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Trial registered on ANZCTR


Registration number
ACTRN12621000880842
Ethics application status
Approved
Date submitted
8/05/2021
Date registered
8/07/2021
Date last updated
9/02/2023
Date data sharing statement initially provided
8/07/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Pelvic floor therapies after surgery for gynaecological cancer: a telehealth intervention trial
Scientific title
The feasibility of pelvic floor therapies to treat pelvic floor dysfunction in women following surgery for gynaecological cancer: a telehealth intervention trial
Secondary ID [1] 304074 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pelvic floor dysfunction 321732 0
gynaecological cancer 321733 0
Condition category
Condition code
Renal and Urogenital 319473 319473 0 0
Other renal and urogenital disorders
Cancer 319903 319903 0 0
Cervical (cervix)
Cancer 319904 319904 0 0
Womb (Uterine or endometrial cancer)
Cancer 319905 319905 0 0
Ovarian and primary peritoneal

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Pelvic floor muscle training (PFMT) + home exercise program + non-exercise components
Pelvic floor muscle training (PFMT) intervention:
o 'What' The intervention: 7 x 30 minute telehealth sessions over 12 weeks (e.g. at 0, 2, 4, 6, 8, 10 & 12 weeks).
o 'Who' The provider: Physiotherapist with postgraduate qualification in pelvic floor physiotherapy
o 'How' Group or individual: Individual telehealth-delivered instruction in PFMT, customised to each participant’s starting level of ability to do PFMT
Supervision: Individually-supervised remotely via telehealth
Each woman will also receive a Femfit® intravaginal pressure biofeedback device to help teach the correct contraction technique, to monitor pelvic floor muscle (PFM) strength gains during telehealth consultations and home practice, and to aid adherence to PFMT home exercise program via the Femfit® app which the participant will download to their phone.
Adherence to exercise measures: Exercise diaries
Motivation strategies: Behaviour change techniques (biofeedback, behaviour goal setting, action planning including implementation intentions, instruction on how to perform behaviour (PFM exercise), outcome goal setting, review of behaviour goals, problem solving, verbal persuasion to boost self-efficacy, self- monitoring, association with prompts or cues)
Progression - decision when to progress: Every 4 weeks
Detailed description of exercise session:
Using real-time feedback from the Femfit biofeedback device and app, the Femfit strength building protocol will be used, as follows:
3 sets of 6 repetitions of a pelvic floor muscle contraction of 6 seconds instructed to be held at maximal voluntary contraction strength, with 6 seconds rest in between, then
3 sets of 6 repetitions of a rapid pelvic floor contraction (1 second hold, 1 second rest) instructed to be completed at maximal voluntary contraction strength, then
3 repetitions of a pelvic floor muscle endurance contractions instructed to be held at 50%-100% of maximal voluntary effort for 18 seconds, followed by 18 seconds rest, then
3 sets of coordination contractions with a rapid pelvic floor contraction and cough, instructed to be performed at the same time, 3 times in a row.
Progression - type: Duration of muscle hold and number of repetitions; increasing anti-gravity positions
Adherence to intervention measure: clinician record of participant attendance or non-attendance to intervention sessions and of the components of therapy completed within each session.
+
Home exercise program component: Exercises detailed in home exercise handout specifying position, time, dosage, effort, which can be done with and without the Femfit® intravaginal pressure biofeedback device.
The exercise is a daily local muscle exercise of the pelvic floor muscles as per the 12-week strength building programme included in the Femfit mobile device app and is the same as the supervised exercise session that will be done with the physiotherapist via telehealth. Exercise sessions will take 8-18 minutes. Intensity of each contraction will be determined by self-perceived percentage of maximal voluntary contraction strength, with each contraction instructed to be done at 50-100% of maximal voluntary contraction strength. This will be done over the same 12 weeks as the weekly telehealth sessions. Adherence will be monitored by the exercise diary included in the Femfit app.
+/-
Non-exercise component:
Participants who present with symptoms of PFD which require conservative therapies other than PFM exercise, as assessed by the clinician providing the intervention, will be provided with these education-based therapies at their first post-operative physiotherapy session, and continued alongside PFM exercise as required:
For urinary urgency and frequency or urge urinary incontinence: bladder training including urinary urge suppression techniques, education on fluid intake modification including caffeine reduction if relevant, and education in good bladder and bowel habits.
For faecal incontinence: bowel routine training, education on dietary fibre including psyllium supplementation, education on faecal urgency suppression techniques and education about defecation dynamics and toileting posture.
These components will be provided with an additional 5-15 minutes at each telehealth session to address each component. Any time spent addressing these components will be recorded by the clinician providing the intervention.
Intervention code [1] 320405 0
Treatment: Other
Intervention code [2] 320837 0
Behaviour
Intervention code [3] 320838 0
Treatment: Devices
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 327345 0
Feasibility:
Coverage: will be evaluated by the proportion of the women who are identified as eligible, who are then recruited and receive the intervention and reasons for ineligibility of ineligible patients.
Timepoint [1] 327345 0
3-month post-intervention time period
Primary outcome [2] 327347 0
Retention: will be evaluated by the proportion of participants who remain in the trial at the 3-month post-intervention time period and provide final data, aiming for greater than or equal to 70% retention.
Timepoint [2] 327347 0
3-months post-intervention
Primary outcome [3] 327348 0
• Sustainability:
o Engagement with physiotherapy telehealth appointments will be recorded by treating physiotherapists and used as a measure of sustainability to the trial protocol. A record of therapies completed in each intervention session will be completed by the treating physiotherapist, including participant self-report of the non-exercise components specified above that have been undertaken or implemented since the previous session
Timepoint [3] 327348 0
3-months after intervention commencement
Secondary outcome [1] 394921 0
Adherence to the prescribed home exercise program for the intervention group will be measured by the proportion of the prescribed exercise program which is documented by the participant in an exercise diary that is incorporated into the Femfit app.
Timepoint [1] 394921 0
End of intervention period
Secondary outcome [2] 394922 0
Self-reported frequency of pelvic floor muscle exercises after the completion of the intervention based on participant answers to study-specific verbal questions from the assessor
Timepoint [2] 394922 0
3-months post-intervention period
Secondary outcome [3] 394923 0
Fidelity: participant recall of intervention program content will be assessed by study-specific questions at the start and end of each intervention session.
Timepoint [3] 394923 0
Repeated at each intervention session
Secondary outcome [4] 394924 0
Acceptability to trial protocol to referring clinicians measured by percentage of eligible participants referred to discuss the trial with the research team
Timepoint [4] 394924 0
Throughout the recruitment period
Secondary outcome [5] 394925 0
Acceptability of trial protocol to patients assessed by the consent to participate rate of patients identified as eligible
Timepoint [5] 394925 0
Throughout the recruitment period
Secondary outcome [6] 394926 0
Acceptability of assessment components measured by the proportion of participants who consent to undertake each assessment component
Timepoint [6] 394926 0
At each assessment timepoint (baseline, 0-1 weeks post-intervention and 3-months post-intervention)
Secondary outcome [7] 394927 0
Acceptability of the intervention protocol measured by specifically designed targeted questionnaire.
Timepoint [7] 394927 0
3-months post intervention
Secondary outcome [8] 394928 0
Acceptability of intervention protocol and appointment schedule assessed by semi-structured interviews with participants
Timepoint [8] 394928 0
After completion of other outcome measures at 3-months post-intervention
Secondary outcome [9] 394929 0
Urinary incontinence: International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF).
Timepoint [9] 394929 0
pre-intervention, 0-1 week post-intervention and 3-months post-intervention
Secondary outcome [10] 394930 0
Anorectal symptoms: International Consultation on Incontinence Questionnaire- Bowel (ICIQ-B) module.
Timepoint [10] 394930 0
pre-intervention, 0-1 week post-intervention and 3-months post-intervention
Secondary outcome [11] 394933 0
Physical activity levels: International Physical Activity Questionnaire - short form
Timepoint [11] 394933 0
pre-intervention, 0-1 week post-intervention and 3-months post-intervention
Secondary outcome [12] 394934 0
Health-related quality of life: European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire (EORTC QLQ-C30)
Timepoint [12] 394934 0
pre-intervention, 0-1 week post-intervention and 3-months post-intervention
Secondary outcome [13] 394935 0
Pelvic floor muscle strength: magnitude of pressure changes using the Femfit intravaginal pressure biofeedback device.
Timepoint [13] 394935 0
pre-intervention, 0-1 week post-intervention and 3-months post-intervention
Secondary outcome [14] 396548 0
Pelvic floor muscle endurance: pressure maintained during an 18 second contraction, measured using the Femfit intravaginal pressure biofeedback device.
Timepoint [14] 396548 0
pre-intervention, 0-1 week post-intervention and 3-months post-intervention
Secondary outcome [15] 396549 0
Fidelity to the exercise protocol will be compared using descriptive statistics, with comparison between the exercise protocol and the exercise data that is obtained using the Femfit biofeedback device.
Timepoint [15] 396549 0
Throughout the intervention period

Eligibility
Key inclusion criteria
Women who have had surgery for primary gynaecological treatment for uterine, endometrial, cervical or ovarian cancer, based on oncology assessment, or a histologically confirmed uterine, endometrial, cervical or ovarian tumour, International Federation of Gynecology and Obstetrics (FIGO) cancer staging system classification stages I-III (if known); have any type of urinary and/or faecal incontinence, have an Eastern Cooperative Oncology Group performance status of between 0-2 (with a score of 0 being fully active to and a score of 2 being resting in bed less than 50% of the day); have the capability and access to use a telecommunication platform in their own home; have sufficient English language skills to participate; and are at least 18 years of age.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Women with a FIGO cancer staging system classification stage IV, who are pregnant, up to 12 months postnatal or who are breastfeeding, have neurological disorders or severe physical/psychiatric impairments, or who have, within the last 2 years, received physiotherapist-supervised PFMT or pelvic surgery for incontinence or pelvic organ prolapse will be excluded.

Study design
Purpose of the study
Treatment
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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Quantitative data analysis
Socio-demographic and medical data will be presented descriptively. Categorical variables will be summarised by counts and percentages. Continuous variables will be summarised by means and standard deviations or medians and ranges.
Descriptive statistics will be used to summarize and report feasibility data, using the percentage thresholds described in the feasibility outcome measure section. Participant flow will be presented in a participant flow diagram, including the numbers of participants who were approached and/or assessed for eligibility, received intended treatment, and were assessed for each outcome measure.
Clinical outcomes data will be analysed estimated proportions or means and 95% confidence intervals for each time. Comparisons between pre and post intervention measures will be analysed using paired t-tests for continuous outcomes and generalised estimating equations for binary outcomes. As this is a feasibility study, the results were reported as 95% confidence intervals, without p-values. Data will be analysed using the SPSS software program.
Interview analysis
Qualitative (interview) data will be analysed using descriptive thematic analysis. Themes will first be identified independently by the Coordinating Principal Investigator and cross-checked by 1-2 Associate Investigators and then discussed until consensus is reached.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/02/2022
Actual
19/01/2022
Date of last participant enrolment
Anticipated
30/06/2022
Actual
28/05/2022
Date of last data collection
Anticipated
31/12/2022
Actual
16/12/2022
Sample size
Target
35
Accrual to date
Final
36
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 19221 0
The Royal Women's Hospital - Parkville
Recruitment hospital [2] 19222 0
Monash Medical Centre - Moorabbin campus - East Bentleigh
Recruitment hospital [3] 19223 0
Mercy Hospital for Women - Heidelberg
Recruitment postcode(s) [1] 33794 0
3052 - Parkville
Recruitment postcode(s) [2] 33795 0
3165 - East Bentleigh
Recruitment postcode(s) [3] 33796 0
3084 - Heidelberg

Funding & Sponsors
Funding source category [1] 308458 0
Charities/Societies/Foundations
Name [1] 308458 0
Physiotherapy Research Foundation
Country [1] 308458 0
Australia
Primary sponsor type
University
Name
University of Melbourne
Address
University of Melbourne
Parkville
VIC 3010
Country
Australia
Secondary sponsor category [1] 309296 0
None
Name [1] 309296 0
Address [1] 309296 0
Country [1] 309296 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308414 0
Monash Health Human Research Ethics Committee
Ethics committee address [1] 308414 0
Ethics committee country [1] 308414 0
Australia
Date submitted for ethics approval [1] 308414 0
12/02/2019
Approval date [1] 308414 0
04/06/2019
Ethics approval number [1] 308414 0
NMA HREC Reference Number: HREC/50085/MonH-2019-165068(v1)

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 110630 0
Ms Robyn Brennen
Address 110630 0
Monash Health Community Continence Service
Level 1, 122 Thomas St
Dandenong
Victoria 3175
Country 110630 0
Australia
Phone 110630 0
+6414862754
Fax 110630 0
Email 110630 0
[email protected]
Contact person for public queries
Name 110631 0
Robyn Brennen
Address 110631 0
Monash Health Community Continence Service
Level 1, 122 Thomas St
Dandenong
Victoria 3175
Country 110631 0
Australia
Phone 110631 0
+6414862754
Fax 110631 0
Email 110631 0
[email protected]
Contact person for scientific queries
Name 110632 0
Robyn Brennen
Address 110632 0
Monash Health Community Continence Service
Level 1, 122 Thomas St
Dandenong
Victoria 3175
Country 110632 0
Australia
Phone 110632 0
+6414862754
Fax 110632 0
Email 110632 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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
SourceTitleYear of PublicationDOI
EmbasePelvic floor muscle training delivered via telehealth to treat urinary and/or faecal incontinence after gynaecological cancer surgery: a single cohort feasibility study.2023https://dx.doi.org/10.1007/s00520-023-08050-5
N.B. These documents automatically identified may not have been verified by the study sponsor.