Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000580774
Ethics application status
Approved
Date submitted
18/03/2022
Date registered
20/04/2022
Date last updated
18/09/2023
Date data sharing statement initially provided
20/04/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
TELE-CONNECT: Telehealth Exercise for Continence After Gynaecological Cancer Treatment
Scientific title
Telehealth-delivered exercise to treat incontinence in women following gynaecological cancer
Secondary ID [1] 306591 0
None
Universal Trial Number (UTN)
Trial acronym
TELE-CONNECT
Linked study record
Yes my trial is related to ACTRN12621000880842 as a follow-up trial.

Health condition
Health condition(s) or problem(s) studied:
Urinary incontinence 325493 0
gynaecological cancer 325494 0
Faecal incontinence 325771 0
Condition category
Condition code
Cancer 322870 322870 0 0
Womb (Uterine or endometrial cancer)
Cancer 322955 322955 0 0
Cervical (cervix)
Cancer 322956 322956 0 0
Ovarian and primary peritoneal
Cancer 328258 328258 0 0
Other cancer types

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:
'What' The intervention: 8 x 30-60 minute telehealth sessions over 16 weeks (e.g. at 1, 2, 4, 6, 8, 10, 13 & 16 weeks). The initial consultation will be 60 minutes, consultations 2 - 7 will be 30 minutes and consultation 8 will be 45 minutes in order to provide all elements of the intervention at the appropriate time.
'Who' The provider: Physiotherapist with postgraduate training in pelvic floor physiotherapy. Per-protocol study training: detailed study manual and training in study processes and procedures, designed specifically for this study, including: pelvic floor muscle (PFM) assessment and exercise instruction processes; instructions for teaching use of the biofeedback device (device name: 'femfit®'); biofeedback data export; practice video-consultations to practice video-consultation skills.
In the 8 weeks before the first participant is enrolled, physiotherapists will undergo protocol training, using live face to face and online training, supplemented by supply of all required resources and standard operating protocols.
During the study: regular meetings with the research team to review per-protocol procedures to ensure adherence to standardised training protocols.
'How' Group or individual: Individual telehealth-delivered instruction in PFMT. The woman will receive the telehealth and home exercise program in her home. The femfit’s® pre-determined, starting level and exercise program will be used. The starting level may be modified and additional tailoring to each woman may also be recommended by the treating study physiotherapist based on assessment findings.
Supervision: Individually-supervised remotely via telehealth. Between telehealth consultations women will complete their PFMT unsupervised, 5 days per week.

After randomisation and before their first telehealth consultation each intervention group participant will receive by registered post a participant study manual that will include:
- a welcome letter describing their involvement in the study and listing all study resources that they will have received
- detailed instructions of how to use the telehealth Zoom Cloud Meetings software (Zoom) for physiotherapy consultations
- information regarding good bladder and bowel health (same as control group) and participant diaries (e.g. exercise and accident diaries)
- detailed instructions of how to use the femfit® biofeedback device and associated smartphone app
- a femfit® biofeedback device to help teach the correct PFM contraction technique, to monitor PFM strength gains during telehealth consultations and home practice, and facilitate PFMT adherence
- prior to participant's first physiotherapy consultation, a member of the research team will schedule a Zoom consultation with the participant, to ensure they are able to connect successfully for their physiotherapy consultations.

Adherence to exercise measures: Adherence to PFMT will be recorded within the femfit® app. The participant can elect to have daily reminders sent ('pushed') to her phone to remind her to do her exercises once a day at a time selected by the participant; this setting is available in the app.
Attendance at physiotherapy consultations will be recorded by the physiotherapist.

Motivation strategies: Biofeedback will be provided via the femfit® device and associated app. Biofeedback is provided to the participant via a visual display of the pressure profile created by the participant's pelvic floor muscle contraction, relative to a target pressure line that the participant aims to match. This pressure profile is only visible to the participant when she is performing her pelvic floor muscle exercises using the sensor and the app.

In addition, physiotherapists will draw from an extensive list of behaviour change motivational strategies according to the woman's needs. Example strategies may include goal setting, specific instructions/wording on how to perform PFMT, verbal persuasion, visual cues.

Progression: The femfit’s ® pre-determined, exercise program and recommended progressions will be used which are evidence-based and clinically validated. Within the femfit® app the intensity and repetitions of the exercises increase every 4 weeks. In the first month, the exercise program will take around 8 minutes to complete daily. This increases to 12 minutes in the second month, 16 minutes in months 3 and 4. The participant will then enter a maintenance phase with exercises performed 3 times per week until 52 weeks. The position to do the exercises also changes from lying to supported standing, to standing.

Detailed description of exercise session: PFM exercises included in the femfit ® training program are: maximal contraction, co-ordination, endurance, contraction with cough. These will be described in the femfit® app as “Squeeze”, “Rapid”, “Enduro”, and “Knack”.

Home program: PFM exercises, as prescribed by the physiotherapist, will be conducted by the woman at her home. Specific home exercise details regarding position, time, dosage, effort and use of the femfit® app will be provided by the physiotherapist at each consultation.

Non-exercise components: Intervention participants will receive the same informational handouts regarding good bladder and bowel health as the usual care group. Additional information will be provided as indicated:
- 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.
Intervention code [1] 323044 0
Treatment: Other
Intervention code [2] 323045 0
Behaviour
Intervention code [3] 323046 0
Treatment: Devices
Comparator / control treatment
Usual care / Control group:
Participants in this group will receive bladder and bowel advice handouts currently available from the Continence Foundation Australia and the Australian Government Department of Health. The research team member will send the handouts via email or post (dependent on the woman’s preference), directly after randomisation. Also, after randomisation the research team member will schedule one, (up to) 15- minute telehealth consultation (via telephone) with the participant, 1-2-weeks after completion of baseline assessments. During this telephone call, the researcher will check the handouts have been received, answer any handout or study related queries and remind the participant of the dates of their follow-up assessments. The researcher will not provide any tailored PFM advice/instruction.
Control group
Active

Outcomes
Primary outcome [1] 330676 0
Impact of urinary incontinence: the International Consultation on Incontinence - Urinary Incontinence Short Form (ICIQ-UI SF)
Timepoint [1] 330676 0
Baseline, and 17 (primary end-point) and 52 weeks post-randomisation
Secondary outcome [1] 407171 0
Impact of any type of urinary incontinence on quality of life: International Consultation on Incontinence Questionnaire Lower Urinary Tract Symptoms Quality of Life (ICIQ-LUTSqol)
Timepoint [1] 407171 0
Baseline, and 17 and 52 weeks post-randomisation
Secondary outcome [2] 407172 0
Bother of pelvic floor symptoms including stress urinary incontinence, urinary urgency and frequency, urge incontinence, dysuria, pelvic organ prolapse, obstructed defecation, faecal incontinence, and dyspareunia: Pelvic Floor Bother Questionnaire (PFBQ)
Timepoint [2] 407172 0
Baseline, 17 and 52 weeks post-randomisation
Secondary outcome [3] 407173 0
Self-reported health-related quality of life: EQ-5D-5L
Timepoint [3] 407173 0
Baseline, 17 and 52 weeks post-randomisation
Secondary outcome [4] 407174 0
Acceptance and use of technology: self-reported custom-built questionnaire modified from the Unified theory of acceptance and use of technology (UTAUT-II) model
Timepoint [4] 407174 0
Baseline and 17 weeks post-randomisation
Secondary outcome [5] 407175 0
Number of leakage episodes: collected by the participant in a custom-developed 7-day Accident Diary.
Timepoint [5] 407175 0
Baseline, 17 and 52 weeks post-randomisation
Secondary outcome [6] 407176 0
Number of continence pads used: collected by the participant in a custom-developed 7-day Accident Diary.
Timepoint [6] 407176 0
Baseline, 17 and 52 weeks post-randomisation
Secondary outcome [7] 407177 0
Patient Global Impression of Change (PGIC) Global Rating of Change Scale: self-reported in response to “Compared to your first assessment in this study (when you completed your baseline information 17 weeks ago) overall, how would you rate your bladder control now?"
Timepoint [7] 407177 0
17 and 52 weeks post-randomisation
Secondary outcome [8] 407178 0
Time spent (days, hours, minutes) sitting in the past 7 days: International Physical Activity Questionnaire Short form last 7 days Self-Administered Format.
Timepoint [8] 407178 0
Baseline, 17 and 52 weeks post-randomisation
Secondary outcome [9] 408016 0
Time spent (days, hours, minutes) on moderate activities in the past 7 days: International Physical Activity Questionnaire Short form last 7 days Self-Administered Format.
Timepoint [9] 408016 0
Baseline, 17 and 52 weeks post-randomisation
Secondary outcome [10] 408017 0
Time spent (days, hours, minutes) on vigorous physical activities in the past 7 days: International Physical Activity Questionnaire Short form last 7 days Self-Administered Format.
Timepoint [10] 408017 0
Baseline, 17 and 52 weeks post-randomisation
Secondary outcome [11] 408019 0
Cost of physiotherapist’s time (intervention group only)
The cost of physiotherapy services provided to each participant will be calculated.
Timepoint [11] 408019 0
17 weeks post-randomisation (intervention group only)
Secondary outcome [12] 408021 0
Cost of resources (intervention group only).
The cost of intervention resources provided to each intervention group participant will be calculated by the research team. Resources include the biofeedback devices and package of participant resources.
Timepoint [12] 408021 0
17 weeks post-randomisation (intervention group only)
Secondary outcome [13] 408023 0
Cost of pads for bladder leakage.
To estimate costs of pad use for incontinence we will collect details of
- disposable pads including brand name, cost and average number used via Table 1 of the Dowell Bryant Incontinence Cost Patients Index (DBICI)
- reusable incontinence underwear including brand and cost.
Timepoint [13] 408023 0
Baseline, 17 and 52 weeks post-randomisation
Secondary outcome [14] 408025 0
Laundry associated with incontinence
Collected from participants using a modified version of Table 3 of the DBICI
Timepoint [14] 408025 0
Baseline, 17 and 52 weeks post-randomisation
Secondary outcome [15] 408026 0
Health service use related to urinary incontinence
Health professional appointments, surgeries, investigations, and medications relating to urinary incontinence will be collected from participants using Section 2 of the DBICI
Timepoint [15] 408026 0
Baseline, 17 and 52 weeks post-randomisation
Secondary outcome [16] 408027 0
Work productivity
Information about paid employment or self-employed, leave and job performance will be collected from participants via a custom-built questionnaire
Timepoint [16] 408027 0
Baseline, 17 and 52 weeks post-randomisation.
Secondary outcome [17] 408833 0
Time spent (days, hours, minutes) walking in the past 7 days: International Physical Activity Questionnaire Short form last 7 days Self-Administered Format.
Timepoint [17] 408833 0
Baseline, 17 and 52 weeks post-randomisation

