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

Sponsor

Groupe Hospitalier Paris Saint Joseph (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT03954509

Collaborator

Hopital Antoine Beclere (Other)

Enrollment

Location

53.7

Anticipated Duration (Months)

1.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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)

Condition or Disease	Intervention/Treatment	Phase
Cancer Chemotherapy Effect

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 Design

Study Type:

Observational

Actual Enrollment :

64 participants

Observational Model:

Other

Time Perspective:

Prospective

Official Title:

Needs Assessment of Cancer Patients With Complementary and Alternative Medicines

Actual Study Start Date :

Jul 9, 2018

Actual Primary Completion Date :

Jul 9, 2020

Anticipated Study Completion Date :

Dec 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
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: to reduce the observer's bias by considering both the literature reviews but also the points of view of patients to develop the questionnaire; 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.

Arm

Intervention/Treatment

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: to reduce the observer's bias by considering both the literature reviews but also the points of view of patients to develop the questionnaire; 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.

Outcome Measures

Primary Outcome Measures

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 of inclusion]
This evaluation is carried out using a semi-directed interview, then a questionnaire

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Groupe Hospitalier Paris Saint-Joseph	Paris		France	75014

Sponsors and Collaborators

Groupe Hospitalier Paris Saint Joseph
Hopital Antoine Beclere

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Groupe Hospitalier Paris Saint Joseph

ClinicalTrials.gov Identifier:

NCT03954509

Other Study ID Numbers:

MAC'EVAL

First Posted:

May 17, 2019

Last Update Posted:

Jan 21, 2022

Last Verified:

Jan 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Groupe Hospitalier Paris Saint Joseph

Complementary and Alternative Medicines

Study Results

No Results Posted as of Jan 21, 2022