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

Sponsor

Assistance Publique - Hôpitaux de Paris (Other)

Overall Status

Completed

CT.gov ID

NCT03230305

Collaborator

National Cancer Institute, France (Other)

313

Enrollment

Location

40.2

Actual Duration (Months)

7.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Elderly Cancer Ethnographic Interview Social Representation of Being Aged Reasons of Non-participation in Clinical Trials Qualitative Method	Other: Ethnographic interview

Study Design

Study Type:

Observational

Actual Enrollment :

313 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Elderly CAncer Patient: Qualitative and Quantitative Factors of Inclusion Failure in Clinical Trials

Actual Study Start Date :

Apr 12, 2017

Actual Primary Completion Date :

Aug 17, 2020

Actual Study Completion Date :

Aug 17, 2020

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

Invitation to participate in at least one clinical trial currently ongoing [one year follow up]

Secondary Outcome Measures

Inclusion in at least one clinical trial currently ongoing [one year follow up]
Secondary exclusion or Premature Termination or Withdrawal [one year follow up]

Eligibility Criteria

Criteria

Ages Eligible for Study:

70 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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