TRAnsFORM: Trial Assessments of Fitness and Outcomes Research in Myeloma

Background
Our population is ageing, and as this happens the rates of cancer are increasing. However, as people age the risk of other diseases also increases, for example heart disease, stroke, diabetes, joint disease and many others, leading to frailty. To provide cancer treatment safely and effectively to older people we therefore need to adjust the therapies we use according to an individual's level of fitness, so that more patients can receive treatment and side effects can be reduced. Unfortunately at present we do not have reliable ways of measuring frailty or judging which therapies are likely to be best for which people. This research tests an entirely new approach to calculating an individual's frailty.

Aims
This project will test whether wearable activity trackers, similar to those often used for sports and exercise, can measure activity levels in older adults undergoing cancer treatment, and whether the information from the trackers can help patients and their doctors make better choices about which therapies are most suitable for them.

Research Plan
We will approach patients who have already agreed to take part in a large clinical study that is testing treatments for older adults with multiple myeloma (a common blood cancer). Patients who take part in our project will wear a tracker before and during their cancer treatment, for about 3 months. We will analyse the data collected and combine this with data collected from the larger clinical study such as how well treatments work and side effects that occur.

Benefits of the Research
We will use the information from the trackers to develop better ways of testing frailty; these could help doctors to personalise the treatments offered to elderly or frail patients in the future. One benefit will be identifying patients who are older but actually very fit and who could benefit from standard treatment. Equally importantly, we will be able to ensure that those for whom standard doses are likely to cause multiple side effects can be offered gentler therapies that would work better. We're starting this research in people with multiple myeloma, however it's likely the tools we develop could help people with other cancers and chronic diseases. We will make sure the results of the research are released quickly and widely so the maximum number of patients can benefit.

About the Researcher
I am a Consultant Haematologist working in Leeds. I spend most of my time caring for people with multiple myeloma, many of whom are elderly. I am passionate about making sure that elderly and frail people get the best possible treatments for their cancers, and I have a superb team of researchers working with me to ensure this project is successful.

The hypothesis of this project is that incorporation of data on physical performance will allow refinement of the frailty assessments currently employed within the clinic, thus better predicting tolerance of therapy and rates of treatment-emergent adverse events. The project will run as a feasibility and biomarker discovery substudy of the NCRI/CRUK/UKMRA FiTNEss trial, which randomises elderly and frail patients with multiple myeloma to reactive dose adjustment vs. frailtyscore-based pre-emptive dose reduction. The feasibility of wearable activity measurement in a frail population with cancer will be determined. Wearable actigraphy and multimodal biophysical fitness data, before and during trial chemotherapy, will be assessed against key outcomes of the FiTNEss study, including rates of dose reduction/delay/omission, treatment discontinuation, early death and disease endpoints. A digital frailty phenotype algorithm will be developed, incorporating activity and biophysical parameters alongside existing clinical frailty scores, for prospective assessment in the next late phase prospective national study for elderly patients with myeloma. Use of raw actigraphy data and non-proprietary formats will maximise generalisability of findings to alternative activity tracking technology and applicability to other populations.