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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
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Scientific title
A SelfRegulation Intervention to Improve Psychological Outcomes in Patients with Head and Neck Cancer and Their Caregivers
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Secondary ID [1]
284932
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Nil known
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Universal Trial Number (UTN)
U111111529215
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Health-related Quality of Life
292409
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Depression
292410
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Anxiety
292411
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Head and neck cancer
292593
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Condition category
Condition code
Cancer
292726
292726
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0
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Head and neck
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Mental Health
292777
292777
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0
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Depression
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Mental Health
292778
292778
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0
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Anxiety
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
289760
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Treatment: Other
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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.
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Control group
Active
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Outcomes
Primary outcome [1]
292571
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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).
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Assessment method [1]
292571
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Timepoint [1]
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Timepoint: Baseline, three months after completing baseline questionnaires, and again six months later.
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Primary outcome [2]
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Depression: Mean General Health Questionnaire 12 (GHQ-12) score
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Assessment method [2]
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Timepoint [2]
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Timepoint: Baseline, three months after completing baseline questionnaires, and again six months later.
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Primary outcome [3]
292573
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Anxiety: Mean Generalized Anxiety Disorder 7 (GAD-7) score
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Assessment method [3]
292573
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Timepoint [3]
292573
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Timepoint: Baseline, three months after completing baseline questionnaires, and again six months later.
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Secondary outcome [1]
309257
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Post-traumatic Stress: Mean score on the PDS (Posttraumatic Diagnostic Scale).
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Assessment method [1]
309257
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Timepoint [1]
309257
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Timepoint: Baseline, three months after completing baseline questionnaires, and again six months later.
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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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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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.
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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.
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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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.
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
1/08/2014
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Actual
1/08/2014
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Date of last participant enrolment
Anticipated
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Actual
20/07/2015
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
100
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Accrual to date
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Final
64
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Recruitment outside Australia
Country [1]
6202
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New Zealand
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State/province [1]
6202
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Funding & Sponsors
Funding source category [1]
289565
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Charities/Societies/Foundations
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Name [1]
289565
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The Oakley Mental Health Research Foundation
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Address [1]
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Physical address:
Management Accountants Limited
Building 1, Unit A, 100 Bush Road
Rosedale, Auckland 0632
Postal address:
PO Box 302499
North Harbour
Auckland 0751
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Country [1]
289565
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New Zealand
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Funding source category [2]
289673
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Charities/Societies/Foundations
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Name [2]
289673
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The Maurice and Phyllis Paykel Trust
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Address [2]
289673
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PO Box 37 760 Parnell
Auckland 1151, New Zealand
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Country [2]
289673
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New Zealand
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Primary sponsor type
University
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Name
The University of Auckland
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Address
The University of Auckland
Private Bag 92019
Auckland 1142
New Zealand
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Country
New Zealand
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Secondary sponsor category [1]
288365
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Hospital
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Name [1]
288365
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Auckland District Health Board
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Address [1]
288365
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Research Office
Level 14, Support Bldg, Auckland City Hospital.
Private Bag 92024, Auckland, New Zealand
Tel: 064 9 307 4949
Fax: 09 307 8913
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Country [1]
288365
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New Zealand
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
291303
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Health and Disability Ethics Committee
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Ethics committee address [1]
291303
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Ministry of Health
C/- MEDSAFE, Level 6, Deloitte House
10 Brandon Street
PO Box 5013
Wellington
6011
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Ethics committee country [1]
291303
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New Zealand
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Date submitted for ethics approval [1]
291303
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Approval date [1]
291303
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04/04/2014
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Ethics approval number [1]
291303
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Summary
Brief summary
The primary purpose of this study is to determine whether a self-regulation intervention can improve health-related quality of life (HRQL) in patients with head and neck cancer (HNC).
The folllowing hypotheses will be tested:
- A self-regulation intervention will lead to better HRQL, and lower depression and anxiety, in patients with HNC.
- The intervention will lower depression, anxiety and post-traumatic stress in the family caregivers of patients with HNC.
- The intervention will cause adaptive changes in illness perceptions and coping strategies in both patients with HNC and their caregivers
- Changes will be maintained over time (three months after the intervention).
- Changes in illness perceptions and coping strategies will be associated with improvements in quality of life and reductions in depression, anxiety, and post-traumatic stress.
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Trial website
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Trial related presentations / publications
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Public notes
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Attachments [1]
116
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/AnzctrAttachments/366673-StudyProtocol.pdf
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Attachments [2]
117
117
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/AnzctrAttachments/366673-HDEC_EthicsApproval.pdf
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Contacts
Principal investigator
Name
49750
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Miss Amy Richardson
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Address
49750
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The University of Auckland
Department of Psychological Medicine
Faculty of Medical and Health Sciences
Private Bag 92019
Auckland 1142
New Zealand
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Country
49750
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New Zealand
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Phone
49750
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+64 09 373 7599 ext 89473
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Fax
49750
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Email
49750
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[email protected]
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Contact person for public queries
Name
49751
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Miss Amy Richardson
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Address
49751
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The University of Auckland
Department of Psychological Medicine
Faculty of Medical and Health Sciences
Private Bag 92019
Auckland 1142
New Zealand
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Country
49751
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New Zealand
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Phone
49751
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+64 09 373 7599 ext 89473
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Fax
49751
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Email
49751
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[email protected]
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Contact person for scientific queries
Name
49752
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Miss Amy Richardson
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Address
49752
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The University of Auckland
Department of Psychological Medicine
Faculty of Medical and Health Sciences
Private Bag 92019
Auckland 1142
New Zealand
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Country
49752
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New Zealand
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Phone
49752
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+64 09 373 7599 ext 89473
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Fax
49752
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Email
49752
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[email protected]
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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.
Download to PDF