Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613001297718
Ethics application status
Approved
Date submitted
18/11/2013
Date registered
21/11/2013
Date last updated
15/04/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of a pelvic floor muscle training program in patients who have undergone surgery for bowel cancer
Scientific title
Effect of a pelvic floor muscle training program in patients who have undergone anterior resection surgery for colorectal cancer
Secondary ID [1] 283595 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pelvic floor symptoms 290517 0
Bowel cancer 290537 0
Condition category
Condition code
Physical Medicine / Rehabilitation 290904 290904 0 0
Other physical medicine / rehabilitation
Cancer 290935 290935 0 0
Bowel - Back passage (rectum) or large bowel (colon)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is general rehabilitation plus pelvic floor muscle training program. The general rehabilitation will consist of a multidisciplinary education and exercise program, which will be provided as group sessions twice weekly for 8 weeks . Each session will last approximately one hour. The education component will include advice about nutrition, exercise, fatigue management and coping with stress and will be provided in a group format. Information will be delivered by a range of clinicians (physiotherapists, occupational therapists, psychologists, and dieticians). The exercise component will include an exercise training program supervised by a physiotherapist. The pelvic floor muscle training program will consist of physiotherapy-supervised pelvic floor muscle training sessions and bladder and bowel function advice over 12 sessions, twice weekly for 6 weeks. The training program will use a combination of 7 individual and 5 group sessions. Biofeedback will be used to facilitate pelvic floor muscle function. The training sessions will be approximately one hour long. The duration of intervention is eight weeks. To encourage adherence to the intervention protocols, telephone calls from a physiotherapist and a self report diary to record training adherence will be provided.
Intervention code [1] 288282 0
Rehabilitation
Comparator / control treatment
General rehabilitation alone, twice weekly for 8 weeks, group sessions
Control group
Active

Outcomes
Primary outcome [1] 290889 0
Pelvic floor symptoms as assessed using the Australian Pelvic Floor Questionnaire and the International Consultation on Incontinence Questionnaire Bowel module
Timepoint [1] 290889 0
at baseline, immediately post-intervention, and at 6, 12, 24, and 60 months following baseline
Secondary outcome [1] 305543 0
Anorectal muscle function as assessed using anal manometry
Timepoint [1] 305543 0
at baseline, immediately post-intervention, and at 6 months following baseline
Secondary outcome [2] 305545 0
Pelvic floor muscle function as assessed using transperineal ultrasound
Timepoint [2] 305545 0
at baseline, immediately post-intervention, and at 6 months following baseline
Secondary outcome [3] 305546 0
Functional capacity as assessed using the six-minute walk test and the Incremental Shuttle Walk Test
Timepoint [3] 305546 0
at baseline, immediately post-intervention, and at 6 months following baseline
Secondary outcome [4] 305548 0
General muscle strength as assessed using a hand-held dynamometer
Timepoint [4] 305548 0
at baseline, immediately post-intervention, and at 6 months following baseline
Secondary outcome [5] 305549 0
Physical activity as assessed using the International Physical Activity Questionnaire
Timepoint [5] 305549 0
at baseline, immediately post-intervention, and at 6, 12, 24, and 60 months following baseline
Secondary outcome [6] 305553 0
Psychological distress as assessed using the Hospital Anxiety and Depression Scale
Timepoint [6] 305553 0
at baseline, immediately post-intervention, and at 6, 12, 24, and 60 months following baseline
Secondary outcome [7] 305554 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 updated colorectal cancer module (QLQ-CR29)
Timepoint [7] 305554 0
at baseline, immediately post-intervention, and at 6, 12, 24, and 60 months following baseline
Secondary outcome [8] 305555 0
Global response change score as assessed using the Global Rating of Change
Timepoint [8] 305555 0
at baseline, immediately post-intervention, and at 6, 12, 24, and 60 months following baseline
Secondary outcome [9] 305556 0
Bladder and bowel function as assessed using a diary
Timepoint [9] 305556 0
at baseline, immediately post-intervention, and at 6 months following baseline
Secondary outcome [10] 305558 0
Overall survival as assessed by data linkage to medical records
Timepoint [10] 305558 0
at one year, two years, and five years after baseline
Secondary outcome [11] 305559 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. Assessment of the pelvic floor muscles is usually painless; however, some patients may experience a feeling of embarrassment.
Timepoint [11] 305559 0
at baseline, immediately post-intervention, and at 6, 12, 24, and 60 months following baseline