Eligibility
Key inclusion criteria
Women aged 18 years or more; following cancer treatment (with or without radiotherapy) for Stage I, II or III uterine, cervical, fallopian tube, primary peritoneal or ovarian cancer or borderline ovarian tumour; have the ability to speak and read English sufficiently for purposes of the study; have primary cancer treatment completed at least 6 months ago or adjuvant therapy completed at least 3 months ago; have self-reported urinary incontinence (at least 1 episode per week for last 4 weeks); have not received (in clinic or telehealth) >1 physiotherapy-supervised pelvic floor treatment session for urinary incontinence since commencing cancer treatment OR in the previous 4 years (whichever is most recent); and have a home internet connection and a smartphone.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Women who are pregnant or breastfeeding; have given birth within the last 12 months; have a severe pelvic organ prolapse; have a vaginal pessary ring in situ; have a significant neurological disorder; have a severe physical or psychiatric impairment; unable to participate in the e-health components of the study; have had pelvic surgery for incontinence or pelvic organ prolapse in the last 2 years; are not willing to use an intra-vaginal biofeedback device or videoconferencing software (Zoom or other) or are unable to give informed consent or complete all study and assessment procedures.

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)
Participants will be enrolled into the study once the informed consent process has been completed and they have completed the baseline questionnaires on the web-based platform (REDCap) or via post (dependent on preference).
Once returned, baseline questionnaires will be checked by the research team for completeness and to confirm relevant eligibility criteria are still met (e.g. self-reported urinary incontinence frequency).
Once this is confirmed, participants will be randomised (in permuted random blocks stratified by radiotherapy or not) into one of two groups.
The randomisation schedule will be created by an independent statistician to ensure study statisticians remain blinded to treatment allocation and stored on a password-protected website (REDCap) at the University of Melbourne, maintained by a researcher not involved in either participant recruitment or administration of primary/secondary outcome measures.
Group allocation will be accessed by a different member of the research team, who has had no contact with participants. This person will notify the research assistant of the assignment, and the research assistant will contact the participant, via the telephone, after baseline assessment has been completed.
Each participant will receive a unique study ID code, and this will be documented in the participant’s record/database in addition to all study documents.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomised (in permuted random blocks stratified by radiotherapy or not) into one of two groups.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample Size Estimation:
We aim to detect a minimal clinically important difference (MCID) of 2.5 units over 17 weeks in the primary outcome of change in urinary incontinence measured using the ICIQ-UI SF. The sample size calculation accounts for potential clustering by physiotherapists in the intervention arm. Based on previous research, we assume a conservative between-participant standard deviation of 3.2 units. We have also assumed a conservative correlation between baseline and 17-week scores of 0.4, an intra-cluster correlation of 0.05 and 3 physiotherapists treating approximately 10 patients each. With these parameters, we need 30 women per arm to achieve 80% power to detect the MCID at a 0.05 significance level. Allowing for 15% attrition, we will recruit 36 women per arm (in total n=72).

