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Trial registered on ANZCTR


Registration number
ACTRN12624000838516
Ethics application status
Approved
Date submitted
28/05/2024
Date registered
8/07/2024
Date last updated
8/07/2024
Date data sharing statement initially provided
8/07/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
An evaluation of early intervention using compression garments following neck dissection surgery for head and neck cancer and the impact on lymphoedema
Scientific title
An evaluation of the feasibility and indication of effectiveness of early intervention using compression garments following neck dissection surgery for head and neck cancer and the impact on lymphoedema in adults
Secondary ID [1] 312097 0
Nil
Universal Trial Number (UTN)
U1111-1307-7821
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Head and neck cancer 333730 0
Lymphoedema 333731 0
Lymphedema 333732 0
Condition category
Condition code
Cancer 330414 330414 0 0
Head and neck
Surgery 330713 330713 0 0
Other surgery
Physical Medicine / Rehabilitation 330714 330714 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Outcome Measurements (experimental and control group) will be taken at 4 time points:
- T0 (baseline) will occur in the anaesthetic peri-operative clinic (APOC), or at a time prior to surgery.
- T1 will occur in the post-operative outpatient clinic which occurs 1 to 2 weeks post discharge following neck dissection surgery (prior to, but on the day, of randomisation)
- T2 will occur in the lymphoedema outpatient setting at 9 ± 2 weeks post discharge, prior to (on the same day of) the lymphoedema appointment. T2 is the primary timepoint. Outcome measurements for T2 will be completed by a blind assessor. All other outcomes timepoints are unblinded.
- T3 will coincide with a routine medical follow-up appointment 24 weeks post-operatively.

Experimental Group:
Compression garments: At 1-2 weeks post discharge (T1), a Jobst chin strap or custom Jobskin face mask will be prescribed to the experimental (intervention) group. These are forms of compression garment for compression of a portion or all of the face and neck. Compression garments apply external pressure to the skin and soft tissue enhancing muscle contraction and skin movement which moves lymphatic fluid into and through the lymphatic vessels (Yoshihara et al., 2022).

The Jobskin custom made face mask (compression garment) may be prescribed based on clinical need (e.g. if oedema is present anterior to the coverage of the ready-to-wear Jobst chin strap garment). If prescribed, one will be ordered and fitted. Once fit is confirmed, a second garment will be ordered. If no changes to the fit of the first garment are required, the second will be ordered and mailed directly to the participant. If adjustments to improve the fit of the custom garment are required, the participant may need to attend for an additional fitting. The Researcher will decide if the adjusted garment can be mailed or needs to be fitted in-person, depending on the extent of adjustment required.

Based on the Researcher’s clinical assessment, a textured insert may be used with the compression garment. The type and coverage of the insert will be individual to the participant’s needs based on clinical assessment. This assists in softening thickened tissue when present and improves the efficacy of the pressure provided by the compression garment on the movement of lymphatic fluid.

All compression garments will be prescribed by the Researcher (certified lymphoedema practitioner). Two garments will be provided (one to wash and one to wear) regardless of whether the garment is ready-to-wear (RTW i.e. Jobst Chin Strap) or custom-made (i.e. Jobskin).

The garments will be free of charge to the participant, funded through the research project budget.
The RTW compression garment fitting will take approximately 15 minutes for prescription of compression and education regarding application, wear time and care.
For a custom garment, the measuring will take approximately 15 minutes and a subsequent fitting appointment will also take approximately 15 minutes. Where possible, the fitting appointment will coincide with other hospital appointments.

Should the experimental group participant require a new garment due to change in sizing, at a time before they are seen in the lymphoedema outpatient clinic for a standard appointment, the participant will be prescribed a new size or custom garment based on clinical assessment. If a ready-to-wear Jobst chin strap is required, the participant may be able to be instructed on how to measure for the garment over video-consult or telephone call to prevent the need to attend clinic. If a custom garment is required, this will necessitate the need for the participant to attend clinic. Any additional garment provided to the participant will be provide free of charge.

Participants in the experimental group will be educated on grading wear of the compression garment over 7 days from the time of prescription. Wear will be graded, commencing for short 15-30 minutes periods to ensure comfort, tolerance and fit, and then graded over the 7 days to wear at night (when sleeping i.e. 6-10 hours depending on sleep duration) and when completing head and neck exercises at home during the day. The head and neck exercises are prescribed as a part of standard care during the participants inpatient stay by either an Occupational Therapist, Physiotherapist or Speech Pathologist. Head and neck exercises include shoulder abduction/adduction, shrugs and rolls, neck exercises include flexion/extension and lateral flexion, mouth exercises include opening and closing the mouth, etc.
The participant is allowed to wear the compression more frequently however must record this in their electronic diary (eDiary).
This education will be provided at the time the garment is fitted with verbal instruction on grading, demonstration and practice of donning/doffing the garment and provision of a patient handout with written instructions. This will be reviewed at the followup videoconsult 1 week later (see videoconsultation below for further information).

Video-consultation (VC): Following prescription of the compression garment, the experimental group will receive video-consultation, completed by the Researcher (lymphoedema-trained Occupational Therapist) 1, 3 and 6 weeks post randomisation i.e. post prescription of the compression garment. The video-consult will include clinical support to aid compression garment wear (e.g. grading, fit, barriers to wear). If clinically indicated a new compression garment of the appropriate size will be prescribed. Participants in the experimental group may contact the Researcher by phone if there are any concerns or difficulties with adherence to compression at any point up until initial assessment in the lymphoedema outpatient clinic (T2). Ad hoc consult frequency, duration, reason and action will be recorded in REDCap. Video and telephone-consultations will not be audio-recorded. All video-consult/phone consult discussions will be documented on REDCap. Only adverse events and the action taken will be recorded on the patient electronic medical record (BOSSnet).
At 23 weeks post surgery, the participant will receive a phone call to remind them to complete the eDiary and of the research followup timepoint at 24 weeks post surgery. This is to assist attrition.
Video-consultation is anticipated to be from 5-20 minutes in duration.

eDiary: Patients will be provided with an electronic diary (via REDCap) to record adherence to all components of standard care + compression daily. If use of an electronic diary is not feasible for the participant, a paper-diary will be provided.
The diary will be provided from inpatient discharge and completed until T1. A new diary will be provided from T1 to T2, then T2 to T3. From T2 to T3 the eDiary will be completed weekly rather than daily.
Intervention code [1] 328538 0
Treatment: Devices
Intervention code [2] 328539 0
Prevention
Intervention code [3] 328775 0
Rehabilitation
Comparator / control treatment
The control group will receive 'standard care' only.
As standard care, all patients at Fiona Stanely Hospital (FSH) are seen by the Anaesthetic Peri-Operative Clinic (APOC) Occupational Therapist (OT) and Physiotherapist (PT) for standard pre-operative education. For the management of post-operative oedema, patients receive the prescription of facial, neck and shoulder range of motion exercises, positioning, skin and scar care education by an inpatient allied health professional. Some patients will have restrictions placed on their range of motion exercises. Patients are advised to continue completing their exercises, skin and scar care daily until they attend the lymphoedema outpatient clinic (usually 9 weeks post-discharge).

In the standard lymphoedema outpatient clinic, assessment for signs/symptoms of lymphoedema is conducted and intervention needs are determined by a lymphoedema-trained OT or PT. Lymphoedema intervention is individualised and may include standard CDT, modified-CDT and/or adjunctive therapies. Frequency and duration of lymphoedema care is determined by the lymphoedema-trained health professional.

eDiary: Patients will be provided with an electronic diary (via REDCap) to record adherence to all components of standard care. If use of an electronic diary is not feasible for the participant, a paper-diary will be provided.
The diary will be provided from inpatient discharge and completed until T1. A new diary will be provided from T1 to T2, then T2 to T3. From T2 to T3 the eDiary will be completed weekly rather than daily.

Telephone Consultation (TPC): TPC will be provided to the control group at 1, 3 and 6 weeks post randomisation,
Discussion will be documented on REDCap. The purpose of the TPC to the control group is to reduce potential attrition through reminding the participants of the research follow up timepoints and to complete the self-management diary during the call. Control group participants are not able to contact the researcher for clinical advice as they have not been prescribed compression garments. This group is to contact the relevant clinic for advice dependent on their concern as per usual care.
TPC is anticipated to be 3 minutes in duration.

If during the TPC any participant from either group reports symptoms that indicate the need for medical review (e.g. signs of infection, signs of recurrency) or need for lymphoedema review (e.g. worsening oedema without sign of infection) the participant will be advised to contact the relevant service for follow-up. No advice will be provided to either participant group regarding the adverse symptom, unless it is specifically related to the compression garment use for the experimental group.

Should adverse events be reported by either group, the health professional or clerk will have a checklist of who the participant should contact relating to a general range of symptoms (checklist to be developed in collaboration with consumer advisors and research assistant). If an adverse event is reported this and the action taken will be documented in the participant’s digital medical record (DMR). The control group’s TPC will be completed by a non-clinical professional (clerk). Where necessary, the appropriate medical/nursing team will be contacted by the clerk.
Control group
Active

Outcomes
Primary outcome [1] 338164 0
Safety of the intervention will be assessed by the incidence of self-reported increase in pain
Timepoint [1] 338164 0
at 1, 3, 6 and 9 (primary timepoint) weeks post randomisation
Primary outcome [2] 338166 0
Feasibility will be assessed through recruitment
Timepoint [2] 338166 0
at time of recruitment (pre-op clinic), 1-2 weeks post surgery, 9 weeks post discharge (primary timepoint) and 24 weeks post surgery
Primary outcome [3] 338661 0
Feasibility will be assessed through adherence to oedema-related home management
Timepoint [3] 338661 0
at 1-2 weeks post surgery, 9 weeks post discharge (primary timepoint) and 24 weeks post surgery
Secondary outcome [1] 434791 0
Indication of effectiveness of adding early compression garment wear to standard care assessed by the incidence of lymphoedema
Timepoint [1] 434791 0
In pre-op clinic or a timepoint prior to surgery (baseline), 1-2 weeks post discharge from neck dissection surgery (immediately prior to randomisation), 9 weeks post discharge and 6 months post-surgery
Secondary outcome [2] 434792 0
Quality of life
Timepoint [2] 434792 0
In pre-op clinic or a timepoint prior to surgery (baseline), 1-2 weeks post discharge from neck dissection surgery (immediately prior to randomisation), 9 weeks post discharge and 6 months post-surgery
Secondary outcome [3] 434793 0
Symptoms using Head and Neck Lymphoedema and Fibrosis symptom inventory (HN-LEF SI)
Timepoint [3] 434793 0
In pre-op clinic or a timepoint prior to surgery (baseline), 1-2 weeks post discharge from neck dissection surgery (immediately prior to randomisation), 9 weeks post discharge and 6 months post-surgery
Secondary outcome [4] 435637 0
Neck range of motion
Timepoint [4] 435637 0
In pre-op clinic or a timepoint prior to surgery (baseline), 1-2 weeks post discharge from neck dissection surgery (immediately prior to randomisation), 9 weeks post discharge and 6 months post-surgery
Secondary outcome [5] 435639 0
Anatomical change using tape-measurements and percentage water content using tissue dielectric constant following the Assessment of Lymphoedema of the Head and Neck (ALOHA) protocol
Timepoint [5] 435639 0
In pre-op clinic or a timepoint prior to surgery (baseline), 1-2 weeks post discharge from neck dissection surgery (immediately prior to randomisation), 9 weeks post discharge and 6 months post-surgery
Secondary outcome [6] 436896 0
Indication of effectiveness of adding early compression garment wear to standard care assessed by the severity of lymphoedema
Timepoint [6] 436896 0
In pre-op clinic or a timepoint prior to surgery (baseline), 1-2 weeks post discharge from neck dissection surgery (immediately prior to randomisation), 9 weeks post discharge and 6 months post-surgery
Secondary outcome [7] 436897 0
Jaw range of motion
Timepoint [7] 436897 0
In pre-op clinic or a timepoint prior to surgery (baseline), 1-2 weeks post discharge from neck dissection surgery (immediately prior to randomisation), 9 weeks post discharge and 6 months post-surgery
Secondary outcome [8] 436898 0
Shoulder range of motion
Timepoint [8] 436898 0
In pre-op clinic or a timepoint prior to surgery (baseline), 1-2 weeks post discharge from neck dissection surgery (immediately prior to randomisation), 9 weeks post discharge and 6 months post-surgery
Secondary outcome [9] 436900 0
Primary Outcome: Feasibility will be assessed through acceptability of the intervention to the participant
Timepoint [9] 436900 0
24 weeks post surgery
Secondary outcome [10] 436910 0
Primary Outcome: Safety of the intervention will be assessed by the incidence of self-reported increase in oedema
Timepoint [10] 436910 0
at 1, 3, 6 and 9 (primary timepoint) weeks post randomisation
Secondary outcome [11] 436911 0
Primary Outcome: Safety of the intervention will be assessed by the incidence of self-reported altered sensation when wearing the compression garment
Timepoint [11] 436911 0
at 1, 3, 6 and 9 (primary timepoint) weeks post randomisation
Secondary outcome [12] 436912 0
Primary Outcome: Safety of the intervention will be assessed by the incidence of self-reported change in skin pallor that does not resolve within 1 hour following wear of compression garment
Timepoint [12] 436912 0
at 1, 3, 6 and 9 (primary timepoint) weeks post randomisation
Secondary outcome [13] 436913 0
Primary Outcome: Safety of the intervention will be assessed by the incidence of self-reported claustrophobia when wearing the compression garment
Timepoint [13] 436913 0
at 1, 3, 6 and 9 (primary timepoint) weeks post randomisation
Secondary outcome [14] 436914 0
Rates of wound dehiscence
Timepoint [14] 436914 0
1-2 weeks post discharge (randomisation), 9 weeks post discharge, 24 weeks post surgery
Secondary outcome [15] 436915 0
Local (head and neck) infection
Timepoint [15] 436915 0
1-2 weeks post discharge (randomisation), 9 weeks post discharge, 24 weeks post surgery
Secondary outcome [16] 436916 0
Return to surgery
Timepoint [16] 436916 0
1-2 weeks post discharge (randomisation), 9 weeks post discharge, 24 weeks post surgery
Secondary outcome [17] 436917 0
Readmission to ward
Timepoint [17] 436917 0
1-2 weeks post discharge (randomisation), 9 weeks post discharge, 24 weeks post surgery
Secondary outcome [18] 436918 0
Cancer recurrence
Timepoint [18] 436918 0
1-2 weeks post discharge (randomisation), 9 weeks post discharge, 24 weeks post surgery
Secondary outcome [19] 436919 0
Emergency Department presentation with the primary or secondary presenting complaint of local (head or neck) infection
Timepoint [19] 436919 0
1-2 weeks post discharge (randomisation), 9 weeks post discharge, 24 weeks post surgery
Secondary outcome [20] 436920 0
Emergency Department presentation with the primary or secondary presenting complaint of head or neck oedema
Timepoint [20] 436920 0
1-2 weeks post discharge (randomisation), 9 weeks post discharge, 24 weeks post surgery
Secondary outcome [21] 436953 0
Primary Outcome: Feasibility will be assessed through acceptability of the intervention to the lymphoedema-trained health professional (who sees the participant as part of standard care)
Timepoint [21] 436953 0
18 months post first recruitment (at end of study intervention period)
Secondary outcome [22] 437224 0
Indication of effectiveness of adding early compression garment wear to standard care assessed by the severity of lymphoedema
Timepoint [22] 437224 0
In pre-op clinic or a timepoint prior to surgery (baseline), 1-2 weeks post discharge from neck dissection surgery (immediately prior to randomisation), 9 weeks post discharge and 6 months post-surgery
Secondary outcome [23] 437225 0
Quality of life
Timepoint [23] 437225 0
In pre-op clinic or a timepoint prior to surgery (baseline), 1-2 weeks post discharge from neck dissection surgery (immediately prior to randomisation), 9 weeks post discharge and 6 months post-surgery

Eligibility
Key inclusion criteria
Adults (> 18 years of age) planned to undergo cancer-related neck dissection surgery at Fiona Stanley Hospital (FSH) will be included.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants will be excluded if they have a history or presence of external HNL at baseline (assessed at time of recruitment), have previously had neck dissection surgery, have previously received radiation therapy to the head or neck, are receiving treatment for another cancer or have a known cognitive impairment.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Statistical analysis – safety and feasibility outcome: Statistical analysis will be performed using SPSS. Safety and feasibility data will be reported using descriptive statistics, where applicable parametric (mean and standard deviations), non-parametric or ordinal (medians and interquartile ranges) and categorical data (frequencies and proportions) will be used.

The study aims to identify potential effectiveness as a secondary intervention-related outcome. Statistical advice has recommended the non-central t-distribution (NCT) approach. This approach provides a sample size based on effect size following a stepped rule of thumb. For this pilot-RCT the standardised effect size is small. Using the NCT approach for a 90% powered main trial, the pilot sample size will be 25 participants per treatment arm. A minimum of 50 participants will be recruited. To allow for 20% attrition, the study will aim to recruit 65 participants. Calculation of sample size will inform feasibility of progression to a larger RCT. Alpha level 0.05.

Statistical analysis – intervention outcome: Normally distributed continuous data will be analysed using a paired t-test, whilst Mann-Whitney U test will be used for non-parametric data. Between-group comparisons of lymphoedema severity rating at each timepoint (T0, 1, 2 and 3) will be estimated using a generalised linear mixed model (GLMM). The GLMM will include baseline MDACC-HNL ratings, group and time as fixed effects, participant as a random effect, and interactions among these variables. Cost per minimum clinical important difference (MCID) will be calculated. The MCID for the MDACC-HNL is a 1-stage change (e.g. stage 1b to 1a). A descriptive analysis of differences in management of the intervention vs control group will be provided.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
18/07/2024
Actual
Date of last participant enrolment
Anticipated
30/06/2025
Actual
Date of last data collection
Anticipated
1/01/2026
Actual
Sample size
Target
65
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 26538 0
Fiona Stanley Hospital - Murdoch
Recruitment postcode(s) [1] 42579 0
6150 - Murdoch

Funding & Sponsors
Funding source category [1] 316455 0
Government body
Name [1] 316455 0
Future Health Research and Innovation Fund, Office of Medical Research and Innovation, Department of Health
Country [1] 316455 0
Australia
Primary sponsor type
University
Name
Curtin University of Technology
Address
Country
Australia
Secondary sponsor category [1] 318673 0
None
Name [1] 318673 0
Address [1] 318673 0
Country [1] 318673 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315246 0
South Metropolitan Health Service Human Research Ethics Committee
Ethics committee address [1] 315246 0
https://smhs.health.wa.gov.au/Our-research/For-researchers
Ethics committee country [1] 315246 0
Australia
Date submitted for ethics approval [1] 315246 0
26/03/2024
Approval date [1] 315246 0
23/05/2024
Ethics approval number [1] 315246 0

Summary
Brief summary
Head and neck lymphoedema (HNL) is a chronic swelling (‘oedema’) that often forms following cancer treatment of the head and neck. People with HNL often experience difficulty breathing, speaking and swallowing along with impaired movement and increased psychological distress and reduced quality of life. Treatment for HNL is inconsistent due to a low level of evidence, no recommended standard of care guidelines and poor assessment protocols leading to the condition being under-diagnosed and under-treated.
This parallel, pilot-randomised control trial will evaluate the safety, feasibility and indication of effectiveness of adding early compression garment wear to standard care through random assignment of compression garments to participants 1-2 weeks following hospital discharge from neck dissection surgery.

Who is it for?
You may be eligible for this study if you are aged 18 years and over, planned to undergo cancer-related neck dissection surgery at Fiona Stanley Hospital (FSH), with no history or presence of external HNL at baseline (assessed at time of recruitment), have not previously had neck dissection surgery, have not previously received radiation therapy to the head or neck, are not receiving treatment for another cancer or have no known cognitive impairment.

Study details
Participants will be randomised to either the experimental group or the control group. Participants in the control group will receive standard treatment and telephone consultation, while participants in the experimental groups will receive 2 head and neck compression garments, standard treatment and video consultations. Safety outcomes include incidence of adverse events. Feasibility outcomes include recruitment data, participant perception of acceptability of the use of compression garments and adherence data. Participants are asked to keep an e-diary to record how frequently they wear the compression garment and complete standard home care. Indication of effectiveness will be evaluated using lymphoedema incidence and severity, symptom severity, quality of life, anatomical changes and range of motion outcomes.

It is hoped that the findings from this study will develop an understanding on the safety, feasibility and effectiveness of adding early compression garment wear to standard care to inform future research.
Trial website
Trial related presentations / publications
Public notes
Outcome Measurements will be taken at 4 time points:
- T0 (baseline) will occur in the anaesthetic peri-operative clinic (APOC), or at a time prior to surgery.
- T1 will occur in the post-operative outpatient clinic which occurs 1 to 2 weeks post discharge following neck dissection surgery (prior to, but on the day, of randomisation)
- T2 will occur in the lymphoedema outpatient setting at 9 ± 2 weeks post discharge, prior to (on the same day of) the lymphoedema appointment. T2 is the primary timepoint. Outcome measurements for T2 will be completed by a blind assessor. All other outcomes timepoints are unblinded.
- T3 will coincide with a routine medical follow-up appointment 24 weeks post-operatively.

Contacts
Principal investigator
Name 134118 0
Miss Melissa Thorne
Address 134118 0
Curtin University of Technology, Kent St, Bentley WA 6102
Country 134118 0
Australia
Phone 134118 0
+61457553695
Fax 134118 0
Email 134118 0
[email protected]
Contact person for public queries
Name 134119 0
Melissa Thorne
Address 134119 0
Curtin University of Technology, Kent St, Bentley WA 6102
Country 134119 0
Australia
Phone 134119 0
+61457553695
Fax 134119 0
Email 134119 0
[email protected]
Contact person for scientific queries
Name 134120 0
Georgia Halkett
Address 134120 0
Curtin University of Technology, Kent St, Bentley WA 6102
Country 134120 0
Australia
Phone 134120 0
+61 8 9266 1762
Fax 134120 0
Email 134120 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Deidentified data will be available upon request (e.g. systematic review authors)
When will data be available (start and end dates)?
Upon trial completion until destruction (15 years post trial completion)
Available to whom?
Determined on a case by case basis
Available for what types of analyses?
Determined on a case by case basis
How or where can data be obtained?
Access subject to approval by Sponsor - contact Scientific Contact to discuss: [email protected]


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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