Colorectal CancerMACHROAPIK65NCT04458740
The Life and Care of Colorectal Cancer Patients After 65 Years and Their Family
An observational study of Colorectal Cancer, run by Poitiers University Hospital at 1 site in France.
Trial summary
Given a context where patients autonomy respect is important, it is necessary to pay a sustained attention to the patients care and life experiences, as well as the families and relatives of patients with colorectal cancer or patients in remission of colorectal cancer. Read more about this study
- Who is it for?
- Ages 65 to 80 years
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- biographical interviews
- How many people
- 18 participants
- Where
- 1 siteFrance
- Study dates
- 29 Oct 2018to 17 May 2019
- 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 65 to 80 years
- All sexes
- Older adult
Study population: Surviving patients between 65 and 80 years and diagnosed with invasive CRC, infiltrating adenocarcinoma of the colon or rectum irrespective of the stage before 65 years old will be selected in the Poitou-Charentes cancer registry 2 to 5 years after announcement of the diagnosis.
Who may be able to join
- The patients will be:
- over the age of 65 and under 80
- with a colorectal cancer operated between 65 and 80 years with a documented histological diagnosis, dating from 2 to 5 years.
- be able to provide informed consent and appoint a caregiver who would be willing to participate in the study.
- The spouse and / or children and / or parents will be eligible:
- if he is at least 18 years old, if he can be considered a caregiver of the index patient for whom a diagnosis of CRC has been made.
Who cannot join
- Patients with a diagnosis of colorectal cancer before the age of 65 or after the age of 80 from 2 to 5 years old.
- Near a deceased patient or under 18 years old.
Trial locations and contacts
1 site in 1 country.
About this study
Given a context where patients autonomy respect is important, it is necessary to pay a sustained attention to the patients care and life experiences, as well as the families and relatives of patients with colorectal cancer or patients in remission of colorectal cancer. Thanks to families and relatives data, it will allow to improve the analyses carried out by the "Societal Cancer Observatory" in 2016.
- Conditions
- Colorectal Cancer
- Being tested
- biographical interviews
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
biographical interviewsOther
A sociologist trained in the sociology of cancer, to enable participants to talk about their experiences and clearly distinguish the experiences of each individual
| Study group | Role | What they receive |
|---|---|---|
| Patient | Patients with a diagnosis of colorectal cancer after 65 years. Receives: Other: biographical interviews | |
| The spouse and /or children and /or parents | The spouse and /or children and /or parents of a patient 's diagnosis of colorectal cancer before 65 years. Receives: Other: biographical interviews |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the interaction between the care path (surgery, chemotherapy, radiotherapy) and the life course in patients after 65 years old with colorectal cancer
semi-structured patients interview
Measured: 2 hours
Assess how the patients and their family members face the disease
semi-structured patients interview
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2020
- Study start29 Oct 2018
- Primary completion17 May 2019
- Study completion17 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Poitiers University HospitalThe 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
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poitiers University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04458740
- Sponsor's protocol ID
- MACHROAPICANCERPLUS65
- Acronym
- MACHROAPIK65
- Status last verified
- Jun 2020
- First submitted
- 7 Nov 2018
- Last updated
- 7 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Life and Care of Colorectal Cancer Patients After 65 Years and Their Family
- ClinicalTrials.gov ID
- NCT04458740
- Acronym / sponsor ID
- MACHROAPIK65 / MACHROAPICANCERPLUS65
- Conditions
- Colorectal Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Poitiers University HospitalUniversity, hospital or other
- Study start
- 29 Oct 2018 (actual)
- Primary completion
- 17 May 2019 (actual)
- Study completion
- 17 May 2019 (actual)
- First posted
- 7 Jul 2020 (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.
Given a context where patients autonomy respect is important, it is necessary to pay a sustained attention to the patients care and life experiences, as well as the families and relatives of patients with colorectal cancer or patients in remission of colorectal cancer. Thanks to families and relatives data, it will allow to improve the analyses carried out by the "Societal Cancer Observatory" in 2016.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient | – | Other: biographical interviewsPatients with a diagnosis of colorectal cancer after 65 years. |
| The spouse and /or children and /or parents | – | Other: biographical interviewsThe spouse and /or children and /or parents of a patient 's diagnosis of colorectal cancer before 65 years. |
Who may qualify
- Ages
- 65 to 80 years
- Sex
- All
- Age groups
- Older adult
- Study population
- Surviving patients between 65 and 80 years and diagnosed with invasive CRC, infiltrating adenocarcinoma of the colon or rectum irrespective of the stage before 65 years old will be selected in the Poitou-Charentes cancer registry 2 to 5 years after announcement of the diagnosis.
Key inclusion criteria (6 listed)
- over the age of 65 and under 80
- with a colorectal cancer operated between 65 and 80 years with a documented histological diagnosis, dating from 2 to 5 years.
- be able to provide informed consent and appoint a caregiver who would be willing to participate in the study.
- if he is at least 18 years old, if he can be considered a caregiver of the index patient for whom a diagnosis of CRC has been made.
Key exclusion criteria (2 listed)
- Patients with a diagnosis of colorectal cancer before the age of 65 or after the age of 80 from 2 to 5 years old.
- Near a deceased patient or under 18 years old.
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 |
|---|---|---|
| biographical interviewsA sociologist trained in the sociology of cancer, to enable participants to talk about their experiences and clearly distinguish the experiences of each individual | Other | Patient, The spouse and /or children and /or parents |
Primary outcome
Assess the interaction between the care path (surgery, chemotherapy, radiotherapy) and the life course in patients after 65 years old with colorectal cancer
Time frame: 2 hours
semi-structured patients interview
Assess how the patients and their family members face the disease
Time frame: 1 hour
semi-structured patients interview
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 7 Jul 2020.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Colorectal Cancer, run by Poitiers University Hospital 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 6 inclusion and 2 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 7 Jul 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?
Assess the interaction between the care path (surgery, chemotherapy, radiotherapy) and the life course in patients after 65 years old with colorectal cancer (time frame: 2 hours). The study lists 2 primary outcomes in all. 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 7 Jul 2020.