A Flexible Individualized ExeRcise Programme for Cancer Patients During ChEmotherapy

NCT06280885 | Completed

• 1 other identifier: FIERCE
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cancer

Outcome Measures

Primary Outcomes (5)

• Feasibility: Recruitment rates

  Recruitment rates will be calculated as the percentage of eligible participants who agreed to take part in the study. Recruitment rates will be calculated for each recruitment timepoint to determine which timepoint yields optimal recruitment. Reasons for declining recruitment will also be recorded.

  At enrolement

• Feasibility: Adherence rates

  Exercise adherence will be used to measure the degree to which the participants performed the exercise at the desired intensity and time. After each exercise session, participants will be asked to rate their perceived exertion that they actually achieved during the exercise class. This RPE will be compared to the prespecified intensity that was chosen by the participant on the BORG scale at the beginning of the class to determine adherence to the intensity of the exercise session. Adherence to exercise time will be calculated by recording the total number of minutes spent exercising in each class compared to the total duration of the class.

  Through study completion, on average 6 months

• Feasibility: Attendance rates

  Exercise attendance will be calculated as the total number of exercise classes attended, either in-person or online, regardless of how much exercise was performed.

  Through study completion, on average 6 months

• Feasibility: Retention Rates

  Retention rates will be calculated as the number of participants who remained in the study at the end of the intervention as a proportion of the total number of participants recruited.

  Through study completion, on average 6 months

• Feasibility: Reason for drop0out

  Reasons for dropout will be recorded descriptively

  Through study completion, on average 6 months

Secondary Outcomes (8)

• Cardiorespiratory Fitness

  Pre and post intervention (on average 6 months)

• Muscular Strength

  Pre and Post intervention, on average 6 months

• Body Mass Index

  Pre and Post intervention, on average 6 months

• Mid-arm circumference

  Pre and Post intervention, on average 6 months

• Waist Circumference

  Pre and Post intervention, on average 6 months

Study Arms (2)

FIERCE Programme

EXPERIMENTAL

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.

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

Pedometer programme

ACTIVE COMPARATOR

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.

Behavioral: Health Behaviour Change (Pedometer)

Interventions

Exercise BEHAVIORAL

Participants will be randomised to either the FIERCE exercise programme involving supervised exercise prescription

FIERCE Programme

Health Behaviour Change (Pedometer) BEHAVIORAL

Participants in both arms will be provided with a pedometer as a health behaviour change intervention

FIERCE Programme; Pedometer programme

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Dublin, Trinity College: lead
• St. James's Hospital, Ireland: collaborator

Study Sites (1)

St James's Hospital

Dublin, Dublin, 8, Ireland

Location

Related Publications (1)

• Kearney N, Connolly D, Bahramian K, Sheill G, Coghlan-Lynch K, O'Sullivan J, Coleman N, O'Hanlon Brown C, Gallagher D, O'Gorman C, O'Brien C, Tierney A, Rankin K, O'Neill L, Guinan E. A Flexible Individualised ExeRcise programme for cancer patients during ChEmotherapy (FIERCE): Protocol for a randomised controlled feasibility trial. Contemp Clin Trials. 2025 Jun;153:107923. doi: 10.1016/j.cct.2025.107923. Epub 2025 Apr 21.

  PMID: 40268238 DERIVED

MeSH Terms

Conditions

Neoplasms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Not indicated for this feasibility study.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Feasibility randomised controlled trial using a 2:1 randomisation

Study Record Dates

• First Submitted: December 6, 2023
• First Posted: February 28, 2024
• Study Start: January 1, 2025
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: April 30, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

IE (1)