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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03840213
Other study ID # 2019-0101SP
Secondary ID 2019-A00093-54
Status Not yet recruiting
Phase
First received
Last updated
Start date February 20, 2019
Est. completion date September 30, 2020

Study information

Verified date February 2019
Source Institut de Cancérologie de la Loire
Contact Pierre Fournel, MD
Phone 04 77 91 70 00
Email pierre.fournel@icloire.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Description:

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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 200
Est. completion date September 30, 2020
Est. primary completion date December 31, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- 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:

Exclusion Criteria:

- 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

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Filling a questionnaire and interviewDescription
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.

Locations

Country Name City State
France Institut de Cancérologie Lucien Neuwirth Saint-Priest-en-Jarez

Sponsors (2)

Lead Sponsor Collaborator
Institut de Cancérologie de la Loire Ligue contre le cancer, France

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of patients who voluntarily changed their eating habits Number of patients who voluntarily changed their eating habits will be reported 1 year
Secondary Number of patients on therapeutic fasting or restrictive diet during chemotherapy treatment Number of patients on therapeutic fasting or restrictive diet during chemotherapy treatment will be reported 1 year
Secondary Number of patients using complementary or alternative medicines Number of patients using complementary or alternative medicines will be reported 1 year
Secondary Number of patients discussing these different practices with their oncologist Number of patients discussing these different practices with their oncologist will be reported 1 year
Secondary Number of patients discussing these different practices with other caregivers Number of patients discussing these different practices with other caregivers will be reported 1 year
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