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

NCT02460549 | Completed

• 2 other identifiers: 2014-042013-A01169-36
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 2

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.

Conditions

Prostate Cancer

Keywords

therapeutic patient education; insulinoresistance; empowerment; prostate cancer; oral endocrine therapy; side effects

Outcome Measures

Primary Outcomes (1)

• Number of patients who refused to participate

  6 months

Secondary Outcomes (2)

• Number of patients in all sessions

  6 months

• Number of withdrawals

  6 months

Study Arms (1)

therapeutic education program

EXPERIMENTAL

patients attend three sessions of therapeutic education

Behavioral: therapeutic education program

Interventions

therapeutic education program BEHAVIORAL

therapeutic education program

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Institut de Cancérologie de la Loire: lead

Study Sites (2)

CHU Saint-Etienne

Saint-Etienne, 42055, France

Location

Institut de Cancérologie de la Loire

Saint-Priest-en-Jarez, 42270, France

Location

Related Publications (15)

• 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.

  PMID: 19516032 BACKGROUND

• 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.

  PMID: 12556711 BACKGROUND

• 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.

  PMID: 15111269 BACKGROUND

• Perol D, Toutenu P, Lefranc A, Regnier 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. French.

  PMID: 17371769 BACKGROUND

• 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.

  PMID: 21129643 BACKGROUND

• 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.

  PMID: 22931259 BACKGROUND

• 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.

  PMID: 16860998 BACKGROUND

• 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.

  PMID: 19348058 BACKGROUND

• 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.

  PMID: 19399748 BACKGROUND

• 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.

  PMID: 15647578 BACKGROUND

• 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.

  PMID: 10799173 BACKGROUND

• 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.

  PMID: 16983113 BACKGROUND

• 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.

  PMID: 17657815 BACKGROUND

• 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.

  PMID: 17925537 BACKGROUND

• 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.

  PMID: 17557956 BACKGROUND

MeSH Terms

Conditions

Prostatic Neoplasms; Empowerment

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Social Behavior; Behavior

Study Officials

• Jean-Etienne Terrier, MD

  CHU SAINT-ETIENNE

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2014
• First Posted: June 2, 2015
• Study Start: April 1, 2014
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: June 2, 2015

Record last verified: 2015-05

Locations

FR (2)