Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000542796
Ethics application status
Approved
Date submitted
8/05/2013
Date registered
15/05/2013
Date last updated
20/01/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Enhancing Head and Neck Cancer Patients’ Experiences of Survivorship
Scientific title
Application of structured interventions to improve quality of life in head and neck cancer survivors: a randomised trial
Secondary ID [1] 282446 0
None
Universal Trial Number (UTN)
U1111-1141-9456
Trial acronym
ENHANCES
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mental Health 289058 0
Cancer
 289059 0
Quality of Life 289060 0
Chronic disease self-management 289061 0
Survivorship 289062 0
Condition category
Condition code
Mental Health 289396 289396 0 0
Depression
Cancer 289397 289397 0 0
Head and neck
Physical Medicine / Rehabilitation 289398 289398 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be randomly allocated to either Usual Care, or one of two possible interventions.

Arm 1
Information: In addition to usual care, patients will receive a written resource “Facing the future: Living with confidence after treatment for head and neck cancer”. This 61-page publication was developed by a number of health professionals involved in the treatment of people with head and neck cancer, and contains detailed information and recommendations about coping with issues such as diet and swallowing problems, oral health, fatigue, pain, stress, emotional concerns and communication. The resource has been reviewed by consumers and pilot tested at Royal Brisbane and Women’s Hospital, Herston, Australia.

Arm 2
Intervention: As with the Information Arm, patients will continue to receive usual care and the resource “Facing the future: Living with confidence after treatment for head and neck cancer”. However they will also meet with an oncology nurse who has undergone specific training in developing a tailored survivorship care plan.
The face-to-face meeting will take between 30 and 60 minutes and will focus on issues which are of concern to the patient. For example the care plan might include a graded approach to improving fatigue, or a plan about how to get into a routine to manage oral health. It might include details about how to cope with social interactions and relationship concerns, or fear of eating in public. The care plan will be designed to not just list information – it will be designed to enable participants to work out how to feel more in control of their health, deal with anxiety and give them confidence about when and how to get professional advice as needed.
Once the survivorship care plan is complete the patient will receive a written copy so that they can keep working on the issues in it. A copy will also be sent to their General Practitioner so that the GP is familiar with the issues the patient is working on can provide ongoing assistance as necessary.
Oncology nurses who are providing the intervention will undergo focused training which will include completion of a self-directed training manual and a day-long skills development session. During the delivery of the intervention the nurses will also participate in fortnightly clinical supervision, facilitated by study investigators highly experienced in health professional education and skill development.
Intervention code [1] 287090 0
Treatment: Other
Intervention code [2] 287091 0
Behaviour
Intervention code [3] 287092 0
Rehabilitation
Comparator / control treatment
Usual care: Patients will continue to receive the standard care provided at the clinic where they received treatment, including usual appointments with dieticians, speech pathologists or other health professionals.
Control group
Active

Outcomes
Primary outcome [1] 289504 0
Change in patient Quality of Life as measured by the Functional Assessment of Cancer Therapy – Head and Neck (FACT–H&N)
Timepoint [1] 289504 0
Baseline, 3-month and 6-month follow-ups
Secondary outcome [1] 302635 0
Change in self-efficacy as measured by the Cancer Behaviour Inventory (CBI.V2)
Timepoint [1] 302635 0
Baseline, 3-month and 6-month follow-ups
Secondary outcome [2] 302636 0
Change in patient mood as measured by the Hospital Anxiety and Depression Scale (HADS)
Timepoint [2] 302636 0
Baseline, 3-month and 6-month follow-ups
Secondary outcome [3] 302637 0
Change in patient general Quality of Life as measured by the EuroQol (EQ-5D)
Timepoint [3] 302637 0
Baseline, 3-month and 6-month follow-ups
Secondary outcome [4] 302638 0
Cost benefit analysis as measured by comparing the intervention resource costs against Medicare data on doctor visits and medication use in relation to the incremental health benefits as reported in the EQ-5D
Timepoint [4] 302638 0
Intervention resources costs – study wide. Medicare data – 3 months pre-intervention, 6 months during the intervention, and 3 months post intervention.
Secondary outcome [5] 302639 0
Assessment of process measures associated with the delivery of the intervention in clinical practice from a delivery perspective as reported in a one-one-one semi-structured interview with oncology nurses who have participated in the study.
Timepoint [5] 302639 0
End of study
Secondary outcome [6] 302640 0
Assessment of the process measures associated with the delivery of the intervention from a management perspective as reported in a one-on-one semi-structured interview with senior clinicians, managers and administrators.
Timepoint [6] 302640 0
End of study
Secondary outcome [7] 302641 0
Assessment of patient perceived effectiveness, satisfaction and accessibility of the intervention as reported in a one-on-one semi-structured interview with patients who have received the Intervention.
Timepoint [7] 302641 0
End of study

Eligibility
Key inclusion criteria
Patients eligible for this study must have a diagnosis of head and neck cancer and must have undergone treatment at one of the participating sites
Inclusion criteria:
* Aged 18 years or over
* Have within the past month completed a defined treatment protocol for cancer of the tongue, mouth, salivary glands. pharynx, the oro-, hypo- and nasopharynx, nasal cavities, middle ear, sinuses or larynx
OR
Within the past month have completed a defined treatment protocol for non-melanoma skin cancers of the head and neck requiring treatment known to cause toxicity (for example, combinations of surgery, radiotherapy or chemotherapy).
* Able to speak and read English
* Physical, cognitive and mental status such that can participate in the study
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria:
* Inability to speak and read English
* Receiving low-toxicity treatment for head and neck cancer (for example laser therapy alone)
* Presence of severe mental, cognitive or physical conditions with would limit the person’s ability to participate in the study, or which require ongoing regular specialist treatment
Advanced disease if life expectancy is considered to be less than 6 months

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)
Treating clinicians at the participating sites will identify patients who are potentially eligible and introduce the study to them, and ask patients if they are agreeable to speak to a research assistant who will explain the study in detail and obtain informed consent. Details of consented patients will be forwarded to the central project manager for allocation to a study arm using a computer-generated list of random numbers.
Patient resources will be sent directly according to the allocation and when appropriate the nurse who will be providing the intervention will be provided with the patient contact details so that a time can be arranged to meet.
The research assistant who will be conducting the follow-up measures will be blind to patient allocation. If the research assistant becomes aware of the patient allocation while completing follow-up measures then this finding is to be recorded, and later reviewed for possible bias.


Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The project manager will randomly allocate patients to either usual care or one of the intervention study arms using a computer-generated list of random numbers.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis
Analyses will be conducted using IBM SPSS v21. Descriptive statistics of patients’ demographic and clinical characteristics at baseline will be generated for each treatment group to consider the success of the randomisation. Summary measures at T1, T2 and T3 will be calculated as means for continuous variables and as proportions for categorical measures, including 95% confidence intervals. Separate analyses will be conducted for each outcome variable. For continuous variables, the difference between groups in the change in mean scores over time will be evaluated using a Linear Mixed Effects Model, and all available data. Otherwise, a logistic regression will be conducted using a Generalized Linear Mixed Effects Model. A group by time interaction effect will be included in all models. All analyses will be done on an intention-to-treat basis.
This study will generate qualitative data which will be critical in understanding the enablers and barriers to implementation of this model of survivorship care into routine clinical practice.

There is insufficient evidence from RCTs to calculate an accurate sample size for a psychosocial intervention in H&N cancer patients. There are limited data about meaningful change in scores in the FACT-HN although this is the most appropriate measure to capture the unique concerns of patient with H&N cancer. Hence for this preliminary study, the sample size of 40 patients per group (a total of 120 patients) is based on our capacity to enroll and retain patients, and conduct the interventions and follow-up, within the limited timeframe.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
1/06/2013
Actual
9/01/2014
Date of last participant enrolment
Anticipated
24/12/2015
Actual
17/12/2015
Date of last data collection
Anticipated
Actual
Sample size
Target
120
Accrual to date
Final
109
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 963 0
Royal Brisbane & Womens Hospital - Herston
Recruitment hospital [2] 964 0
Princess Alexandra Hospital - Woolloongabba
Recruitment postcode(s) [1] 6821 0
4029 - Royal Brisbane Hospital
Recruitment postcode(s) [2] 6822 0
4102 - Woolloongabba

