Pre-operative Prehabilitation in Cancer Surgery - Objective Recovery Assessment (Popcorn)

To compare prehabilitation with physical exercise, psychological support, nutritional support and smoke/alchol stop to "standard of care" before canceer surgery.

Study Overview

• Status: Not yet recruiting
• Conditions: Cancer
• Intervention / Treatment: Other: Prehabilitation; Other: Standard care

• Study Type: Interventional
• Enrollment (Anticipated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Bergthor Björnsson, MD, PhD; Phone Number: +46703766890; Email: bergthor.bjornsson@liu.se

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

Patients, aged 18 or older, who have been evaluated as eligible for surgery for malignancy in the esophagus, rectum or liver (only metastases from colorectal cancer) will be evaluated for participation.

Exclusion Criteria:

• Surgery is scheduled in less than 12 weeks.
• Paralytic or completely immobilized patient, condition making physical training impractical.
• Cognitive disability making participation impossible.
• Not speaking or understanding the Swedish language well enough to read and understand the informed consent form.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Prehabilitation; Prehabilitation with physical exercise, psychological support, nutritional support and smoking/alchohol stop	Other: Prehabilitation; prehabilitation
Active Comparator: Standard care; Standard preoperative recomendations	Other: Standard care; No intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
6 minute walk test (6mwt)	6 minute walk test (6mwt)	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival	Overall survival	5 years
30 s chair stand test	30 s chair stand test	12 weeks
Test of hand grip strength	Test of hand grip strength	12 weeks
International Physical Activity Questionnaire	International Physical Activity Questionnaire	12 weeks
Cardiopulmonary exercise test with ventilatory gas analysis	Cardiopulmonary exercise test with ventilatory gas analysis making it possible to calculate VOmax as well as other established measures of cardiopulmonary function	12 weeks
The presence of malnutrition evaluated with the Global Leadership Initiative on Malnutrition (GLM) criteria	The presence of malnutrition evaluated with the Global Leadership Initiative on Malnutrition (GLM) criteria	12 weeks
Appetite and eating behavior is evaluated with Eating Symptom Questionnaire (ESQ)	Appetite and eating behavior is evaluated with Eating Symptom Questionnaire (ESQ)	12 weeks
Appetite and eating behavior is evaluated with Disease Related Appetite Questionnaire (DRAQ)	Appetite and eating behavior is evaluated with Disease Related Appetite Questionnaire (DRAQ)	12 weeks
4-week point prevalence of smoking abstinence (among baseline smokers)	4-week point prevalence of smoking abstinence (among baseline smokers), measured with Fagerstroms scale	12 weeks
Weekly alcohol consumption	Weekly alcohol consumption as reported in standard units	12 weeks
Episodes of heavy drinking per month	Episodes of heavy drinking per month as reported in standard units at a single occation	12 weeks
The most severe complication occurring	The most severe complication occurring (according to the Clavien-Dindo scale) until 90 days after surgery	90d after surgery
Sum of all complications in each patient (comprehensive complication index, CCI)	Sum of all complications in each patient (comprehensive complication index, CCI) occuring up to 90 days after surgery	90d after surgery
Length of hospitalization	Length of hospitalization	90d after surgery
Time to functional recovery of physical status as compared to baseline values	Defined as number of days after surgery until the patient has reached all of the following: being mobile at the preoperative level, having sufficient pain control with only oral or transdermal medication, being able to maintain food intake without intravenous fluids and not being in need of intravenous medications	90d after surgery
Clinical Frailty Scale	Clinical Frailty Scale	12 weeks
Grade of sarcopenia	Grade of sarcopenia	12 weeks
The frequency of failures to go through the full treatment program as planned at the first MDT (including, but not limited to, the full oncological chemotherapy program, radiation treatment and final surgery)	The frequency of failures to go through the full treatment program as planned at the first MDT (including, but not limited to, the full oncological chemotherapy program, radiation treatment and final surgery)	90 days
Time from surgery until the day of first dose of adjuvant chemotherapy (among liver and rectal cancer patients for whom postoperative chemotherapy is planned)	Time from surgery until the day of first dose of adjuvant chemotherapy (among liver and rectal cancer patients for whom postoperative chemotherapy is planned)	90 day after surgery
Proportion of patients not able to receive all treatment despite no dissemination of disease	Proportion of patients not able to receive all treatment despite no dissemination of disease	90 day after surgery
Quality of Life (QoL)	Quality of Life (QoL)	2 years after surgery
Incremental cost-effectiveness ratio	Incremental cost-effectiveness ratio, calculated as the median cost divided by the quality adjusted life years obtained until 2 years after surgery	2 years after surgery

Collaborators and Investigators

• Sponsor: Linkoeping University
• Investigators: Principal Investigator: Bergthor Björnsson, MD, PhD, Linköping University

Study record dates

Study Major Dates

• Study Start (Anticipated): March 1, 2022
• Primary Completion (Anticipated): December 1, 2023
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: February 16, 2022
• First Submitted That Met QC Criteria: February 26, 2022
• First Posted (Actual): March 8, 2022

Study Record Updates

• Last Update Posted (Actual): March 8, 2022
• Last Update Submitted That Met QC Criteria: February 26, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: POPCORN

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No