Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000882527
Ethics application status
Approved
Date submitted
4/08/2015
Date registered
24/08/2015
Date last updated
16/07/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Healthy Living after Cancer (HLaC) - a telephone-delivered healthy lifestyle coaching program for cancer survivors
Scientific title
Healthy Living after Cancer (HLaC) - a dissemination and implementation study evaluating a telephone-delivered healthy lifestyle coaching program for cancer survivors, targeting physical activity, healthy eating and weight control
Secondary ID [1] 287202 0
None
Universal Trial Number (UTN)
Trial acronym
HLaC
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cancer of any type that was treated with curative intent 295795 0
Condition category
Condition code
Cancer 296062 296062 0 0
Any cancer

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The aim of the Healthy Living after Cancer program is to evaluate the integration of a telephone-delivered lifestyle intervention for cancer survivors into the existing 13 11 20 information and support telephone service offered by Cancer Councils New South Wales, Victoria, South Australia and Western Australia. Cancer survivors who take part in the program receive, free of charge, up to 12 telephone coaching calls over a period of 6 months (1 call each week for 1 month, then 1 call every fortnight for the next 2 months, then 1 call per month for the next 3 months), along with a participant workbook. Each call lasts approximately 20-30 minutes, and focuses on increasing physical activity, improving eating habits, and working towards moderate weight loss if appropriate. The calls are delivered by Cancer Council nurses / information and support consultants trained in project recruitment, intervention and evaluation protocols.
Intervention code [1] 292486 0
Lifestyle
Intervention code [2] 292487 0
Behaviour
Comparator / control treatment
No control group - all participants receive the intervention.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 295868 0
Referral source
Timepoint [1] 295868 0
Recruitment and eligibility screening telephone call
Primary outcome [2] 295869 0
Total number of patients referred
Timepoint [2] 295869 0
Recruitment and eligibility screening telephone call
Primary outcome [3] 295870 0
Percent uptake among eligible patients - i.e., number of patients who consent to take part in the program
Timepoint [3] 295870 0
Consent telephone call
Secondary outcome [1] 316757 0
Withdrawal rates and reasons - date of withdrawal, reason for withdrawal (primary outcome four)
Timepoint [1] 316757 0
Collected at point of withdrawal during telephone-delivered intervention calls
Secondary outcome [2] 316758 0
Completion rates – date of completion of the post-program assessment (primary outcome five)
Timepoint [2] 316758 0
Post-program telephone assessment
Secondary outcome [3] 316759 0
Average number of intervention calls delivered per participant (primary outcome six)
Timepoint [3] 316759 0
Date of each intervention call for each participant recorded in Cancer Council database
Secondary outcome [4] 316770 0
Average length of calls per participant (primary outcome seven)
Timepoint [4] 316770 0
Length of each intervention call for each participant recorded in Cancer Council database
Secondary outcome [5] 316771 0
Cancer Council nurse / information and support consultant and manager satisfaction with program delivery (primary outcome eight)
Timepoint [5] 316771 0
Qualitative semi-structured telephone interviews conducted by University of Queensland project staff with a sample of nurses / information and support consultants at each Cancer Council and at least one manager at each Cancer Council involved with program delivery
Secondary outcome [6] 316772 0
Costs to deliver the Healthy Living after Cancer program (primary outcome nine)
Timepoint [6] 316772 0
The fixed costs (i.e., expenditure required to deliver the HLaC program, including resources associated with modifying Cancer Council databases, refining referral pathways, adapting the HLaC intervention and evaluation protocols and recruiting and training nurses/consultants) will be documented. Dollar values will be attached to these resources using publicly available information such as appropriate salary rates for the time of personnel involved in the above activities and commercial prices for the production of any training materials, etc. Fixed costs will be allocated equally over all participants who consent to participate in HLaC. Variable costs (i.e., those that are proportional to the volume of service provided) will be allocated in proportion to the stage of HLaC reached by individuals. For the purposes of the economic appraisal, outcomes will be defined using a series of pre-defined benchmarks based on pre-post intervention changes to the behavioural and anthropometric variables. Regression analysis will be used to assess the relationship between completion of stages and outcomes achieved. Pre- and post-test differences will be calculated as changes in Quality of Life (SF-12) and Quality Adjusted Life Years (QALYs) SF6D (calculated from SF-12).