Funding & Sponsors
Funding source category [1] 287224 0
Government body
Name [1] 287224 0
National Health and Medical Research Council
Country [1] 287224 0
Australia
Primary sponsor type
Individual
Name
Associate Professor Jane Turner
Address
Royal Brisbane and Women's Hospital
University of Queensland, Discipline of Psychiatry
K Floor, Mental Health Centre
Cnr Butterfield St and Bowen Bridge Rd
Herston Qld 4029
Country
Australia
Secondary sponsor category [1] 285977 0
University
Name [1] 285977 0
The University of Queensland
Address [1] 285977 0
UQ School of Medicine
Mayne Medical School
288 Herston Road
Herston QLD 4006
Country [1] 285977 0
Australia
Other collaborator category [1] 277377 0
Individual
Name [1] 277377 0
Professor Patsy Yates
Address [1] 277377 0
Queensland University of Technology
School of Nursing and Midwifery
Victoria Park Rd
Kelvin Grove Qld 4059
Country [1] 277377 0
Australia
Other collaborator category [2] 277378 0
Individual
Name [2] 277378 0
Dr Liz Kenny
Address [2] 277378 0
Cancer Care Services
Radiation Oncology
Royal Brisbane and Women's Hospital
Herston Qld 4029
Country [2] 277378 0
Australia
Other collaborator category [3] 277379 0
Individual
Name [3] 277379 0
Dr Louisa Gordon
Address [3] 277379 0
Centre for Applied Health Economics
Griffith Health Institute
Griffith University
University Dr
Meadowbrook Qld 4131
Country [3] 277379 0
Australia
Other collaborator category [4] 277380 0
Individual
Name [4] 277380 0
Professor Bryan Burmeister
Address [4] 277380 0
Director of Radiation Oncology
Division of Cancer Services
Princess Alexandra Hospital
199 Ipswich Rd
Woollongabba Qld 4102
Country [4] 277380 0
Australia
Other collaborator category [5] 277381 0
Individual
Name [5] 277381 0
Dr Damien Thomson
Address [5] 277381 0
Director of Medical Oncology
Division of Cancer Services
Princess Alexandra Hospital
199 Ipswich Rd
Wollloongabba Qld 4102
Country [5] 277381 0
Australia
Other collaborator category [6] 277382 0
Individual
Name [6] 277382 0
Dr Brett Hughes
Address [6] 277382 0
Cancer Care Services
Division of Medical Oncology
Royal Brisbane and Women's Hospital
Herston Qld 4029
Country [6] 277382 0
Australia
Other collaborator category [7] 277383 0
Individual
Name [7] 277383 0
Associate Professor Alexandra McCarthy
Address [7] 277383 0
Cancer Services Southern Clinical Network
Victoria Park Rd
Kelvin Grove Qld 4059
Country [7] 277383 0
Australia
Other collaborator category [8] 277384 0
Individual
Name [8] 277384 0
Associate Professor Chris Perry
Address [8] 277384 0
4th Floor
Watkins Medical Centre
225 Wickham Terrace
Brisbane Qld 4000
Country [8] 277384 0
Australia
Other collaborator category [9] 277385 0
Individual
Name [9] 277385 0
Mr Raymond Chan
Address [9] 277385 0
Nurse Researcher
Cancer Care Services
Royal Brisbane and Women's Hospital
Herston Qld 4029
Country [9] 277385 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289225 0
Royal Brisbane and Women's Hospital Human Research Ethics Committee
Ethics committee address [1] 289225 0
Ethics committee country [1] 289225 0
Australia
Date submitted for ethics approval [1] 289225 0
Approval date [1] 289225 0
15/04/2013
Ethics approval number [1] 289225 0
EC00172

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

Contacts
Principal investigator
Name 39794 0
A/Prof Jane Turner
Address 39794 0
Royal Brisbane and Women's Hospital
University of Queensland, Discipline of Psychiatry
K Floor, Mental Health Centre
Cnr Butterfield St and Bowen Bridge Rd
Hertston Qld 4029
Country 39794 0
Australia
Phone 39794 0
+61 7 3365 5154
Fax 39794 0
+61 7 3365 5488
Email 39794 0
[email protected]
Contact person for public queries
Name 39795 0
Jane Turner
Address 39795 0
Royal Brisbane and Women's Hospital
University of Queensland, Discipline of Psychiatry
K Floor, Mental Health Centre
Cnr Butterfield St and Bowen Bridge Rd
Hertston Qld 4029
Country 39795 0
Australia
Phone 39795 0
+61 7 3365 5154
Fax 39795 0
+61 7 3365 5488
Email 39795 0
[email protected]
Contact person for scientific queries
Name 39796 0
Jane Turner
Address 39796 0
Royal Brisbane and Women's Hospital
University of Queensland, Discipline of Psychiatry
K Floor, Mental Health Centre
Cnr Butterfield St and Bowen Bridge Rd
Hertston Qld 4029
Country 39796 0
Australia
Phone 39796 0
+61 7 3365 5154
Fax 39796 0
+61 7 3365 5488
Email 39796 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes The ENHANCES study: a randomised controlled trial ... [More Details]

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseThe ENHANCES study: a randomised controlled trial of a nurse-led survivorship intervention for patients treated for head and neck cancer.2019https://dx.doi.org/10.1007/s00520-019-04748-7
N.B. These documents automatically identified may not have been verified by the study sponsor.