Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001166864
Ethics application status
Approved
Date submitted
28/06/2021
Date registered
27/08/2021
Date last updated
29/07/2022
Date data sharing statement initially provided
27/08/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluating the feasibility of an online healthy living program for post-treatment cancer survivors
Scientific title
Evaluating the feasibility of Healthy Living after Cancer Online: an online program targeted at quality of life in post-treatment cancer survivors.
Secondary ID [1] 304640 0
None
Universal Trial Number (UTN)
U1111-1266-8239
Trial acronym
HLaC Online
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cancer 322582 0
Condition category
Condition code
Cancer 320193 320193 0 0
Any cancer

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Healthy Living after Cancer Online (HLaC Online) is an online delivered intervention aimed at supporting those who have completed cancer treatment achieve their healthy living goals. The development of HLaC Online was informed by the previous telephone-delivered Healthy Living after Cancer program and by stakeholder engagement conducted in 2019 and 2020. HLaC Online takes a holistic view of health and targets physical activity, healthy eating, maintaining a healthy weight, mental health, finding the new normal after cancer treatment, and fatigue management. It is recommended that participants use the program for 12 weeks and spend approximately an hour per week on the program to read through the information provided and utilise the physical activity, meal, and mood trackers provided. Adherence to the program will be monitored using website and google analytics, and a post-program interview.
Below is a brief description of each of the sections and some example exercises.

My goals: involves participant’s aims, SMART goal setting, and action plans [1].
Physical activity: involves information about aerobic activity, flexibility/stretching, strength training, incidental physical activity, and reducing sitting time. Includes videos of example exercises [1,2]. An online exercise tracker is also provided in the program.
Healthy eating: includes information on food guidelines, portion control, and incorporating ‘fun foods’ [1, 3]. An example exercise for this section involves asking participants to reflect on their own diet and to identify where they can make changes, such as reducing fat or sugar intake or making healthy food swaps. An online meal tracker is also provided in the program.
Maintaining a healthy weight: includes information about what a healthy weight looks like and information about weight management [1,4]. An online weight tracker is provided in the program.
Mental Health: involves information about mindfulness, connecting how we think, act and feel, and where to find support [5,6]. An example exercise for this section involves asking participants to complete a thought record. In this exercise, the participant is asked to write a down a situation where they felt distressed and to identify what their thoughts, feelings, and behaviours were in that situation. Participants will also be asked to identify an alternative thought and asked how this might have changed how they felt in that situation.
Finding the new normal: includes stories about how other cancer survivors established their new normal and myths about completing treatment [7].
Fatigue management: Information about what causes fatigue, long-term fatigue management, and the ‘three P’s: plan, prioritise, and pace” for daily energy management [8]. An online fatigue and mood tracker is provided in the program.
Peer support: Information about different peer support avenues, including support groups, Cancer Connect, and Cancer Council Online Community [9].
Staying on track: includes information about habit formation, getting back after a slip, planning ahead, getting support from others, and celebrating success [1]. An example exercise for this section asks participants to identify situations where they may find it challenging to meet their goals (e.g., while on holiday) and to problem-solve ways to help them stay on track with their goals.

[1] Information supplied by the telephone-delivered Healthy Living after Cancer Program
[2] Exercise videos supplied by Cancer Council NSW
[3] Information about reading a food label supplied by National Health and Medical Research Council (representing the Commonwealth of Australia)
[4] Information about gaining weight derived from the Nutrition and Cancer booklet, Cancer Council Australia
[5] Information regarding thoughts, feelings, and behaviour developed for Finding My Way, supplied by A/Prof Lisa Beatty.
[6] Information regarding mindfulness derived from Mindfulness-based cognitive therapy for cancer: Gently turning towards by Trish Bartley.
[7] Information derived from Life after Cancer booklet, Cancer Council Australia.
[8] Information derived from Fatigue and Cancer, Cancer Council Australia
[9]Information was provided by stakeholder focus groups and interviews, and various Cancer Council websites regarding support groups they are associated with.
Intervention code [1] 320990 0
Lifestyle
Intervention code [2] 320991 0
Behaviour
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 328073 0
Feasibility as determined by adherence (number of times participant logs into the website, session duration, and number of modules completed), usability and satisfaction with the intervention, and attrition at the completion of the program.
Adherence will be assessed using website analytics and google analytics.
Usability and satisfaction with the program will be assessed in a post-program feedback interview, where participants will be asked to provide their feedback on the program's content, exercises, and navigation of the website. The usability of the website will also be assessed quantitatively using the System Usability Scale.
Timepoint [1] 328073 0
12 weeks after intervention commencement
Secondary outcome [1] 397485 0
Change in total quality of life score as measured by the Functional Assessment of Cancer Therapy - General
Timepoint [1] 397485 0
Baseline and 12 weeks after intervention commencement
Secondary outcome [2] 397486 0
Change in leisure time physical activity as measured by the Active Australia Survey
Timepoint [2] 397486 0
Baseline and 12 weeks after intervention commencement
Secondary outcome [3] 397487 0
Diet Quality as measured by the Fat and Fibre Behaviour Questionnaire
Timepoint [3] 397487 0
Baseline and 12 weeks after intervention commencement
Secondary outcome [4] 397488 0
Fatigue as measured by the Functional Assessment of Chronic Illness - Fatigue scale
Timepoint [4] 397488 0
Baseline and 12 weeks after intervention commencement
Secondary outcome [5] 397489 0
Psychological Distress measured by the Depression, Anxiety, and Stress Scale -21
Timepoint [5] 397489 0
Baseline and 12 weeks after intervention commencement
Secondary outcome [6] 397490 0
Cancer related symptoms measured by the MD Anderson Symptom Inventory
Timepoint [6] 397490 0
Baseline and 12 weeks after intervention commencement
Secondary outcome [7] 397491 0
Fear of Cancer recurrence measured by the 4-item Concerns about Recurrence Questionnaire
Timepoint [7] 397491 0
Baseline and 12 weeks after intervention commencement

