CancerPAPRIKANCT04295668
PAPRIKA - Patients Empowerment for Major Surgery Preparation @Home
An observational study of Cancer and Surgical Procedure, Unspecified, run by Hospital Clinic of Barcelona at 1 site in Spain.
Trial summary
PAPRIKA establishes a technologically enabled and personalized prehabilitation and follow-up after surgical intervention program for patients undergoing elective major surgery Program creates close collaboration between the medical environment and the patients empowering them to co-create their own care. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cancer, Surgical Procedure, Unspecified
- What is being tested?
- Prehabilitation
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- How many people
- 300 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jan 2020to 30 Jul 2020
- How long will I take part?
- 8 Weeks
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Prospective sample of risk patients who are candidates for major surgery attended in the outpatient offices of the Hospital Clínic de Barcelona.
Who may be able to join
- Age > 70 years old and/or American Society of Anesthesiologist (ASA) index 3-4 and/or highly aggressive surgery or solid organ transplantation.
Who cannot join
- Non-elective surgery; metastatic disease.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Clínic de Barcelona
Barcelona, Catalonia, 08036
Anael Barberan-Garcia, PhD, +34 932775540, anaelbg@gmail.com
About this study
PAPRIKA establishes a technologically enabled and personalized prehabilitation and follow-up after surgical intervention program for patients undergoing elective major surgery Program creates close collaboration between the medical environment and the patients empowering them to co-create their own care.
It is at the first stage aimed to high-risk patients undergoing major surgery. Better condition before the surgery is proved to reduce the perioperative complications and to improve patients' health-related quality of life while cutting the associated costs. The concept integrates short-term (average 4 weeks) preoperative interventions including endurance training, promotion of physical activity and nutritional and psychological support. Interventions are planned both at community and at hospital reducing unnecessary interactions between patients and tertiary care.
PAPRIKA tackles three major drivers: i) human perspective ii) organizational challenges and iii) technical aspects. The project is based on previous experience on prehabilitation and the already refined service using design thinking methodologies. It will be also based on the proven reduction of associated costs for the healthcare system.
- Conditions
- Cancer, Surgical Procedure, Unspecified
- Being tested
- Usual care, Prehabilitation
- Keywords
- Prehabilitation, Exercise training, Physical activity, Nutrition, Cognitive behavioural therapy, Smoking cessation, eHealth
- Medical subject headings
- Neoplasms, Motor Activity, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Usual careBehavioural
The preoperative standard measures consist of physical activity recommendation and advice on both smoking cessation and alcohol intake reduction. Moreover, in patients presenting with anemia, the anesthesiologists will assess its etiology and treat it accordingly, and nutritional intervention will be performed by a registered dietitian in to those patients at risk of malnutrition (Malnutrition Universal Screening Tool ≥2).
PrehabilitationBehavioural
- Exercise training: Ambulatory exercise training sessions with two main components, namely: high-intensity endurance exercise training and strength muscular training. ii) Promotion of physical activity: Pedometer-based program using a physical activity tracker linked to a mobile app. iv) Nutritional optimization: Recommendations of a healthy balanced diet or adapted to their digestive symptoms. Daily amount of protein intake will be close to 2 g•Kg-1•day-1. iv) Smoking cessation: Use of both cognitive behavioral intervention and pharmacological therapy by varenicline or nicotine replacement therapies.
- Cognitive behavioral therapy: Weekly group sessions conducted by a clinical health psychologist, including psychoeducation, motivational and behavioral change, self-efficacy and adherence enhancement, coping strategies acquisition and patient empowerment.
| Study group | Role | What they receive |
|---|---|---|
| Usual care | A contemporaneous control group of patients was build using propensity score matching (PSM) methodologies taking into account the following matching variables: type of surgery, age, sex, American Society of Anesthesiologists Index (ASA) and adjusted morbidity groups (GMA) grading. Receives: Behavioral: Usual care | |
| Prehabilitation | Prospective sample of risk patients who are candidates for major surgery attended in the outpatient offices of the Hospital Clínic de Barcelona.
Inclusion criteria: i) American Society of Anesthesiologists Index (ASA) 3-4; and / or, ii) age ≥ 75 years; and / or iii) major aggressive surgery; and, iv) solid organ transplant candidate.
Exclusion criteria: i) Non-elective surgery; ii) Known metastatic disease before surgery; iii) Unstable respiratory or heart disease; or, iv) Locomotive or cognitive limitations that prevent adherence to the program. Receives: Behavioral: Prehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative complications
Number of postoperative complications during the initial hospitalization for surgery
Measured: Duration of the initial hospitalization for surgery
Hospital length of stay
Number of days of hospital length of stay during the initial hospitalization for surgery
Measured: Duration of the initial hospitalization for surgery
Severity of postoperative complications
Severity of postoperative complications during the initial hospitalization for surgery using the Clavien-Dindo classification
Measured: Duration of the initial hospitalization for surgery
Secondary outcomes (4)
Hospital readmissions at 30 days
Number of postoperative complications during a 30-day period after surgery
Measured: From initial hospital discharge to 30 days follow-up
Emergency room visits at 30 days
Number of emergency room visits during a 30-day period after surgery
Measured: From initial hospital discharge to 30 days follow-up
Surgical reinterventions at 30 days
Number of surgical reinterventions during a 30-day period after surgery
Measured: From initial hospital discharge to 30 days follow-up
Mortality at 30 days
Number of exitus during a 30-day period after surgery
Measured: From initial hospital discharge to 30 days follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2020
- Study start1 Jan 2020
- Primary completion30 Jun 2020 (estimated)
- Study completion30 Jul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Hospital Clinic of BarcelonaThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
- Target duration
- 8 Weeks
Sponsor and investigators
- Lead sponsor
- Hospital Clinic of Barcelona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anael Barberan-Garcia, Hospital Clinic of Barcelona
- Investigators
- Josep Roca, Prof, Study director, Hospital Clinic of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04295668
- Sponsor's protocol ID
- HCB/2019/1030
- Acronym
- PAPRIKA
- Status last verified
- Mar 2020
- First submitted
- 27 Feb 2020
- Last updated
- 4 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PAPRIKA - Patients Empowerment for Major Surgery Preparation @Home
- ClinicalTrials.gov ID
- NCT04295668
- Acronym / sponsor ID
- PAPRIKA / HCB/2019/1030
- Conditions
- Cancer, Surgical Procedure, Unspecified
- Keywords
- Prehabilitation, Exercise training, Physical activity, Nutrition, Cognitive behavioural therapy, Smoking cessation, eHealth
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Hospital Clinic of BarcelonaUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 30 Jun 2020 (estimated)
- Study completion
- 30 Jul 2020 (estimated)
- First posted
- 4 Mar 2020 (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.
