A Tailored Exercise Oncology Program for Neuro-Oncology Patients (ACE-Neuro)
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|ClinicalTrials.gov Identifier: NCT04831190|
Recruitment Status : Active, not recruiting
First Posted : April 5, 2021
Last Update Posted : January 18, 2023
|First Submitted Date ICMJE||April 1, 2021|
|First Posted Date ICMJE||April 5, 2021|
|Last Update Posted Date||January 18, 2023|
|Actual Study Start Date ICMJE||April 15, 2021|
|Actual Primary Completion Date||December 2, 2022 (Final data collection date for primary outcome measure)|
|Current Primary Outcome Measures ICMJE
|Original Primary Outcome Measures ICMJE||Same as current|
|Current Secondary Outcome Measures ICMJE
|Original Secondary Outcome Measures ICMJE||Same as current|
|Current Other Pre-specified Outcome Measures||Not Provided|
|Original Other Pre-specified Outcome Measures||Not Provided|
|Brief Title ICMJE||A Tailored Exercise Oncology Program for Neuro-Oncology Patients|
|Official Title ICMJE||ACE-Neuro: A Tailored Exercise Oncology Program for Neuro-Oncology Patients|
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.
BACKGROUND & RATIONALE
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.
Within Alberta (AB), the investigators have been able to very successfully implement the Alberta Cancer Exercise (ACE) program to start to address the gap between research and practice. As a hybrid implementation effectiveness study, ACE is building a model for exercise oncology delivery within standard cancer care. With over 2500 participants across AB, the investigators have substantial evidence supporting the feasibility of ACE, as well as the potential benefits. Despite these successes, ACE remains primarily represented by participants from breast, prostate, and colorectal tumour groups. This represents a lack of connection between smaller and more high risk tumour groups within referral pathways for the ACE program, both at TBCC and CCI, but also within the regional community cancer clinics (Grande Prairie, Red Deer, Medicine Hat, Lethbridge).
RESEARCH QUESTION & OBJECTIVES
The purpose of this feasibility-implementation study is to build exercise into the clinical care pathway in neuro-oncology clinics at the two major cancer centres in AB, where all neuro-oncology patients provincially are treated (Tom Baker Cancer Centre, TBCC; and the Cross Cancer Institute, CCI). Specifically, the objectives of the proposed work are: (1) to tailor the ACE exercise program for all neuro- oncology patients, to ACE-Neuro; this includes considering additional tailoring to address needs earlier in the care pathway, from diagnosis through treatment (i.e., prehabilitation phases) and into longer term survivorship (wellness cancer survivorship care plans), (2) to provide models of delivery of exercise oncology programs to enhance access (i.e., remote delivery, home support, individual vs group), and (3) to build this systematically within the neuro-oncology clinics at the TBCC and CCI, to ensure that all patients diagnosed with brain tumours can access wellness during their cancer care journey. The investigators hypothesize that there will be improvements in patients' physical and psychosocial well-being (individual level outcomes), as well as a more integrated workflow in the clinical cancer care setting that includes exercise as part of standard clinical practice (systems level outcome). 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.
Using the successful implementation model developed in ACE, the proposed work will build a neuro-oncology cohort within a mixed methods study design. There will be multiple phases to the implementation of ACE-Neuro, including:
REFERRAL AND RECRUITMENT
Because the main outcome of this study is feasibility, and the ultimate goal is to build ACE-Neuro into standard neuro-oncology care, no a priori sample size has been calculated. Based on current clinical numbers, and previous work done with neuro-oncology patients at CCI, the investigators anticipate approximately 25-30 eligible patients per year, per site. Our aim is to referral of all eligible neuro-oncology patients from TBCC. For recruitment, patients can:
The clinical team, based on their judgment, may not refer patients they deem to be ineligible. This may include for the following reasons:
As a feasibility study, reasons for non-referral will be tracked, with no identifying patient information, across the recruitment period. After consenting to the study, all patients will undergo a two-part screening procedure prior to beginning the exercise program:
As part of this study, the investigators will be tracking the referral pathway, and which method of referral is most feasible as part of standard clinical workflow.
In addition to exercise delivery and assessments, all participants will have the choice to participate in evidence-based health coaching calls, provided by a trained Health Coach. Health coaching is an evidence-based tool that supports positive health behaviour change across cancer populations. Health coaching calls will take place weekly for 15-30 minutes following an individualized exercise training session, and include topics surrounding goal setting, social support, stress management, maintaining motivation, and overcoming barriers. Health coaching calls will be delivered remotely (e.g., via end-to-end encrypted Zoom or phone call) at the participants' preferred date and time.
The described exercise program and data collection of PROs and functional fitness assessments are in addition to standard practices. The timeline for these assessments include: baseline (at recruitment into ACE-Neuro), 12-weeks (post-intervention), 6-months, and 12-months.
ANALYSIS Quantitative analysis will include descriptive statistics (means, medians, standard deviations), and change scores to measure changes in outcomes over time. Qualitative data will be analyzed by verbatim transcription (in NVivo), using an interpretive description methodology. Both quantitative and qualitative data will be analyzed to provide a deeper understanding of the feasibility and impact of 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.
|Study Type ICMJE||Interventional|
|Study Phase ICMJE||Not Applicable|
|Study Design ICMJE||Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
Feasibility-Implementation StudyMasking: None (Open Label)
Primary Purpose: Supportive Care
|Intervention ICMJE||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.
|Study Arms ICMJE||Experimental: Intervention
All participants will be involved in a tailored exercise intervention for 12 weeks.
Intervention: Behavioral: Tailored Exercise Intervention
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Active, not recruiting|
|Actual Enrollment ICMJE
|Original Estimated Enrollment ICMJE
|Estimated Study Completion Date ICMJE||April 15, 2024|
|Actual Primary Completion Date||December 2, 2022 (Final data collection date for primary outcome measure)|
|Eligibility Criteria ICMJE||
|Ages ICMJE||18 Years to 100 Years (Adult, Older Adult)|
|Accepts Healthy Volunteers ICMJE||Yes|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||Canada|
|Removed Location Countries|
|NCT Number ICMJE||NCT04831190|
|Other Study ID Numbers ICMJE||HREBA.CC-20-0322|
|Has Data Monitoring Committee||No|
|U.S. FDA-regulated Product||
|IPD Sharing Statement ICMJE||
|Current Responsible Party||University of Calgary|
|Original Responsible Party||Same as current|
|Current Study Sponsor ICMJE||University of Calgary|
|Original Study Sponsor ICMJE||Same as current|
|PRS Account||University of Calgary|
|Verification Date||January 2023|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP