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

Not Applicable

Active, not recruiting

Conditions: Chemotherapy induced peripheral neuropathy
Cancer
Cancer - Any cancer
Neurological - Other neurological disorders

Registration Number: ACTRN12617001211358

Lead Sponsor: Queensland University of Technology

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Active, not recruiting

Sex: All

Target Recruitment: 649

Inclusion Criteria

Greater than or equal to 18 years of age
• Able to read, write, and understand English
• Internet access is not essential but participant must be willing and able to see a health care professional and or send photo/s via email or phone in relation to any adverse events
• Capacity to give informed consent
• Have an Australian-modified KPS score of greater than or equal to 60
• Are within greater than or equal to 3 months to less than or equal to 5 years of completing a course of CTX known to cause peripheral neuropathy such as those containing taxane or platinum-based agents for the treatment of cancer
• Meet study definition of CIPN:
a) Changes in sensation and/or pain in their feet and/or hands of greater than or equal to 3 month duration following the completion of CTX; and
b) A current rating of greater than or equal to 3 on a 0 to 10 numerical rating scale (NRS) on any one of the following sensations from the PQAS (i.e., numb, tender, shooting, sensitive, electrical, tingling radiating, throbbing, cramping, itchy, unpleasant)
• Able to comply with all study requirements

Exclusion Criteria

The presence of any of the following criteria will constitute cause for the exclusion of the participant:
• Any prior history of conditions associated with neuropathy, including diabetes mellitus (treated with insulin); peripheral vascular disease; history of chronic vitamin B12 deficiency; unstable/severe thyroid dysfunction (confirmed by treating medical practitioner); HIV neuropathy; current cervical or lumbar pain with radiculopathy, or another painful condition that is difficult for them to distinguish from CIPN; or a history of hereditary sensory or autonomic neuropathy; and/or a hereditary mitochondrial disorder. These exclusion criteria will minimise a number of confounding factors that could influence analysis of the study data.
• Any condition or treatment for which heat or massage therapy may be contraindicated, including increased risk of haemorrhage, impaired cognitive ability, impaired skin integrity, known malignant hypertension, pacemaker and pregnancy.