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Trial registered on ANZCTR


Registration number
ACTRN12622001111763
Ethics application status
Approved
Date submitted
3/08/2022
Date registered
11/08/2022
Date last updated
13/09/2023
Date data sharing statement initially provided
11/08/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluating the feasibility of adding brief telephone guidance to an online healthy living program for post-treatment cancer survivors.
Scientific title
Evaluating the feasibility of adding brief telephone guidance to Healthy Living after Cancer Online: an online physical activity, nutrition, and psychosocial program for post-treatment cancer survivors.
Secondary ID [1] 304490 0
None
Universal Trial Number (UTN)
Trial acronym
HLaC Online
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cancer 322336 0
Condition category
Condition code
Cancer 320006 320006 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 access the program for 12 weeks, complete at least three modules, and log in once per week to utilise the trackers provided to track their progress. Adherence to the program will be monitored using website and google analytics, a questionnaire, 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.

Participants will also be offered two 15-minute telephone guidance calls with a Provisional Psychologist in week 1 and week 4. For each phone call, the participants will be asked to have the program available in front of them. The first phone call will involve orientation to the Healthy Living after Cancer Online website, discussing the establishing the participant's aims in using the program, and establishing one relevant SMART goal and action plan using the My Goals module. Participants will be recommended three modules to use based on their aims for the program. Participants will be asked to access these modules and establish two more SMART goals prior to the next phone call. The second phone call will involve checking in with the participant to review their SMART goals and action plans, discuss the modules they have completed, and answer any questions they have regarding the program.


[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 the 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] 320852 0
Lifestyle
Intervention code [2] 320853 0
Behaviour
Comparator / control treatment
Participants allocated to the control condition will also be provided with access to the Healthy Living after Cancer Online program as described above with the exception of the telephone guidance calls.
Control group
Active

Outcomes
Primary outcome [1] 327877 0
The feasibility of the HLaC Online will be determined by a composite of the following:
(1) Intervention uptake, which will be measured by the percentage of participants who visit the website and subsequently sign up / log in. This will be assessed using a combination of Google analytics to determine the number of visitors to the website and enrolment logs from the website analytics.
(2) Usage of the intervention which will be measured by the number of times participants log into the website, session duration, and the number of modules completed. This will be assessed using the website analytics, which includes a record of participants' website usage.
(3) Adherence will be measured by asking participants to identify three aims for engaging in the program and comparing their responses to their module usage
(4) Satisfaction with intervention which will be measured using the Client Satisfaction Survey and qualitative feedback
(5) Usability of the intervention which will be measured using the System Usability Survey and qualitative feedback
Timepoint [1] 327877 0
12 weeks after intervention commencement
Secondary outcome [1] 396837 0
Change in leisure time physical activity as measured by the Active Australia Survey
Timepoint [1] 396837 0
Baseline, 12 weeks, 16 weeks, and 24 weeks after intervention commencement.
Secondary outcome [2] 396838 0
Diet Quality as measured by the Fat and Fibre Behaviour Questionnaire
Timepoint [2] 396838 0
Baseline, 12 weeks, 16 weeks, and 24 weeks after intervention commencement.
Secondary outcome [3] 396839 0
Fatigue as measured by the Functional Assessment of Chronic Illness - Fatigue scale
Timepoint [3] 396839 0
Baseline, 12 weeks, 16 weeks, and 24 weeks after intervention commencement.
Secondary outcome [4] 396840 0
Psychological Distress measured by the Depression, Anxiety, and Stress Scale -21
Timepoint [4] 396840 0
Baseline, 12 weeks, 16 weeks, and 24 weeks after intervention commencement.
Secondary outcome [5] 396841 0
Cancer related symptoms measured by the MD Anderson Symptom Inventory
Timepoint [5] 396841 0
Baseline, 12 weeks, 16 weeks, and 24 weeks after intervention commencement.
Secondary outcome [6] 396842 0
Fear of Cancer recurrence measured by the 4-item Concerns about Recurrence Questionnaire
Timepoint [6] 396842 0
Baseline, 12 weeks, 16 weeks, and 24 weeks after intervention commencement.
Secondary outcome [7] 412183 0
Change in total quality of life score as measured by the Functional Assessment of Cancer Therapy - General
Timepoint [7] 412183 0
Baseline, 12 weeks, 16 weeks, and 24 weeks after intervention commencement.