PAPRIKA establishes a technologically enabled and personalized prehabilitation and follow-up after surgical intervention program for patients undergoing elective major surgery Program creates close collaboration between the medical environment and the patients empowering them to co-create their own care.
It is at the first stage aimed to high-risk patients undergoing major surgery. Better condition before the surgery is proved to reduce the perioperative complications and to improve patients' health-related quality of life while cutting the associated costs. The concept integrates short-term (average 4 weeks) preoperative interventions including endurance training, promotion of physical activity and nutritional and psychological support. Interventions are planned both at community and at hospital reducing unnecessary interactions between patients and tertiary care.
PAPRIKA tackles three major drivers: i) human perspective ii) organizational challenges and iii) technical aspects. The project is based on previous experience on prehabilitation and the already refined service using design thinking methodologies. It will be also based on the proven reduction of associated costs for the healthcare system.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 8 Weeks
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual care | – | Behavioral: Usual careA contemporaneous control group of patients was build using propensity score matching (PSM) methodologies taking into account the following matching variables: type of surgery, age, sex, American Society of Anesthesiologists Index (ASA) and adjusted morbidity groups (GMA) grading. |
| Prehabilitation | – | Behavioral: PrehabilitationProspective sample of risk patients who are candidates for major surgery attended in the outpatient offices of the Hospital Clínic de Barcelona. Inclusion criteria: i) American Society of Anesthesiologists Index (ASA) 3-4; and / or, ii) age ≥ 75 years; and / or iii) major aggressive surgery; and, iv) solid organ transplant candidate. Exclusion criteria: i) Non-elective surgery; ii) Known metastatic disease before surgery; iii) Unstable respiratory or heart disease; or, iv) Locomotive or cognitive limitations that prevent adherence to the program. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Prospective sample of risk patients who are candidates for major surgery attended in the outpatient offices of the Hospital Clínic de Barcelona.
Key inclusion criteria (1 listed)
- Age > 70 years old and/or American Society of Anesthesiologist (ASA) index 3-4 and/or highly aggressive surgery or solid organ transplantation.
Key exclusion criteria (1 listed)
- Non-elective surgery; metastatic disease.
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 |
|---|---|---|
| Usual careThe preoperative standard measures consist of physical activity recommendation and advice on both smoking cessation and alcohol intake reduction. Moreover, in patients presenting with anemia, the anesthesiologists will assess its etiology and treat it accordingly, and nutritional intervention will be performed by a registered dietitian in to those patients at risk of malnutrition (Malnutrition Universal Screening Tool ≥2). | Behavioural | Usual care |
| Prehabilitationi) Exercise training: Ambulatory exercise training sessions with two main components, namely: high-intensity endurance exercise training and strength muscular training. ii) Promotion of physical activity: Pedometer-based program using a physical activity tracker linked to a mobile app. iv) Nutritional optimization: Recommendations of a healthy balanced diet or adapted to their digestive symptoms. Daily amount of protein intake will be close to 2 g•Kg-1•day-1. iv) Smoking cessation: Use of both cognitive behavioral intervention and pharmacological therapy by varenicline or nicotine replacement therapies. v) Cognitive behavioral therapy: Weekly group sessions conducted by a clinical health psychologist, including psychoeducation, motivational and behavioral change, self-efficacy and adherence enhancement, coping strategies acquisition and patient empowerment. | Behavioural | Prehabilitation |
Primary outcome
Postoperative complications
Time frame: Duration of the initial hospitalization for surgery
Number of postoperative complications during the initial hospitalization for surgery
Hospital length of stay
Time frame: Duration of the initial hospitalization for surgery
Number of days of hospital length of stay during the initial hospitalization for surgery
Severity of postoperative complications
Time frame: Duration of the initial hospitalization for surgery
Severity of postoperative complications during the initial hospitalization for surgery using the Clavien-Dindo classification
4 secondary outcomes
Hospital readmissions at 30 days
Time frame: From initial hospital discharge to 30 days follow-up
Emergency room visits at 30 days
Time frame: From initial hospital discharge to 30 days follow-up
Surgical reinterventions at 30 days
Time frame: From initial hospital discharge to 30 days follow-up
Mortality at 30 days
Time frame: From initial hospital discharge to 30 days follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2020.
- Individual participant dataSharing planned: Undecided
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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.
Josep Roca, Prof study director
Hospital Clinic of Barcelona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer and Surgical Procedure, Unspecified, run by Hospital Clinic of Barcelona at 1 site in Spain.
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 1 inclusion and 1 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 4 Mar 2020. 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 Spain. 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 Anael Barberan-Garcia, PhD (+34 932775540, anaelbg@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative complications (time frame: Duration of the initial hospitalization for surgery). The study lists 3 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 4 Mar 2020.