Needs Assessment of Cancer Patients With Complementary and Alternative Medicines

NCT03954509 | Completed

• 1 other identifier: MAC'EVAL
• Study Type: observational
• Target: 64
• Locations: 1 country
• Sites: 1

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)

Conditions

Cancer; Chemotherapy Effect

Keywords

Complementary and Alternative Medicines

Outcome Measures

Primary Outcomes (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.

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

  Time of inclusion

Secondary Outcomes (6)

• Prevalence of CAM used in cancer patients

  Time of inclusion

• Number of factors influencing the consumption of CAM

  Time of inclusion

• Number of iatrogenic risks related to CAM and chemotherapy

  Time of inclusion

• Number of the CAM supply sources

  Time of inclusion

• Number of the information sources used by patients

  Time of inclusion

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondation Hôpital Saint-Joseph: lead
• Hopital Antoine Beclere: collaborator

Study Sites (1)

Groupe Hospitalier Paris Saint-Joseph

Paris, 75014, France

Location

Related Publications (17)

• 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.

  PMID: 11702957 RESULT

• 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.

  PMID: 28912824 RESULT

• 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.

  PMID: 9708945 RESULT

• 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.

  PMID: 22019489 RESULT

• 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.

  PMID: 23777242 RESULT

• 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.

  PMID: 28667389 RESULT

• 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.

  PMID: 26599199 RESULT

• 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.

  PMID: 10893280 RESULT

• 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.

  PMID: 10833691 RESULT

• 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.

  PMID: 11283941 RESULT

• 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. doi: 10.1089/107555302760253676.

  PMID: 12230908 RESULT

• 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.

  PMID: 11855870 RESULT

• 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. doi: 10.1016/j.ctcp.2005.09.007. Epub 2005 Nov 14.

  PMID: 16401528 RESULT

• 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.

  PMID: 23863085 RESULT

• 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-randomized, mixed-method pilot study. BMC Cancer. 2016 Nov 4;16(1):843. doi: 10.1186/s12885-016-2884-y.

  PMID: 27809814 RESULT

• 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.

  PMID: 16985600 RESULT

• 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.

  PMID: 26816707 RESULT

MeSH Terms

Conditions

Neoplasms

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 10, 2018
• First Posted: May 17, 2019
• Study Start: July 9, 2018
• Primary Completion: July 9, 2020
• Study Completion: April 26, 2023
• Last Updated: April 27, 2023

Record last verified: 2023-04

Locations

FR (1)