Secondary outcome [7] 316785 0
Self-reported weight and height (to allow the calculation of BMI)
Timepoint [7] 316785 0
Structured telephone interviews conducted at three time-points: pre-program (baseline), post-program (when participants either decide to terminate intervention calls, which can take place at any point after calls begin, or complete their 12 intervention calls which is expected to take approximately 6 months), and follow-up (6 months after the date of completion of the post-program assessment).
Secondary outcome [8] 316786 0
Self-reported waist circumference
Timepoint [8] 316786 0
Structured telephone interviews conducted at three time-points: pre-program (baseline), post-program (when participants either decide to terminate intervention calls, which can take place at any point after calls begin, or complete their 12 intervention calls which is expected to take approximately 6 months), and follow-up (6 months after the date of completion of the post-program assessment).
Secondary outcome [9] 316787 0
Physical activity as measured by the Active Australia Survey (AAS - 8 items)
Timepoint [9] 316787 0
Structured telephone interviews conducted at three time-points: pre-program (baseline), post-program (when participants either decide to terminate intervention calls, which can take place at any point after calls begin, or complete their 12 intervention calls which is expected to take approximately 6 months), and follow-up (6 months after the date of completion of the post-program assessment).
Secondary outcome [10] 316788 0
Dietary behaviour as measured by the Fat & Fibre Behaviour Questionnaire (FFBQ - 20 items)
Timepoint [10] 316788 0
Structured telephone interviews conducted at three time-points: pre-program (baseline), post-program (when participants either decide to terminate intervention calls, which can take place at any point after calls begin, or complete their 12 intervention calls which is expected to take approximately 6 months), and follow-up (6 months after the date of completion of the post-program assessment).
Secondary outcome [11] 316789 0
Quality of life as measured by the Short Form (12) Health Survey (SF-12 - 12 items)
Timepoint [11] 316789 0
Structured telephone interviews conducted at three time-points: pre-program (baseline), post-program (when participants either decide to terminate intervention calls, which can take place at any point after calls begin, or complete their 12 intervention calls which is expected to take approximately 6 months), and follow-up (6 months after the date of completion of the post-program assessment).
Secondary outcome [12] 316790 0
Cancer-related symptoms and side-effects as measured by the MD Anderson Symptom Inventory (MDASI - 16 items)
Timepoint [12] 316790 0
Structured telephone interviews conducted at three time-points: pre-program (baseline), post-program (when participants either decide to terminate intervention calls, which can take place at any point after calls begin, or complete their 12 intervention calls which is expected to take approximately 6 months), and follow-up (6 months after the date of completion of the post-program assessment).
Secondary outcome [13] 316791 0
Fear of cancer recurrence as measured by the Concerns about Recurrence Questionnaire (CARQ-4 - 4 items)
Timepoint [13] 316791 0
Structured telephone interviews conducted at three time-points: pre-program (baseline), post-program (when participants either decide to terminate intervention calls, which can take place at any point after calls begin, or complete their 12 intervention calls which is expected to take approximately 6 months), and follow-up (6 months after the date of completion of the post-program assessment).
Secondary outcome [14] 316792 0
Distress as measured by the National Comprehensive Cancer Network Distress Thermometer (1 item) along with an item measuring the impact of that distress, modified from Akizuki and colleagues (2005) (1 item)
Timepoint [14] 316792 0
Structured telephone interviews conducted at three time-points: pre-program (baseline), post-program (when participants either decide to terminate intervention calls, which can take place at any point after calls begin, or complete their 12 intervention calls which is expected to take approximately 6 months), and follow-up (6 months after the date of completion of the post-program assessment).
Secondary outcome [15] 316793 0
Patient satisfaction with Healthy Living after Cancer (11 items) – questions written specifically for the purposes of this project
Timepoint [15] 316793 0
Structured telephone interviews conducted at three time-points: pre-program (baseline), post-program (when participants either decide to terminate intervention calls, which can take place at any point after calls begin, or complete their 12 intervention calls which is expected to take approximately 6 months), and follow-up (6 months after the date of completion of the post-program assessment).

