Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612001292864
Ethics application status
Approved
Date submitted
11/12/2012
Date registered
13/12/2012
Date last updated
24/05/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
Self-management support in colorectal cancer care pilot study
Scientific title
A phase I/II randomised supportive care trial for people co-managing colorectal cancer and co-morbidity in Aotearoa, New Zealand, comparing exposure to self-management support to standard supportive care in the outpatient cancer clinic, in order to assess change in patient-reported outcomes between the conditions
Secondary ID [1] 281649 0
None
Universal Trial Number (UTN)
U1111-1133-0947
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Colorectal cancer 287936 0
Co-morbidity 287937 0
Condition category
Condition code
Cancer 288315 288315 0 0
Bowel - Back passage (rectum) or large bowel (colon)
Public Health 288340 288340 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention involves administration of The Flinders Program at the Wellington Blood & Cancer Centre. Approximately fifty eligible patients diagnosed with colorectal cancer will be randomised into intervention and control groups after completing an initial assessment. Those in the intervention group will be given three cancer coaching sessions with a trained coach over 3-months during regularly scheduled outpatient treatment appointments.

The Flinders Program is a set of generic tools and processes enabling health professionals and health consumers to undertake a structured process that allows for assessment of self-management behaviours, collaborative identification of problems and goal setting leading to the development of individualised care plans (Flinders Human Behaviour & Health Research Unit, 2005).

Each 30-60 minute cancer coaching session involves discussions centred around the person, not the disease. Support provided attempts to encourage collaboration and problem-solving; ideally resulting in increased resilience, information sharing, referral (if appropriate) and care planning.
Intervention code [1] 286186 0
Behaviour
Comparator / control treatment
Standard supportive care is defined as usual care for the purposes of this trial.
Control group
Active

Outcomes
Primary outcome [1] 288486 0
Self-management competency as measured by the Flinders Partners in Health scale.
Timepoint [1] 288486 0
Pre- and post-intervention (4-months)
Secondary outcome [1] 300292 0
Quality of life as measured by the FACT-C and SF12v2
Timepoint [1] 300292 0
Pre- and post-intervention (4-months)
Secondary outcome [2] 300293 0
Patient Activation Status as measured by the Patient Activation Measure
Timepoint [2] 300293 0
Pre- and post-intervention (4-months)
Secondary outcome [3] 300294 0
Chronic disease self-efficacy as measured by the Self-Efficacy for Managing Chronic Disease 6-Item Scale
Timepoint [3] 300294 0
Pre- and post-intervention (4-months)
Secondary outcome [4] 300339 0
Distress as measured by the Distress Thermometer
Timepoint [4] 300339 0
Pre- and post-intervention (4-months)
Secondary outcome [5] 300340 0
Chronic Condition Care as measured by the Assessment of Care for Chronic Conditions (ACIC)
Timepoint [5] 300340 0
Pre- and post-intervention (4-months)
Secondary outcome [6] 300345 0
Resilience as measured by the Connor-Davidson resilience scale (CD-RISC)
Timepoint [6] 300345 0
Pre- and post-intervention (4-months)
Secondary outcome [7] 300346 0
Patient experience measured qualitatively
Timepoint [7] 300346 0
Post-treatment (6-weeks)

Eligibility
Key inclusion criteria
* Aged 45 years or older;
* Confirmed diagnosis of primary colorectal cancer, stage 2 or 3 or fully resected stage 4, who are receiving adjuvant chemotherapy;
* No previous cancer diagnosis (other than a non-melanoma skin cancer);
* No apparent or reported physical or mental distress that would deem the trial be overly burdensome;
* No apparent or reported impaired ability to comprehend the intervention and assessments;
* No history of taking part in Flinders or lay-led self-management programmes
* Resident of Aotearoa New Zealand.
Minimum age
45 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
There are no exclusion criteria related to socioeconomic status, ethnicity or gender. Exclusion criteria include:
* Aged 44 years and younger
* Confirmed diagnosis of any cancer except colorectal cancer
* Previous cancer diagnosis
* High distress levels
* Impaired ability to comprehend the intervention and assessments
* History of taking part in Flinders or lay-led self-management programmes

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
29/01/2013
Actual
Date of last participant enrolment
Anticipated
30/07/2013
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment outside Australia
Country [1] 4741 0
New Zealand
State/province [1] 4741 0

Funding & Sponsors
Funding source category [1] 286449 0
Charities/Societies/Foundations
Name [1] 286449 0
Cancer Society Wellington Division
Country [1] 286449 0
New Zealand
Funding source category [2] 287346 0
Charities/Societies/Foundations
Name [2] 287346 0
New Zealand Lottery Health Research Committee/New Zealand Lottery Grants Board
Country [2] 287346 0
New Zealand
Primary sponsor type
University
Name
University of Otago Wellington
Address
23a Mein St
Newtown
Wellington 6242
Country
New Zealand
Secondary sponsor category [1] 285235 0
Hospital
Name [1] 285235 0
Capital & Coast District Health Board
Address [1] 285235 0
Wellington Hospital
Riddiford St
Newtown
Wellington 6242
Country [1] 285235 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288528 0
Central Region Health & Disability Ethics Committee
Ethics committee address [1] 288528 0
Ethics committee country [1] 288528 0
New Zealand
Date submitted for ethics approval [1] 288528 0
Approval date [1] 288528 0
29/10/2012
Ethics approval number [1] 288528 0
12/CEN/12

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

Contacts
Principal investigator
Name 36518 0
Ms Inga O'Brien
Address 36518 0
Department of Public Health
23a Mein Street
Newtown
Wellington 6242
Country 36518 0
New Zealand
Phone 36518 0
+6449186549
Fax 36518 0
Email 36518 0
obrin889@student.otago.ac.nz
Contact person for public queries
Name 36519 0
Inga O'Brien
Address 36519 0
Department of Public Health
23a Mein Street
Newtown
Wellington 6242
Country 36519 0
New Zealand
Phone 36519 0
+6449186549
Fax 36519 0
Email 36519 0
obrin889@student.otago.ac.nz
Contact person for scientific queries
Name 36520 0
Inga O'Brien
Address 36520 0
Department of Public Health
23a Mein Street
Newtown
Wellington 6242
Country 36520 0
New Zealand
Phone 36520 0
+6449186549
Fax 36520 0
Email 36520 0
obrin889@student.otago.ac.nz

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
No additional documents have been identified.