Participant information

Participants in the CIPN clinical trial can expect to follow these steps.

1. Confirm you are eligible to participate

You will meet with someone from the research team, who will ask questions about your symptoms and your treatment to confirm you meet the criteria for participating in the study.

2. Try a home-based therapy for four weeks

On a ‘chance’ basis (like flipping a coin), we will assign you to a group that receives standard care, or an intervention of standard care plus heat therapy. If you’re in the heat therapy intervention group, we will teach you how to use the heat pads in your home. You will be asked to use the heat therapy for four weeks.

3. Did your symptoms improve?

The research team will ask about your symptoms to determine if they have improved, or ‘responded’ to the intervention. If your symptoms have improved, you will continue following the same care routine for another four weeks.

4. ‘Non-responders’ try a different therapy for four weeks

If your symptoms have not improved, we will assign you (on a chance basis again) to a group to receive a different intervention.

  • If you received standard care the first time, you’ll receive standard care plus either heat therapy or massage therapy.
  • If you received standard care plus heat therapy the first time, you’ll receive standard care plus either massage therapy or heat and massage therapy.

We will teach you how to use the massage balls or heat pads, and ask you to use them for four weeks.

5. Did your symptoms improve?

We will have another discussion with you to find out if your symptoms responded to the care you received.

Common questions

  1. Do I have to visit a hospital while on the study?

No, all the surveys can be completed online or mailed out to you. Study materials are mailed out to you, the interventions are done at home and the study team will be in contact with you regularly while you are on the study.

  1. What if I’m going on a holiday during the study?
  • You can commence after your holiday, or
  • The study can be put on hold while you’re on holiday, or
  • You can continue while on your holiday as long as the study team can make regular contact with you and you have access to electricity if you are randomised to heat therapy.
  1. Are my details confidential?

We will keep all information confidential and securely stored. We will use and retain information that we collect about you only for this clinical trial. We will not disclose your information without your permission, except in compliance with the law.

  1. How long does the study go for?

Participants are on the study for six months but can withdraw at any time without affecting your future health care.

  1. What do I have to do on the study?

During the study, data will be collected at five time points:

  • Upon commencement of the study
  • 4 weeks
  • 8 weeks
  • Month 3
  • Month 6.

At these five time points, you will be asked to:

  • Complete a series of online surveys
  • Document in a diary.

During the first eight week intervention period:

  • you may be randomised to heat or massage therapy and will be asked to follow a regime that you will document in your diary
  • you will also need to be available for weekly follow ups via phone with the intervention nurse.