Clinical trial NCT03230305: Elderly CAncer Patient: Qualitative and Quantitative Factors of Inclusion Failure in Clinical Trials
Official title: Elderly CAncer Patient: Qualitative and Quantitative Factors of Inclusion Failure in Clinical Trials
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Elderly
Cancer
Ethnographic Interview
Social Representation of Being Aged
Reasons of Non-participation in Clinical Trials
Qualitative Method
Keywords: Elderly
Cancer
Ethnographic interview
Social representation
Clinical trials
Reasons of non-participation
Qualitative method
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: National Cancer Institute, France
First posted: 2017-07-26
Enrollment: 313
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.


Eligibility criteria: 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

Primary outcomes:
measure: Invitation to participate in at least one clinical trial currently ongoing
timeFrame: one year follow up
Secondary outcomes:
measure: Inclusion in at least one clinical trial currently ongoing
timeFrame: one year follow up
measure: Secondary exclusion or Premature Termination or Withdrawal
timeFrame: one year follow up
Other outcomes:
Locations:
city: Creteil
country: France
facility: Henri Mondor Hospital
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Florence Canouï-Poitrine, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: