A Tailored Exercise Oncology Program for Neuro-Oncology Patients

NCT04831190 | Unknown

• 1 other identifier: HREBA.CC-20-0322
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 4

Brief Summary

Background: Exercise, or physical activity, is beneficial for all cancer survivors. Despite this knowledge, there is generally a gap between the evidence and practice. And this gap is widened with (a) underserved tumour groups in exercise oncology, such as neuro-oncology patients, or (b) underutilized timelines across the cancer treatment phases to deliver exercise oncology education or programming. Thus, our current work is building a hybrid implementation effectiveness study into the clinical care pathway across Alberta in neuro-oncology - ACE-Neuro. Objectives: The purpose of this study is to assess the impact of an online, tailored exercise oncology program for neuro-oncology patients using a participant-oriented research (POR) approach as well as both quantitative and qualitative research methods. Specifically, the primary outcome of this study is to determine the feasibility of recruitment, referral, triage, adherence, and adverse events. The secondary outcome is to examine the preliminary effectiveness of the neuro-oncology exercise program on patient-reported outcomes and physical function. Methods: Neuro-oncology patients \>18 years and able to consent in English will be referred to a study-based Rehabilitation Triage Clinic, where a Physician-Researcher will assess patients on their overall health and functional status, and next triage them to either ACE-Neuro, rehabilitation oncology, or cancer physiatry. Once referred to ACE-Neuro, participants will partake in a 12-week online exercise program, delivered by a Clinical Exercise Physiologist. Participants will complete online assessments of physical function, patient-reported outcomes, and objective physical activity at baseline (pre-program), 12-weeks (post-program completion), 6-months, and 12-months. The exercise program includes weekly one-on-one online exercise delivery, health coaching to support behaviour change, and access to an online group exercise session. Participants will also be invited to a post-program qualitative interview to get perspectives on their experiences participating in ACE-Neuro. Relevance: By working directly with patients, healthcare providers, and community partners, this implementation project will develop a framework that streamlines patient triage, and provides a tailored online exercise program for neuro-oncology patients, thereby advancing exercise oncology research and clinical practice.

Conditions

Cancer; Brain Tumor, Primary

Keywords

Neuro-Oncology; Cancer; Exercise; Quality of Life; Feasibility; Implementation

Outcome Measures

Primary Outcomes (11)

• Feasibility of Referral: Referral Rate

  The percentage of patient referrals to the study team from the clinical team from patients eligible.

  From start of study recruitment to end of study (2 years).

• Feasibility of Enrolment: Enrolment Rate

  The percentage of patients that enrol in the study once they hear the full study introduction.

  From start of study recruitment to end of study (2 years).

• Feasibility of Triage: Triage Completion Rate

  The percentage of participants that attend, from those that are referred, to the Neuro-Oncology Rehabilitation Triage Clinic.

  From start of study recruitment to end of study (2 years).

• Feasibility of Program Attendance: Program Attendance Rate

  Percentage of classes attended by enrolled participants.

  Baseline to 12 weeks.

• Feasibility of Measurement Completion: Measurement Completion Rate (Baseline)

  Percentage of measures (i.e., patient-reported outcomes and physical function) completed by enrolled participants.

  At baseline (0 weeks).

• Feasibility of Measurement Completion: Measurement Completion Rate (12 Weeks)

  Percentage of measures (i.e., patient-reported outcomes and physical function) completed by enrolled participants.

  Post-program completion (12 weeks).

• Feasibility of Measurement Completion: Measurement Completion Rate (6 Months)

  Percentage of measures (i.e., patient-reported outcomes and physical function) completed by enrolled participants.

  At 6 months post study enrolment.

• Feasibility of Measurement Completion: Measurement Completion Rate (12 Months)

  Percentage of measures (i.e., patient-reported outcomes and physical function) completed by enrolled participants.

  At 12 months post study enrolment.

• Safety of Intervention

  Record of any adverse events related to the intervention.

  Baseline to 12 weeks.

• Attrition Rate

  Number of participants who consent but do not complete the intervention.

  Baseline to 12 weeks.

• Qualitative Feasibility: Qualitative Semi-Structured One-on-One Interviews

  Participant perception of intervention feasibility via semi-structured one-on-one interviews (qualitative data, not reported on a scale).

  Conducted between weeks 12-14.

