Feasibility study of a multimodal prehabilitation programme in women receiving neoadjuvant therapy for breast cancer in a major cancer hospital: a protocol
Introduction Neoadjuvant therapy has become a standard treatment for patients with stage II/III HER2 positive and triple negative breast cancer, and in well-selected patients with locally advanced and borderline resectable high risk, luminal B breast cancer. Side effects of neoadjuvant therapy, such...
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BMJ Publishing Group
2024-03-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/14/3/e080239.full |
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| author | Sanjeev Kumar María González Judith Lacey Cindy Mak Gillian Heller Suzanne J Grant Shelley Kay Kim Kerin-Ayres Justine Stehn Sandra Templeton Jane Cockburn Sara Wahlroos Ashanya Malalasekera Susannah Graham |
| author_facet | Sanjeev Kumar María González Judith Lacey Cindy Mak Gillian Heller Suzanne J Grant Shelley Kay Kim Kerin-Ayres Justine Stehn Sandra Templeton Jane Cockburn Sara Wahlroos Ashanya Malalasekera Susannah Graham |
| author_sort | Sanjeev Kumar |
| collection | DOAJ |
| description | Introduction Neoadjuvant therapy has become a standard treatment for patients with stage II/III HER2 positive and triple negative breast cancer, and in well-selected patients with locally advanced and borderline resectable high risk, luminal B breast cancer. Side effects of neoadjuvant therapy, such as fatigue, cardiotoxicity, neurotoxicity, anxiety, insomnia, vasomotor symptoms, gastrointestinal disturbance as well as a raft of immune-related adverse events, may impact treatment tolerance, long-term outcomes, and quality of life. Providing early supportive care prior to surgery (typically termed ‘prehabilitation’) may mitigate these side effects and improve quality of life.During our codesign of the intervention, consumers and healthcare professionals expressed desire for a programme that ‘packaged’ care, was easy to access, and was embedded in their care pathway. We hypothesise that a multimodal supportive care programme including exercise and complementary therapies, underpinned by behavioural change theory will improve self-efficacy, quality of life, readiness for surgery and any additional treatment for women with breast cancer. We seek to explore cardiometabolic, residual cancer burden and surgical outcomes, along with chemotherapy completion (relative dose intensity). This article describes the protocol for a feasibility study of a multimodal prehabilitation programme.Methods and analysis This is a prospective, mixed-method, feasibility study of a multi-modal programme in a hospital setting for 20–30 women with breast cancer receiving neoadjuvant therapy. Primary outcomes are recruitment rate, retention rate, adherence and acceptability. Secondary outcomes include patient reported outcome measures (PROMs), surgical outcomes, length of stay, satisfaction with surgery, chemotherapy completion rates, changes in metabolic markers and adverse events. Interviews and focus groups to understand the experience with prehabilitation and different factors that may affect feasibility of the intervention . The output of this study will be a codesigned, evidence-informed intervention assessed for feasibility and acceptability by women with breast cancer and the healthcare professionals that care for them.Ethics and dissemination The study received ethics approval from the St Vincents Hospital HREC (HREC/2021/ETH12198). Trial results will be communicated to participants, healthcare professionals, and the public via publication and conferences.Trial registration number ACTRN12622000584730. |
| format | Article |
| id | doaj-art-20109bf75fc447a2bd853497fda83776 |
| institution | OA Journals |
| issn | 2044-6055 |
| language | English |
| publishDate | 2024-03-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-20109bf75fc447a2bd853497fda837762025-08-20T02:13:49ZengBMJ Publishing GroupBMJ Open2044-60552024-03-0114310.1136/bmjopen-2023-080239Feasibility study of a multimodal prehabilitation programme in women receiving neoadjuvant therapy for breast cancer in a major cancer hospital: a protocolSanjeev Kumar0María González1Judith Lacey2Cindy Mak3Gillian Heller4Suzanne J Grant5Shelley Kay6Kim Kerin-Ayres7Justine Stehn8Sandra Templeton9Jane Cockburn10Sara Wahlroos11Ashanya Malalasekera12Susannah Graham13Cardiovascular Radiology and Endovascular Interventions, All India Institute of Medical Sciences, New Delhi, IndiaSupportive Care and Integrative Oncology, Chris O`Brien Lifehouse, Camperdown, New South Wales, AustraliaDepartment of Supportive Care and Integrative Oncology, Chris O`Brien Lifehouse, Camperdown, New South Wales, AustraliaSurgical Oncology Department, Chris O`Brien Lifehouse, Camperdown, New South Wales, AustraliaNHMRC Clinical Trials Centre, The University of Sydney, Sydney, New South Wales, AustraliaSupportive Care and Integrative