A sequential multiple assignment randomised trial (SMART) of nursing interventions to reduce pain associated with chemotherapy induced peripheral neuropathy

Funding / Grants

  • NHMRC Project Grant (APP 1129532): $713,418 (2017 – 2021)

Project Details

Chemotherapy-induced peripheral neuropathy (CIN) is the most prevalent neurologic complication from the most commonly used cytotoxic agents in cancer treatment– the taxanes and plantinums. CIN is a dysfunction in peripheral neurons that results in a variable set of signs and symptoms. These symptoms occur predominantly in the extremities and include pain, numbness, tingling, and burning; gait and balance disturbances; difficulty with fine motor skills; reduced vibratory sense, touch, and proprioception; and progressive loss of deep tendon reflexes. Importantly, CIN is a dose-limiting toxicity of chemotherapy. It can cause treatment delays or cessation which in turn can lead to disease progression and reduced survival.

For patients with persistent, post-treatment CIN, the objectives of this study are to:

  1. compare the effectiveness of the initial and adaptive non-pharmacological  interventions;
  2. identify the best adaptive non-pharmacological interventions embedded within the SMART design; and
  3. evaluate the cost-effictiveness of each of the non-pharmacological intervention approaches for CIN in the respective trial arms.

This study uses a sequential multiple assignment randomised trial (SMART), to build optimal adaptive interventions aimed at decreasing the sensory, motor and autonomic impairments associated with CIN and improving mood and quality of life. Through evaluation of sequential non-pharmacological interventions, this novel study design enables comparison of separate interventions (heat therapy, massage, standard care), while allowing the intervention approach to be adapted according to patient response. For more information, please contact the lead PI – Professor Patsy Yates.

QCCS Team Members

A/Prof David Wyld

Medical Oncologist (QCCS Co-Chair/Founding Chair)

Director, Department of Medical Oncology, RBWH

Qualifications: MBBS (Hons), University of Qld, 1987; RACP Advanced Training in Medical Oncology, 1996; Fellowship of Royal Australian College of Physicians (FRACP), 1996.

Current Appointments:

  • Associate Professor, School of Medicine, University of Queensland (UQ)
  • Adjunct Associate Professor, Faculty of Health, Queensland University of Technology (QUT)
  • Affiliate, QIMR Berghofer Medical Research Institute

A/Prof Wyld is a Medical Oncologist who has practiced as a staff specialist (currently Eminent status) at Royal Brisbane and Women’s Hospital (RBWH) for over 20 years, after having undertaken an ICRF Cancer Research Fellowship in Leeds, UK, in 1996-97. He has been the Director of Medical Oncology at RBWH for 20 years, during which time he has overseen the development of the large, highly regarded Medical Oncology clinical trials unit at RBWH, and has managed the unit continuously for almost 20 years. Over the last 20 years as a full-time practicing cancer clinician at RBWH, A/Prof Wyld has maintained an active research focus, predominantly in the area of clinical research, including a major focus on clinical trials (see below). A/Prof Wyld’s research involvement over 20 years has been broad, but with a particular focus on gastrointestinal cancers, gynaecologic malignancies and qualitative patient-focused research. His current major research interests are in the area of neuroendocrine tumours (NETs), pancreatic cancer, colorectal cancer and the area of supportive care, survivorship and qualitative patient focused research. He also has a long history of mentoring staff in clinical research and a proven track record of research collaboration.

Prof Ray Chan

Nurse (QCCS Co-Chair/Founding Co-Chair)

Doctor of Philosophy (Queensland University of Technology), Master of Applied Science (Research) (Queensland University of Technology), Bachelor of Nursing (Queensland University of Technology)

Dr Raymond Chan is Professor of Cancer Nursing, Princess Alexandra Hospital and Queensland University of Technology. To date, he has attracted over 8.5 million (AUD) of research project grants as a chief investigator (> $2 Million as CIA) to undertake research in supportive cancer care. Dr Chan is a chief investigator for 4 current/past NHMRC project grants and 1 NHMRC Fellowship, and has published 97 peer-reviewed articles. Ray is currently the Chair for the Survivorship Group, Multinational Association for Supportive Care in Cancer (MASCC), and the Board Director (Knowledge Development and Dissemination) for the International Society of Nurses in Cancer Care (ISNCC). He is a past President for the Cancer Nurses Society of Australia (CNSA), the peak professional body representing cancer nurses across Australia.

Recent funded project highlights include:

  • (2019-2020): ImplEMenting a nurse-coordinated, INtegrated, shared-care model involving specialists and general practitioners in breast cancer post-treatmENT follow-up: a Phase II randomised controlled trial (The EMINENT Trial). Metro South Health (CIA)
  • (2017-2020): A sequential multiple assignment randomised trial (SMART) of nursing interventions to reduce pain associated with chemotherapy induced peripheral neuropathy. NHMRC (CID)
  • (2016-2019): Peripherally InSerted Central catheter Securement: the PISCES Trial. NHMRC (CIC)
  • (2014-2017): Development and evaluation of a nurse-led, tailored self-management behavioural intervention for managing distressing symptoms in patients with advanced cancer (The SM2 Study). RBWH Foundation and NHMRC (CIA)
  • (2014-2015): Younger women’s wellness after cancer program.  RBWH Foundation (CID)
  • (2014): Central venous Access device SeCurement And Dressing Effectiveness in Cancer Care: The CASCADE Trial.  RBWH Foundation (CIA)
  • (2013-2016): Improving quality of life in high-risk cancer populations: a randomised trial of a structured intervention for head and neck cancer survivors. NHMRC (CIJ)
  • (2012-2013): A double-blind randomised controlled trial of Moogoo Udder Cream® versus aqueous cream for managing radiation-induced skin reactions in patients with cancer.  RBWH Foundation; Office of Health and Medical Research; Cancer Nurses Society of Australia; Moogoo Skincare
  • (2011-2014): The RSVP Trial:  Replacement of Intravascular device administration sets after Standard Versus Prolonged use. NHMRC and RBWH Foundation (CIG)
  • (2010): Self-management associated with fatigue in patients with advanced cancer. RBWH Foundation, Queensland Nursing Council, Royal College of Nursing Australia (CIA)

Recent QCCS Project

Research Keywords 

Cancer Care, Supportive Care, Cancer Nursing, Survivorship Care
40%

 

Symptom Management, Quality of Life, Palliative Care, End-of-life Care
40%

 

Evidence-based Practice, Cochrane Systematic Reviews
20%

 

  

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