NCT03840213

Brief Summary

Patients treated for cancer nowadays have many means of information and tend to become more and more involved in their health. The interest of a therapeutic fast with detoxifying or even curative properties, with a specific indication for cancer patients treated by chemotherapy, is nowadays relayed by the media. To date, there are no studies conducted on the scope of this information in cancer patients or on the attitudes of oncologists towards this practice and possible positioning requests from patients. We hypothesize that the choice of this practice and its modalities are rarely discussed with oncologists, although it may have deleterious repercussions on the patient's health. We propose a research based on the principles of sociological intervention. Its objectives are a first review of the issue and the establishment of a joint working group, including patients, carers and researchers, which will propose solutions to improve the patient/carer dialogue on this issue.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2019

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 11, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 15, 2019

Completed
5 days until next milestone

Study Start

First participant enrolled

February 20, 2019

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2020

Completed
Last Updated

February 15, 2019

Status Verified

February 1, 2019

Enrollment Period

10 months

First QC Date

February 11, 2019

Last Update Submit

February 11, 2019

Conditions

Keywords

Chemotherapynutritionself-carecare/caregiver relationshipfasting

Outcome Measures

Primary Outcomes (1)

  • Number of patients who voluntarily changed their eating habits

    Number of patients who voluntarily changed their eating habits will be reported

    1 year

Secondary Outcomes (4)

  • Number of patients on therapeutic fasting or restrictive diet during chemotherapy treatment

    1 year

  • Number of patients using complementary or alternative medicines

    1 year

  • Number of patients discussing these different practices with their oncologist

    1 year

  • Number of patients discussing these different practices with other caregivers

    1 year

Study Arms (1)

Patients undergoing chemotherapy treatment

Patients over 18 years of age, followed at the ICLN day hospital or hospitalized and undergoing chemotherapy treatment

Behavioral: Filling a questionnaire and interviewDescription

Interventions

The questionnaire focuses on the dietary practices of patients treated with chemotherapy. It consists of 35 questions, completing an average of 20 minutes. Interviews will be conducted with patients who have changed their diet since the beginning of their treatment in order to further develop the results of the quantitative survey.

Patients undergoing chemotherapy treatment

Eligibility Criteria

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

Patients who intend to practice, or who practice a form of fasting during their chemotherapy treatment will be proposed to participate to a qualitative study to collect more information about their fasting.

You may qualify if:

  • Major patients, follow-up on Institut de Cancerology Lucien Neuwirth day service chemotherapy treatment
  • Patient affiliated or entitled to a social security scheme
  • Patient who received informed information about the study
  • Patient able to read French
  • Patients participating in the qualitative study:

You may not qualify if:

  • Refusal to participate, protected adult person, under guardianship or curatorship
  • Person unable to understand the conduct of the study
  • Person with a documented history of cognitive or psychiatric disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut de Cancérologie Lucien Neuwirth

Saint-Priest-en-Jarez, 42270, France

Location

MeSH Terms

Conditions

NeoplasmsFasting

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Study Officials

  • Pierre Fournel, MD

    Institut de Cancérologie Lucien Neuwirth

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Véronique Régnier-Denois

CONTACT

Study Design

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

Study Record Dates

First Submitted

February 11, 2019

First Posted

February 15, 2019

Study Start

February 20, 2019

Primary Completion

December 31, 2019

Study Completion

September 30, 2020

Last Updated

February 15, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will not share

Locations