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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03954509
Other study ID # MAC'EVAL
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 9, 2018
Est. completion date April 26, 2023

Study information

Verified date April 2023
Source Groupe Hospitalier Paris Saint Joseph
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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)


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.


Recruitment information / eligibility

Status Completed
Enrollment 64
Est. completion date April 26, 2023
Est. primary completion date July 9, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
France Groupe Hospitalier Paris Saint-Joseph Paris

Sponsors (2)

Lead Sponsor Collaborator
Groupe Hospitalier Paris Saint Joseph Hopital Antoine Beclere

Country where clinical trial is conducted

France, 

References & Publications (17)

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 i — View Citation

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. — View Citation

Blodt S, Mittring N, Schutzler 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-randomiz — View Citation

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. doi: 10.1002/1097-0142(20010401)91:73.0.co;2-c. — View Citation

Ernst E, Cassileth BR. The prevalence of complementary/alternative medicine in cancer: a systematic review. Cancer. 1998 Aug 15;83(4):777-82. doi: 10.1002/(sici)1097-0142(19980815)83:43.0.co;2-o. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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 — View Citation

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. — View Citation

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 — View Citation

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;2017:8434 — View Citation

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 — View Citation

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. doi: 10.1200/JCO.2000.18.13.2505. — View Citation

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. — View Citation

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. — View Citation

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. doi: 10.1006/gyno.2001.6515. — View Citation

* Note: There are 17 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary 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. This evaluation is carried out using a semi-directed interview, then a questionnaire Time of inclusion
Secondary Prevalence of CAM used in cancer patients Number of cancer patients that use CAM Time of inclusion
Secondary Number of factors influencing the consumption of CAM e.g. age, sex, type of cancer, perpeptions of the CAM Time of inclusion
Secondary Number of iatrogenic risks related to CAM and chemotherapy CAM used by cancer patients and their chemotherapy Time of inclusion
Secondary Number of the CAM supply sources e.g community pharmacies, supermarket, internet) Time of inclusion
Secondary Number of the information sources used by patients questionnaire (eg internet, health professionals, TV) Time of inclusion
Secondary Identification of the roles of health professionals in the patient's treatment process to help secure information about CAM questionnaire (eg health professionals,roles) Time of inclusion
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