Eligibility
Key inclusion criteria
Adults (18+ years)
Diagnosed with localised (i.e., non-metastatic) potentially curative cancer of any type
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
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
Randomised controlled 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)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
40 participants will be recruited (intervention n = 20, active control n = 20).
Descriptive Statistics will be used to summarise participants' sociodemographic and clinical characteristics, current health behaviors, and website usage.
Group comparisons for all outcomes will be conducted using Linear Mixed Modelling.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/09/2022
Actual
23/08/2022
Date of last participant enrolment
Anticipated
1/02/2023
Actual
17/01/2023
Date of last data collection
Anticipated
31/12/2023
Actual
6/08/2023
Sample size
Target
40
Accrual to date
Final
52
Recruitment in Australia
Recruitment state(s)
NT,QLD,SA,VIC

Funding & Sponsors
Funding source category [1] 308852 0
University
Name [1] 308852 0
Flinders University
Country [1] 308852 0
Australia
Funding source category [2] 308914 0
Charities/Societies/Foundations
Name [2] 308914 0
Cancer Council SA
Country [2] 308914 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] 309768 0
Individual
Name [1] 309768 0
Dr Tony Daly
Address [1] 309768 0
Cancer Council SA, 168 Greenhill Rd, Parkside SA 5063
Country [1] 309768 0
Australia
Other collaborator category [1] 281865 0
Individual
Name [1] 281865 0
Ms Morgan Leske
Address [1] 281865 0
Flinders University, Sturt Rd, Bedford Park SA 5042
Country [1] 281865 0
Australia
Other collaborator category [2] 281866 0
Individual
Name [2] 281866 0
Prof Bogda Koczwara
Address [2] 281866 0
Flinders Medical Centre, Sturt Rd, Bedford Park SA 5042
Country [2] 281866 0
Australia
Other collaborator category [3] 281867 0
Individual
Name [3] 281867 0
Dr Jason Blunt
Address [3] 281867 0
Cancer Council SA, 168 Greenhill Rd, Parkside SA 5063
Country [3] 281867 0
Australia
Other collaborator category [4] 281882 0
Individual
Name [4] 281882 0
Dr Camille Short
Address [4] 281882 0
Room 703, Level 7, Redmond Barry Building, University of Melbourne Parkville Campus, Melbourne VIC 3010
Country [4] 281882 0
Australia
Other collaborator category [5] 281883 0
Individual
Name [5] 281883 0
Prof Elizabeth Eakin
Address [5] 281883 0
Level 6, UQ Oral Health Centre, 288 Herston Rd, Herston QLD 4006
Country [5] 281883 0
Australia
Other collaborator category [6] 281884 0
Individual
Name [6] 281884 0
Mr Jon Degner
Address [6] 281884 0
Cancer Voices SA, PO Box 588, Kensington Park, SA 5068
Country [6] 281884 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308759 0
Research Governance and Optimal Care Unit
Ethics committee address [1] 308759 0
Cancer Council Victoria, 615 St Kilda Rd, Melbourne, Victoria 3004
Ethics committee country [1] 308759 0
Australia
Date submitted for ethics approval [1] 308759 0
27/05/2021
Approval date [1] 308759 0
14/07/2021
Ethics approval number [1] 308759 0
HREC2160

Summary
Brief summary
The purpose of the current study is to evaluate the feasibility and efficacy of adding a telephone coaching element to the Healthy living after Cancer Online program.

Who is it for?
You may be eligible for this study if you are aged 18 years or older, live in Australia, you have been diagnosed with a localised cancer and you have completed your cancer treatment, which may include surgery, chemotherapy, radiation. Patients on hormonal treatment or Herceptin will still be eligible.

Study details
Participants who choose to enrol in this study will be randomly allocated by chance (similar to flipping a coin) to receive either the Healthy living after Cancer Online program plus telephone coaching, or to receive the Healthy living after Cancer Online program only. Participants in both groups will be asked to work through an online program for 12 weeks that addresses multiple areas of health, including physical activity, healthy eating, mental health, finding the new normal after cancer treatment, fatigue, and weight management. Questionnaires will be collected before and after the intervention. Participants who are allocated to the telephone coaching group will also receive 2x one-on-one 15 minute telephone sessions with a Provisional Psychologist during the first and fourth weeks of the program. The purpose of these sessions will be to help the participants to identify goals that are meaningful to them, to help plan activities that will assist them to meet their goals and to check their progress in meeting these goals over time.

It is hoped this research will determine whether the combination of an online cancer program and telephone support sessions are feasible and acceptable to cancer patients. If this pilot program is successful, a larger study enrolling a greater number of patients may go ahead and could lead to future benefits for more cancer patients.
Trial website
healthylivingaftercancer.org
Trial related presentations / publications
Public notes
This study has been informed by a previously conducted feasibility trial of HLaC Online (ACTRN12621001166864)

Contacts
Principal investigator
Name 111790 0
A/Prof Lisa Beatty
Address 111790 0
Flinders University, Sturt Rd, Bedford Park SA 5042
Country 111790 0
Australia
Phone 111790 0
+61 8 82012506
Fax 111790 0
Email 111790 0
[email protected]
Contact person for public queries
Name 111791 0
Morgan Leske
Address 111791 0
Flinders University, Sturt Rd, Bedford Park SA 5042
Country 111791 0
Australia
Phone 111791 0
+61 8 82012192
Fax 111791 0
Email 111791 0
[email protected]
Contact person for scientific queries
Name 111792 0
Lisa Beatty
Address 111792 0
Flinders University, Sturt Rd, Bedford Park SA 5042
Country 111792 0
Australia
Phone 111792 0
+61 8 82012506
Fax 111792 0
Email 111792 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 and secondary 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.