Statistical Analysis Plan:
A biostatistician will analyse blinded data using all available data from all randomised participants. Demographic and baseline characteristics of participants will be summarised as appropriate (means and standard deviations for continuous variables that appear to be distributed approximately symmetrically, medians and interquartile ranges for other continuous variables, counts and percentages for categorical variables). Main comparative analyses between groups will be performed using intention-to-treat. Multiple imputation will be applied if more than 5% of the primary outcome data is missing. For the primary hypotheses, differences in mean change in urinary incontinence (baseline minus follow-up) at 17 weeks (primary time point) will be compared between groups using mixed-effects linear regression models adjusted for baseline value of the outcome, stratification variable (radiotherapy) and including random effects for physiotherapist (intervention arm only) to account for any clustering by treating physiotherapist. Similar analyses will be conducted for continuous secondary outcomes. Standard diagnostic plots will be used to check model assumptions. For binary outcomes, the proportion of participants with self-perceived improvement (measured via Global Rating of Change Scale) and the proportion that met or exceeded MCIDs for the primary outcome will each be compared between groups separately using logistic regression, adjusting for the stratifying variable of radiotherapy, and fit using generalized estimating equations to account for clustering, with results reported as risk ratios and risk differences. For ordinal outcomes, ordinal logistic regression models will be fitted if the proportional odds assumption holds, otherwise multinomial regression models will be fitted. We will conduct a separate analysis at 52-weeks applying the same methods. The 52-week analysis will be reported separate from the main trial.

The economic evaluation will have a societal perspective and will assess both the cost of the intervention at 17 weeks and the cost-effectiveness and cost-utility of the intervention group versus the control group at 52-weeks. Quality-adjusted life years (QALYs) gained for the intervention compared to control at 52 weeks will be assessed. QALYs will be calculated based on utility scores using the EQ-5D-5L at baseline and 52 weeks. QALYs will also be calculated using the ICIQ-LUTSqol, a condition specific quality of life measure, at baseline and 52 weeks. Analysis will be combined with the primary clinical outcome measure to establish the incremental cost-effectiveness ratio of the intervention. The difference in participant resource use related to incontinence (e.g. pad use, medication use, health service use) and productivity lost between baseline and 52 weeks will be compared for intervention and control groups. The association between utility gains on the EQ-5D-5L and productivity will be compared between the intervention and control groups. The 52-week economic evaluation will be reported separate from the main trial.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
13/06/2022
Actual
13/10/2022
Date of last participant enrolment
Anticipated
29/12/2023
Actual
Date of last data collection
Anticipated
30/06/2025
Actual
Sample size
Target
72
Accrual to date
24
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 21899 0
The Royal Women's Hospital - Parkville
Recruitment hospital [2] 21901 0
Monash Medical Centre - Moorabbin campus - East Bentleigh
Recruitment hospital [3] 21903 0
Mercy Hospital for Women - Heidelberg
Recruitment postcode(s) [1] 36983 0
3052 - Parkville
Recruitment postcode(s) [2] 36987 0
3084 - Heidelberg
Recruitment postcode(s) [3] 36985 0
3165 - East Bentleigh

Funding & Sponsors
Funding source category [1] 310922 0
Government body
Name [1] 310922 0
Victorian Cancer Agency (Grant ID: MCRF20029)
Country [1] 310922 0
Australia
Primary sponsor type
University
Name
The University of Melbourne
Address
The University of Melbourne,
Level 5, 161 Barry Street, Carlton Vic 3010
Country
Australia
Secondary sponsor category [1] 312217 0
None
Name [1] 312217 0
Address [1] 312217 0
Country [1] 312217 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310482 0
Mercy Health Human Research and Ethics Committee
Ethics committee address [1] 310482 0
Administration Officer, Human Research Ethics Committee
c/- Mercy Hospital for Women
163 Studley Road Heidelberg, VIC. 3084

(NB: Mercy Health HREC is not an NHMRC accredited HREC).
Ethics committee country [1] 310482 0
Australia
Date submitted for ethics approval [1] 310482 0
25/11/2021
Approval date [1] 310482 0
17/12/2021
Ethics approval number [1] 310482 0
2021-063
Ethics committee name [2] 310512 0
Monash Health Human Research and Ethics Committee
Ethics committee address [2] 310512 0
Research Support Services
Monash Health
Level 2, I Block
Monash Medical Centre
246 Clayton Road
Clayton Victoria 3168
Ethics committee country [2] 310512 0
Australia
Date submitted for ethics approval [2] 310512 0
25/11/2021
Approval date [2] 310512 0
03/03/2022
Ethics approval number [2] 310512 0
ES-21-0000-626A
Ethics committee name [3] 310513 0
Science, Technology, Engineering, Mathematics and Medicine ethics committee (STEMM 1 committee)
Ethics committee address [3] 310513 0
Office of Research Ethics and Integrity
Research, Innovation & Commercialisation
Level 5, Alan Gilbert Building, 161 Barry Street, Carlton
The University of Melbourne, Victoria 3010 Australia
Ethics committee country [3] 310513 0
Australia
Date submitted for ethics approval [3] 310513 0
03/12/2021
Approval date [3] 310513 0
21/01/2022
Ethics approval number [3] 310513 0
2022-23573-24784-1

Summary
Brief summary
This study (called TELE-CONNECT) is a telehealth program to deliver pelvic floor muscle training to women with gynaecological cancer who suffer from urinary incontinence. Urinary incontinence affects around one-third of women causing signifcant physical, social, emotional and financial burden. The prevalence of incontinence is doubled in women with gynaecological cancer. Although evidence supports pelvic floor muscle training as first-line treatment for urinary incontinence, it is not known whether this treatment is as effective for women following gynaecological cancer treatment. This will be the first randomised trial to address this vital clinical question using the novel method of telehealth.

Who is it for?
You may be eligible for this study if you are an adult female following cancer treatment (with and without radiotherapy) for Stage I, II or III uterine, cervical, fallopian tube, primary peritoneal or ovarian cancer or borderline ovarian tumour.

Study details:
Participants who consent to be contacted by the research team will receive a phone call to determine their eligibility. Those who are suitable for the study and consent to participate will complete a baseline assessment and record any bladder leakage experienced over a 7-day period using an ‘Accident Diary’. They will then be asked to participate in one of two different treatment groups 1) usual care or 2) pelvic floor physiotherapy delivered via video-calls. Each participant is put into a group by chance (randomly) using a computer program. Participants in both groups will be sent high quality bladder and bowel advice handouts. Group 1 will receive one, 15-minute telephone call with a female member of the research team. Group 2 will receive an intensive, supervised, 16-week telehealth-delivered pelvic floor muscle training program (including 8 video-consultations) from a female, qualified and experienced physiotherapist. They will also receive their own pelvic floor muscle biofeedback device. All participants will complete questionnaires at the end of 17 and 52 weeks from the commencement of the study.

It is hoped that this research trial will demonstrate that a 16-week, physiotherapist-supervised, telehealth-delivered pelvic floor muscle training program can reduce urinary incontinence compared with usual care, in women following gynaecological cancer treatment.
Trial website
Trial related presentations / publications
Public notes
We will submit the study protocol for publication.

Contacts
Principal investigator
Name 117822 0
A/Prof Helena Frawley
Address 117822 0
School of Health Sciences
Faculty of Medicine, Dentistry & Health Sciences
University of Melbourne Parkville VIC 3010
Country 117822 0
Australia
Phone 117822 0
+61 0418 584 813
Fax 117822 0
Email 117822 0
h.frawley@unimelb.edu.au
Contact person for public queries
Name 117823 0
A/Prof Helena Frawley
Address 117823 0
School of Health Sciences
Faculty of Medicine, Dentistry & Health Sciences
University of Melbourne Parkville VIC 3010
Country 117823 0
Australia
Phone 117823 0
+61 0418 584 813
Fax 117823 0
Email 117823 0
h.frawley@unimelb.edu.au
Contact person for scientific queries
Name 117824 0
A/Prof Helena Frawley
Address 117824 0
School of Health Sciences
Faculty of Medicine, Dentistry & Health Sciences
University of Melbourne Parkville VIC 3010
Country 117824 0
Australia
Phone 117824 0
+61 0418 584 813
Fax 117824 0
Email 117824 0
h.frawley@unimelb.edu.au

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


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
No additional documents have been identified.