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Trial registered on ANZCTR


Registration number
ACTRN12614000813684
Ethics application status
Approved
Date submitted
8/07/2014
Date registered
31/07/2014
Date last updated
26/05/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Effects of a Self Regulation Intervention on Coping, Quality of Life, and Psychological Wellbeing in Patients with Head and Neck Cancer and Their Caregivers: A Randomized Controlled Trial
Scientific title
A SelfRegulation Intervention to Improve Psychological Outcomes in Patients with Head and Neck Cancer and Their Caregivers
Secondary ID [1] 284932 0
Nil known
Universal Trial Number (UTN)
U111111529215
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Health-related Quality of Life 292409 0
Depression 292410 0
Anxiety 292411 0
Head and neck cancer 292593 0
Condition category
Condition code
Cancer 292726 292726 0 0
Head and neck
Mental Health 292777 292777 0 0
Depression
Mental Health 292778 292778 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients with HNC and their caregivers will be randomly assigned to receive either standard care plus a selfregulation
intervention or to standard care alone.
Prior to randomization, after the intervention (3 months), and again 6 months after diagnosis, all patients and caregivers will complete assessments of coping, depression, anxiety, and posttraumatic stress. Patients will also complete a health related quality of life questionnaire.
Those randomized to the ‘self-regulation’ intervention will participate in three 45minute sessions and a 30minute telephone call, over the space of three months. The sessions will be conducted by a health psychologist and will take place at Auckland Hospital, or in patients’ homes if necessary. The sessions will be standardised, individually delivered, and individually tailored. Session one will be before treatment, session two during treatment, and session three will be near the end of treatment. The telephone call will take place one month later. The sessions will address patients’ and caregivers’ illness perceptions, including causal beliefs, provide education about cancer and treatment, and discuss and normalise concerns. Coping techniques will be taught, including relaxation skills and selfcare. A personal action plan will be developed, with coping strategies and plans for when and where to implement these. Concerns about the future will be covered and referrals to ongoing support will be made if necessary.
Intervention code [1] 289760 0
Treatment: Other
Comparator / control treatment
Standard treatment- This involves care from a multidisciplinary team (MDT) at Auckland City Hospital, who are well trained to deal with any issues in head and neck cancer. Members of the MDT include head and neck surgeons, a plastic surgeon, a radiation oncologist, a medical oncologist, an oral medicine specialist, a radiologist, a histopathologist, head and neck nurse specialists, a speech and language therapist, a dietician, and a social worker.
For this study, standard treatment is defined as standard information and care from the Auckland City Hospital Head and Neck Multidisciplinary team.
Control group
Active

Outcomes
Primary outcome [1] 292571 0
Health-related quality of life: Mean Functional Adjustment to Cancer Therapy - Head and Neck (FACT-H&N) score across the intervention period (with at least a 6-12 unit average difference in scores between patients in the intervention group and patients receiving standard care) (Ringash, Bezjak, O'Sullivan, Redelmeier, 2004).

Timepoint [1] 292571 0
Timepoint: Baseline, three months after completing baseline questionnaires, and again six months later.
Primary outcome [2] 292572 0
Depression: Mean General Health Questionnaire 12 (GHQ-12) score
Timepoint [2] 292572 0
Timepoint: Baseline, three months after completing baseline questionnaires, and again six months later.
Primary outcome [3] 292573 0
Anxiety: Mean Generalized Anxiety Disorder 7 (GAD-7) score
Timepoint [3] 292573 0
Timepoint: Baseline, three months after completing baseline questionnaires, and again six months later.
Secondary outcome [1] 309257 0
Post-traumatic Stress: Mean score on the PDS (Posttraumatic Diagnostic Scale).
Timepoint [1] 309257 0
Timepoint: Baseline, three months after completing baseline questionnaires, and again six months later.

