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Trial registered on ANZCTR


Registration number
ACTRN12609000601235
Ethics application status
Approved
Date submitted
16/07/2009
Date registered
20/07/2009
Date last updated
4/09/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
The CONNECT Program Pilot Study: Evaluation of a nurse delivered telephone supportive care interventon for post-operative patients with colorectal cancer
Scientific title
The CONNECT Program Pilot Study: Evaluation of acceptance, feasibility and impact on supportive care needs of a nurse delivered supportive care intervention for post-operative patients with coloretcal cancer
Secondary ID [1] 273322 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Colorectal cancer 237275 0
Condition category
Condition code
Cancer 239598 239598 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. People diagnosed with colorectal cancer (colorectal Australian clinicopathological staging (ACPS) system A to D) will be asked to complete a baseline questionnaire during thier hospital admission. Patients will then be randomised into the intervention or control group. Patients in the intervention group will receive five telephone calls from the cancer nurse in the 6 months following their discharged from hospital (the first call is at Day 3 post-discharge and then the remaining four will be at Day 10 and then 1, 3 and 6 months post-discharge). Calls will vary in duration and be dependent on each individual patient's need. It is anticipated that calls will last about 20 minutes.
Intervention code [1] 236958 0
Other interventions
Comparator / control treatment
Patients assigned to the control group will not receive any additional support and follow-up other than what has been provided or arranged for them by the treating medical team at Royal Prince Alfred Hospital in the six months following their discharge from hospital.
Control group
Active

Outcomes
Primary outcome [1] 238389 0
Acceptability. Acceptability will be assessed by ascertaining the proportion of patients who complete each call at each time point. Demographic and clinical characteristics of patients allocated to the intervention group who did or did not accept or complete each call will be compared to assess the acceptability. Furthermore, a series of questions will be sent to patients at 6 months following the patient's hospital discharge and when the intervention is complete in order to gather detailed feedback of participant's views of the intervention.
Timepoint [1] 238389 0
Days 3 and 10 and 1, 3 and 6 months after the patient's hospital discharge.
Primary outcome [2] 238390 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] 238390 0
Days 3 and 10 and 1, 3 and 6 months after the patient's hospital discharge.
Primary outcome [3] 238391 0
Unmet supportive care needs will be measured using the Supportive Care Needs Survey (SCNS). The SCNS is a 34-item questionnaire that determines participants level of unmet need for a range of items for five supportive care domains.
Timepoint [3] 238391 0
1, 3 and 6 months after the patient's hospital discharge.
Secondary outcome [1] 244851 0
Quality of Life will be measured using the Functional Assessment of Cancer Therapy - Colorectal (FACT-C), a 36-item colorectal quality of life questionnaire.
Timepoint [1] 244851 0
1, 3 and 6 months after the patient's hospital discharge.
Secondary outcome [2] 244852 0
Psychological distress will be measured using the "Distress thermometer" where distress is rated using a sclae with scores ranging from 0 ("no distress") to 10 ("extreme distress")
Timepoint [2] 244852 0
1, 3 and 6 months after the patient's hospital discharge.
Secondary outcome [3] 244853 0
Health Service Utlisation will be ascertained during telephone interviews with patients. During these interviews health service utilisation for a range of specialist and community based health professionals will be recorded.
Timepoint [3] 244853 0
1, 3 and 6 months after the patient's hospital discharge.

