A Flexible Individualized ExeRcise Programme for Cancer Patients During ChEmotherapy (FIERCE)

University of Dublin, Trinity College

Status: Enrolling

Conditions: Cancer

Treatments: Behavioral: Health Behaviour Change (Pedometer); Behavioral: Exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT06280885

FIERCE

Details and patient eligibility

About

The primary aim of this study is to measure the feasibility of delivering a co-designed exercise programme for patients with cancer receiving chemotherapy treatment.

Full description

Exercise has been shown to play an important role in reducing many of the side effects associated with chemotherapy treatment. Exercise can help to improve symptoms of fatigue, nausea, muscle weakness, and pain, which in turn can help to improve patients overall quality of life and wellbeing. In addition to this, exercising during chemotherapy can also help to maintain physical fitness and preserve muscle mass, which has been shown to significantly reduce treatment toxicities. Despite these benefits of exercise, performing regular physical activity during chemotherapy poses significant challenges. Patients are faced with a number of physical and logistical barriers during chemotherapy which makes it difficult to engage in regular exercise. In addition to this, exercise programs that are being designed lack flexibility and individualization, and don't account for the unpredictable nature of chemotherapy treatment. It is, therefore, no surprise that patients struggle to meet the exercise recommendations during chemotherapy, and highlights the need for careful consideration when prescribing exercise during this time. In preparation for this study, the research team held a number of workshops which included a mixture of patients and healthcare professionals with the aim of co-designing an exercise intervention for patients during chemotherapy. Including public and patient involvement (PPI) in the design process will help to ensure that the exercise program that is developed is pragmatic and, most importantly, patient-centred.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Aged >18.
• Histological confirmed diagnosis of stage I to IIIc breast, ovarian or colorectal cancer.
• Scheduled to receive chemotherapy ± immunotherapy with curative intent.
• Medical clearance from oncologist to partake in regular exercise in accordance with American College of Sports Medicine (ACSM) preparticipation screening algorithm.
• Ability to provide written informed consent.

Exclusion criteria

• Advanced/metastatic disease.
• Scheduled to receive concurrent chemoradiotherapy.
• Scheduled to receive high-dose chemotherapy during hospital admission.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

FIERCE Programme

Experimental group

Description:

The FIERCE programme will consist of an aerobic and resistance exercise program delivered for the duration of chemotherapy. Exercise will be prescribed with the aim of achieving an overall exercise volume over the course of a chemotherapy cycle. The total volume of exercise prescribed in each cycle will be targeted towards achieving the exercise guidelines for cancer survivors which recommends 90 minutes of aerobic activity per week, in addition to resistance exercise at least two times per week. Exercise intensity will be autoregulated by participants based on how they are feeling on a given day. Participants will be given a choice of exercising at low, moderate, or higher intensity based on how BORG rating of perceived exertion (RPE) scale. Weekly check ins will be made to each participant over the phone by an exercise physiologist for goal setting. Participants will also be given a pedometer to monitor daily physical activity levels.

Treatment:

Behavioral: Exercise

Behavioral: Health Behaviour Change (Pedometer)

Pedometer programme

Active Comparator group

Description:

Participants randomized to the pedometer programme will receive individualised advice about exercising during chemotherapy and will also receive a pedometer to encourage daily activity. Participant in both groups will receive a personal exercise consultation to identify their individual needs and understand their exercise preferences.

Treatment:

Behavioral: Health Behaviour Change (Pedometer)