None listed
Conditions
Brief summary
Relatives or friends who care for a person diagnosed with pancreatic cancer have a high need for support themselves. The purpose of this study is to determine if it is helpful and cost-effective for carers to regularly talk to an experienced nurse-counsellor via video conferencing or over the telephone. Who is it for? You may be eligible for this study if you care for someone who has been diagnosed with pancreatic cancer, you and the person you care for live in Australia, you are over 18 years old and can speak and write in English. Study Details Carers of people who have been recently diagnosed with Pancreatic Cancer will be randomly allocated by chance to one of two groups. One group will be offered ten 60 minute counselling sessions with a trained oncology nurse-counsellor over 4 months. The other group will be offered written information only. Both groups will be asked to complete questionnaires about how they are feeling at enrolment and at 2, 4 and 6 months after joining the study. In addition, each person will be interviewed over the telephone each month for other relevant health event information and, with consent, de-identified data will be matched with Medicare and the Queensland Hospital Admitted Patient Data Collection in order to measure if each group has used hospital and medical services differently. It is optional for the person with cancer that participating carers look after to also complete 4 surveys and/or give permission to access their medical records too. Our aim is to determine whether taking part in our support service reduces carers’ anxiety, depression, tiredness, and need for help. We will also see if the service makes carers feel better able to cope and improves their overall quality of life. We will also investigate whether supporting carers reduces the number of times patients with pancreatic cancer have to go to the hospital emergency department and the length of time in hospital. We will see if our service for carers improves patients’ quality of life. Finally, we will determine if the service is cost-effective. Ultimately, it is hoped this research will improve the standard of care, education and support for people affected by pancreatic cancer and their carers in the future.
Interventions
PRoCESS is a pragmatic trial of a nurse-led telehealth counselling service for family carers of people diagnosed with pancreatic cancer. The study design is a two-arm randomised controlled trial in which 200 people who are caring for patients with pancreatic cancer will be randomised in a 1:1 ratio to: A four-month structured telephone counselling intervention plus a comprehensive information package supplied by PanKind, The Australian Pancreatic Cancer Foundation (Arm 1); or the information pac
PRoCESS is a pragmatic trial of a nurse-led telehealth counselling service for family carers of people diagnosed with pancreatic cancer. The study design is a two-arm randomised controlled trial in which 200 people who are caring for patients with pancreatic cancer will be randomised in a 1:1 ratio to: A four-month structured telephone counselling intervention plus a comprehensive information package supplied by PanKind, The Australian Pancreatic Cancer Foundation (Arm 1); or the information package alone (Arm 2). The study duration for each participant will be 6 months of follow-up. Participants in Arm 1 will be offered ten one-hour counselling sessions over four months (weekly for 4 weeks, then fortnightly) and then if desired further monthly booster sessions until the end of the study. The mode of delivery will be by video conferencing (zoom, skype or equivalent) or telephone, based on participant preference. With consent, all sessions will be recorded. The intervention is based on a self-efficacy paradigm and involves assessing needs, delivering intervention components appropriate to those needs, revaluating needs at each session, and providing a care plan or referrals where the nurse’s assessment is that further management may be warranted. The intervention will be delivered by a trained palliative care or oncology nurse and will cover the following components (as required): 1. Psychoeducation about the psychological impact of cancer 2. Coping, problem-solving and stress management skills 3. Cognitive therapy and challenging unhelpful thoughts 4. Enhancing relationships and support networks 5. Psychoeducation about non-pharmacological approaches for stress management (mindfulness, exercise, relaxation) 6. Education about pharmacotherapy for patients’ pain 7. Education about management of pancreatic exocrine insufficiency 8. Psychoeducation about managing complex medication regimens and their side-effects 9. Psychoeducation about decline in mobility and/or functional status 10. End-of-life decision-making, care planning, strategies to enhance hope 11. Bereavement counselling Intervention implementation will be evaluated using the RE-AIM Framework. In terms of intervention fidelity our study database will track completed session as per the planned schedule over four months/enrolled intervention participants.
Sponsors
QIMR Berghofer Medical Research Institute
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Educational / counselling / training
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Primary carer for a patient diagnosed with pancreatic cancer * Resident in Australia
Exclusion criteria
* Inability to read and speak English * Intention to complete fewer than 6 counselling sessions
Outcome results
None listed