Eligibility
Key inclusion criteria
Inclusion criteria - patients: will include patients of any age with a diagnosis of any cancer site/type in the head and neck region within the last four weeks (specifically, carcinoma in the pharynx, larynx, oral cavity, nose, sinuses, oesophagus, salivary glands or a skin cancer in the head and neck region)
Inclusion criteria - caregivers: will include a family member, friend, spouse or formal caregiver who is responsible for providing physical and/or emotional care.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
HNC patients and their caregivers will be excluded if they are unable to speak or read English, if they have conditions that would interfere with their participation (including cognitive impairment, significant physical disability, or severe psychiatric conditions), or if the patient is to be treated with palliative intent.

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)
The person who will determine eligibility to this trial will be unaware of allocation to group, as the allocation decision will be made after participants have been enrolled in the study. Allocation will be concealed by computer randomization.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A person independent of the study (a doctoral student with no contact at all with study participants) will do the randomization and allocation of treatment, using a randomization table created by computer software. This information will then be placed in a sealed envelope.
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
Data will be analysed using SPSS. Analysis of covariance will be carried out to compare change scores between HNC patients and caregivers in the intervention and standard care groups with respect to outcomes of HRQL, depression, and anxiety (while controlling for baseline measurements).

The AFTER intervention trial found an effect size of d=.7 for reducing anxious pre-occupation in patients with HNC(Humphris & Rogers, 2012). Setting power of 0.80, and an alpha of .05, G-power software indicates that a total sample of 68 participants would be needed to detect this effect. Since not all patients will have caregivers who can participate, we will aim to recruit a total of 100 patients and 70 caregivers, to give us sufficient power to detect an effect of this size.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/08/2014
Actual
1/08/2014
Date of last participant enrolment
Anticipated
Actual
20/07/2015
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
64
Recruitment outside Australia
Country [1] 6202 0
New Zealand
State/province [1] 6202 0

Funding & Sponsors
Funding source category [1] 289565 0
Charities/Societies/Foundations
Name [1] 289565 0
The Oakley Mental Health Research Foundation
Country [1] 289565 0
New Zealand
Funding source category [2] 289673 0
Charities/Societies/Foundations
Name [2] 289673 0
The Maurice and Phyllis Paykel Trust
Country [2] 289673 0
New Zealand
Primary sponsor type
University
Name
The University of Auckland
Address
The University of Auckland
Private Bag 92019
Auckland 1142
New Zealand
Country
New Zealand
Secondary sponsor category [1] 288365 0
Hospital
Name [1] 288365 0
Auckland District Health Board
Address [1] 288365 0
Research Office
Level 14, Support Bldg, Auckland City Hospital.
Private Bag 92024, Auckland, New Zealand
Tel: 064 9 307 4949
Fax: 09 307 8913
Country [1] 288365 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291303 0
Health and Disability Ethics Committee
Ethics committee address [1] 291303 0
Ethics committee country [1] 291303 0
New Zealand
Date submitted for ethics approval [1] 291303 0
Approval date [1] 291303 0
04/04/2014
Ethics approval number [1] 291303 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 116 116 0 0
/AnzctrAttachments/366673-StudyProtocol.pdf
Attachments [2] 117 117 0 0
/AnzctrAttachments/366673-HDEC_EthicsApproval.pdf

Contacts
Principal investigator
Name 49750 0
Miss Amy Richardson
Address 49750 0
The University of Auckland
Department of Psychological Medicine
Faculty of Medical and Health Sciences
Private Bag 92019
Auckland 1142
New Zealand
Country 49750 0
New Zealand
Phone 49750 0
+64 09 373 7599 ext 89473
Fax 49750 0
Email 49750 0
[email protected]
Contact person for public queries
Name 49751 0
Amy Richardson
Address 49751 0
The University of Auckland
Department of Psychological Medicine
Faculty of Medical and Health Sciences
Private Bag 92019
Auckland 1142
New Zealand
Country 49751 0
New Zealand
Phone 49751 0
+64 09 373 7599 ext 89473
Fax 49751 0
Email 49751 0
[email protected]
Contact person for scientific queries
Name 49752 0
Amy Richardson
Address 49752 0
The University of Auckland
Department of Psychological Medicine
Faculty of Medical and Health Sciences
Private Bag 92019
Auckland 1142
New Zealand
Country 49752 0
New Zealand
Phone 49752 0
+64 09 373 7599 ext 89473
Fax 49752 0
Email 49752 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

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