A sequential multiple assignment randomised trial (SMART) of nursing interventions to reduce pain associated with chemotherapy induced peripheral neuropathy (Status: Ongoing)
Funding / Grants
- NHMRC Project Grant (APP 1129532): $713,418 (2017 – 2021)
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:
- compare the effectiveness of the initial and adaptive non-pharmacological interventions;
- identify the best adaptive non-pharmacological interventions embedded within the SMART design; and
- 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.