Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201908916815403 Date of Approval: 14/08/2019
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title The impact of pre-operative education on post-operative outcomes in patients with colorectal cancer in Johannesburg, South Africa
Official scientific title The impact of pre-operative education on post-operative outcomes in patients with colorectal cancer in Johannesburg, South Africa
Brief summary describing the background and objectives of the trial The incidence of colorectal cancer has increased over the last few decades. Worldwide, colorectal cancer is the third most common type of cancer and is a major cause of mortality and morbidity (Wahid et al., 2017). In South Africa, colorectal cancer is the fourth most prevalent type of cancer in males and females (Brand, Gaylard & Ramos, 2018). Objectives 1. To describe the demographic, clinical and physical activity profiles of patients who had surgery for colorectal cancer. 2. To determine the factors that influenced post-operative hospital length of stay, complications that developed post-operatively and survival outcomes at hospital discharge for these patients. 3. To review the available evidence related to physiotherapy pre-operative education interventions for patients undergoing abdominal surgery due to colorectal cancer. 4. To develop and validate a formalised physiotherapy pre-operative education tool for patients undergoing abdominal surgery due to colorectal cancer. 5. To test the effect of a formalised physiotherapy pre-operative education tool on the postoperative outcomes of patients undergoing abdominal surgery for colorectal cancer.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Cancer
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Education /Training
Anticipated trial start date 01/01/2020
Actual trial start date
Anticipated date of last follow up 30/06/2021
Actual Last follow-up date
Anticipated target sample size (number of participants) 126
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
M181075 University of the Witwatersrand Human Research Ethics Committee
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Stratified allocation where factors such as age, gender, center, or previous treatment are used in the stratification Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Control group Once pre-operatively not applicable No intervention 42 Uncontrolled
Experimental Group Intervention group one Once pre-operatively Approximately 10 minutes Intervention group one will receive a pre-operative physiotherapy intervention consisting of an introduction by the physiotherapist as well as the developed and content validated education handout. No further verbal information will be given to the patients and they will be advised to read the handout in their own time prior to their surgery. 42
Experimental Group Intervention group two Once pre-operatively Approximately 30 minutes Intervention group two will receive a pre-operative physiotherapy intervention consisting of an introduction by the physiotherapist as well as the developed and content validated education handout mentioned above. These patients will also receive a 30 minute one-on-one education session where the physiotherapist will explain the contents of the handout and field any questions that the patient may have. 42
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
All adult patients (classified as 18 years or older) at WDGMC admitted with colorectal cancer through the colorectal unit, who underwent open or laparoscopic surgery. Patients who are independently mobile with or without an assistive device . Patients who have undergone complete laparoscopic surgery. Patients unable to undergo exercise testing as a result of cardiac or physical impairments. 80 and over: 80+ Year,Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 100 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 26/10/2018 University of the Witwatersrand Human Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
7 York Road, School of Therapeutic Sciences, University of the Witwatersrand Johannesburg 2193 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Hospital length of stay Hospital discharge
Primary Outcome Post-operative complications Hospital discharge
Primary Outcome ICU length of stay ICU discharge
Primary Outcome Survival Hospital discharge
Secondary Outcome Physical performance and functional capacity Pre-operatively, ICU discharge, hospital discharge
Secondary Outcome Exercise tolerance Pre-operatively, hospital discharge
Secondary Outcome Physical function ICU discharge, hospital discharge
Secondary Outcome Muscle strength Pre-operatively, ICU discharge, hospital discharge
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Wits University Donald Gordon Medical Centre 21 Eton Road, Parktown Johannesburg South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
South African Society of Physiotherapy Unit 4, Parade on Kloof Offices, Bedfordview Germiston 2007 South Africa
Faculty Research Committee University of the Witwatersrand 7 York Road, Parktown Johannesburg 2193 South Africa
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor University of the Witwatersrand 7 York Road, Parktown Johannesburg 2193 South Africa University
COLLABORATORS
Name Street address City Postal code Country
Heleen van Aswegen School of Therapeutic Sciences, University of the Witwatersrand, 7 York Road, Parktown Johannesburg 2193 South Africa
Ronel Roos School of Therapeutic Sciences, University of the Witwatersrand, 7 York Road, Parktown Johannesburg 2193 South Africa
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Megan Whelan meganwhelanphysio@gmail.com 0714822036 71 Glen Avenue, Highway Gardens
City Postal code Country Position/Affiliation
Edenvale 1609 South Africa Postgraduate physiotherapy student
Role Name Email Phone Street address
Public Enquiries Megan Whelan meganwhelanphysio@gmail.com 0714822036 71 Glen Avenue, Highway Gardens
City Postal code Country Position/Affiliation
Edenvale 1609 South Africa postgraduate physiotherapy student
Role Name Email Phone Street address
Scientific Enquiries Megan Whelan meganwhelanphysio@gmail.com 0714822036 71 Glen Avenue, Highway Gardens
City Postal code Country Position/Affiliation
Edenvale 1609 South Africa postgraduate physiotherapy student
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes In adherence to WHO requirements related to individual participant data (IPD) sharing, summary results or a link to summary results will be made available within the trial registration record. This will be done within 12 months of the study completion date Informed Consent Form,Statistical Analysis Plan,Study Protocol This will be done within 12 months of the study completion date Access to the summary results will be open
URL Results Available Results Summary Result Posting Date First Journal Publication Date
To be created once data collection for the RCT has commenced No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information