exclusion or Premature Termination or Withdrawal
Time Frame: one year follow up
one year follow up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Collaborators

National Cancer Institute, France

Investigators

  • Principal Investigator: Florence Canouï-Poitrine, MD, PhD, Assistance Publique - Hôpitaux de Paris

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 12, 2017

Primary Completion (Actual)

August 17, 2020

Study Completion (Actual)

August 17, 2020

Study Registration Dates

First Submitted

July 24, 2017

First Submitted That Met QC Criteria

July 24, 2017

First Posted (Actual)

July 26, 2017

Study Record Updates

Last Update Posted (Actual)

November 23, 2020

Last Update Submitted That Met QC Criteria

November 19, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • NI15022

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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