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Impact of Patient's Therapeutic Education in APA and Dietetic on Radiotherapy Reproducibility Sessions for Prostate Cancer (ETADAPT)

Primary Purpose

Prostate Cancer

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Adapted Physical Activity and Dietetic
conventional management
Sponsored by
Centre Leon Berard
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Prostate Cancer

Eligibility Criteria

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

Inclusion Criteria:

I1: Age >= 18 years old.

I2: Patient with prostatic adenocarcinoma with indication for first-line or post-operative radiotherapy (adjuvant or biologic recurrence).

I3: Patient able to practice a physical activity (certificate of aptitude for adapted physical activity).

I4: Life expectancy greater than 6 months.

I5: Absence of chronic inflammatory intestinal disease or intestinal surgery.

I6: Signed informed consent.

I7: Patient covered by a medical insurance.

I8. At least 20 sessions of radiotherapy planned

Exclusion Criteria:

E1: Patient does not understand and cannot read French.

E2: Patient followed for a psychiatric pathology or presenting cognitive disorders.

E3: Inability to comply with study follow-up goegraphical, social or psychological reasons.

E4: Patient requiring tutorship or curatorship or patient deprived of liberty.

E5: Participation to another clinical trial which may interfere with principal Endpoint assessment.

Sites / Locations

  • Chu de saint etienne
  • Groupe Hospitalier Mutualiste de Grenoble Institut Daniel HOLLARDRecruiting
  • Centre Hospitalier Lyon Sud
  • Centre Eugène MarquisRecruiting
  • Institut de Cancérologie de l'Ouest René Gauducheau

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Patient Therapeutics Education (PTE)

Conventional support

Arm Description

Educational diagnosis prior radiotherapy and participation to Patient Therapeutics Education (PTE) in Adapted Physical Activity (APA) and dietetic sessions. In addition to conventional support (dietary and hydration advice).

Dietary and hydration advices

Outcomes

Primary Outcome Measures

Evaluate the impact of Patient's Therapeutic Education in APA on the reduction of interventions number on rectum
Number of uninstallation during the radiotherapy session

Secondary Outcome Measures

Evaluate the contribution of Patient's Therapeutic Education on patient's repositionning efficiency
Rate of patients never uninstalled compared to patients uninstalled during prostate's radiotherapy
Evaluate the contribution of Patient's Therapeutic Education on the gastrointestinal toxicity
Acute gastrointestinal toxicity ≥ grade 2 (NCI- CTCAE V5)
Evaluate the contribution of Patient's Therapeutic Education on the use of laxative or transit regulating treatment or techniques
Prescribed laxatives or transit regulation treatments or techniques
Evaluate the contribution of Patient's Therapeutic Education on patients' quality of life
Using European Organisation for Research and Treatment of Cancer - Core Quality of life questionnaire (QLQC30) (Evaluation of patient's quality of life during the last 7 days - From 4 [worse reply] to 1 [better reply])
Evaluate the contribution of Patient's Therapeutic Education on the undernutrition
Collection of patients' weight (kg)
Evaluate the contribution of Patient's Therapeutic Education on the food intake
Collection of patients' weight (kg)
Evaluate the contribution of Patient's Therapeutic Education on the undernutrition
Using Socio Economic Factor Index scale (SEFI) (Scale from 10 [I ate my entire meal] to 0 [I did not eat anything])
Evaluate the contribution of Patient's Therapeutic Education on the food intake
Using Socio Economic Factor Index scale (SEFI) (Scale from 10 [I ate my entire meal] to 0 [I did not eat anything])
Evaluate the contribution of Patient's Therapeutic Education on the undernutrition
Using the "Eating and hydration habits questionnaire"
Evaluate the contribution of Patient's Therapeutic Education on the food intake
Using the "Eating and hydration habits questionnaire"
Evaluate the contribution of Patient's Therapeutic Education on the evolution in eating habits
Using the "Eating and hydration habits questionnaire"
Evaluate the contribution of Patient's Therapeutic Education on the evolution in hydratation habits
Using the "Eating and hydration habits questionnaire"
Evaluate the contribution of Patient's Therapeutic Education on the evolution in APA habits
Using International Physical Activity Questionnaire (IPAQ) (Description of the physical activity during the last 7 days)
Evaluate patient's satisfaction with Patient's Therapeutic Education program (experimental arm)
Using satisfaction questionnaire (scale from 1 [worse evaluation] to 4 [better evaluation])
Evaluate the compliance to APA session recommendations
Daily collection of steps numbers
Evaluate the compliance to APA session recommendations
Evaluation during phone calls every 15 days
Evaluate the number of patients requiring additional dietetic session
Evaluation during phone calls every 15 days
Evaluate the number of patients requiring additional APA session
Evaluation during phone calls every 15 days

