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Trial registered on ANZCTR


Registration number
ACTRN12609000920291
Ethics application status
Approved
Date submitted
22/10/2009
Date registered
26/10/2009
Date last updated
10/11/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Improving psychosocial outcomes for patients with poor prognosis gastrointestinal cancer and their carers: A randomised controlled trial
Scientific title
Randomised telephone intervention to improve psychosocial outcomes for patients with poor prognosis gastrointestinal cancer and their carers
Secondary ID [1] 287858 0
nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gastrointestinal cancer 252049 0
Condition category
Condition code
Cancer 252241 252241 0 0
Bowel - Back passage (rectum) or large bowel (colon)
Cancer 252243 252243 0 0
Stomach
Cancer 252257 252257 0 0
Oesophageal (gullet)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 241447 0
Behaviour
Comparator / control treatment
Carers assigned to the control group will not receive any additional support and follow-up other than what has been provided or arranged for them (or the person they are caring for) by the treating medical team at Royal Prince Alfred, Concord or Westmead Hospitals
Control group
Active

Outcomes
Primary outcome [1] 253114 0
Quality of Life (QoL).
QoL of carers and patients will be measured using the SF-12, a generic measure of health-related quality of life. The SF-12 comprises of 12 items relating to physical and psychological QoL
Timepoint [1] 253114 0
Baseline (during the patients hospital admission) then 1, 3 and 6 months after the patient's hospital discharge.
Secondary outcome [1] 257984 0
Unmet supportive care needs.
Unmet supportive care needs of carers and patients will be measured using the Partner and Caregiver version of the Supportive Care Needs Survey. This is a 44 item questionnaire assessing physical, psychosocial, information and practical needs.
Timepoint [1] 257984 0
Baseline (during the patients hospital admission) then 1, 3 and 6 months after the patient's hospital discharge.
Secondary outcome [2] 257985 0
Carer and patient psychological distress will be measured using the "Distress Thermometer".
Timepoint [2] 257985 0
Baseline (during the patients hospital admission) then 1, 3 and 6 months after the patient's hospital discharge.
Secondary outcome [3] 257986 0
Carer burden will be measured using the Caregiver Reaction Assessment, a 24-item questionnaire that assesses four negative and one positive dimensions of burden.
Timepoint [3] 257986 0
Baseline (during the patient they are a carers for hospital admission) then 1, 3 and 6 months after the patient's hospital discharge.
Secondary outcome [4] 257987 0
Unplanned health service utlisation. Patients unplanned health service utilisation (emergency department visits, general practitioner, surgeon, oncologist, palliative care, allied health, community services) will be ascertained in a telephone interview with the carer
Timepoint [4] 257987 0
1, 3 and 6 months after the patient's hospital discharge.

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
All patients who are admitted to Royal Prince Alfred Hospital (RPAH), Concord Repatriation General Hospital (CRGH) and Westmead Hospital for surgery for an upper gastrointestinal malignancy (oesophagus, stomach, pancreas, gall bladder or bile duct, small bowel) or for Dukes D colorectal cancer will be invited to participate by their surgeon who will provide them with written and verbal information about the study and obtain written consent. Patients will be asked to nominate their main carer. The surgeon will provide the details of consenting patients to the research coordinator [RC] who will then visit the patient prior to their discharge from hospital. The RC will explain the study processes in more detail and will obtain contact details for the nominated carer and permission from the patient for their carer to be contacted by a member of the research team. The RC will then contact each nominated carer and arrange to meet them prior to the patient’s discharge from hospital. The RC will explain the study to the carer, obtain written consent and ask them to complete a baseline self-administered questionnaire. Demographic information about the carer will be obtained in a short face-to-face interview with the RC. The details of consenting carers and patients and baseline data will be forwarded by the RC to a central second, independent researcher who will randomly allocate carers to the intervention or control groups using a computer-generated randomisation schedule. This will ensure allocation concealment in that the surgeons and RC who are actively involved in recruiting participants will be unaware of the group allocation sequence.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by using a randomisation table created by computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/03/2010
Actual
5/04/2011
Date of last participant enrolment
Anticipated
25/03/2013
Actual
25/03/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
160
Accrual to date
Final
128
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 2158 0
2050
Recruitment postcode(s) [2] 2159 0
2145
Recruitment postcode(s) [3] 2160 0
2139

Funding & Sponsors
Funding source category [1] 243917 0
Government body
Name [1] 243917 0
NHMRC
Country [1] 243917 0
Australia
Primary sponsor type
Individual
Name
A/Prof Jane Young
Address
Surgical Outcomes Research Centre (SOuRCe), Royal Prince Alfred Hospital, PO BOX M157, Missenden Road, Camperdown, NSW, 2050
Country
Australia
Secondary sponsor category [1] 251269 0
Individual
Name [1] 251269 0
Prof Phyllis Butow
Address [1] 251269 0
Surgical Outcomes Research Centre (SOuRCe), Royal Prince Alfred Hospital, PO BOX M157, Missenden Road, Camperdown, NSW, 2050
Country [1] 251269 0
Australia
Secondary sponsor category [2] 251270 0
Individual
Name [2] 251270 0
Prof Michael Solomon
Address [2] 251270 0
Surgical Outcomes Research Centre (SOuRCe), Royal Prince Alfred Hospital, PO BOX M157, Missenden Road, Camperdown, NSW, 2050
Country [2] 251270 0
Australia
Secondary sponsor category [3] 251272 0
Individual
Name [3] 251272 0
Dr David Storey
Address [3] 251272 0
Department of Upper Gastrointestinal Surgery, Suite 306, RPAH Medical Centre, 100 Carillon Avenue, Newtown, NSW, 2042
Country [3] 251272 0
Australia
Secondary sponsor category [4] 251273 0
Individual
Name [4] 251273 0
Prof Patricia Davidson
Address [4] 251273 0
Centre for Cardiovascular & Chronic Care, Curtin University of Technology, 39 Regent Street, Chippendale, NSW, 2008
Country [4] 251273 0
Australia
Secondary sponsor category [5] 251274 0
Individual
Name [5] 251274 0
Dr David Martin
Address [5] 251274 0
Department of Upper Gastrointestinal Surgery, Suite 2, 3 Everton Drive, Strathfield, NSW, 2139
Country [5] 251274 0
Australia
Secondary sponsor category [6] 251275 0
Individual
Name [6] 251275 0
Dr Michael Hollands
Address [6] 251275 0
Department of Gastrointestinal and Hepatopancreatobilary Surgery, Westmead Hospital, Darcy Rd & Hawkesbury Rd, Westmead, NSW, 2145
Country [6] 251275 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 244031 0
Sydney South West Area Health Service (RPAH Zone)
Ethics committee address [1] 244031 0
Research & Development Office, Level 3, Building 92, Royal Prince Alfred Hospital, Missenden Road, Camperdown, NSW, 2050
Ethics committee country [1] 244031 0
Australia
Date submitted for ethics approval [1] 244031 0
28/10/2009
Approval date [1] 244031 0
27/07/2011
Ethics approval number [1] 244031 0

Summary
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).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30411 0
Prof Jane Young
Address 30411 0
Surgical Outcomes Research Centre
RPAH
level 9 Bld 89
Missenden Rd Camperdown NSW 2050
Country 30411 0
Australia
Phone 30411 0
+61 2 95153200
Fax 30411 0
Email 30411 0
[email protected]
Contact person for public queries
Name 13658 0
Prof Jane Young
Address 13658 0
Surgical Outcomes Research Centre (SOuRCe), Royal Prince Alfred Hospital, PO BOX M157, Missenden Road, Camperdown, NSW, 2050
Country 13658 0
Australia
Phone 13658 0
+61 9515 3200
Fax 13658 0
+61 2 9515 3222
Email 13658 0
[email protected]
Contact person for scientific queries
Name 4586 0
Prof Jane Young
Address 4586 0
Surgical Outcomes Research Centre (SOuRCe), Royal Prince Alfred Hospital, PO BOX M157, Missenden Road, Camperdown, NSW, 2050
Country 4586 0
Australia
Phone 4586 0
+61286270359
Fax 4586 0
+61 2 9515 3222
Email 4586 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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseImproving psychosocial outcomes for caregivers of people with poor prognosis gastrointestinal cancers: a randomized controlled trial (Family Connect).2016https://dx.doi.org/10.1007/s00520-015-2817-3
N.B. These documents automatically identified may not have been verified by the study sponsor.