ANZCTR - Registration

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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]

Nil known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Pelvic floor dysfunction

gynaecological cancer

Condition category

Condition code

Renal and Urogenital

Other renal and urogenital disorders

Cancer

Cervical (cervix)

Cancer

Womb (Uterine or endometrial cancer)

Cancer

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]

Treatment: Other

Intervention code [2]

Behaviour

Intervention code [3]

Treatment: Devices

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

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]

3-month post-intervention time period

Primary outcome [2]

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]

3-months post-intervention

Primary outcome [3]

• 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]

3-months after intervention commencement

Secondary outcome [1]

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]

End of intervention period

Secondary outcome [2]

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]

3-months post-intervention period

Secondary outcome [3]

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]

Repeated at each intervention session

Secondary outcome [4]

Acceptability to trial protocol to referring clinicians measured by percentage of eligible participants referred to discuss the trial with the research team

Timepoint [4]

Throughout the recruitment period

Secondary outcome [5]

Acceptability of trial protocol to patients assessed by the consent to participate rate of patients identified as eligible

Timepoint [5]

Throughout the recruitment period

Secondary outcome [6]

Acceptability of assessment components measured by the proportion of participants who consent to undertake each assessment component

Timepoint [6]

At each assessment timepoint (baseline, 0-1 weeks post-intervention and 3-months post-intervention)

Secondary outcome [7]

Acceptability of the intervention protocol measured by specifically designed targeted questionnaire.

Timepoint [7]

3-months post intervention

Secondary outcome [8]

Acceptability of intervention protocol and appointment schedule assessed by semi-structured interviews with participants

Timepoint [8]

After completion of other outcome measures at 3-months post-intervention

Secondary outcome [9]

Urinary incontinence: International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF).

Timepoint [9]