ACE-Neuro: A Tailored Exercise Oncology Program for Neuro-Oncology Patients
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 70
- 试验地点
- 8
- 主要终点
- Feasibility of Referral: Referral Rate
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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)
排除标准
- •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
结局指标
主要结局
Feasibility of Referral: Referral Rate
时间窗: From start of study recruitment to end of study (2 years).
The percentage of patient referrals to the study team from the clinical team from patients eligible.
Feasibility of Measurement Completion: Measurement Completion Rate (12 Weeks)
时间窗: Post-program completion (12 weeks).
Percentage of measures (i.e., patient-reported outcomes and physical function) completed by enrolled participants.
Attrition Rate
时间窗: Baseline to 12 weeks.
Number of participants who consent but do not complete the intervention.
Feasibility of Measurement Completion: Measurement Completion Rate (6 Months)
时间窗: At 6 months post study enrolment.
Percentage of measures (i.e., patient-reported outcomes and physical function) completed by enrolled participants.
Qualitative Feasibility: Qualitative Semi-Structured One-on-One Interviews
时间窗: Conducted between weeks 12-14.
Participant perception of intervention feasibility via semi-structured one-on-one interviews (qualitative data, not reported on a scale).
Feasibility of Enrolment: Enrolment Rate
时间窗: From start of study recruitment to end of study (2 years).
The percentage of patients that enrol in the study once they hear the full study introduction.
Safety of Intervention
时间窗: Baseline to 12 weeks.
Record of any adverse events related to the intervention.
Feasibility of Triage: Triage Completion Rate
时间窗: From start of study recruitment to end of study (2 years).
The percentage of participants that attend, from those that are referred, to the Neuro-Oncology Rehabilitation Triage Clinic.
Feasibility of Program Attendance: Program Attendance Rate
时间窗: Baseline to 12 weeks.
Percentage of classes attended by enrolled participants.
Feasibility of Measurement Completion: Measurement Completion Rate (Baseline)
时间窗: At baseline (0 weeks).
Percentage of measures (i.e., patient-reported outcomes and physical function) completed by enrolled participants.
Feasibility of Measurement Completion: Measurement Completion Rate (12 Months)
时间窗: At 12 months post study enrolment.
Percentage of measures (i.e., patient-reported outcomes and physical function) completed by enrolled participants.
次要结局
- Physical Activity Minutes Per Week(Baseline to 12 weeks.)
- Body Composition(Baseline to post 12-week exercise intervention.)
- Upper Extremity Flexibility(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.)
- 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.)
- Lower Extremity Flexibility(Baseline to post 12-week exercise intervention and maintenance of change from 12-weeks to 6-months; and from 12 weeks to 12 months.)
- Weekly Step Count(Baseline to 12 weeks.)
- Cognition(Baseline to post 12-week exercise intervention and maintenance of change from 12-weeks to 6-months; and from 12 weeks to 12 months.)
- Program Implementation and Evaluation(Baseline to 2 years.)
- Muscular Endurance(Baseline to post 12-week exercise intervention and maintenance of change from 12-weeks to 6-months; and from 12 weeks to 12 months.)
- Static Balance(Baseline to post 12-week exercise intervention and maintenance of change from 12-weeks to 6-months; and from 12 weeks to 12 months.)
- Fatigue(Baseline to post 12-week exercise intervention and maintenance of change from 12-weeks to 6-months; and from 12 weeks to 12 months.)
- Symptom Burden(Baseline to post 12-week exercise intervention and maintenance of change from 12-weeks to 6-months; and from 12 weeks to 12 months.)
- Subjective Reporting of Average Weekly Physical Activity(Baseline to post 12-week exercise intervention and maintenance of change from 12-weeks to 6-months; and from 12 weeks to 12 months.)
- Quality of Life - Brain Subscale(Baseline to post 12-week exercise intervention and maintenance of change from 12-weeks to 6-months; and from 12 weeks to 12 months.)