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Trial registered on ANZCTR


Registration number
ACTRN12614000580673
Ethics application status
Approved
Date submitted
22/05/2014
Date registered
30/05/2014
Date last updated
23/04/2021
Date data sharing statement initially provided
23/11/2018
Date results information initially provided
23/11/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
An allied health rehabilitation program for patients following surgery
for abdomino-pelvic cancer: a feasibility and pilot clinical study
Scientific title
An allied health rehabilitation program for patients following surgery
for abdomino-pelvic cancer: a feasibility and pilot clinical study
Secondary ID [1] 284617 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Colorectal cancer 291924 0
Gynaecological cancer 295034 0
Prostate cancer 295035 0
Condition category
Condition code
Cancer 292277 292277 0 0
Bowel - Back passage (rectum) or large bowel (colon)
Physical Medicine / Rehabilitation 292278 292278 0 0
Other physical medicine / rehabilitation
Cancer 295293 295293 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The general rehabilitation program will consist of a multidisciplinary education and exercise program, which will be provided as group sessions twice weekly for 8 weeks. The education component will include 1-hour nutritional advice and management provided by a dietitian; 1-hour exercise education regarding the importance of exercise to well-being, bladder and bowel advice, and adherence to exercise provided by a physiotherapist; 1-hour fatigue management and return to work strategies provided by an occupational therapist; and 5-hours health behavior change and self-management strategies provided by a psychologist. The exercise component will consist of a moderate intensity (Borg Rating of Perceived Exertion (RPE) Scale 12-14), physiotherapist-supervised, combined aerobic and resistance training program. The exercise program will be individualized based on the results from baseline outcome measures. Participants will be required to attend an one hour education session per week and an one hour exercise session per week over the 8-week intervention period. The home-based walking program requires participants to perform daily walking with duration and intensity individually prescribed based on the results of baseline walking tests. To encourage adherence to the home-based walking program, 6 telephone motivational coaching sessions (1 to 2 calls per month) will be provided from a physiotherapist, between data collection time-points 2 (immediately post-intervention) and 3 (6 months following baseline) . Daily feedback for participants regarding distance and number of steps taken will be encouraged with a simple pedometer.
Intervention code [1] 289395 0
Rehabilitation
Comparator / control treatment
Questionnaire only. Participants in this quasi-control group will complete a postal questionnaire at the start of the study and at 8 weeks, 6 months, 1 year, 2 years and 5 years following the start of the study.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 292140 0
Functional capacity as assessed using the six-minute walk test
Timepoint [1] 292140 0
At baseline, immediately post-intervention, and at 6 months following baseline
Primary outcome [2] 292141 0
Feasibility as assessed by the recruitment rate, adherence, withdrawals, and adverse events. There are minimal risks associated with the rehabilitation and measurement tests. Participants may feel some general muscle discomfort after exercise, which is a normal response to exercise.
Timepoint [2] 292141 0
At baseline, immediately post-intervention, and at 6, 12, 24, and 60 months following baseline
Secondary outcome [1] 308275 0
Adherence to physical activity as assessed using the International Physical Activity Questionnaire
Timepoint [1] 308275 0
At baseline, immediately post-intervention, and at 6, 12, 24, and 60 months following baseline
Secondary outcome [2] 308276 0
General muscle strength as assessed using a hand-held dynamometer
Timepoint [2] 308276 0
At baseline, immediately post-intervention, and at 6 months following baseline
Secondary outcome [3] 308277 0
Psychological distress as assessed using the Hospital Anxiety and Depression Scale
Timepoint [3] 308277 0
At baseline, immediately post-intervention, and at 6, 12, 24, and 60 months following baseline
Secondary outcome [4] 308278 0
Health-related quality of life as assessed using the European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire (EORTC QLQ-C30) and the EORTC disease-specific health-related quality of life questionnaires (i.e. endometrial cancer module [QLQ-EN24], cervical cancer module [QLQ-CX24], ovarian cancer module [QLQ-OV28], and prostate cancer module [QLQ-PR25])
Timepoint [4] 308278 0
At baseline, immediately post-intervention, and at 6, 12, 24, and 60 months following baseline
Secondary outcome [5] 308279 0
Self-efficacy as assessed using the Physical Exercise Self-Efficacy (PESE) and Nutrition Self-Efficacy (NSE) subscales of the Health-Specific Self-Efficacy Scale
Timepoint [5] 308279 0
At baseline, immediately post-intervention, and at 6, 12, 24, and 60 months following baseline
Secondary outcome [6] 308280 0
Global response change score as assessed using the Global Rating of Change
Timepoint [6] 308280 0
Immediately post-intervention, and at 6, 12, 24, and 60 months following baseline
Secondary outcome [7] 308281 0
Overall survival as assessed by data linkage to medical records
Timepoint [7] 308281 0
At one year, two years, and five years after baseline
Secondary outcome [8] 308282 0
Pelvic floor symptoms as assessed using the Australian Pelvic Floor Questionnaire, the International Consultation on Incontinence Questionnaire Urinary Incontinence short form module, and the International Consultation on Incontinence Questionnaire Bowel module
Timepoint [8] 308282 0
At baseline, immediately post-intervention, and at 6, 12, 24, and 60 months following baseline