Oncology, Chris O`Brien Lifehouse, Camperdown, New South Wales, AustraliaSupportive Care and Integrative Oncology, Chris O`Brien Lifehouse, Camperdown, New South Wales, AustraliaSupportive Care and Integrative Oncology, Chris O`Brien Lifehouse, Camperdown, New South Wales, AustraliaSupportive Care and Integrative Oncology, Chris O`Brien Lifehouse, Camperdown, New South Wales, AustraliaSupportive Care and Integrative Oncology, Chris O`Brien Lifehouse, Camperdown, New South Wales, AustraliaPatient Advocate, Chris O`Brien Lifehouse, Camperdown, New South Wales, AustraliaMedical Oncology Department, Chris O`Brien Lifehouse, Camperdown, New South Wales, AustraliaSupportive Care and Integrative Oncology, Chris O`Brien Lifehouse, Camperdown, New South Wales, AustraliaSurgical Oncology Department, Chris O`Brien Lifehouse, Camperdown, New South Wales, AustraliaIntroduction Neoadjuvant therapy has become a standard treatment for patients with stage II/III HER2 positive and triple negative breast cancer, and in well-selected patients with locally advanced and borderline resectable high risk, luminal B breast cancer. Side effects of neoadjuvant therapy, such as fatigue, cardiotoxicity, neurotoxicity, anxiety, insomnia, vasomotor symptoms, gastrointestinal disturbance as well as a raft of immune-related adverse events, may impact treatment tolerance, long-term outcomes, and quality of life. Providing early supportive care prior to surgery (typically termed ‘prehabilitation’) may mitigate these side effects and improve quality of life.During our codesign of the intervention, consumers and healthcare professionals expressed desire for a programme that ‘packaged’ care, was easy to access, and was embedded in their care pathway. We hypothesise that a multimodal supportive care programme including exercise and complementary therapies, underpinned by behavioural change theory will improve self-efficacy, quality of life, readiness for surgery and any additional treatment for women with breast cancer. We seek to explore cardiometabolic, residual cancer burden and surgical outcomes, along with chemotherapy completion (relative dose intensity). This article describes the protocol for a feasibility study of a multimodal prehabilitation programme.Methods and analysis This is a prospective, mixed-method, feasibility study of a multi-modal programme in a hospital setting for 20–30 women with breast cancer receiving neoadjuvant therapy. Primary outcomes are recruitment rate, retention rate, adherence and acceptability. Secondary outcomes include patient reported outcome measures (PROMs), surgical outcomes, length of stay, satisfaction with surgery, chemotherapy completion rates, changes in metabolic markers and adverse events. Interviews and focus groups to understand the experience with prehabilitation and different factors that may affect feasibility of the intervention . The output of this study will be a codesigned, evidence-informed intervention assessed for feasibility and acceptability by women with breast cancer and the healthcare professionals that care for them.Ethics and dissemination The study received ethics approval from the St Vincents Hospital HREC (HREC/2021/ETH12198). Trial results will be communicated to participants, healthcare professionals, and the public via publication and conferences.Trial registration number ACTRN12622000584730.https://bmjopen.bmj.com/content/14/3/e080239.full |
| spellingShingle | Sanjeev Kumar María González Judith Lacey Cindy Mak Gillian Heller Suzanne J Grant Shelley Kay Kim Kerin-Ayres Justine Stehn Sandra Templeton Jane Cockburn Sara Wahlroos Ashanya Malalasekera Susannah Graham Feasibility study of a multimodal prehabilitation programme in women receiving neoadjuvant therapy for breast cancer in a major cancer hospital: a protocol BMJ Open |
| title | Feasibility study of a multimodal prehabilitation programme in women receiving neoadjuvant therapy for breast cancer in a major cancer hospital: a protocol |
| title_full | Feasibility study of a multimodal prehabilitation programme in women receiving neoadjuvant therapy for breast cancer in a major cancer hospital: a protocol |
| title_fullStr | Feasibility study of a multimodal prehabilitation programme in women receiving neoadjuvant therapy for breast cancer in a major cancer hospital: a protocol |
| title_full_unstemmed | Feasibility study of a multimodal prehabilitation programme in women receiving neoadjuvant therapy for breast cancer in a major cancer hospital: a protocol |
| title_short | Feasibility study of a multimodal prehabilitation programme in women receiving neoadjuvant therapy for breast cancer in a major cancer hospital: a protocol |
| title_sort | feasibility study of a multimodal prehabilitation programme in women receiving neoadjuvant therapy for breast cancer in a major cancer hospital a protocol |
| url | https://bmjopen.bmj.com/content/14/3/e080239.full |
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