Eligibility
Key inclusion criteria
Participants must meet the following eligibility criteria in order to take part in the Healthy Living after Cancer program:
1. Adults (18+ years)
2. Diagnosed with localised (i.e., non-metastatic) potentially curative cancer of any type
3. Completed treatment (i.e., surgery, chemotherapy, radiation; patients on hormonal treatment or Herceptin are still eligible)
4. Want support for healthy living via physical activity and healthy eating and willing to make a 6-month commitment to Healthy Living after Cancer program participation
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Contraindications to engaging in unsupervised physical activity (i.e., active heart disease, breathing problems requiring hospitalisation in the past 6 months, undergoing dialysis, diabetic complications such as severe neuropathy or retinopathy, planning a knee or hip replacement in the next six months, pregnant)
2. Cognitive or mental health impairments that would hinder program participation
3. Unable to speak and read English sufficiently to allow for program participation

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised 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
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Primary (Healthy Living after Cancer implementation) outcomes will be reported descriptively. Analyses of secondary (effectiveness) outcomes will be by mixed models, which allow for repeated measures (baseline and follow-up) and will include all participants with baseline data (including those with missing data at follow-up) with adjustment for predictors of dropouts to minimise selection bias. Results from each Cancer Council will be analysed individually as well as collectively (pooled). To minimise type I errors because of testing multiple outcomes, significance will be set at p<0.001 (two-tailed). Sensitivity of conclusions to missing data assumptions will be evaluated.

Service delivery is expected to provide a sample size of approximately 900 participants across the four participating Cancer Councils over the three year recruitment period. This sample provides >90% power with two-tailed significance of p<0.001 to detect pre-post changes of 60 minutes of physical activity per week, 0.5 serves of fruit or vegetables, 2 kg weight and clinically relevant changes in physical and mental components of quality of life (3 units each), based on assumed standard deviations of change of 300 min/week, 1.5 fruit and 2 vegetable serves, 8kg weight, and 8 units on the mental and physical component scores. These calculations allow for 30% participant attrition and adjustment for up to 10 covariates (10 observations per covariate).

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/06/2015
Actual
1/06/2015
Date of last participant enrolment
Anticipated
30/09/2018
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
900
Accrual to date
330
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA,WA,VIC

