Needs Assessment of Cancer Patients With Complementary and Alternative Medicines (MAC'EVAL)

April 26, 2023 updated by: Groupe Hospitalier Paris Saint Joseph
The chronic cancer status, multidisciplinary and ambulatory care, as well as the cumbersome effects of the disease and treatments, lead patients to consider other options than those offered by traditional medicine, such as alternative medicine and complementary (CAM)

Study Overview

Status

Completed

Conditions

Detailed Description

In order to put in place a policy on CAM based on the knowledge held by the patient and the health professionals, it is imperative to obtain and analyze the following information: why this type of medicine is used, what are its benefits, how does the patient get information and what are his sources, who practices them and how the patient perceives the place of the hospital and the various health professionals to develop and secure the use of CAM.

Our study will focus on CAM that can bring iatrogenic risk (phytotherapy, food supplements, acupuncture, traditional Chinese medicine, homeopathy, essential oils), and the following techniques: hypnosis and sophrology.

The study is carried out in two successive phases: the interview phase which will make it possible to obtain results to carry out the questionnaires phase. Patients who will be included in the interview phase will not participate in the questionnaire phase. Finally, patients who participate in the questionnaire phase will not have semi-structured interviews. They will only have to answer the questionnaire.

Study Type

Observational

Enrollment (Actual)

64

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75014
        • Groupe Hospitalier Paris Saint-Joseph

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The study is carried out in two successive phases: the interview phase which will make it possible to obtain results to carry out the questionnaires phase. Patients who will be included in the interview phase will not participate in the questionnaire phase. Finally, patients who participate in the questionnaire phase will not have semi-structured interviews. They will only have to answer the questionnaire.

Description

Inclusion Criteria:

  • Woman and man over 18
  • Francophone (speaking and reading French)
  • Patient followed for the management of cancer, hospitalized or not, receiving or having already received a treatment cancer administered orally and / or systemically.

Exclusion Criteria:

  • Patient who has not been treated for cancer with anticancer treatment
  • Support in a palliative care service
  • Refusal to participate in the study
  • Patient under tutorship or curatorship
  • Patient deprived of liberty

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
semi-structured interview

Screening and inclusion of patients hospitalized or seen in day hospital to conduct semi-structured interviews according to the interview grid. This interview schedule was established after review of the literature and identification of primary and secondary objectives.

  • Identification of key ideas through content analysis of the interviews conducted and based of the anchored theory.
  • This step is performed until the results are saturated (approximately 15 patients). The principle of saturation is based on the fact that from a threshold, the diversity of the elements collected decreases. Much more than an end signal, this principle is "a methodological guarantee" since it allows the possibility of comparing divergent or contradictory data and thus validating the data.
questionnaires

  • From the previous results: elaboration of a written questionnaire built according to the results obtained thanks to the previous interviews. In order to apply the simple correspondence factor analysis method, this questionnaire will be constructed on a Likert scale. The objective is twofold:

    1. to reduce the observer's bias by considering both the literature reviews but also the points of view of patients to develop the questionnaire;
    2. reach a larger patient population (more than 100 patients) compared to the previous qualitative analysis (15 patients planned), in order to generalize the results. This methodology combines both qualitative and quantitative study to minimize bias induced by both types of study.
  • Dissemination of the questionnaire and filling by the patient independently. The health professional who submitted the questionnaire will remain available to answer any questions the patient may have.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of the perception of patients regarding complementary and alternative medicines (CAM) in the management of cancer or its complications but also the place of different health professionals.
Time Frame: Time of inclusion
This evaluation is carried out using a semi-directed interview, then a questionnaire
Time of inclusion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence of CAM used in cancer patients
Time Frame: Time of inclusion
Number of cancer patients that use CAM
Time of inclusion
Number of factors influencing the consumption of CAM
Time Frame: Time of inclusion
e.g. age, sex, type of cancer, perpeptions of the CAM
Time of inclusion
Number of iatrogenic risks related to CAM and chemotherapy
Time Frame: Time of inclusion
CAM used by cancer patients and their chemotherapy
Time of inclusion
Number of the CAM supply sources
Time Frame: Time of inclusion
e.g community pharmacies, supermarket, internet)
Time of inclusion
Number of the information sources used by patients
Time Frame: Time of inclusion
questionnaire (eg internet, health professionals, TV)
Time of inclusion
Identification of the roles of health professionals in the patient's treatment process to help secure information about CAM
Time Frame: Time of inclusion
questionnaire (eg health professionals,roles)
Time of inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Groupe Hospitalier Paris Saint Joseph

Collaborators

Hopital Antoine Beclere

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 9, 2018

Primary Completion (Actual)

July 9, 2020

Study Completion (Actual)

April 26, 2023

Study Registration Dates

First Submitted

August 10, 2018

First Submitted That Met QC Criteria

May 15, 2019

First Posted (Actual)

May 17, 2019

Study Record Updates

Last Update Posted (Actual)

April 27, 2023

Last Update Submitted That Met QC Criteria

April 26, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • MAC'EVAL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cancer

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Algeria

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe