NCT04451343

Brief Summary

In a context the respect of the autonomy of the patients is important, it is necessary to pay a sustained attention to the experiences and the lived experience as well of the patients suffering or in remission of cancer as of their family. It is therefore, for the family, to deepen the synthesis carried out by the Societal Cancer Observatory which is a societal observatory of cancer

Trial Health

87
On Track

Trial Health Score

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

Enrollment
72

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2018

Typical duration 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

July 6, 2018

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 7, 2018

Completed
1.6 years until next milestone

First Posted

Study publicly available on registry

June 30, 2020

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 6, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2021

Completed
Last Updated

September 29, 2021

Status Verified

September 1, 2021

Enrollment Period

3 years

First QC Date

November 7, 2018

Last Update Submit

September 28, 2021

Conditions

Outcome Measures

Primary Outcomes (2)

  • Assess the interaction between the care path (surgery, chemotherapy, radiotherapy) and the life course in patients before 65 years old with colorectal cancer

    semi-structured patients interview

    2 hours

  • Assess how the patients, their relatives and their family members, face the disease.

    semi-structured patients interview

    1 hour

Study Arms (2)

Patients

Patients with a diagnosis of colorectal cancer before 65 years.

Other: biographical interviews

Family

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

FamilyPatients

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Surviving patients over the age of 18 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:

  • Patients will be
  • over 18 years old
  • with a diagnosis of CRC before 65 years.
  • able to give their non-opposition and to nominate at least 2 family members who would be willing to participate in the study
  • The spouse and / or children and / or parents will be eligible:
  • if they are at least 18 years old, if they can be considered a caregiver or are first-degree relatives of the index patient for whom a diagnosis of CRC has been made. .

You may not qualify if:

  • Patients under 18 years of age or with a diagnosis of CRC after 65 years.
  • 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

June 30, 2020

Study Start

July 6, 2018

Primary Completion

July 6, 2021

Study Completion

September 1, 2021

Last Updated

September 29, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations