Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000770662
Ethics application status
Approved
Date submitted
16/06/2023
Date registered
14/07/2023
Date last updated
14/07/2023
Date data sharing statement initially provided
14/07/2023
Type of registration
Retrospectively registered

Titles & IDs
Public title
Mixed methods evaluation of the feasibility, acceptability and adherence of prehabilitation for head and neck cancer patients undergoing radiotherapy.
Scientific title
Mixed methods evaluation of the feasibility, acceptability and adherence of prehabilitation for head and neck cancer patients undergoing radiotherapy.
Secondary ID [1] 309607 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Head and neck cancer
 329919 0
Mental health 329920 0
Malnutrition 329921 0
Impaired communication 329922 0
Sarcopenia 329923 0
impaired physical functioning 329924 0
Radiotherapy 329925 0
weak swallowing function 330514 0
Condition category
Condition code
Cancer 326827 326827 0 0
Head and neck
Diet and Nutrition 327361 327361 0 0
Other diet and nutrition disorders
Mental Health 327362 327362 0 0
Other mental health disorders
Oral and Gastrointestinal 327363 327363 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Musculoskeletal 327364 327364 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients with head and neck cancer planned for radiotherapy will receive screening for risk of physical and psychological concerns. All patients planned for radiotherapy will receive Preparing for Head and Neck Radiotherapy (Prep-4-RT) self-management resources. Patients who are identified in the high risk range for psychological distress, malnutrition, sarcopenia, eating difficulties or poor physical functioning, will be referred for a one-on-one appointment with a psychologist, dietitian, speech pathologist or physiotherapist for specialist prehabilitation. Feasibility and acceptability data of the self-management and specialist prehabilitation pathways will be collected.

SELF-MANAGEMENT
The Prep-4-RT resources comprise of 5 webpages on the following topics: Introduction to Prehabilitation; What to expect?; How to prepare?; Guide to feeding tubes; Guidance for carers and support people. Each webpage has a short video with information from clinicians and consumers, as well as written and pictorial information sheets and links to relevant resources. It is anticipated participants will need between 30 to 60 minutes to review the resources. These resources are readily available at: www.petermac.org/Prep-4-RT. Webpage analytics will be monitored to provide an indication of webpage access, usage and adherence.

SPECIALIST PREHABILITATION:
Screening for specialist prehabilitation was a short online survey completed on an ipad with a head and neck nurse consultant as part of the clinical interview at the first nursing appointment. The survey is estimated to take 5-10 minutes. Screening will be completed within 7 days of enrolment. Enrolment is the day patients are identified as planned for radiotherapy treatment. One-on-one appointments with specialist clinicians are anticipated to have a duration of between 30-60 minutes. A one-on-one appointment will be provided with each specialist discipline for which a participant meets the high risk criteria (e.g. scoring high risk for malnutrition and mental health would trigger one-on-one prehabilitation with a dietitian and psychologist). The timing of the appointments is that at least one appointment is provided prior to commencing radiotherapy with additional appointments scheduled as clinically indicated. Adherence to specialist prehabilitation appointments will be monitored by audit of appointment attendance, compliance and barriers to engagement.
Intervention code [1] 326030 0
Behaviour
Intervention code [2] 326432 0
Treatment: Other
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 334684 0
Participant satisfaction with the self-management resources and specialist prehabilitation pathways assessed using the Client Satisfaction Questionnaire..
Timepoint [1] 334684 0
Prior to radiotherapy at the end of the prehabilitation period
Primary outcome [2] 335232 0
Participant acceptability of the self-management resources and specialist prehabilitation pathways assessed using the Theoretical Framework of Acceptability.
Timepoint [2] 335232 0
Prior to radiotherapy at the end of the prehabilitation period
Primary outcome [3] 335233 0
Patient uptake as measured by the number of patients who consent to screening as per medical records.
Timepoint [3] 335233 0
Prior to radiotherapy at the end of the prehabilitation period
Secondary outcome [1] 421643 0
Participant intention to try the intervention as measured by the number of patients who utilise the self-management resources (as self-reported in study-designed questions and website analytics) and number of patients who accept the referral to specialist prehabilitation.
Timepoint [1] 421643 0
Prior to radiotherapy at the end of the prehabilitation period
Secondary outcome [2] 423560 0
Participant adherence to specialist prehabiltiation measured by attendance at appointments (as per medical record).
Timepoint [2] 423560 0
Prior to radiotherapy at the end of the prehabilitation period
Secondary outcome [3] 423561 0
Staff acceptability of the model of care assessed using the Theoretical Framework of Acceptability.
Timepoint [3] 423561 0
Prior to radiotherapy at the end of the prehabilitation period

Eligibility
Key inclusion criteria
• Be aged 18 years or older at the time of recruitment
• Be able to speak and read English
• Be able to give informed consent (i.e., no psychiatric/cognitive condition that would impact informed consent, as based on clinical judgement)
• Be planned for radiotherapy for HNC
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Planned for palliative radiotherapy (e.g., less than 40Gy)
• Reporting extreme distress (e.g., risk of harm to themselves or psychotic symptoms)

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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Descriptive statistics will be used to summarise participant demographic and clinical characteristics of all participants screened. Statistics will include counts and percentages for nominal and crude-scale ordinal valued variables; and means and standard deviations or medians and interquartile ranges, as appropriate, for fine-scale ordinal and continuous valued variables. Descriptive statistics will also be used to summarise operational and self-reported data relevant to evaluation outcomes.

Acceptability, satisfaction, adoption, and fidelity of the Prep-4-RT model of care will be summarised using descriptive statistics. The evaluation of acceptability, adoption and fidelity will be assessed by calculating percentages of participants who completed screening, percentage of participants who consented to evaluation, the percentage who accessed the self-management resources, adherence to program protocol, and clinician time to deliver the screening and interventions. Free text items from participant questionnaires will be summarised using content analysis, whereby the content of free responses will be coded and grouped, where applicable.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
9/03/2023
Date of last participant enrolment
Anticipated
28/07/2023
Actual
Date of last data collection
Anticipated
1/09/2023
Actual
Sample size
Target
60
Accrual to date
30
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 24680 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment postcode(s) [1] 40300 0
3000 - Melbourne

Funding & Sponsors
Funding source category [1] 313787 0
Government body
Name [1] 313787 0
Western and Central Melbourne Integrated Cancer Service
Country [1] 313787 0
Australia
Primary sponsor type
Hospital
Name
Peter MacCallum Cancer Centre
Address
305 Grattan St, Melbourne, Vicotria, 3000
Country
Australia
Secondary sponsor category [1] 315661 0
None
Name [1] 315661 0
Address [1] 315661 0
Country [1] 315661 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312955 0
Peter MacCallum Cancer Centre Human Research Ethics Committee
Ethics committee address [1] 312955 0
Ethics committee country [1] 312955 0
Australia
Date submitted for ethics approval [1] 312955 0
Approval date [1] 312955 0
18/07/2022
Ethics approval number [1] 312955 0
HREC/86559/PMCC

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

Contacts
Principal investigator
Name 126470 0
Ms Jenelle Loeliger
Address 126470 0
Peter MacCallum Cancer Centre, 305 Grattan St, Melbourne, Victoria, 3000
Country 126470 0
Australia
Phone 126470 0
+61 3 85595221
Fax 126470 0
Email 126470 0
[email protected]
Contact person for public queries
Name 126471 0
Jenelle Loeliger
Address 126471 0
Peter MacCallum Cancer Centre, 305 Grattan St, Melbourne, Victoria, 3000
Country 126471 0
Australia
Phone 126471 0
+61 3 85595221
Fax 126471 0
Email 126471 0
[email protected]
Contact person for scientific queries
Name 126472 0
Jenelle Loeliger
Address 126472 0
Peter MacCallum Cancer Centre, 305 Grattan St, Melbourne, Victoria, 3000
Country 126472 0
Australia
Phone 126472 0
+61 3 85595221
Fax 126472 0
Email 126472 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
No additional documents have been identified.