Secondary Outcomes (15)

• Physical Activity Minutes Per Week

  Baseline to 12 weeks.

• Weekly Step Count

  Baseline to 12 weeks.

• Body Composition

  Baseline to post 12-week exercise intervention.

• Cardiorespiratory Fitness

  Baseline to post 12-week exercise intervention and maintenance of change from 12-weeks to 6-months; and from 12 weeks to 12 months.

• Muscular Strength

  Baseline to post 12-week exercise intervention and maintenance of change from 12-weeks to 6-months; and from 12 weeks to 12 months.

Study Arms (1)

Intervention

EXPERIMENTAL

All participants will be involved in a tailored exercise intervention for 12 weeks.

Behavioral: Tailored Exercise Intervention

Interventions

Tailored Exercise Intervention BEHAVIORAL

The exercise program to be implemented for neuro-oncology patients will combine aerobic, resistance, balance, and flexibility exercises delivered in one-to-one setting (i.e., personal training) twice per week, for 12 weeks. Based on needs and preferences, participants will have the option to join a circuit-type group class once per week in place of one of their personal training sessions. During COVID-19, all sessions will be delivered remotely. If facilities are open and deemed safe for cancer patients, participants will have the option to attend an in-person session, integrated in the community. Whether delivered in-class or remotely, the intervention will follow exercise progression principles (i.e., frequency, intensity, time, type, overload, and progression) over the 12-weeks, with tailoring of any exercise to meet individual participant needs, with aims of promoting wellness and physical function. The exercise intervention is based on the Alberta Cancer Exercise (ACE) program.

Intervention

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• are a neuro-oncology patient with primary brain tumour (malignant or benign)
• are pre-, on, or completed treatment
• are over the age of 18 years
• are able to read/write in English
• are able to participate in mild levels of exercise
• are able to access remote programming (i.e., has internet access and a computer or tablet)

You may not qualify if:

• diagnosis is not primary brain
• unable to read/write in English
• are unable to participate in light exercise
• for online programs, do not have internet or computer access

Sponsors & Collaborators

• University of Calgary: lead
• Alberta Cancer Foundation: collaborator
• University of Alberta: collaborator
• Tom Baker Cancer Centre: collaborator
• Cross Cancer Institute: collaborator

Study Sites (4)

Health and Wellness Lab, University of Calgary

Calgary, Alberta, T2N 1N4, Canada

Location

Tom Baker Cancer Centre

Calgary, Alberta, T2N 4N2, Canada

Location

Cross Cancer Institute, University of Alberta

Edmonton, Alberta, T6G 1Z2, Canada

Location

Cancer Rehabilitation Clinic, Faculty of Rehabilitation Medicine, University of Alberta

Edmonton, Alberta, T6G 2G4, Canada

Location

Related Publications (1)

• Daun JT, Capozzi LC, Dhruva T, Roldan Urgoiti G, McDonough MH, McLaughlin E, Bansal M, Brett A, Easaw JC, McNeely ML, Francis GJ, Williamson T, Danyluk J, Ospina PA, Lesiuk C, de Robles P, Leckie C, Culos-Reed SN. The feasibility of a multi-site, clinic-supported, and tailored neuro-oncology exercise program. Neurooncol Pract. 2024 Oct 10;12(1):131-142. doi: 10.1093/nop/npae093. eCollection 2025 Feb.

  PMID: 39917754 DERIVED

MeSH Terms

Conditions

Neoplasms; Brain Neoplasms; Motor Activity

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Behavior

Study Officials

• S. Nicole Culos-Reed, PhD

  University of Calgary, Calgary, AB, Canada

  PRINCIPAL INVESTIGATOR

• Gloria Roldan Urgoiti, MD

  Department of Medical Oncology, Tom Baker Cancer Centre, Calgary, AB, Canada

  PRINCIPAL INVESTIGATOR

• Jay Easaw, MD

  Department of Oncology, Cross Cancer Institute, Edmonton, AB, Canada

  PRINCIPAL INVESTIGATOR

• Margaret McNeely, PT, PhD

  University of Alberta, Edmonton, AB, Canada

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Feasibility-Implementation Study

Study Record Dates

• First Submitted: April 1, 2021
• First Posted: April 5, 2021
• Study Start: April 15, 2021
• Primary Completion: December 2, 2022
• Study Completion: April 15, 2024
• Last Updated: January 18, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (4)