Funding & Sponsors
Funding source category [1] 291771 0
Government body
Name [1] 291771 0
National Health and Medical Research Council
Country [1] 291771 0
Australia
Funding source category [2] 291772 0
Charities/Societies/Foundations
Name [2] 291772 0
Cancer Council New South Wales
Country [2] 291772 0
Australia
Funding source category [3] 291773 0
Charities/Societies/Foundations
Name [3] 291773 0
Cancer Council Victoria
Country [3] 291773 0
Australia
Funding source category [4] 291774 0
Charities/Societies/Foundations
Name [4] 291774 0
Cancer Council South Australia
Country [4] 291774 0
Australia
Funding source category [5] 291775 0
Charities/Societies/Foundations
Name [5] 291775 0
Cancer Council Western Australia
Country [5] 291775 0
Australia
Primary sponsor type
University
Name
The University of Queensland
Address
School of Public Health, Cancer Prevention Research Centre,
Level 4, Public Health Building,
Herston road
HERSTON QLD 4006
Country
Australia
Secondary sponsor category [1] 290438 0
Charities/Societies/Foundations
Name [1] 290438 0
Cancer Council New South Wales
Address [1] 290438 0
153 Dowling Street
Woolloomooloo NSW 2011
Country [1] 290438 0
Australia
Secondary sponsor category [2] 290439 0
Charities/Societies/Foundations
Name [2] 290439 0
Cancer Council Victoria
Address [2] 290439 0
615 St Kilda Road
Melbourne VIC 3004
Country [2] 290439 0
Australia
Secondary sponsor category [3] 290440 0
Charities/Societies/Foundations
Name [3] 290440 0
Cancer Council South Australia
Address [3] 290440 0
202 Greenhill Road
Eastwood SA 5063
Country [3] 290440 0
Australia
Secondary sponsor category [4] 290441 0
Charities/Societies/Foundations
Name [4] 290441 0
Cancer Council Western Australia
Address [4] 290441 0
420 Bagot Road
Subiaco WA 6008
Country [4] 290441 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293291 0
Cancer Council Victoria HREC (on behalf of Cancer Council's Victoria and South Australia)
Ethics committee address [1] 293291 0
Ethics committee country [1] 293291 0
Australia
Date submitted for ethics approval [1] 293291 0
Approval date [1] 293291 0
08/08/2014
Ethics approval number [1] 293291 0
1407
Ethics committee name [2] 293292 0
University of Queensland HREC
Ethics committee address [2] 293292 0
Ethics committee country [2] 293292 0
Australia
Date submitted for ethics approval [2] 293292 0
Approval date [2] 293292 0
20/08/2014
Ethics approval number [2] 293292 0
2014001106
Ethics committee name [3] 293297 0
University of Western Australia HREC
Ethics committee address [3] 293297 0
Ethics committee country [3] 293297 0
Australia
Date submitted for ethics approval [3] 293297 0
Approval date [3] 293297 0
25/11/2014
Ethics approval number [3] 293297 0
RA/4/1/7253
Ethics committee name [4] 293298 0
Cancer Council New South Wales HREC
Ethics committee address [4] 293298 0
Ethics committee country [4] 293298 0
Australia
Date submitted for ethics approval [4] 293298 0
Approval date [4] 293298 0
12/01/2015
Ethics approval number [4] 293298 0
293
Ethics committee name [5] 293301 0
Southern Adelaide Clinical HREC (on behalf of Flinders Medical Centre, Peter MacCallum Cancer Centre, Concord Repatriation General Hospital and Mater Hospital Sydney)
Ethics committee address [5] 293301 0
Ethics committee country [5] 293301 0
Australia
Date submitted for ethics approval [5] 293301 0
Approval date [5] 293301 0
14/05/2015
Ethics approval number [5] 293301 0
39.15 - HREC/15/SAC/15
Ethics committee name [6] 293302 0
St John of God Health Care HREC
Ethics committee address [6] 293302 0
Ethics committee country [6] 293302 0
Australia
Date submitted for ethics approval [6] 293302 0
Approval date [6] 293302 0
26/06/2015
Ethics approval number [6] 293302 0
822
Ethics committee name [7] 295616 0
Northern Health Human Research Ethics Committee
Ethics committee address [7] 295616 0
Ethics committee country [7] 295616 0
Australia
Date submitted for ethics approval [7] 295616 0
Approval date [7] 295616 0
25/02/2016
Ethics approval number [7] 295616 0
HREC/15/NH/60

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

Contacts
Principal investigator
Name 59266 0
Prof Elizabeth Eakin
Address 59266 0
The University of Queensland, Faculty of Medicine, Oral Health Centre, Herston road, Herston, Brisbane, QLD, Australia, 4006
Country 59266 0
Australia
Phone 59266 0
+61 7 3346 5305
Fax 59266 0
+61 7 3365 5540
Email 59266 0
[email protected]
Contact person for public queries
Name 59267 0
Erin Robson
Address 59267 0
The University of Queensland, School of Public Health, Level 4, Public Health Building, Herston road, Herston, Brisbane, QLD, Australia, 4006
Country 59267 0
Australia
Phone 59267 0
+61 7 3365 5078
Fax 59267 0
+61 7 3365 5540
Email 59267 0
[email protected]
Contact person for scientific queries
Name 59268 0
Elizabeth Eakin
Address 59268 0
The University of Queensland, Faculty of Medicine, Oral Health Centre, Herston road, Herston, Brisbane, QLD, Australia, 4006
Country 59268 0
Australia
Phone 59268 0
+61 7 3346 5305
Fax 59268 0
+61 7 3365 5540
Email 59268 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
EmbaseHealthy Living after Cancer: A dissemination and implementation study evaluating a telephone-delivered healthy lifestyle program for cancer survivors.2015https://dx.doi.org/10.1186/s12885-015-2003-5
EmbaseTranslating research into practice: Outcomes from the Healthy Living after Cancer partnership project.2020https://dx.doi.org/10.1186/s12885-020-07454-4
EmbaseEvaluation of the Healthy Living after Cancer text message-delivered, extended contact intervention using the RE-AIM framework.2021https://dx.doi.org/10.1186/s12885-021-08806-4
N.B. These documents automatically identified may not have been verified by the study sponsor.