Colo-rectal CancerPIGEONNCT05851235
Prehabilitation in Geriatric Patients With Colorectal Neoplasia
A study testing Prehabilitation course in people with Colo-rectal Cancer, run by Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS at 1 site in Italy.
Trial summary
This an interventional, non-pharmacologic study. Prehabilitation is a multidisciplinary preoperative intervention aimed at preventing or reducing functional decline related to surgery and improving perioperative outcomes. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Colo-rectal Cancer
- What is being tested?
- Prehabilitation course
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteItaly
- Study dates
- 22 Mar 2023to Mar 2024
- 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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- The participant (or legally acceptable representative if applicable) provides written informed consent for the trial.
- Male/female participants who are at least 70 years of age on the day of signing informed consent.
- Patients with confirmed diagnosis of colorectal cancer awaiting major surgery.
Who cannot join
- Clinical need for emergency intervention.
- Severe cognitive impairment (MMSE<20*)
- Severe dependency (ADL<3)
- Stage IV colorectal neoplasia
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
AUSL della Romagna
Ravenna, RA, 48100
Isacco Montroni, MD, isacco.montroni@auslromagna.it
About this study
Official title: Results of a Programme of Intensive Prehabilitation in GEriatric Patients Operated for Colo-Rectal Neoplasia
This an interventional, non-pharmacologic study. Prehabilitation is a multidisciplinary preoperative intervention aimed at preventing or reducing functional decline related to surgery and improving perioperative outcomes. The current study is aimed at standardizing a prehabilitation pathway, evaluating its feasibility within the AUSL Romagna in collaboration with the PRIME Centre and the multiple professions that populate the two institutes in the spirit of confirming the beneficial effect of an integrated prehabilitation programme on surgical outcomes.
Patients will follow an intensive prehabilitation course before surgery:
Read more
- Colon cancer patients will do 4 weeks of prehabilitation before surgery.
- Rectal cancer patients will do 12 weeks of prehabilitation after neoadjuvant therapy and before surgery.
The prehabilitation course is structured around the following aspects:
- Frailty assessment and identification of optimisation fields
- Optimisation of modifiable factors (anaemia, polypharmacotherapy, smoking, alcoholism, diabetes)
- Assessment by an integrative medicine specialist
- Nutritional pre-qualification
- Cardiovascular, respiratory, motor prehabilitation
- Emotional and psychological prehabilitation
- Conditions
- Colo-rectal Cancer
- Being tested
- Prehabilitation course
- Keywords
- Prehabilitation
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prehabilitation courseOther
During prehabilitation course, patients will follow a nutritional programme, a cardiovascular and motor programme and a psychological programme.
| Study group | Role | What they receive |
|---|---|---|
| Colorectal cancer patients | Experimental | Patients with colon or rectal cancer awaiting surgery Receives: Other: Prehabilitation course |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of eligible participants completed the personalized proposed prehabilitation program
The primary endpoint of the study will be the feasibility of delivering a prehabilitation program, based on adherence. This study will be deemed as feasible if ≥80% of eligible participants completed the personalized proposed prehabilitation program.
Measured: 4 months
Secondary outcomes (6)
Adherence to prescription
Percentage of patients with compliance greater than 80% to prehabilitation prescription
Measured: 4 months
30-days mortality
Proportion of patients who died for all causes within 30 days after the surgery
Measured: 30 days after the surgery
Overall morbidity rate and major morbidity rate
Calculated according Clavien-Dindo classification
Measured: 4 months
Preservation/improvement of pre-operative quality of life before vs. 1-month after surgery
Questionnaire EQ-5D-3L. Test results are presented in the form of an index and a VAS scale. The index is based on patients' quality of life in 5 domains across 3 levels. Distribution of EQ-5D-3L dimension responses at different times were calculated. The index, which is a value attached to an EQ-5D-3L profile according to a set of weights that reflect, on average, people's preferences about how good or bad the state is, ranges from 0 (poorest quality of life) to 1 (perfect health). The value set generated from the European population (EQ) was used as the reference cohort for index calculation.
The VAS score is generated by asking the patient how he/she ranked his/her QoL, as compared to his/her peers, on a scale from 0 to 100, where higher values were associated to a better quality of life. EQ-5D-3L index and VAS were expressed as mean (Standard Deviation-SD) and median (minimum-maximum), while frequency will be calculated for categorical variables (five domains of EQ-5D-3L).
Measured: 30 days after the surgery
Preservation/improvement of pre-operative quality of life before vs. 1-month after surgery.
Questionnaire EORTC QLQ-ELD14, a questionnaire that comprise five scales (mobility, worries about others, future worries, maintaining purpose and burden of illness) and two single items (joint stiffness and family support). Four levels were available for the response (1=not at all, 2=a little, 3=quite a bit, 4=very much). Distribution of EORTC QLQ-ELD14 items at different times were calculated. All scale and item scores are transformed to a 0-100 scale, higher scores representing a worse outcome except for maintaining purpose and family support.
