Evidence map›Paper›PMID 35918737›Full record

ArticlePilot and feasibility studies2022

Protocol of trans-Tasman feasibility randomised controlled trial of the Younger Women's Wellness After Breast Cancer (YWWACP) lifestyle intervention.

K Sharples, N K Vear, J Porter-Steele, D J Anderson, T H Moeke-Maxwell, B B Laing, L Young, T G Bailey, S Benge, Y Huang and 8 more

Open access · goldAbstract read
In one paragraph

Article in Pilot and feasibility studies, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.2field-weighted citation impact, top 46% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 2 citations in OpenAlex.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

18 authors at 7 institutions in 2 countries.

K SharplesCancer Trials New Zealand, Auckland, New Zealand.
N K VearUniversity of Queensland, Brisbane, Australia. n.vear@uq.edu.au.ORCID http://orcid.org/0000-0001-6068-1248
J Porter-SteeleWesley Choices Cancer Support Centre, Brisbane, Australia.
D J AndersonUniversity of Technology, Sydney, Australia.
T H Moeke-MaxwellUniversity of Auckland, Auckland, New Zealand.
B B LaingUniversity of Auckland, Auckland, New Zealand.
L YoungWesley Choices Cancer Support Centre, Brisbane, Australia.
T G BaileyUniversity of Queensland, Brisbane, Australia.
S BengeCancer Trials New Zealand, Auckland, New Zealand.
Y HuangCancer Trials New Zealand, Auckland, New Zealand.
E CrowleyCancer Trials New Zealand, Auckland, New Zealand.
R DayCancer Trials New Zealand, Auckland, New Zealand.
R CartwrightCancer Trials New Zealand, Auckland, New Zealand.
M FindlayCancer Trials New Zealand, Auckland, New Zealand.
D PorterDepartment of Oncology, Auckland Hospital, Auckland, New Zealand.
M KuperDepartment of Oncology, Waikato Hospital, Hamilton, New Zealand.
I CampbellDepartment of Surgery, Waikato Hospital, Hamilton, New Zealand.
A L McCarthyUniversity of Queensland, Brisbane, Australia.
Clinical Trials New Zealand · NZThe University of Queensland · AUUniversity of Auckland · NZWaikato Hospital · NZAuckland City Hospital · NZQueensland University of Technology · AUUniversity of Technology Sydney · AU

Funding

Health Research Council Aotearoa/New Zealand 19/622Wesley Medical Research ID2020CR02
6 · The paper itself

Abstract

backgroundYounger women (defined as those < 50 years who are likely pre-menopausal at time of diagnosis) with breast cancer often experience persistent treatment-related side effects that adversely affect their physical and psychological wellbeing. The Women's Wellness After Cancer Program (WWACP) was adapted and piloted in Australia to address these outcomes in younger women. The aims of this feasibility study are to determine (1) the potential to translate the Younger WWACP (YWWACP) intervention to a broader population base in Aotearoa/New Zealand and Australia, and (2) the potential for success of a larger, international, phase ΙΙΙ, randomised controlled trial.

methodsThis bi-national, randomised, single-blinded controlled trial involves two main study sites in Aotearoa/New Zealand (Kōwhai study) and Australia (EMERALD study). Young women aged 18 to 50 years who completed intensive treatment (surgery, chemotherapy, and/or radiotherapy) for breast cancer in the previous 24 months are eligible. The potential to translate the YWWACP to women in these two populations will be assessed according to several feasibility outcomes. These include examining intervention accessibility, acceptability and uptake; intervention sustainability and adherence; the prevalence components of the intervention in the control group; intervention efficacy; participants' perception of measurement burden; the effectiveness of planned recruitment strategies; and trial methods and procedures. The studies collectively aim to enrol 60 participants in the intervention group and 60 participants in the control group (total = 120 participants). DISCUSSION: Ethical approval has been received from the Southern Health and Disability Ethics Committee (Kōwhai ref: 19/STH/215), and UnitingCare Human Research Ethics Committee (EMERALD ref: 202103). This study will provide important data on the feasibility of the refined YWWACP in the trans-Tasman context. This study will account for and harmonise cross-country differences to ensure the success of a proposed international grant application for a phase ΙΙΙ randomised controlled trial of this program to improve outcomes in younger women living with breast cancer.

trial registrationAustralian New Zealand Clinical Trials Registry (ANZCTR): Kōwhai ACTRN12620000260921 , registered on 27 February 2020. EMERALD ACTRN12621000447853 , registered on 19 April 2021.

Indexed as

AcceptabilityBreast cancerFeasibilityTranslation

Identifiers

PMID35918737
PMCPMC9343821
OpenAlexW4289519719

What Socratic holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.