Full Information

First Posted
March 11, 2021
Last Updated
August 30, 2023
Sponsor
Centre Leon Berard
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1. Study Identification

Unique Protocol Identification Number
NCT04832113
Brief Title
Impact of Patient's Therapeutic Education in APA and Dietetic on Radiotherapy Reproducibility Sessions for Prostate Cancer
Acronym
ETADAPT
Official Title
ETADAPT- Evaluation of the Impact of Patient's Therapeutic Education (PTE) in Adapted Physical Activity (APA) and Dietetic on the Reproducibility of Radiotherapy Sessions for Prostate Cancers.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 21, 2021 (Actual)
Primary Completion Date
October 2024 (Anticipated)
Study Completion Date
April 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Leon Berard

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The primary objective of this study is to evaluate the impact of Patient's Therapeutic Education (PTE) in Adapted Physical Activity (APA) ans dietetic on the reduction of interventions number on rectal volume (laxative or probe). The secondary objectives are to evaluate the contribution of Patient's Therapeutic Education (PTE) between the 2 arms on repositionnind during the radiotherapy session, the gastrointestinal toxicity, the need to use laxative or transit regulating treatment or techniques, the quality of life, the undernutrition and food intake, the evolution in eating/hydratation and physical habits. For the experimetal arm, the satisfaction and the compliance with PTE program will be evaluated, as well as the need of additionnal use of dietary and APA consultations.
Detailed Description
Prostate cancer is the 3rd cause of cancer mortality in patient aged over 50 years. Radiotherapy treatment plans require specific conditions: Reproductibility of patient's positioning (requiring management of bladder and rectal fillings at each session). An image-guided treatment consisting in acquiring an image before each session. This pre-treatment Imaging allows the optimal adjustment of the target volume and organs at risk (bladder and rectum). To allow reproductibility of target volume positioning at each radiotherapy session, it's recommended to have an empty rectum at the time of the radiotherapy preparation scan, and to check repletion before each session. It's recommended that the patient has a comfortably full bladder to limit the volume of irradiated bladder mucosa. The radiotherapy teams don't have any recommendations concerning the rectum and manage this problem session by session, according to the repositioning Imaging of the current day. According to a pilot study carried out in 2017 in the radiotherapy department of the Léon Bérard center, an intervention for a dilated rectum (probe or laxative) was necessary for an average of 25% of session per patient. These rectal problems can be partly explained by the age (60-80 years) and sedentary lifestyle of patients with prostate cancer. Physical activities, adapted hydratation and changes in eating habits are an integral part of the constipation and flatulence prevention.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
216 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patient Therapeutics Education (PTE)
Arm Type
Experimental
Arm Description
Educational diagnosis prior radiotherapy and participation to Patient Therapeutics Education (PTE) in Adapted Physical Activity (APA) and dietetic sessions. In addition to conventional support (dietary and hydration advice).
Arm Title
Conventional support
Arm Type
Other
Arm Description
Dietary and hydration advices
Intervention Type
Other
Intervention Name(s)
Adapted Physical Activity and Dietetic
Other Intervention Name(s)
Follow-up of Adapted Physical Activity and Dietetic Hydratation
Intervention Description
session in addtion conventional management dietetic, hydratation and physical activity
Intervention Type
Other
Intervention Name(s)
conventional management
Other Intervention Name(s)
conventional management dietary and hydratation
Intervention Description
Dietary and hydratation advices according to the recommendations
Primary Outcome Measure Information:
Title
Evaluate the impact of Patient's Therapeutic Education in APA on the reduction of interventions number on rectum
Description
Number of uninstallation during the radiotherapy session
Time Frame
An average of 4 months
Secondary Outcome Measure Information:
Title
Evaluate the contribution of Patient's Therapeutic Education on patient's repositionning efficiency
Description
Rate of patients never uninstalled compared to patients uninstalled during prostate's radiotherapy
Time Frame
An average of 4 months
Title
Evaluate the contribution of Patient's Therapeutic Education on the gastrointestinal toxicity
Description
Acute gastrointestinal toxicity ≥ grade 2 (NCI- CTCAE V5)
Time Frame
An average of 4 months
Title
Evaluate the contribution of Patient's Therapeutic Education on the use of laxative or transit regulating treatment or techniques
Description
Prescribed laxatives or transit regulation treatments or techniques
Time Frame
An average of 4 months
Title
Evaluate the contribution of Patient's Therapeutic Education on patients' quality of life
Description
Using European Organisation for Research and Treatment of Cancer - Core Quality of life questionnaire (QLQC30) (Evaluation of patient's quality of life during the last 7 days - From 4 [worse reply] to 1 [better reply])