EORTC QLQ-ELD14 scores were expressed as mean (Standard Deviation-SD) and median (minimum-maximum), while frequency will be calculated for categorical variables (for the five scales and two single items).
Measured: 30 days after the surgery
Postoperative functional recovery at one month after surgery
Percentage of patients experiences functional recovery as described in protocol.
Measured: 30 days after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2023
- Study start22 Mar 2023
- Primary completionSep 2023 (estimated)
- Study completionMar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colo-rectal CancerStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS
- Sponsor type
- University, hospital or other
- Collaborators
- Istituto Oncologico Romagnolo (IOR)
- Responsible party
- Sponsor
- Investigators
- Isacco Montroni, MD, Study chair, AUSL della Romagna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05851235
- Sponsor's protocol ID
- IRST153.08
- Acronym
- PIGEON
- Status last verified
- Mar 2023
- First submitted
- 22 Mar 2023
- Last updated
- 9 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Results of a Programme of Intensive Prehabilitation in GEriatric Patients Operated for Colo-Rectal Neoplasia
- ClinicalTrials.gov ID
- NCT05851235
- Acronym / sponsor ID
- PIGEON / IRST153.08
- Conditions
- Colo-rectal Cancer
- Keywords
- Prehabilitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCSUniversity, hospital or other
- Collaborators
- Istituto Oncologico Romagnolo (IOR)
- Study start
- 22 Mar 2023 (actual)
- Primary completion
- Sep 2023 (estimated)
- Study completion
- Mar 2024 (estimated)
- First posted
- 9 May 2023 (actual)
- 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.
This an interventional, non-pharmacologic study. Prehabilitation is a multidisciplinary preoperative intervention aimed at preventing or reducing functional decline related to surgery and improving perioperative outcomes. The current study is aimed at standardizing a prehabilitation pathway, evaluating its feasibility within the AUSL Romagna in collaboration with the PRIME Centre and the multiple professions that populate the two institutes in the spirit of confirming the beneficial effect of an integrated prehabilitation programme on surgical outcomes.
Patients will follow an intensive prehabilitation course before surgery:
- Colon cancer patients will do 4 weeks of prehabilitation before surgery.
- Rectal cancer patients will do 12 weeks of prehabilitation after neoadjuvant therapy and before surgery.
The prehabilitation course is structured around the following aspects:
- Frailty assessment and identification of optimisation fields
- Optimisation of modifiable factors (anaemia, polypharmacotherapy, smoking, alcoholism, diabetes)
- Assessment by an integrative medicine specialist
- Nutritional pre-qualification
- Cardiovascular, respiratory, motor prehabilitation
- Emotional and psychological prehabilitation
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Colorectal cancer patients | Experimental | Other: Prehabilitation coursePatients with colon or rectal cancer awaiting surgery |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- The participant (or legally acceptable representative if applicable) provides written informed consent for the trial.
- Male/female participants who are at least 70 years of age on the day of signing informed consent.
- Patients with confirmed diagnosis of colorectal cancer awaiting major surgery.
Key exclusion criteria (4 listed)
- Clinical need for emergency intervention.
- Severe cognitive impairment (MMSE<20*)
- Severe dependency (ADL<3)
- Stage IV colorectal neoplasia
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 |
|---|---|---|
| Prehabilitation courseDuring prehabilitation course, patients will follow a nutritional programme, a cardiovascular and motor programme and a psychological programme. | Other | Colorectal cancer patients |
Primary outcome
Percentage of eligible participants completed the personalized proposed prehabilitation program
Time frame: 4 months
The primary endpoint of the study will be the feasibility of delivering a prehabilitation program, based on adherence. This study will be deemed as feasible if ≥80% of eligible participants completed the personalized proposed prehabilitation program.
6 secondary outcomes
Adherence to prescription
Time frame: 4 months
30-days mortality
Time frame: 30 days after the surgery
Overall morbidity rate and major morbidity rate
Time frame: 4 months
Preservation/improvement of pre-operative quality of life before vs. 1-month after surgery
Time frame: 30 days after the surgery
Preservation/improvement of pre-operative quality of life before vs. 1-month after surgery.
Time frame: 30 days after the surgery
Postoperative functional recovery at one month after surgery
Time frame: 30 days after the surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2023.
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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.
Isacco Montroni, MD study chair
AUSL della Romagna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prehabilitation course in people with Colo-rectal Cancer, run by Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS at 1 site in Italy.
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 3 inclusion and 4 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 9 May 2023. 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 Italy. 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 Isacco Montroni, MD (0544 285111, isacco.montroni@auslromagna.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of eligible participants completed the personalized proposed prehabilitation program (time frame: 4 months). 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 9 May 2023.