None listed
Conditions
Brief summary
A pilot randomised study (ACTRN12609000452291) has been conducted and this current study is a larger multi-centre randomised controlled trial (RCT). This RCT will further evaluate a novel telephone-based intervention for carers of patients with advanced gastrointestinal cancer. The intervention involves five structured calls from a nurse to the carer over 10 weeks, aiming to improve psychosocial outcomes for carers. This study aims to assess the effectiveness of the intervention on carers quality of life, unmet supportive care needs, psychological distress and carer burden. This study will also ascertain effectiveness of the carer intervention to improve patient outcomes (patients unmet needs, psychological distress, quality of life and unplanned health service utilisation).
Interventions
A structured telephone intervention delivered by a cancer nurse. The primary carers of people diagnosed with poor prognosis gastrointestinal cancer (colorectal Duke's stage D, oesophagus, stomach, pancreas, gall bladder, bile duct or small bowel) will be asked to complete a baseline questionnaire. Carers will then be randomised into the intervention or control group. Carers in the intervention group will receive five telephone calls from the cancer nurse in the 10 weeks following the patient that they are carer for is discharged from hospital (the first call is at Day 3 post-discharge and then the remaining four will be fortnightly ie Day 17, 31, 45 and 59). Calls will vary in duration and be dependent on each individual carer's need however will be based a standardised structured screening tool. The intervention will provide information and advice to the carer on physical, psychosocial, information, practical and supportive care needs. Other needs that carers have will also be explored. It is anticipated that calls will last about 20-30 minutes.
Sponsors
A/Prof Jane Young
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Educational / counselling / training
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Carers must be the *principal informal carer of a patient who has had a surgical procedure for poor prognosis gastrointestinal cancer (colorectal Duke's stage D, oesophagus, stomach, pancreas, gall bladder, bile duct or small bowel). Carers must *have access to a telephone, *have sufficient English skills to participate, *are able to understand the study and give informed consent.
Exclusion criteria
Carers without *access to a telephone or unable to use a telephone (eg due to deafness), *are cognitively impaired, *do not speak and read English to a level that would allow them to participate or *do not plan to reside in Australia for the next three months will be excluded from the study
Outcome results
None listed