None listed
Conditions
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.
Interventions
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 w
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.
Sponsors
The University of Auckland
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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.
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.
Outcome results
None listed