Eligibility
Key inclusion criteria
Patients who have undergone surgery for histologically confirmed, stage I-III pelvic cancer;; have completed all medical treatment; have an Eastern Cooperative Oncology Group performance status of between 0-2 (0 = fully active, 2 = up and about for 50% of a day); and have sufficient English language skills to participate
Minimum age
18 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients who are pregnant or up to 12 months postpartum, have a permanent ostomy, have severe physical/psychiatric impairments, presence of other malignancies or have received post-operative supervised exercise or rehabilitation similar to the programs in this study in the preceding 6 months

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Changes to each measure across time (baseline, post-intervention, and 6-month, 12-month, 24-month, and 60-month after baseline) will be assessed with repeated measures analysis of variance (ANOVA) comparing different assessment time-points. All analyses will be tested with a significance level of p<0.05 using the intention to treat principle. The sample size calculation for the pre-post study is based on the results from a previous study. The mean (standard deviation) difference in the 6-MWT distance before and after intervention is 37meters +/- 70meters. Sixty participants will be needed to reject the null hypothesis with a power of 0.8 and alpha 0.05 (two tailed). Allowing for 30% attrition, a total of 80 participants will be recruited.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
2/06/2014
Actual
2/07/2014
Date of last participant enrolment
Anticipated
Actual
28/09/2016
Date of last data collection
Anticipated
28/09/2021
Actual
Sample size
Target
80
Accrual to date
Final
83
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 289242 0
Hospital
Name [1] 289242 0
Cabrini Health
Country [1] 289242 0
Australia
Primary sponsor type
Hospital
Name
Cabrini Health
Address
Cabrini Institute
154 Wattletree Road
Malvern Victoria 3144
Country
Australia
Secondary sponsor category [1] 287916 0
University
Name [1] 287916 0
The University of Melbourne
Address [1] 287916 0
Physiotherapy
Melbourne School of Health Sciences
The University of Melbourne
Alan Gilbert Building
161 Barry Street, Carlton
Victoria 3053
AUSTRALIA
Country [1] 287916 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294825 0
Cabrini Human Research Ethics Committee
Ethics committee address [1] 294825 0
154 Wattletree Road, Malvern VIC 3144
Ethics committee country [1] 294825 0
Australia
Date submitted for ethics approval [1] 294825 0
16/09/2013
Approval date [1] 294825 0
13/11/2013
Ethics approval number [1] 294825 0
07-16-09-13

Summary
Brief summary
The purpose of this study is to see if general exercise and education are helpful for patients who have had pelvic cancer (colorectal cancer, gynaecological cancer, or urological cancer).

Who is it for?
Patients may be eligible to join this study if they are aged 18 - 85 years, have undergone surgery for stage I – III pelvic cancer, and are able to walk and manage self-care, out of bed more than 50% of waking hours (Eastern Cooperative Oncology Group performance status 0 – 2).

Trial details
All eligible patients will be invited to join the general exercise and education group 6 weeks after all their surgical and medical treatments are finished. The general multidisciplinary rehabilitation will consist of a group education and exercise program, which will be provided twice weekly for 8 weeks. Each session will last approximately one hour. The education component will include advice about nutrition, exercise, fatigue management, health behavior change, and coping with stress. Information will be delivered by a range of clinicians (physiotherapists, occupational therapists, psychologists, and dieticians). The exercise component will include a general (combined aerobic and resistance) exercise training program supervised by a physiotherapist. All participants will be required to complete some questionnaires and tests (e.g. six-minute walk test, shuttle walk test etc) at the end of the intervention, and at 6, 12, 24 and 60 months from baseline.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 48486 0
A/Prof Helena Frawley
Address 48486 0
Cabrini Institute
154 Wattletree Road
Malvern Victoria 3144
Country 48486 0
Australia
Phone 48486 0
+61418584813
Fax 48486 0
Email 48486 0
helena.frawley@monash.edu
Contact person for public queries
Name 48487 0
Helena Frawley
Address 48487 0
Cabrini Institute
154 Wattletree Road
Malvern Victoria 3144
Country 48487 0
Australia
Phone 48487 0
+61418584813
Fax 48487 0
Email 48487 0
helena.frawley@monash.edu
Contact person for scientific queries
Name 48488 0
Helena Frawley
Address 48488 0
Cabrini Institute
154 Wattletree Road
Malvern Victoria 3144
Country 48488 0
Australia
Phone 48488 0
+61418584813
Fax 48488 0
Email 48488 0
helena.frawley@monash.edu

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Only non-identifiable data will be available and reported in peer-reviewed journal publication and in conference presentations.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes Frawley HC, Lin KY, Granger CL, Higgins R, Butler ... [More Details]

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseAn allied health rehabilitation program for patients following surgery for abdomino-pelvic cancer: a feasibility and pilot clinical study.2020https://dx.doi.org/10.1007/s00520-019-04931-w
N.B. These documents automatically identified may not have been verified by the study sponsor.