Cancer of RectumPROSPERNCT01403883
Psychological and Enterostomal Therapy Care
A study testing Optimal care (Psychological and enterostomal therapy clinics) in people with Cancer of Rectum, run by Association de Recherche Experimentale et Clinique en Chirurgie Digestive at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cancer of Rectum
- What is being tested?
- Optimal care (Psychological and enterostomal therapy clinics)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2011to Feb 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Yves PANIS, PhD, MD contact
France1 site, 1 recruiting
- Recruiting
Hôpital Beaujon
Clichy, 92110
Frederic Bretagnol, PhD-MD, frederic.bretagnol@bjn.aphp.fr
Frédéric Bretagnol, PhD-MD
About this study
Official title: Impact of Psychological and Enterostomal Therapy Care for Patient Undergoing Rectal Cancer Resection With a Temporary Stoma. Monocentric Randomized Study
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.
Read the 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.
- Conditions
- Cancer of Rectum
- Being tested
- Standard Care, Optimal care (Psychological and enterostomal therapy clinics)
- Keywords
- Rectal cancer, Temporary stoma, Psychological disorders
- Medical subject headings
- Rectal Neoplasms, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard CareBehavioural
Psychological \& enterostomal therapy clinics on demand only
Optimal care (Psychological and enterostomal therapy clinics)Behavioural
Psychological clinics at D-45, D0, D45, D60, D90 enterostomal therapy clinics at D-45, D0, D45, D60
| Study group | Role | What they receive |
|---|---|---|
| Standard care | Active comparator | standard care of patient with psychological and enterostomal therapy clinic if necessary Receives: Behavioral: Standard Care |
| Optimal care | Experimental | Optimal care of patient with systematic and repeated psychological and enterostomal therapy follow up Receives: Behavioral: Optimal care (Psychological and enterostomal therapy clinics) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evolution of Global Quality of life (SF36)
Measured: at Day45, Day0, Day45, Day60, Day90
Evolution of Psychological anxiety score (STAI/Beck)
Measured: at Day-45, Day0, Day45, Day60, Day90
Secondary outcomes (4)
Evolution of Specific stoma score and stoma care learning
Measured: at Day-45, Day0, Day45, Day60, Day90
Hospital stay
Measured: at Day90
Overall morbidity
Measured: at Day45, Day60, Day90
Specific stoma related morbidity
Measured: at Day45, Day60, Day90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2011 (estimated)
- Study startOct 2011
- Primary completionFeb 2015 (estimated)
- Study completionFeb 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer of RectumStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Association de Recherche Experimentale et Clinique en Chirurgie Digestive
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yves PANIS, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01403883
- Sponsor's protocol ID
- UK10005
- Acronym
- PROSPER
- Status last verified
- Jan 2015
- First submitted
- 30 Nov 2010
- Last updated
- 16 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Psychological and Enterostomal Therapy Care for Patient Undergoing Rectal Cancer Resection With a Temporary Stoma. Monocentric Randomized Study
- ClinicalTrials.gov ID
- NCT01403883
- Acronym / sponsor ID
- PROSPER / UK10005
- Conditions
- Cancer of Rectum
- Keywords
- Rectal cancer, Temporary stoma, Psychological disorders
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Association de Recherche Experimentale et Clinique en Chirurgie DigestiveUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Feb 2015 (estimated)
- Study completion
- Feb 2015 (estimated)
- First posted
- 27 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard care | Active comparator | Behavioral: Standard Carestandard care of patient with psychological and enterostomal therapy clinic if necessary |
| Optimal care | Experimental | Behavioral: Optimal care (Psychological and enterostomal therapy clinics)Optimal care of patient with systematic and repeated psychological and enterostomal therapy follow up |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard CarePsychological \& enterostomal therapy clinics on demand only | Behavioural | Standard care |
| Optimal care (Psychological and enterostomal therapy clinics)Psychological clinics at D-45, D0, D45, D60, D90 enterostomal therapy clinics at D-45, D0, D45, D60 | Behavioural | Optimal care |
Primary outcome
Evolution of Global Quality of life (SF36)
Time frame: at Day45, Day0, Day45, Day60, Day90
Evolution of Psychological anxiety score (STAI/Beck)
Time frame: at Day-45, Day0, Day45, Day60, Day90
4 secondary outcomes
Evolution of Specific stoma score and stoma care learning
Time frame: at Day-45, Day0, Day45, Day60, Day90
Hospital stay
Time frame: at Day90
Overall morbidity
Time frame: at Day45, Day60, Day90
Specific stoma related morbidity
Time frame: at Day45, Day60, Day90
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yves PANIS, PhD, MD contact
Yves PANIS principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Optimal care (Psychological and enterostomal therapy clinics) in people with Cancer of Rectum, run by Association de Recherche Experimentale et Clinique en Chirurgie Digestive at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yves PANIS, PhD, MD (yves.panis@bjn.aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evolution of Global Quality of life (SF36) (time frame: at Day45, Day0, Day45, Day60, Day90). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2015.