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Trial registered on ANZCTR


Registration number
ACTRN12614001104640
Ethics application status
Approved
Date submitted
25/09/2014
Date registered
17/10/2014
Date last updated
16/04/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Working towards meeting the information needs of patients with head and neck cancer and their partner, carer or family member. A randomised study comparing DVD and internet resources versus standard patient education.
Scientific title
A randomised clinical trial to examine anxiety levels in patients with head and neck cancer by comparing standard pre and post-operative patient education to DVD/internet-based education.
Secondary ID [1] 285382 0
Nil
Universal Trial Number (UTN)
Trial acronym
MINT study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anxiety 293116 0
Depression 293146 0
Head and neck cancer 293173 0
Condition category
Condition code
Cancer 293387 293387 0 0
Head and neck
Mental Health 293447 293447 0 0
Depression
Mental Health 293448 293448 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Those randomised to intervention will receive the intervention DVD (or website for those with internet access) for pre and post-operative education as well as the standard hard copy booklet. As the pre-operative time is variable, it will be up to the participant to view the video, and it can be viewed as many times as the participant chooses. Post-oerpatively it is also up to the participant when to view the video.
The video-based intervention contains presentations about key issues faced during surgical treatment for head and neck cancer and will take up to 60 minutes to view.
The patient is also contacted at 3 timepoints of:
-pre-op clinic
-at discharge from hospital after surgery
-at 3 months post-surgery
At these timepoints patients will be asked what parts of the video they may have watched.
Intervention code [1] 290295 0
Treatment: Other
Comparator / control treatment
Standard education is made up of anaitial contact with the Head and Neck Cancer Clinical Nurse Consultant who provides the patient with the Cancer Council Australia Head and Neck Cancer Information booklet. It is then up to the patient to make further contact if they have any questions regarding his/her treatment. These patients do not receive any post-op nursing follow-up, but are seen by the treating surgeon.
Control group
Active

Outcomes
Primary outcome [1] 293219 0
7-item Hospital Anxiety and Depression Scale (HADS) -Anxiety Subscale
Timepoint [1] 293219 0
Pre-operatively, post-discharge, and at 3 months post-operatively.
Secondary outcome [1] 310615 0
7-item HADS Depression subscale for patient only.
Timepoint [1] 310615 0
Pre-op, post discharge and 3 months post-op
Secondary outcome [2] 310616 0
Quality of life (QOL) 35-item Assessment of Quality of Life – 8 Dimensions Scale for patient only.
Timepoint [2] 310616 0
Pre-operatively, post-discharge, and at 3 months post-op.
Secondary outcome [3] 310617 0
For patient and partner:
Appraisal 28-item Kessler Cognitive Appraisal of Health Scale
Timepoint [3] 310617 0
Pre-operatively, post-discharge, and at 3 months post-op.
Secondary outcome [4] 310652 0
Self-efficacy:
For patient and partner:
-12-item Communication and Attitudinal Self-Efficacy Scale for cancer
-29-item Strategies Used by People to Promote Health
-10-item Perceived Efficacy in Patient-Physician Interactions
For partner only:
-48-item Caregiver Empowerment Scale
Timepoint [4] 310652 0
Pre-operatively, post-discharge, and at 3 months post-op.
Secondary outcome [5] 310654 0
Shame and Stigma Scale in head and neck cancer:
For patient only:
20-item Shame and Stigma Scale in head and neck cancer
Timepoint [5] 310654 0
Pre-operatively, post-discharge, and at 3 months post-op.
Secondary outcome [6] 310655 0
Information needs:
Patient only:
37-item Cancer Information Needs Survey
Timepoint [6] 310655 0
Pre-operatively, post-discharge, and at 3 months post-op.

Eligibility
Key inclusion criteria
-Written informed consent
-18 years and older
-diagnosed with a primary, early-stage head and neck cancer and
-treatment plan includes surgery.
-Patients and their carers or family members also need sufficient fluency in English and be cognitively able to 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
-Do not meet inclusion criteria.
-Pregnant females

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
After written informed consent has been provided the patient will be randomised by an independent person, who will notify the treating team of the allocated treatment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation will be computer-generated with block lengths of variable size and stratified by surgeon and site.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Based on historical Hospital Anxiety and Depression Scale data the standard deviation of the response variable is 3.75. With a power of 0.8 and an alpha level of 0.05 (2-sided) and in order to detect a treatment difference if the true difference between treatments is 1.500 units, the sample size calculation is then that we need 250 patients to have at 0.8 power to make a comparison (125 in in the intervention group and 125 in the control group).

Recruitment
Recruitment status
Stopped early
Data analysis
No data analysis planned
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
20/10/2014
Actual
20/10/2015
Date of last participant enrolment
Anticipated
Actual
13/06/2016
Date of last data collection
Anticipated
Actual
31/08/2016
Sample size
Target
250
Accrual to date
Final
50
Recruitment in Australia
Recruitment state(s)
NSW,SA
Recruitment hospital [1] 3009 0
John Hunter Hospital Royal Newcastle Centre - New Lambton
Recruitment hospital [2] 3017 0
The Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 8725 0
2305 - New Lambton Heights
Recruitment postcode(s) [2] 8732 0
5000 - Adelaide

Funding & Sponsors
Funding source category [1] 289992 0
Hospital
Name [1] 289992 0
John Hunter Hospital
Country [1] 289992 0
Australia
Primary sponsor type
Hospital
Name
John Hunter Hospital
Address
Lookout Road
New Lambton Heights NSW 2305
Country
Australia
Secondary sponsor category [1] 288677 0
None
Name [1] 288677 0
Address [1] 288677 0
Country [1] 288677 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291701 0
Huner New England Human Research Ethics Committee
Ethics committee address [1] 291701 0
Ethics committee country [1] 291701 0
Australia
Date submitted for ethics approval [1] 291701 0
Approval date [1] 291701 0
10/09/2014
Ethics approval number [1] 291701 0
14/08/20/4.09

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 194 194 0 0
/AnzctrAttachments/367139-1408204 09 Approval Multi-site LeadHREC.pdf

Contacts
Principal investigator
Name 51614 0
Prof Vicki Parker
Address 51614 0
James Fletcher Campus
Locked Bag 1
Newcastle NSW 2011
Country 51614 0
Australia
Phone 51614 0
+61 2 49246724
Fax 51614 0
Email 51614 0
vicki.parker@hnehealth.nsw.gov.au
Contact person for public queries
Name 51615 0
Vicki Parker
Address 51615 0
James Fletcher Campus
Locked Bag 1
Newcastle NSW 2011
Country 51615 0
Australia
Phone 51615 0
+61 2 49246724
Fax 51615 0
Email 51615 0
vicki.parker@hnehealth.nsw.gov.au
Contact person for scientific queries
Name 51616 0
Vicki Parker
Address 51616 0
James Fletcher Campus
Locked Bag 1
Newcastle NSW 2011
Country 51616 0
Australia
Phone 51616 0
+61 2 49246724
Fax 51616 0
Email 51616 0
vicki.parker@hnehealth.nsw.gov.au

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
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.