The PAPHIO study protocol: a randomised controlled trial with a 2 x 2 crossover design of physical activity adherence, psychological health and immunological outcomes in breast cancer survivors

Supa Pudkasam, Meron Pitcher, Melanie Fisher, Anne O'Connor, Nanthaphan Chinlumprasert, Lily Stojanovska, Remco Polman, Vasso Apostolopoulos

Research output: Contribution to journalArticlepeer-review

2 Citations (Scopus)

Abstract

BACKGROUND: The PAPHIO study; a randomized controlled trial with 2X2 crossover design will implement a self-directed physical activity program in which participants will engage in self-monitoring and receive motivational interviewing to enhance physical activity adherence. The study aims to determine the effects of 24 weeks self-directed activity combined with motivational interviewing (MI) on (i) psychological health, (ii) quality of life (QoL) and (iii) immune function in female breast cancer survivors. METHODS: The study will recruit 64 female breast cancer survivors within 3 years of diagnosis and at least 6 months post primary treatments at Western Health Sunshine Hospital, Melbourne, Australia. They will be randomly allocated to immediate intervention (IIG group) or delayed intervention groups (DIG group) in a 1:1 ratio. All participants will be given a wearable device (Fitbit Alta HR) and undertake self-directed physical activity for 24 weeks and will receive MI for 12 weeks (IIG; during week 0 to week 12 and DIG; during week 13 to week 24). Participants' daily step count and the changes of immune cell functionality will be assessed at the beginning (week 1: T1), week 12 (T2) and week 24 (T3) of the program. Physical activity adherence will be assessed at T2 and T3. Participants will also complete four questionnaires assessing exercise self-regulation (BREQ2), exercise barrier and task self-efficacy, mental health (DASS-21) and QoL (FACT-B) at three time points (T1 to T3). Linear-mixed models will be used to assess the relationship between physical activity volume by step counting and mental health (DASS-21), QoL (FACT-B), immune biomarkers, self-regulation (BREQ2) and self-efficacy at T1, T2 and T3;between 2 groups. DISCUSSION: We expect this physical activity intervention to be acceptable and beneficial to the participants in terms of psychological and immunological well-being with the potential outcomes to be implemented more widely at relatively low cost to these or other patient populations. TRIAL REGISTRATION: Australian New Zealand Clinical trials Registry- ACTRN12619001271190. Prospectively registered on 13 September 2019.

Original languageEnglish
Pages (from-to)696
Number of pages1
JournalBMC public health
Volume20
Issue number1
DOIs
Publication statusPublished - May 15 2020

Keywords

  • And immunological biomarker
  • Breast cancer survivor
  • Motivational interviewing
  • Pedometer
  • Physical activity adherence
  • Psychological health
  • Quality of life
  • Self-directed physical activity

ASJC Scopus subject areas

  • Public Health, Environmental and Occupational Health

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