Feasibility Study of an Intervention Therapeutic Education for Patients Treated With Androgen Deprivation

Prostate Cancer Clinical Trial

— Nutriprophy  

Official title:

Feasibility Study of an Intervention Therapeutic Education for Patients Treated With Androgen Deprivation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02460549
• Other study ID #: 2014-04
• Secondary ID: 2013-A01169-36
• Status: Completed
• Phase: N/A
• First received: April 15, 2014
• Last updated: June 1, 2015
• Start date: April 2014
• Est. completion date: November 2014

Study information

• Verified date: May 2015
• Source: Institut de Cancérologie de la Loire
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.)

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Behavioral:
• therapeutic education program

Locations

Country	Name	City	State
France	CHU Saint-Etienne	Saint-Etienne
France	Institut de Cancérologie de la Loire	Saint-Priest-en-Jarez

Sponsors (1)

Lead Sponsor	Collaborator
Institut de Cancérologie de la Loire

Country where clinical trial is conducted

France, 

References & Publications (15)

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. Epub 2006 Jul 24. Review. — View 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, Piérart 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. — View 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. Erratum in: N Engl J Med. 2012 Dec 6;367(23):2262. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Pérol D, Toutenu P, Lefranc A, Régnier V, Chvetzoff G, Saltel P, Chauvin F. [Therapeutic education in oncology: involving patient in the management of cancer]. Bull Cancer. 2007 Mar;94(3):267-74. Review. French. — View Citation

Rébillard X, Grosclaude P, Lebret T, Patard JJ, Pfister C, Richaud P, Rigaud J, Salomon L, Soulié 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. French. — View 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. — View 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. — View 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. Review. — View 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. Epub 2007 Oct 9. — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients who refused to participate		6 months	No
Secondary	Number of patients in all sessions		6 months	No
Secondary	Number of withdrawals		6 months	No