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

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
therapeutic education program
Sponsored by
Institut de Cancérologie de la Loire
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Prostate Cancer focused on measuring therapeutic patient education, insulinoresistance, empowerment, prostate cancer, oral endocrine therapy, side effects

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.)

Sites / Locations

  • CHU Saint-Etienne
  • Institut de Cancérologie de la Loire

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

therapeutic education program

Arm Description

patients attend three sessions of therapeutic education

Outcomes

Primary Outcome Measures

Number of patients who refused to participate

Secondary Outcome Measures

Number of patients in all sessions
Number of withdrawals

Full Information

First Posted
April 15, 2014
Last Updated
June 1, 2015
Sponsor
Institut de Cancérologie de la Loire
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1. Study Identification

Unique Protocol Identification Number
NCT02460549
Brief Title
Feasibility Study of an Intervention Therapeutic Education for Patients Treated With Androgen Deprivation
Acronym
Nutriprophy
Official Title
Feasibility Study of an Intervention Therapeutic Education for Patients Treated With Androgen Deprivation
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
April 2014 (undefined)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
November 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut de Cancérologie de la Loire

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
therapeutic patient education, insulinoresistance, empowerment, prostate cancer, oral endocrine therapy, side effects

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Arm Title
therapeutic education program
Arm Type
Experimental
Arm Description
patients attend three sessions of therapeutic education
Intervention Type
Behavioral
Intervention Name(s)
therapeutic education program
Primary Outcome Measure Information:
Title
Number of patients who refused to participate
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Number of patients in all sessions
Time Frame
6 months
Title
Number of withdrawals
Time Frame
6 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Etienne Terrier, MD
Organizational Affiliation
CHU Saint-Etienne
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Saint-Etienne
City
Saint-Etienne
ZIP/Postal Code
42055
Country
France
Facility Name
Institut de Cancérologie de la Loire
City
Saint-Priest-en-Jarez
ZIP/Postal Code
42270
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
19516032
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.
Results Reference
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PubMed Identifier
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Citation
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Results Reference
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PubMed Identifier
15111269
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.
Results Reference
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PubMed Identifier
17371769
Citation
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Results Reference
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PubMed Identifier
21129643
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.
Results Reference
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PubMed Identifier
22931259
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.
Results Reference
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PubMed Identifier
16860998
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.
Results Reference
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PubMed Identifier
19348058
Citation
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Results Reference
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PubMed Identifier
19399748
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.
Results Reference
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PubMed Identifier
15647578
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.
Results Reference
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PubMed Identifier
10799173
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.
Results Reference
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PubMed Identifier
16983113
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.
Results Reference
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PubMed Identifier
17657815
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.
Results Reference
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PubMed Identifier
17925537
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.
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PubMed Identifier
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Citation
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Results Reference
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Feasibility Study of an Intervention Therapeutic Education for Patients Treated With Androgen Deprivation

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