Time Frame
An average of 4 months
Title
Evaluate the contribution of Patient's Therapeutic Education on the undernutrition
Description
Collection of patients' weight (kg)
Time Frame
An average of 4 months
Title
Evaluate the contribution of Patient's Therapeutic Education on the food intake
Description
Collection of patients' weight (kg)
Time Frame
An average of 4 months
Title
Evaluate the contribution of Patient's Therapeutic Education on the undernutrition
Description
Using Socio Economic Factor Index scale (SEFI) (Scale from 10 [I ate my entire meal] to 0 [I did not eat anything])
Time Frame
An average of 4 months
Title
Evaluate the contribution of Patient's Therapeutic Education on the food intake
Description
Using Socio Economic Factor Index scale (SEFI) (Scale from 10 [I ate my entire meal] to 0 [I did not eat anything])
Time Frame
An average of 4 months
Title
Evaluate the contribution of Patient's Therapeutic Education on the undernutrition
Description
Using the "Eating and hydration habits questionnaire"
Time Frame
An average of 4 months
Title
Evaluate the contribution of Patient's Therapeutic Education on the food intake
Description
Using the "Eating and hydration habits questionnaire"
Time Frame
An average of 4 months
Title
Evaluate the contribution of Patient's Therapeutic Education on the evolution in eating habits
Description
Using the "Eating and hydration habits questionnaire"
Time Frame
An average of 4 months
Title
Evaluate the contribution of Patient's Therapeutic Education on the evolution in hydratation habits
Description
Using the "Eating and hydration habits questionnaire"
Time Frame
An average of 4 months
Title
Evaluate the contribution of Patient's Therapeutic Education on the evolution in APA habits
Description
Using International Physical Activity Questionnaire (IPAQ) (Description of the physical activity during the last 7 days)
Time Frame
An average of 4 months
Title
Evaluate patient's satisfaction with Patient's Therapeutic Education program (experimental arm)
Description
Using satisfaction questionnaire (scale from 1 [worse evaluation] to 4 [better evaluation])
Time Frame
An average of 4 months
Title
Evaluate the compliance to APA session recommendations
Description
Daily collection of steps numbers
Time Frame
An average of 4 months
Title
Evaluate the compliance to APA session recommendations
Description
Evaluation during phone calls every 15 days
Time Frame
An average of 4 months
Title
Evaluate the number of patients requiring additional dietetic session
Description
Evaluation during phone calls every 15 days
Time Frame
An average of 4 months
Title
Evaluate the number of patients requiring additional APA session
Description
Evaluation during phone calls every 15 days
Time Frame
An average of 4 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: I1: Age >= 18 years old. I2: Patient with prostatic adenocarcinoma with indication for first-line or post-operative radiotherapy (adjuvant or biologic recurrence). I3: Patient able to practice a physical activity (certificate of aptitude for adapted physical activity). I4: Life expectancy greater than 6 months. I5: Absence of chronic inflammatory intestinal disease or intestinal surgery. I6: Signed informed consent. I7: Patient covered by a medical insurance. I8. At least 20 sessions of radiotherapy planned Exclusion Criteria: E1: Patient does not understand and cannot read French. E2: Patient followed for a psychiatric pathology or presenting cognitive disorders. E3: Inability to comply with study follow-up goegraphical, social or psychological reasons. E4: Patient requiring tutorship or curatorship or patient deprived of liberty. E5: Participation to another clinical trial which may interfere with principal Endpoint assessment.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Séverine METZGER
Phone
+33478782786
Email
severine.metzger@lyon.unicancer.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Pascale Roux
Phone
+33478787200
Email
pascale.roux@lyon.unicancer.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pascale Roux
Organizational Affiliation
Centre Leon Berard
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chu de saint etienne
City
Saint-Étienne
State/Province
Rhône-Alpes Auvergne
ZIP/Postal Code
42000
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thomas REYNAUD, MD
Email
Thomas.Reynaud@chu-st-etienne.fr
Facility Name
Groupe Hospitalier Mutualiste de Grenoble Institut Daniel HOLLARD
City
Grenoble
ZIP/Postal Code
38028
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Olivia DIAZ, MD
Email
o-diaz@ghm-grenoble.fr
Facility Name
Centre Hospitalier Lyon Sud
City
Pierre-Bénite
ZIP/Postal Code
69495
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Samy HORN, MD
Email
samy.horn@chu-lyon.fr
Facility Name
Centre Eugène Marquis
City
Rennes
ZIP/Postal Code
35042
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Manon BATY, MD
Email
m.baty@rennes.unicancer.fr
Facility Name
Institut de Cancérologie de l'Ouest René Gauducheau
City
Saint-Herblain
ZIP/Postal Code
44805
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stéphane SUPIOT, MD
Email
stephane.supiot@ico.unicancer.fr

12. IPD Sharing Statement

Learn more about this trial

Impact of Patient's Therapeutic Education in APA and Dietetic on Radiotherapy Reproducibility Sessions for Prostate Cancer

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