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Psychological and Enterostomal Therapy Care (PROSPER)

Primary Purpose

Cancer of Rectum

Status

Unknown status

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Standard Care

Optimal care (Psychological and enterostomal therapy clinics)

About this trial

This is an interventional prevention trial for Cancer of Rectum focused on measuring Rectal cancer, Temporary stoma, Psychological disorders

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age > 18 y
Rectal adenocarcinoma (tumor height < 15 cm from the anal verge) with or without pre operative radiochemotherapy.
Open or laparoscopic rectal excision with partial or total meso rectal excision with sphincter preservation by colo rectal or colo anal anastomosis.
Temporary stoma.
Patient consent
Patient with national health affiliation

Exclusion Criteria:

Stage IV disease with synchronous hepatic or pulmonary metastases
Colonic cancer > 16 cm
Associated surgical procedure (Hepatic resection, small bowel resection subtotal colectomy)
Abdominal perineal resection
Associated comorbidity
Emergency surgery
Psychological care refusal

Sites / Locations

Hôpital BeaujonRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard care

Optimal care

Arm Description

standard care of patient with psychological and enterostomal therapy clinic if necessary

Optimal care of patient with systematic and repeated psychological and enterostomal therapy follow up

Outcomes

Primary Outcome Measures

Evolution of Global Quality of life (SF36)

Evolution of Psychological anxiety score (STAI/Beck)

Secondary Outcome Measures

Evolution of Specific stoma score and stoma care learning

Hospital stay

Overall morbidity

Specific stoma related morbidity

Full Information

NCT ID

NCT01403883

First Posted

November 30, 2010

Last Updated

January 15, 2015

Sponsor

Association de Recherche Experimentale et Clinique en Chirurgie Digestive

1. Study Identification

Unique Protocol Identification Number

NCT01403883

Brief Title

Psychological and Enterostomal Therapy Care

Acronym

PROSPER

Official Title

Impact of Psychological and Enterostomal Therapy Care for Patient Undergoing Rectal Cancer Resection With a Temporary Stoma. Monocentric Randomized Study

Study Type

Interventional

2. Study Status

Record Verification Date

January 2015

Overall Recruitment Status

Unknown status

Study Start Date

October 2011 (undefined)

Primary Completion Date

February 2015 (Anticipated)

Study Completion Date

February 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Association de Recherche Experimentale et Clinique en Chirurgie Digestive

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

In case of rectal cancer surgery, temporary stoma is recommended to decrease the risk of postoperative anastomotic leakage. The aim of the study was to assess the benefit of an optimal care, i.e., both psychological and enterostomal therapy care.

Detailed Description

The aim of the study is to asses the benefit of an optimal and specific care concerning the temporary stoma in patients operated for rectal cancer surgery in term of psychological and enterostomal therapy effect. This study is a monocentric and randomized trial.

6. Conditions and Keywords

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

Cancer of Rectum

Keywords

Rectal cancer, Temporary stoma, Psychological disorders

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Standard care

Arm Type

Active Comparator

Arm Description

standard care of patient with psychological and enterostomal therapy clinic if necessary

Arm Title

Optimal care

Arm Type

Experimental

Arm Description

Optimal care of patient with systematic and repeated psychological and enterostomal therapy follow up

Intervention Type

Behavioral

Intervention Name(s)

Standard Care

Intervention Description

Psychological & enterostomal therapy clinics on demand only

Intervention Type

Behavioral

Intervention Name(s)

Optimal care (Psychological and enterostomal therapy clinics)

Intervention Description

Psychological clinics at D-45, D0, D45, D60, D90 enterostomal therapy clinics at D-45, D0, D45, D60

Primary Outcome Measure Information:

Title

Evolution of Global Quality of life (SF36)

Time Frame

at Day45, Day0, Day45, Day60, Day90

Title

Evolution of Psychological anxiety score (STAI/Beck)

Time Frame

at Day-45, Day0, Day45, Day60, Day90

Secondary Outcome Measure Information:

Title

Evolution of Specific stoma score and stoma care learning

Time Frame

at Day-45, Day0, Day45, Day60, Day90

Title

Hospital stay

Time Frame

at Day90

Title

Overall morbidity

Time Frame

at Day45, Day60, Day90

Title

Specific stoma related morbidity

Time Frame

at Day45, Day60, Day90

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age > 18 y Rectal adenocarcinoma (tumor height < 15 cm from the anal verge) with or without pre operative radiochemotherapy. Open or laparoscopic rectal excision with partial or total meso rectal excision with sphincter preservation by colo rectal or colo anal anastomosis. Temporary stoma. Patient consent Patient with national health affiliation Exclusion Criteria: Stage IV disease with synchronous hepatic or pulmonary metastases Colonic cancer > 16 cm Associated surgical procedure (Hepatic resection, small bowel resection subtotal colectomy) Abdominal perineal resection Associated comorbidity Emergency surgery Psychological care refusal

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Yves PANIS, PhD, MD

yves.panis@bjn.aphp.fr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yves PANIS

Organizational Affiliation

Assistance Publique - Hôpitaux de Paris

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hôpital Beaujon

City

Clichy

ZIP/Postal Code

92110

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Frederic Bretagnol, PhD-MD

frederic.bretagnol@bjn.aphp.fr

First Name & Middle Initial & Last Name & Degree

Frédéric Bretagnol, PhD-MD

12. IPD Sharing Statement

Learn more about this trial

Psychological and Enterostomal Therapy Care

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