A Tailored Exercise Oncology Program for Neuro-Oncology Patients

NCT04831190 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2023-01-18

No results posted yet for this study

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

Interventions

BEHAVIORAL

Tailored Exercise Intervention

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.

Sponsors & Collaborators

  • Alberta Cancer Foundation

    collaborator OTHER
  • University of Alberta

    collaborator OTHER
  • Tom Baker Cancer Centre

    collaborator OTHER
  • Cross Cancer Institute

    collaborator OTHER
  • University of Calgary

    lead OTHER

Principal Investigators

  • S. Nicole Culos-Reed, PhD · University of Calgary, Calgary, AB, Canada

  • Gloria Roldan Urgoiti, MD · Department of Medical Oncology, Tom Baker Cancer Centre, Calgary, AB, Canada

  • Jay Easaw, MD · Department of Oncology, Cross Cancer Institute, Edmonton, AB, Canada

  • Margaret McNeely, PT, PhD · University of Alberta, Edmonton, AB, Canada

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-04-15
Primary Completion
2022-12-02
Completion
2024-04-15

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04831190 on ClinicalTrials.gov