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出境医 / 临床实验 / Needs Assessment of Cancer Patients With Complementary and Alternative Medicines (MAC'EVAL)

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

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
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
Layout table for study information
Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Needs Assessment of Cancer Patients With Complementary and Alternative Medicines
Actual Study Start Date : July 9, 2018
Estimated Primary Completion Date : July 9, 2020
Estimated Study Completion Date : December 1, 2020
Arms 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.
Outcome Measures
Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Prevalence of CAM used in cancer patients [ Time Frame: Time of inclusion ]
    Number of cancer patients that use CAM

  2. Number of factors influencing the consumption of CAM [ Time Frame: Time of inclusion ]
    e.g. age, sex, type of cancer, perpeptions of the CAM

  3. Number of iatrogenic risks related to CAM and chemotherapy [ Time Frame: Time of inclusion ]
    CAM used by cancer patients and their chemotherapy

  4. Number of the CAM supply sources [ Time Frame: Time of inclusion ]
    e.g community pharmacies, supermarket, internet)

  5. Number of the information sources used by patients [ Time Frame: Time of inclusion ]
    questionnaire (eg internet, health professionals, TV)

  6. 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)


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
Criteria

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

Contacts
Layout table for location contacts
Contact: Sophie RENET, PharmD., PhD + 33 1 44 12 71 91 srenet@hpsj.fr
Contact: Audrey DECOTTIGNIES, PharmD, MSc + 33 1 45 37 44 44 audrey.decottignies@aphp.fr

