Poster Presentation Clinical Oncology Society of Australia Annual Scientific Meeting 2023

Protocol of a feasibility randomised controlled trial of an intervention to enhance recovery from breast cancer treatment (#513)

Janine Porter-Steele 1 2 3 , Katrina Sharples 4 5 , Dorothy Chan 6 , Sarah Benge 4 7 , Bobbi Laing 4 7 , Sarah Balaam 2 , Debra Anderson 8 , Alexandra McCarthy 2
  1. The Wesley Choices Cancer Support Centre. , Auchenflower, Qld, Australia
  2. The University of Queensland, St Lucia, Qld, Australia
  3. Wesley Research Institute, Auchenflower, Qld, Australia
  4. Cancer Trials New Zealand, Auckland, Aotearoa / New Zealand
  5. University of Otago, Dunedin, Aotearoa / New Zealand
  6. The Nethersole School of Nursing, The Chinese University of Hong Kong, Hong Kong, China
  7. The University of Auckland, Auckland, Aotearoa / New Zealand
  8. University of Technology Sydney, Sydney, NSW, Australia

ABSTRACT

 

Background: Younger women (i.e., <50 years and likely pre-menopausal at diagnosis) treated for breast cancer often experience persistent treatment-related side effects that adversely affect their physical and psychological wellbeing. The Younger Women’s Wellness After Cancer Program (YWWACP) was developed to address these outcomes.

 

Aims

The aims of these three identical feasibility studies are to determine:

  1. The potential to deliver the YWWACP to target cohorts in Aotearoa/New Zealand, Australia and Hong Kong.
  2. The potential for success of a larger, international, Phase III, randomised controlled trial.

 

Two of the three studies are complete, with the Australian study due to finish at the end of this year.

 

Methods

This longitudinal, randomised, single-blinded controlled trial involves three study sites in Aotearoa/New Zealand (“KOWHAI”), Australia (“EMERALD”) and Hong Kong (“YWWACPHK”— Cantonese version).

 

Eligibility

Women 18-50 years; completed intensive treatment (surgery, chemotherapy, and/or radiotherapy) for Stage I-II breast cancer in previous 24 months; internet access; minimum Year 8 schooling-level.

 

Sample size

Target of 60 participants in each country (total N=180) achieved.

 

Outcome measures

The potential to translate the YWWACP to women in three countries will be assessed according to the following feasibility outcomes:

  1. Examining intervention accessibility, acceptability and uptake
  2. Intervention sustainability and adherence
  3. The prevalence components of the intervention in the control group
  4. Potential intervention efficacy
  5. Participants’ perception of measurement burden
  6. The effectiveness of planned recruitment strategies; and trial methods and procedures.

 

Discussion

The analysis will provide important data on the feasibility of the YWWACP method and intervention in each country. Combined, these three feasibility studies will harmonise cross-country differences to ensure the success of a proposed international grant application for a Phase III randomised controlled trial of this program to improve outcomes in younger women living with breast cancer in three countries.