Eligibility
Key inclusion criteria
To be eligible patients must be *over 18 years *diagnosed with primary colorectal cancer (ACPS A to D) * admitted for a surgical intervention with curative intent *have access to a telephone * have sufficient English skills (or have a person available to act as an interpreter) to participate *are able to give informed consent
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients will be ineligible to participate if they *do not have access to or are unable to use (eg due to deafness) a telephone *do not speak or read English (or have a person who can act as an interpreter) *plan to not reside in Australia for the next 6 months

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 colorectal cancer (ACPS A to D) will be invited to participate by their surgeon who will provide them with written and verbal information about the study and obtain written consent. 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 written consent and ask them to complete a baseline self-administered questionnaire. Demographic information about the patient will be obtained during a short face-to-face interview with the RC. The details of consenting patients and baseline data will be forwarded by the RC to a second, independent researcher who will randomly allocate patients 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 a computer.
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
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 237343 0
Hospital
Name [1] 237343 0
Surgical Outcomes Research Centre (SOURCe)
Address [1] 237343 0
Royal Prince Alfred Hospital & University of Sydney, PO BOX M157, Missenden Road, Camperdown, NSW, 2050
Country [1] 237343 0
Australia
Primary sponsor type
Individual
Name
A/Prof Jane Young
Address
Surgical Outcomes Research Centre (SOURCe), Royal Prince Alfred Hospital & University of Sydney, PO BOX M157, Missenden Road, Camperdown, NSW, 2050
Country
Australia
Secondary sponsor category [1] 236832 0
Individual
Name [1] 236832 0
Prof Phyllis Butow
Address [1] 236832 0
Surgical Outcomes Research Centre (SOURCe), Royal Prince Alfred Hospital & University of Sydney, PO BOX M157, Missenden Road, Camperdown, NSW, 2050
Country [1] 236832 0
Australia
Secondary sponsor category [2] 236833 0
Individual
Name [2] 236833 0
Prof Michael Solomon
Address [2] 236833 0
Surgical Outcomes Research Centre (SOURCe), Royal Prince Alfred Hospital & University of Sydney, PO BOX M157, Missenden Road, Camperdown, NSW, 2050
Country [2] 236833 0
Australia
Secondary sponsor category [3] 236834 0
Individual
Name [3] 236834 0
Mr James Harrison
Address [3] 236834 0
Surgical Outcomes Research Centre (SOURCe), Royal Prince Alfred Hospital & University of Sydney, PO BOX M157, Missenden Road, Camperdown, NSW, 2050
Country [3] 236834 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 239461 0
Sydney South West Area Health Service (RPAH Zone)
Ethics committee address [1] 239461 0
Research & Development Office, RPAH Medical Centre, 100 Carillon Avenue, Newtown, NSW, 2042
Ethics committee country [1] 239461 0
Australia
Date submitted for ethics approval [1] 239461 0
29/06/2006
Approval date [1] 239461 0
01/08/2006
Ethics approval number [1] 239461 0
X06-0154

Summary
Brief summary
This trial is the pilot randomised controlled trial to trial ACTRN12608000252314. The pilot randomised controlled trial (RCT) will test a novel telephone-based supportive care intervention for people with colorectal cancer. The intervention involves five structured calls from a nurse to the patients over the 6 month period after discharge from surgery. The intervention aims to improve psychosocial outcomes for patients. This pilot study aims to assess the feasibilty and acceptability of the intervention and determine any impact on patient 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
www.source.org.au
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29914 0
Address 29914 0
Country 29914 0
Phone 29914 0
Fax 29914 0
Email 29914 0
Contact person for public queries
Name 13161 0
James Harrison
Address 13161 0
Surgical Outcomes Research Centre (SOuRCe), Royal Prince Alfred Hospital, PO BOX M157, Missenden Road, Camperdown, NSW, 2050
Country 13161 0
Australia
Phone 13161 0
+61 2 9515 3200
Fax 13161 0
+61 2 9515 3222
Email 13161 0
james.harrison@sswahs.nsw.gov.au
Contact person for scientific queries
Name 4089 0
A/Prof Jane Young
Address 4089 0
Surgical Outcomes Research Centre (SOuRCe), Royal Prince Alfred Hospital, PO BOX M157, Missenden Road, Camperdown, NSW, 2050
Country 4089 0
Australia
Phone 4089 0
+61 2 9515 3200
Fax 4089 0
+61 2 9515 3222
Email 4089 0
jane.young@sydney.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary