Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12608000399392
Ethics application status
Approved
Date submitted
16/07/2008
Date registered
8/08/2008
Date last updated
3/07/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
CanChange: A psychosocial and lifestyle intervention for colorectal cancer survivors
Scientific title
The feasibility and efficacy of a telephone-delivered lifestyle and psychosocial supportive care program for colorectal cancer patients
Secondary ID [1] 657 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Colorectal cancer 3418 0
Condition category
Condition code
Cancer 3571 3571 0 0
Bowel - Back passage (rectum) or large bowel (colon)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants in the intervention arm will receive a telephone-delivered lifestyle and psychosocial supportive care program. The program will be delivered over 6 months and include up to 12 sessions two weeks apart for approximately 30 minutes each.
Intervention code [1] 3147 0
Lifestyle
Comparator / control treatment
Participants randomised to the usual care will be posted a range of colorectal cancer and lifestyle materials.
Control group
Active

Outcomes
Primary outcome [1] 4473 0
Quality of Life: Short Form 36 (SF-36)
Timepoint [1] 4473 0
Baseline, 6 and 12 months
Primary outcome [2] 4474 0
Psychological adjustment: Hospital Anxiety and Depression Scale (HADS)
Timepoint [2] 4474 0
Baseline, 6 and 12 months
Secondary outcome [1] 7555 0
Physical Activity: Active Australia
Timepoint [1] 7555 0
Baseline, 6 and 12 months
Secondary outcome [2] 7556 0
Nutrition: The Anti Cancer Council of Victoria Food Frequency Questionnaire
Timepoint [2] 7556 0
Baseline, 6 and 12 months

Eligibility
Key inclusion criteria
A histologically confirmed diagnosis of first primary colorectal cancer (C18-C20, C218) between 01/07/08 and 01/07/09, and notified to the Queensland Cancer Registry. (QCR)
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Persons with cognitive impairment; non-English speaking; no telephone; any concurrent cancers; and contraindications to exercise

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation concealment.
central randomisation by a computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by using a randomization 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
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
1/10/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
300
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 3603 0
Government body
Name [1] 3603 0
Cancer Australia
Country [1] 3603 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Cancer Council Queensland
Address
553 Gregory Terrace
Fortitude Valley
QLD 4006
Country
Australia
Secondary sponsor category [1] 3239 0
Charities/Societies/Foundations
Name [1] 3239 0
Viertel Centre for Research in Cancer Control
Address [1] 3239 0
553 Gregory Terrace
Fortitude Valley
QLD 4006
Country [1] 3239 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5651 0
The University of Queensland
Ethics committee address [1] 5651 0
Human Ethics
Research and Research Training Division
Cumbrae-Stewart Building (#72)
St Lucia
BRISBANE QLD 4072
Ethics committee country [1] 5651 0
Australia
Date submitted for ethics approval [1] 5651 0
Approval date [1] 5651 0
27/09/2007
Ethics approval number [1] 5651 0
2007000656

Summary
Brief summary
This study looks at the feasibility and usefulness of a telephone-delivered lifestyle and psychosocial supportive care program for patients with cancer of the back passage (rectum) or large bowel (colon).

CanChange: A psychosocial and lifestyle intervention for colorectal cancer survivors

Who is it for?

You can join this study if you have been diagnosed with first primary colorectal cancer between 01/07/08 and 01/07/09, and this has been notified to the Queensland Cancer Registry.

Trial details

Participants will be randomly divided into two groups. Participants in one group (the intervention group) will receive a telephone-delivered lifestyle and psychosocial supportive care program. The program will be delivered over 6 months and include up to 12 sessions two weeks apart for approximately 30 minutes each.

Participants in the other group (the control group) will receive the standard care and will be posted a range of colorectal cancer and lifestyle materials.

This study will implement and evaluate a telephone-delivered cancer rehabilitation program (CanChange) for colorectal cancer survivors. It is hypothesised that, compared with usual care participants, CanChange participants will have decreased psychological distress and cancer-related fatigue and will show improvements in quality of life, symptom management, nutrition and physical activity.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28758 0
Address 28758 0
Country 28758 0
Phone 28758 0
Fax 28758 0
Email 28758 0
Contact person for public queries
Name 11915 0
Anna Hawkes
Address 11915 0
Cancer Council Queensland
Viertel Centre for Research in Cancer Control
553 Gregory Terrace
Fortitude Valley
QLD 4006
Country 11915 0
Australia
Phone 11915 0
+617 3258 2305
Fax 11915 0
+617 3258 2228
Email 11915 0
[email protected]
Contact person for scientific queries
Name 2843 0
Anna Hawkes
Address 2843 0
Viertel Centre for Research in Cancer Control
553 Gregory Terrace
Fortitude Valley
QLD 4006
Country 2843 0
Australia
Phone 2843 0
+617 3258 2305
Fax 2843 0
+617 3258 2228
Email 2843 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
EmbasePredictors of physical activity in colorectal cancer survivors after participation in a telephone-delivered multiple health behavior change intervention.2015https://dx.doi.org/10.1007/s11764-014-0389-8
EmbaseA telephone-delivered multiple health behaviour change intervention for colorectal cancer survivors: making the case for cost-effective healthcare.2015https://dx.doi.org/10.1111/ecc.12345
Dimensions AIA randomised controlled trial of a tele-based lifestyle intervention for colorectal cancer survivors ('CanChange'): study protocol2009https://doi.org/10.1186/1471-2407-9-286
N.B. These documents automatically identified may not have been verified by the study sponsor.