NCT04458740

Brief 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. Thanks to families and relatives data, it will allow to improve the analyses carried out by the "Societal Cancer Observatory" in 2016.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 29, 2018

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

November 7, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 17, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 17, 2019

Completed
1.1 years until next milestone

First Posted

Study publicly available on registry

July 7, 2020

Completed
Last Updated

July 7, 2020

Status Verified

June 1, 2020

Enrollment Period

7 months

First QC Date

November 7, 2018

Last Update Submit

July 2, 2020

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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

    2 hours

  • Assess how the patients and their family members face the disease

    semi-structured patients interview

    1 hour

Study Arms (2)

Patient

Patients with a diagnosis of colorectal cancer after 65 years.

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.

Other: biographical interviews

Interventions

A sociologist trained in the sociology of cancer, to enable participants to talk about their experiences and clearly distinguish the experiences of each individual

PatientThe spouse and /or children and /or parents

Eligibility Criteria

Age65 Years - 80 Years
Sexall
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Registre du Cancer

Poitiers, 86021, France

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 7, 2018

First Posted

July 7, 2020

Study Start

October 29, 2018

Primary Completion

May 17, 2019

Study Completion

May 17, 2019

Last Updated

July 7, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share

Locations