ElderlyQuali-SAGENCT03230305
Elderly CAncer Patient: Qualitative and Quantitative Factors of Inclusion Failure in Clinical Trials
An observational study of Elderly and Cancer, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Elderly, Cancer, Ethnographic Interview
- What is being tested?
- Ethnographic interview
- Type of treatment
- Pill or oral medicine
- How many people
- 313 participants
- Where
- 1 siteFrance
- Study dates
- 12 Apr 2017to 17 Aug 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- No healthy volunteers
- Older adult
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
Who may be able to join
- 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
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
- Conditions
- Elderly, Cancer, Ethnographic Interview, Social Representation of Being Aged, Reasons of Non-participation in Clinical Trials, Qualitative Method
- Being tested
- Ethnographic interview
- Keywords
- Elderly, Cancer, Ethnographic interview, Social representation, Clinical trials, Reasons of non-participation, Qualitative method
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ethnographic interviewOther
Also called Socio-demographic 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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Ethnographic interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
Invitation to participate in at least one clinical trial currently ongoing
Measured: one year follow up
Secondary outcomes (2)
Inclusion in at least one clinical trial currently ongoing
Measured: one year follow up
Secondary exclusion or Premature Termination or Withdrawal
Measured: one year follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2017
- Study start12 Apr 2017
- Primary completion17 Aug 2020
- Study completion17 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ElderlyStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 313 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute, France
- Responsible party
- Sponsor
- Investigators
- Florence Canouï-Poitrine, MD, PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03230305
- Sponsor's protocol ID
- NI15022
- Acronym
- Quali-SAGE
- Status last verified
- Nov 2020
- First submitted
- 24 Jul 2017
- Last updated
- 23 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Elderly CAncer Patient: Qualitative and Quantitative Factors of Inclusion Failure in Clinical Trials
- ClinicalTrials.gov ID
- NCT03230305
- Acronym / sponsor ID
- Quali-SAGE / NI15022
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 313 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- National Cancer Institute, France
- Study start
- 12 Apr 2017 (actual)
- Primary completion
- 17 Aug 2020 (actual)
- Study completion
- 17 Aug 2020 (actual)
- First posted
- 26 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Elderly cancer patient cohort | – | Other: Ethnographic interview* 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 |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- 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
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ethnographic interviewAlso: Socio-demographic interviewIf 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 | Elderly cancer patient cohort |
Primary outcome
Invitation to participate in at least one clinical trial currently ongoing
Time frame: one year follow up
2 secondary outcomes
Inclusion in at least one clinical trial currently ongoing
Time frame: one year follow up
Secondary exclusion or Premature Termination or Withdrawal
Time frame: one year follow up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2020.
Related trials for Elderly
Recruiting
Comparıson of the Effıcacy of Conventıonal Exercıse and Pılates ın Pre-fraıl and Fraıl Older Adults
Frailty Syndrome, Prefrail Elderly
RecruitingPhase 4
Comparison of Hemodynamics and Respiratory Function Between Ciprofol and Propofol in Elderly Patients Undergoing Non-intubated General Anesthesia
Comparison of Hemodynamics and Respiratory Function Between Ciprofol and Propofol in Elderly Patients Undergoing Non-intubated General Anesthesia
Not yet recruitingPhase 2
MF-300 for Treatment of Age-Related Sarcopenia
Sarcopenia in Elderly
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Recruiting
Effects of Breathing Exercises on Cognition in Older Adults
Older Adults (65 Years and Older), Cognition
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Florence Canouï-Poitrine, MD, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Elderly and Cancer, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Invitation to participate in at least one clinical trial currently ongoing (time frame: one year follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Nov 2020.