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Trial registered on ANZCTR


Registration number
ACTRN12608000252314
Ethics application status
Approved
Date submitted
15/05/2008
Date registered
19/05/2008
Date last updated
4/09/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
Cancer care after surgery – the CONNECT study
Scientific title
A randomised trial to assess the effectiveness of a centralised telephone-based ‘remote access’ care coordination service to improve care processes and patient outcomes for people who have had surgery for colorectal cancer
Secondary ID [1] 273324 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Colorectal cancer 3147 0
Condition category
Condition code
Cancer 3306 3306 0 0
Bowel - Back passage (rectum) or large bowel (colon)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A centralised telephone-based ‘remote access’ cancer care coordination intervention, administered by a cancer nurse. After submitting a self-complete questionnaire at baseline (just prior to, or in the days following, surgery for colorectal cancer), participants will be randomised into the intervention or control group. Patients in the intervention group will receive the nursing care coordination and support service telephone calls from the cancer nurse at 3 days, 10 days, 1 month, 3 months, and 6 months after their discharge from hospital.
Intervention code [1] 2884 0
Other interventions
Comparator / control treatment
Usual care (regular standard follow-up appointments with the patient’s surgeon, general practitioner [GP], oncologist (if applicable), radiologist (if applicable).
Control group
Active

Outcomes
Primary outcome [1] 4198 0
Care coordination (as measured by a self-complete multiple-choice questionnaire we developed in the pilot study for this project)
Timepoint [1] 4198 0
At baseline, then 1, 3 and 6 months after discharge from hospital
Primary outcome [2] 4199 0
Quality of life (as measured by the self-complete FACT-C questionnaire).
Timepoint [2] 4199 0
At baseline, then 1, 3 and 6 months after discharge from hospital
Secondary outcome [1] 7096 0
Health service utilisation (as measured by a self-complete questionnaire about frequency of visits to a range of health professionals including the surgeon, general practitioner, oncologist, radiologist. Also measured by determining number of attendances at GP, hospital admissions, and emergency department attendances from medical records).
Timepoint [1] 7096 0
At baseline, then 1, 3 and 6 months after discharge from hospital
Secondary outcome [2] 7097 0
Cost effectiveness of the telephone intervention. A cost consequence analysis will be conducted whereby the net difference in costs associated with the intervention and health service utilisation between the intervention and control groups will be compared to the net difference in the primary outcome measures. The cost data will be collected via self completed questionnaires about health service utilisation (and other outcomes described above).
Timepoint [2] 7097 0
1, 3 and 6 months after discharge from hospital
Secondary outcome [3] 7098 0
Satisfaction with health services (as measured by the self-complete FACIT-TS-PS questionnaire).
Timepoint [3] 7098 0
6 months after discharge from hospital

Eligibility
Key inclusion criteria
Patients who:
* Are aged 18 years or more
* Are having surgery for a newly diagnosed primary colorectal cancer (Dukes stage A-D)
* Are aware of cancer diagnosis
* Are able to understand the study and give consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients who:
* Are diagnosed with recurrent colorectal cancer
* Die during the admission
* Are cognitively impaired or cannot give informed consent
* Do not have access to a telephone at their primary residence
* Do not plan to reside in Australia for the next 6 months
* Are hearing impaired to a level that they are unable to participate in a telephone conversation
* Do not speak and read English to a level that would allow them to participate in the telephone discussions and follow-up interviews (unless a family member or friend is able to translate for them).

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)
Surgeons from the participating hospitals will recruit patients for this study. During a pre-surgery consultation (which is usually 1 - 2 weeks prior to surgery), the surgeon will invite the patient to participate in the study. If the patient is an emergency admission, the surgeon will invite them to participate in the study at a suitable time during the patient's post-operative hospital stay. The surgeon will provide the patient with written and verbal information about the study. At baseline (just prior to, or during their hospital stay for colorectal cancer surgery) patients will be asked by their surgeon to complete a questionnaire. The patients will return the questionnaire signed consent forms via reply paid post to the central research office. Once these forms have been received, patients will be randomly allocated to the intervention or control group by the project manager (located in the central research office) who holds the allocation schedule.
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
15/06/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
720
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 3383 0
Government body
Name [1] 3383 0
Cancer Institute NSW
Country [1] 3383 0
Australia
Primary sponsor type
Individual
Name
A/Prof Jane Young
Address
Surgical Outcomes Research Centre
PO Box M157
Missenden Rd
NSW 2050
Country
Australia
Secondary sponsor category [1] 3025 0
Individual
Name [1] 3025 0
Prof Phyllis Butow
Address [1] 3025 0
Medical Psychology Research Unit
Brennan MacCallum Building (A19)
University of Sydney
NSW 2006
Country [1] 3025 0
Australia
Secondary sponsor category [2] 3026 0
Individual
Name [2] 3026 0
Prof Michael Solomon
Address [2] 3026 0
Surgical Outcomes Research Centre
PO Box M157
Missenden Rd
NSW 2050
Country [2] 3026 0
Australia
Secondary sponsor category [3] 3027 0
Individual
Name [3] 3027 0
Prof Glenn Salkeld
Address [3] 3027 0
School of Public Health
Edward Ford Building (A27)
University of Sydney
NSW 2006
Country [3] 3027 0
Australia
Secondary sponsor category [4] 3028 0
Individual
Name [4] 3028 0
Prof Kate White
Address [4] 3028 0
Faculty of Nursing and Midwifery
Mallet Street Campus
University of Sydney
NSW 2006
Country [4] 3028 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5408 0
Sydney South West Area Health Service Ethics Review Committee (RPAH Zone)
Ethics committee address [1] 5408 0
Ethics committee country [1] 5408 0
Australia
Date submitted for ethics approval [1] 5408 0
26/03/2008
Approval date [1] 5408 0
15/04/2008
Ethics approval number [1] 5408 0
08/RPAH/138

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28588 0
Address 28588 0
Country 28588 0
Phone 28588 0
Fax 28588 0
Email 28588 0
Contact person for public queries
Name 11745 0
James Harrison
Address 11745 0
Surgical Outcomes Research Centre
PO Box M157
Missenden Rd
NSW 2050
Country 11745 0
Australia
Phone 11745 0
02 9515 3200
Fax 11745 0
02 95153222
Email 11745 0
james.harrison@sswahs.nsw.gov.au
Contact person for scientific queries
Name 2673 0
A/Prof Jane Young
Address 2673 0
PO Box M157
Missenden Rd
NSW 2050
Country 2673 0
Australia
Phone 2673 0
02 9515 3200
Fax 2673 0
02 95153222
Email 2673 0
jane.young@sydney.edu.au

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
EmbaseMulticenter randomized trial of centralized nurse-led telephone-based care coordination to improve outcomes after surgical resection for colorectal cancer: The CONNECT intervention.2013https://dx.doi.org/10.1200/JCO.2012.48.1036
N.B. These documents automatically identified may not have been verified by the study sponsor.