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Trial registered on ANZCTR


Registration number
ACTRN12609000452291
Ethics application status
Approved
Date submitted
21/04/2009
Date registered
12/06/2009
Date last updated
4/09/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
Improving psychosocial outcomes for cancer carers: A pilot study
Scientific title
Telephone intervention to improve psychosocial outcomes for carers of people with poor prognosis gastrointestinal cancer
Secondary ID [1] 273325 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gastrointestinal cancer 4634 0
Condition category
Condition code
Public Health 4936 4936 0 0
Health service research
Cancer 237308 237308 0 0
Bowel - Back passage (rectum) or large bowel (colon)

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. It is anticipated that calls will last about 20 minutes.
Intervention code [1] 4394 0
Other interventions
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 Hospital
Control group
Active

Outcomes
Primary outcome [1] 5782 0
Acceptability. Acceptability will be assessed by ascertaining the proportion of carers who complete each call at each time point. Demographic and clinical characteristics of carers allocated to the intevrention group who did or did not accpet or complete each call will be compared to assess the acceptability. Furthermore, qualitative semi-structured interviews will be conducted at 3 months following the patient's hopital discharge and when the intervention is complete in order to gather detailed feedback of participant's views of the intervention.
Timepoint [1] 5782 0
Days 3, 17, 31, 45 and 59 after the patient's hospital discharge.
Primary outcome [2] 5783 0
Feasibility. Feasibility of the intervention will be determined by assessing the number of calls required to achieve a successful intervention call. Mean, standard devaitions, median and range of time taken for calls at each time point will also be calculated.
Timepoint [2] 5783 0
Days 3, 17, 31, 45 and 59 after the patient's hospital discharge.
Secondary outcome [1] 241756 0
Self-efficacy will be measured using The General Self-Efficacy Scale, a 10-item questionnaire that determines a general sense of percived self-efficacy relating to daily life hassles and adaption after experiencing stressful life events.
Timepoint [1] 241756 0
Carer's will be assessed at 1 and 3 month after the patient's hospital discharge.
Secondary outcome [2] 241757 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 [2] 241757 0
Carer's will be assessed at 1 and 3 month after the patient's hospital discharge.
Secondary outcome [3] 241758 0
Psychological distress will be measured using the "Distress Thermometer".
Timepoint [3] 241758 0
Carer's will be assessed at 1 and 3 month after the patient's hospital discharge.
Secondary outcome [4] 241759 0
Mental well-being will be measured using the Mental Component Scale of the SF-12 Quality of Life Instrument.
Timepoint [4] 241759 0
Carer's will be assessed at 1 and 3 month after the patient's hospital discharge.
Secondary outcome [5] 241760 0
Mastery will be assessed using the Mastery Scale, a 7-item scale that assesses control over life events.
Timepoint [5] 241760 0
Carer's will be assessed at 1 and 3 month 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) 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 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
1/07/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
44
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 4816 0
Hospital
Name [1] 4816 0
Surgical Outcomes Research Centre (SOuRCe)
Country [1] 4816 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] 4350 0
Individual
Name [1] 4350 0
Prof Phyllis Butow
Address [1] 4350 0
Surgical Outcomes Research Centre (SOuRCe), Royal Prince Alfred Hospital, PO BOX M157, Missenden Road, Camperdown, NSW, 2050
Country [1] 4350 0
Australia
Secondary sponsor category [2] 4351 0
Individual
Name [2] 4351 0
Prof Michael Solomon
Address [2] 4351 0
Surgical Outcomes Research Centre (SOuRCe), Royal Prince Alfred Hospital, PO BOX M157, Missenden Road, Camperdown, NSW, 2050
Country [2] 4351 0
Australia
Secondary sponsor category [3] 4352 0
Individual
Name [3] 4352 0
Dr David Story
Address [3] 4352 0
Department of Upper Gastrointestinal Surgery, Suite 306, RPAH Medical Centre, 100 Carillon Avenue, Newtown, NSW, 2042
Country [3] 4352 0
Australia
Secondary sponsor category [4] 4353 0
Individual
Name [4] 4353 0
Prof Patricia Davidson
Address [4] 4353 0
Centre for Cardiovascular & Chronic Care, Curtin University of Technology, 39 Regent Street, Chippendale, NSW, 2008
Country [4] 4353 0
Australia
Secondary sponsor category [5] 4354 0
Individual
Name [5] 4354 0
Dr David Martin
Address [5] 4354 0
Department of Upper Gastrointestinal Surgery, Suite 2, 3 Everton Drive, Strathfield, NSW, 2139
Country [5] 4354 0
Australia
Secondary sponsor category [6] 4355 0
Individual
Name [6] 4355 0
Mr Brian Dea
Address [6] 4355 0
Consumer Representative, 22 Eastview Avenue, North Ryde, NSW, 2113
Country [6] 4355 0
Australia
Secondary sponsor category [7] 4356 0
Individual
Name [7] 4356 0
Mr James Harrison
Address [7] 4356 0
Surgical Outcomes Research Centre (SOuRCe), Royal Prince Alfred Hospital, PO BOX M157, Missenden Road, Camperdown, NSW, 2050
Country [7] 4356 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6864 0
Sydney South West Area Health Service (RPAH Zone)
Ethics committee address [1] 6864 0
Research & Development Office, RPAH Medical Centre, 100 Carillon Avenue, Newtown, NSW 2042
Ethics committee country [1] 6864 0
Australia
Date submitted for ethics approval [1] 6864 0
Approval date [1] 6864 0
12/05/2009
Ethics approval number [1] 6864 0
HREC09/09/RPAH/129

Summary
Brief summary
This pilot randomised controlled trial (RCT) will test 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 pilot study aims to assess the feasibilty and acceptability of the intervention and determine any impact on carer outcomes. If the results are positive, this telephone intervention will be evaluated in a multi-centre randomised controlled trial (RCT) and could be implemented broadly in both metropolitan and rural areas, and could be adapted for other groups of carers.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29513 0
Address 29513 0
Country 29513 0
Phone 29513 0
Fax 29513 0
Email 29513 0
Contact person for public queries
Name 12760 0
Mr James Harrison
Address 12760 0
Surgical Outcomes Research Centre (SOuRCe), Royal Prince Alfred Hospital, PO BOX M157, Missenden Road, Camperdown, NSW, 2050
Country 12760 0
Australia
Phone 12760 0
+61 2 9515 3200
Fax 12760 0
+61 2 9515 3222
Email 12760 0
[email protected]
Contact person for scientific queries
Name 3688 0
A/Prof Jane Young
Address 3688 0
Surgical Outcomes Research Centre (SOuRCe), Royal Prince Alfred Hospital, PO BOX M157, Missenden Road, Camperdown, NSW, 2050
Country 3688 0
Australia
Phone 3688 0
+61 2 9515 3200
Fax 3688 0
+61 2 9515 3222
Email 3688 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

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