Healthy Living after Cancer (HLaC) - a telephone-delivered healthy lifestyle coaching program for cancer survivors

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12615000882527
• Date of registration: 24/08/2015
• Prospective Registration: No
• Primary sponsor: The University of Queensland
• 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
• Date of first enrolment: 01/06/2015
• Target sample size: 900
• Recruitment status: Recruiting
• URL: https://anzctr.org.au/ACTRN12615000882527.aspx
• Study type: Interventional
• Study design: Purpose: Educational / counselling / training; Allocation: Non-randomised trial; Masking: Open (masking not used);Assignment: Single group;Type of endpoint: Efficacy;
• Phase: Not Applicable

Countries of recruitment

Australia

Contacts

• Name: Ms Erin Robson

• Name: Prof Elizabeth Eakin

Key inclusion & exclusion criteria

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
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

Age minimum: 18 Years
Age maximum: No limit
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Cancer - Any cancer

Cancer of any type that was treated with curative intent;
Cancer of any type that was treated with curative intent

Intervention(s)

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.

Primary Outcome(s)

Percent uptake among eligible patients - i.e., number of patients who consent to take part in the program[Consent telephone call]

Total number of patients referred[Recruitment and eligibility screening telephone call]

Referral source[Recruitment and eligibility screening telephone call]

Secondary Outcome(s)

Average length of calls per participant (primary outcome seven)[Length of each intervention call for each participant recorded in Cancer Council database]

Dietary behaviour as measured by the Fat & Fibre Behaviour Questionnaire (FFBQ - 20 items)[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).]

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)[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).]

Cancer Council nurse / information and support consultant and manager satisfaction with program delivery (primary outcome eight)[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]

Completion rates – date of completion of the post-program assessment (primary outcome five)[Post-program telephone assessment]

Self-reported waist circumference[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).]

Self-reported weight and height (to allow the calculation of BMI)[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). ]

Cancer-related symptoms and side-effects as measured by the MD Anderson Symptom Inventory (MDASI - 16 items)[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).]

Patient satisfaction with Healthy Living after Cancer (11 items) – questions written specifically for the purposes of this project[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).]

Fear of cancer recurrence as measured by the Concerns about Recurrence Questionnaire (CARQ-4 - 4 items)[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).]

Average number of intervention calls delivered per participant (primary outcome six)[Date of each intervention call for each participant recorded in Cancer Council database]

Physical activity as measured by the Active Australia Survey (AAS - 8 items)[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).]

Withdrawal rates and reasons - date of withdrawal, reason for withdrawal (primary outcome four)[Collected at point of withdrawal during telephone-delivered intervention calls]

Costs to deliver the Healthy Living after Cancer program (primary outcome nine)[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).]

Quality of life as measured by the Short Form (12) Health Survey (SF-12 - 12 items)[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 ID(s)

None

Source(s) of Monetary Support

Cancer Council South Australia

National Health and Medical Research Council

Cancer Council New South Wales

Cancer Council Victoria

Cancer Council Western Australia

Secondary Sponsor(s)

Cancer Council New South Wales

Cancer Council Western Australia

Cancer Council South Australia

Cancer Council Victoria

Ethics review

Status: Approved
Approval date:
Contact:

Cancer Council New South Wales HREC

Status: Approved
Approval date:
Contact:

Cancer Council Victoria HREC (on behalf of Cancer Council's Victoria and South Australia)

Status: Approved
Approval date:
Contact:

Northern Health Human Research Ethics Committee

Status: Approved
Approval date:
Contact:

Southern Adelaide Clinical HREC (on behalf of Flinders Medical Centre, Peter MacCallum Cancer Centre, Concord Repatriation General Hospital and Mater Hospital Sydney)

Status: Approved
Approval date:
Contact:

St John of God Health Care HREC

Status: Approved
Approval date:
Contact:

University of Queensland HREC

Status: Approved
Approval date:
Contact:

University of Western Australia HREC