Locations
Layout table for location information
France
Groupe Hospitalier Paris Saint-Joseph Recruiting
Paris, France, 75014
Contact: Hélène BEAUSSIER, PhD, PharmD    0144127038    crc@hpsj.fr   
Sponsors and Collaborators
Groupe Hospitalier Paris Saint Joseph
Hopital Antoine Beclere
Tracking Information
First Submitted Date August 10, 2018
First Posted Date May 17, 2019
Last Update Posted Date August 8, 2019
Actual Study Start Date July 9, 2018
Estimated Primary Completion Date July 9, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 15, 2019) 		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
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: May 15, 2019)
  • Prevalence of CAM used in cancer patients [ Time Frame: Time of inclusion ]
    Number of cancer patients that use CAM
  • Number of factors influencing the consumption of CAM [ Time Frame: Time of inclusion ]
    e.g. age, sex, type of cancer, perpeptions of the CAM
  • Number of iatrogenic risks related to CAM and chemotherapy [ Time Frame: Time of inclusion ]
    CAM used by cancer patients and their chemotherapy
  • Number of the CAM supply sources [ Time Frame: Time of inclusion ]
    e.g community pharmacies, supermarket, internet)
  • Number of the information sources used by patients [ Time Frame: 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 Frame: Time of inclusion ]
    questionnaire (eg health professionals,roles)
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Needs Assessment of Cancer Patients With Complementary and Alternative Medicines
Official Title Needs Assessment of Cancer Patients With Complementary and Alternative Medicines
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)
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
Study Design Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition
  • Cancer
  • Chemotherapy Effect
Intervention Not Provided
Study Groups/Cohorts
  • 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.
Publications *
  • Bernstein BJ, Grasso T. Prevalence of complementary and alternative medicine use in cancer patients. Oncology (Williston Park). 2001 Oct;15(10):1267-72; discussion 1272-8, 1283.
  • Naja F, Anouti B, Shatila H, Akel R, Haibe Y, Tfayli A. Prevalence and Correlates of Complementary and Alternative Medicine Use among Patients with Lung Cancer: A Cross-Sectional Study in Beirut, Lebanon. Evid Based Complement Alternat Med. 2017;2017:8434697. doi: 10.1155/2017/8434697. Epub 2017 Aug 24.
  • Ernst E, Cassileth BR. The prevalence of complementary/alternative medicine in cancer: a systematic review. Cancer. 1998 Aug 15;83(4):777-82. Review.
  • Horneber M, Bueschel G, Dennert G, Less D, Ritter E, Zwahlen M. How many cancer patients use complementary and alternative medicine: a systematic review and metaanalysis. Integr Cancer Ther. 2012 Sep;11(3):187-203. doi: 10.1177/1534735411423920. Epub 2011 Oct 21. Review.
  • Garland SN, Valentine D, Desai K, Li S, Langer C, Evans T, Mao JJ. Complementary and alternative medicine use and benefit finding among cancer patients. J Altern Complement Med. 2013 Nov;19(11):876-81. doi: 10.1089/acm.2012.0964. Epub 2013 Jun 18.
  • Samuels N, Ben-Arye E, Maimon Y, Berger R. Unmonitored use of herbal medicine by patients with breast cancer: reframing expectations. J Cancer Res Clin Oncol. 2017 Nov;143(11):2267-2273. doi: 10.1007/s00432-017-2471-x. Epub 2017 Jun 30.
  • Ben-Arye E, Samuels N, Goldstein LH, Mutafoglu K, Omran S, Schiff E, Charalambous H, Dweikat T, Ghrayeb I, Bar-Sela G, Turker I, Hassan A, Hassan E, Saad B, Nimri O, Kebudi R, Silbermann M. Potential risks associated with traditional herbal medicine use in cancer care: A study of Middle Eastern oncology health care professionals. Cancer. 2016 Feb 15;122(4):598-610. doi: 10.1002/cncr.29796. Epub 2015 Nov 24.
  • Richardson MA, Sanders T, Palmer JL, Greisinger A, Singletary SE. Complementary/alternative medicine use in a comprehensive cancer center and the implications for oncology. J Clin Oncol. 2000 Jul;18(13):2505-14.
  • Sparber A, Bauer L, Curt G, Eisenberg D, Levin T, Parks S, Steinberg SM, Wootton J. Use of complementary medicine by adult patients participating in cancer clinical trials. Oncol Nurs Forum. 2000 May;27(4):623-30.
  • Cassileth BR, Schraub S, Robinson E, Vickers A. Alternative medicine use worldwide: the International Union Against Cancer survey. Cancer. 2001 Apr 1;91(7):1390-3.
  • Patterson RE, Neuhouser ML, Hedderson MM, Schwartz SM, Standish LJ, Bowen DJ, Marshall LM. Types of alternative medicine used by patients with breast, colon, or prostate cancer: predictors, motives, and costs. J Altern Complement Med. 2002 Aug;8(4):477-85.
  • Swisher EM, Cohn DE, Goff BA, Parham J, Herzog TJ, Rader JS, Mutch DG. Use of complementary and alternative medicine among women with gynecologic cancers. Gynecol Oncol. 2002 Mar;84(3):363-7.
  • Molassiotis A, Panteli V, Patiraki E, Ozden G, Platin N, Madsen E, Browall M, Fernandez-Ortega P, Pud D, Margulies A. Complementary and alternative medicine use in lung cancer patients in eight European countries. Complement Ther Clin Pract. 2006 Feb;12(1):34-9. Epub 2005 Nov 14.
  • Frenkel M, Cohen L. Effective communication about the use of complementary and integrative medicine in cancer care. J Altern Complement Med. 2014 Jan;20(1):12-8. doi: 10.1089/acm.2012.0533. Epub 2013 Jul 17. Review.
  • Blödt S, Mittring N, Schützler L, Fischer F, Holmberg C, Horneber M, Stapf A, Witt CM. A consultation training program for physicians for communication about complementary medicine with breast cancer patients: a prospective, multi-center, cluster-randomized, mixed-method pilot study. BMC Cancer. 2016 Nov 4;16(1):843.
  • Fong YK, Marihart S, Harik M, Djavan B. Preventing progression in men with mild symptoms of benign prostatic hyperplasia: a potential role for phytotherapy. Rev Urol. 2004 Fall;6(4):187-92.
  • Kim SW. Phytotherapy: emerging therapeutic option in urologic disease. Transl Androl Urol. 2012 Sep;1(3):181-91. doi: 10.3978/j.issn.2223-4683.2012.05.10. Review.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: May 15, 2019) 		100
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 1, 2020
Estimated Primary Completion Date July 9, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Sophie RENET, PharmD., PhD + 33 1 44 12 71 91 srenet@hpsj.fr
Contact: Audrey DECOTTIGNIES, PharmD, MSc + 33 1 45 37 44 44 audrey.decottignies@aphp.fr
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT03954509
Other Study ID Numbers MAC'EVAL
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Groupe Hospitalier Paris Saint Joseph
Study Sponsor Groupe Hospitalier Paris Saint Joseph
Collaborators Hopital Antoine Beclere
Investigators Not Provided
PRS Account Groupe Hospitalier Paris Saint Joseph
Verification Date August 2019

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