Eligibility
Key inclusion criteria
Patients who have undergone anterior resection for histologically confirmed, stage I-III colorectal cancer; 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
No limit
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 in the preceeding 12 months

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
After recruitment and baseline testing, participants will be randomized by an independent, off-site, computer generated random number sequence into two groups and inserted into sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The random allocation sequence will be generated using computer-generated random number sequence.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis
Repeated-measures analysis of variance will be used to compare the mean differences between- and within-groups. All analyses will be tested with a significance level of p < 0.05 using the intention to treat principle. The sample size calculation is based upon finding a 1.6-point difference with a standard deviation of 1.7 in the bowel function score of Australian Pelvic Floor Questionnaire, giving 18 patients per group. Allowing 20% for drop outs, a total of 44 patients will be needed to detect a change in the primary outcome measure.

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Date of first participant enrolment
Anticipated
3/03/2014
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
44
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 288275 0
Hospital
Name [1] 288275 0
Cabrini Institute
Country [1] 288275 0
Australia
Primary sponsor type
University
Name
The University of Melbourne
Address
Physiotherapy
Melbourne School of Health Sciences
The University of Melbourne
Alan Gilbert Building
161 Barry Street, Carlton
Victoria 3053
AUSTRALIA
Country
Australia
Secondary sponsor category [1] 286990 0
Hospital
Name [1] 286990 0
Cabrini Institute
Address [1] 286990 0
Cabrini Institute
154 Wattletree Road
Malvern Victoria 3144
Country [1] 286990 0
Australia

Ethics approval
Ethics application status
Approved

Summary
Brief summary
The study is investigating the effectiveness of pelvic floor muscle (PFM) training plus general multidisciplinary rehabilitation in patients who have undergone bowel cancer surgery. Who is it for? You may be eligible to join this study if you are aged 18 years and over, have undergone anterior resection for stage I – III bowel 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 Participants in this study will be randomly (by chance) divided into one of two groups. Participants in one group will receive general multidisciplinary rehabilitation and PFM training program. The general multidisciplinary rehabilitation will consist of a multidisciplinary 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 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. The PFM training program will consist of physiotherapy-supervised pelvic floor muscle training sessions, and bladder and bowel function advice over 12 sessions. Biofeedback will be used to facilitate pelvic floor muscle function. The training sessions will be approximately one hour long. The duration of intervention is eight weeks. Participants in the second group will only receive the general multidisciplinary rehabilitation twice weekly for 8 weeks. All participants will be required to complete some questionnaires and tests (e.g. transperineal ultrasound, six-minute walk test, etc) at the end of the intervention, and at 6, 12, 24 and 60 months from baseline to evaluate their pelvic floor symptoms and outcomes.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 44326 0
Dr Helena Frawley
Address 44326 0
Alan Gilbert Building, 161 Barry Street, The University of Melbourne Carlton 3053 Victoria, Australia
Country 44326 0
Australia
Phone 44326 0
+61 3 8344 4837
Fax 44326 0
Email 44326 0
[email protected]
Contact person for public queries
Name 44327 0
Dr Helena Frawley
Address 44327 0
Alan Gilbert Building, 161 Barry Street, The University of Melbourne Carlton 3053 Victoria, Australia
Country 44327 0
Australia
Phone 44327 0
+61 3 8344 4837
Fax 44327 0
Email 44327 0
[email protected]
Contact person for scientific queries
Name 44328 0
Dr Helena Frawley
Address 44328 0
Alan Gilbert Building, 161 Barry Street, The University of Melbourne Carlton 3053 Victoria, Australia
Country 44328 0
Australia
Phone 44328 0
+61 3 8344 4837
Fax 44328 0
Email 44328 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
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