Eligibility
Key inclusion criteria
Adults (18+ years)
Diagnosed with localised (i.e., non-metastatic) potentially curative cancer of any type within the last five years
Completed treatment (i.e., surgery, chemotherapy, radiation; patients on hormonal treatment or Herceptin will still be eligible)
Able to speak and read English
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Diagnosed with metastatic cancer
Have not completed cancer treatment
Diagnosed with cancer more than 5 years ago
Contraindications to engaging in unsupervised exercise (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, or pregnancy due to specific nutrition and physical activity requirements).
Cognitive or mental health impairments that would hinder 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)
Allocation is not concealed
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
Statistical methods / analysis
Descriptive Statistics will be used to summarise feasibility variables and participant's sociodemographic and clinical characteristics, and current health behaviours. Change over time will be analyses will be conducted using Linear Mixed Modelling.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/09/2021
Actual
29/12/2021
Date of last participant enrolment
Anticipated
15/10/2021
Actual
10/03/2022
Date of last data collection
Anticipated
7/01/2022
Actual
5/07/2022
Sample size
Target
12
Accrual to date
Final
11
Recruitment in Australia
Recruitment state(s)
NT,SA,VIC

Funding & Sponsors
Funding source category [1] 309001 0
University
Name [1] 309001 0
Flinders University
Country [1] 309001 0
Australia
Funding source category [2] 309003 0
Charities/Societies/Foundations
Name [2] 309003 0
Cancer Council SA
Country [2] 309003 0
Australia
Primary sponsor type
Individual
Name
A/Prof Lisa Beatty
Address
Flinders University, Sturt Rd, Bedford Park SA 5042
Country
Australia
Secondary sponsor category [1] 309937 0
Individual
Name [1] 309937 0
Dr Tony Daly
Address [1] 309937 0
Cancer Council SA, 168 Greenhill Rd, Parkside SA 5063
Country [1] 309937 0
Australia
Other collaborator category [1] 281885 0
Individual
Name [1] 281885 0
Ms Morgan Leske
Address [1] 281885 0
Flinders University, Sturt Rd, Bedford Park SA 5042
Country [1] 281885 0
Australia
Other collaborator category [2] 281886 0
Individual
Name [2] 281886 0
Prof Bogda Koczwara
Address [2] 281886 0
Flinders Medical Centre, Sturt Rd, Bedford Park SA 5042
Country [2] 281886 0
Australia
Other collaborator category [3] 281887 0
Individual
Name [3] 281887 0
Dr Jason Blunt
Address [3] 281887 0
Cancer Council SA, 168 Greenhill Rd, Parkside SA 5063
Country [3] 281887 0
Australia
Other collaborator category [4] 281888 0
Individual
Name [4] 281888 0
Prof Elizabeth Eakin
Address [4] 281888 0
Level 6, UQ Oral Health Centre, 288 Herston Rd, Herston QLD 4006
Country [4] 281888 0
Australia
Other collaborator category [5] 281889 0
Individual
Name [5] 281889 0
Dr Camille Short
Address [5] 281889 0
The University of Melbourne, Room 703, Level 7, Redmond Barry Building, Parkville Campus, Melbourne VIC 3010
Country [5] 281889 0
Australia
Other collaborator category [6] 281890 0
Individual
Name [6] 281890 0
Mr Jon Degner
Address [6] 281890 0
Cancer Voices SA, PO Box 588, Kensington Park SA 5068
Country [6] 281890 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308891 0
Research Governance and Optimal Care Unit
Ethics committee address [1] 308891 0
Ethics committee country [1] 308891 0
Australia
Date submitted for ethics approval [1] 308891 0
27/05/2021
Approval date [1] 308891 0
14/07/2021
Ethics approval number [1] 308891 0
HREC 2106

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

Contacts
Principal investigator
Name 112238 0
A/Prof Lisa Beatty
Address 112238 0
Flinders University, Sturt Rd, Bedford Park SA 5042
Country 112238 0
Australia
Phone 112238 0
+61 8 8201 2506
Fax 112238 0
Email 112238 0
[email protected]
Contact person for public queries
Name 112239 0
Morgan Leske
Address 112239 0
Flinders University, Sturt Rd, Bedford Park SA 5042
Country 112239 0
Australia
Phone 112239 0
+61 8 8201 2192
Fax 112239 0
Email 112239 0
[email protected]
Contact person for scientific queries
Name 112240 0
Lisa Beatty
Address 112240 0
Flinders University, Sturt Rd, Bedford Park SA 5042
Country 112240 0
Australia
Phone 112240 0
+61 8 8201 2506
Fax 112240 0
Email 112240 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Raw individual participant data of primary outcomes
When will data be available (start and end dates)?
Upon study completion with no end date
Available to whom?
All
Available for what types of analyses?
Meta-analyses
How or where can data be obtained?
Data can be obtain by contacting either of the Authors below:
A/Prof Lisa Beatty
E: [email protected]
Ph: +61 8 8201 2506

Ms Morgan Leske
E: [email protected]
Ph: +61 8 8201 2192


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.