Clinical trial NCT02460549: Feasibility Study of an Intervention Therapeutic Education for Patients Treated With Androgen Deprivation
Official title: Feasibility Study of an Intervention Therapeutic Education for Patients Treated With Androgen Deprivation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Keywords: therapeutic patient education
insulinoresistance
empowerment
prostate cancer
oral endocrine therapy
side effects
Lead sponsor: Institut de Cancérologie de la Loire
Sponsor class: OTHER
First posted: 2015-06-02
Enrollment: 9
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of the study is to build and assess the feasibility of a therapeutic education program, constructed in collaboration with the urologists of the University Hospital of Saint Etienne. The aim of this therapeutic education program is to delay the onset or to reduce the amplitude of the development of insulin resistance and side effects of androgen deprivation therapy in patients treated with androgen deprivation in the context of an evolutive prostate cancer.


Eligibility criteria: Inclusion Criteria:

* Patients supported in consultation Urology at the University Hospital North Saint Etienne.
* Aged over 18 years
* Having an evolutive prostate cancer
* Patient treated with LHRH agonist for at least 6 months - Affiliated with the national health insurance system
* And having completed the worksheet informed consent to participate in the program.

Exclusion Criteria:

* Refusal of participation, protected or under guardianship patients.
* Patients unable to understand the study or unable to follow the educational sessions.
* Patient (s) with documented cognitive or psychiatric history.
* Geographical remotness (more than 100 Kms.)

Primary outcomes:
measure: Number of patients who refused to participate
timeFrame: 6 months
Secondary outcomes:
measure: Number of patients in all sessions
timeFrame: 6 months
measure: Number of withdrawals
timeFrame: 6 months
Other outcomes:
Locations:
city: Saint-Etienne
country: France
facility: CHU Saint-Etienne
city: Saint-Priest-en-Jarez
country: France
facility: Institut de Cancérologie de la Loire
Study officials:
affiliation: CHU SAINT-ETIENNE
name: Jean-Etienne Terrier, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bolla M, de Reijke TM, Van Tienhoven G, Van den Bergh AC, Oddens J, Poortmans PM, Gez E, Kil P, Akdas A, Soete G, Kariakine O, van der Steen-Banasik EM, Musat E, Pierart M, Mauer ME, Collette L; EORTC Radiation Oncology Group and Genito-Urinary Tract Cancer Group. Duration of androgen suppression in the treatment of prostate cancer. N Engl J Med. 2009 Jun 11;360(24):2516-27. doi: 10.1056/NEJMoa0810095.
citation: Golant M, Altman T, Martin C. Managing cancer side effects to improve quality of life: a cancer psychoeducation program. Cancer Nurs. 2003 Feb;26(1):37-44; quiz 45-6. doi: 10.1097/00002820-200302000-00005.
citation: Diefenbach MA, Butz BP. A multimedia interactive education system for prostate cancer patients: development and preliminary evaluation. J Med Internet Res. 2004 Jan 21;6(1):e3. doi: 10.2196/jmir.6.1.e3.
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citation: Rebillard X, Grosclaude P, Lebret T, Patard JJ, Pfister C, Richaud P, Rigaud J, Salomon L, Soulie M. [Projected incidence and mortality from urologic cancer in France in 2010.]. Prog Urol. 2010 Nov;20 Suppl 4:S211-4. doi: 10.1016/S1166-7087(10)70041-5. No abstract available. French.
citation: Crook JM, O'Callaghan CJ, Duncan G, Dearnaley DP, Higano CS, Horwitz EM, Frymire E, Malone S, Chin J, Nabid A, Warde P, Corbett T, Angyalfi S, Goldenberg SL, Gospodarowicz MK, Saad F, Logue JP, Hall E, Schellhammer PF, Ding K, Klotz L. Intermittent androgen suppression for rising PSA level after radiotherapy. N Engl J Med. 2012 Sep 6;367(10):895-903. doi: 10.1056/NEJMoa1201546.
citation: Alibhai SM, Gogov S, Allibhai Z. Long-term side effects of androgen deprivation therapy in men with non-metastatic prostate cancer: a systematic literature review. Crit Rev Oncol Hematol. 2006 Dec;60(3):201-15. doi: 10.1016/j.critrevonc.2006.06.006. Epub 2006 Jul 24.
citation: Hoffmann P, Schulman C. Complications of androgen-deprivation therapy in prostate cancer: the other side of the coin. BJU Int. 2009 Apr;103(8):1020-3. doi: 10.1111/j.1464-410x.2008.08293.x. No abstract available.
citation: Taylor LG, Canfield SE, Du XL. Review of major adverse effects of androgen-deprivation therapy in men with prostate cancer. Cancer. 2009 Jun 1;115(11):2388-99. doi: 10.1002/cncr.24283.
citation: Shahinian VB, Kuo YF, Freeman JL, Goodwin JS. Risk of fracture after androgen deprivation for prostate cancer. N Engl J Med. 2005 Jan 13;352(2):154-64. doi: 10.1056/NEJMoa041943.
citation: Herr HW, O'Sullivan M. Quality of life of asymptomatic men with nonmetastatic prostate cancer on androgen deprivation therapy. J Urol. 2000 Jun;163(6):1743-6.
citation: Keating NL, O'Malley AJ, Smith MR. Diabetes and cardiovascular disease during androgen deprivation therapy for prostate cancer. J Clin Oncol. 2006 Sep 20;24(27):4448-56. doi: 10.1200/JCO.2006.06.2497.
citation: Saigal CS, Gore JL, Krupski TL, Hanley J, Schonlau M, Litwin MS; Urologic Diseases in America Project. Androgen deprivation therapy increases cardiovascular morbidity in men with prostate cancer. Cancer. 2007 Oct 1;110(7):1493-500. doi: 10.1002/cncr.22933.
citation: Tsai HK, D'Amico AV, Sadetsky N, Chen MH, Carroll PR. Androgen deprivation therapy for localized prostate cancer and the risk of cardiovascular mortality. J Natl Cancer Inst. 2007 Oct 17;99(20):1516-24. doi: 10.1093/jnci/djm168. Epub 2007 Oct 9.
citation: D'Amico AV, Denham JW, Crook J, Chen MH, Goldhaber SZ, Lamb DS, Joseph D, Tai KH, Malone S, Ludgate C, Steigler A, Kantoff PW. Influence of androgen suppression therapy for prostate cancer on the frequency and timing of fatal myocardial infarctions. J Clin Oncol. 2007 Jun 10;25(17):2420-5. doi: 10.1200/JCO.2006.09.3369.