From Exercise Oncology Research to Clinical Practice (PAC ICare)
Bridging the Gap Between Exercise Oncology Research and Its Implementation in Clinical Practice
연구 개요
상세 설명
The ICARE study is a comprehensive hybrid Type 3 effectiveness-implementation trial aimed at evaluating the integration of an evidence-based exercise program into routine cancer care in real-world clinical settings. Its primary focus is on understanding the feasibility, acceptability, and practical aspects of implementing this intervention through the application of targeted implementation strategies, including the automation of referrals into the clinical workflow to streamline and standardize the process. Specifically, the study assesses the extent of program adoption at multiple levels: first, at the clinician level by measuring the proportion and representativeness of oncology care providers who refer patients to the exercise program; second, at the clinic level by evaluating the proportion and diversity of cancer centers and community clinics that successfully incorporate the exercise intervention into their standard workflows; and third, at the patient level by examining the reach of the program, including the number, proportion, and demographic diversity of participating patients. The study also seeks to identify contextual factors, such as organizational culture, resources, and clinician attitudes, as well as barriers and facilitators that influence successful implementation and sustainment of the program.
While the primary focus is on implementation, the study also has a secondary aim to evaluate the clinical effectiveness of the tailored, evidence-based exercise intervention on important patient-centered outcomes. These include improvements in physical functioning, enhancements in quality of life, better symptom management, and overall wellbeing, measured across various stages of the post-diagnosis cancer journey (i.e., pretreatment/prehabilitation, active treatment, post-treatment/rehabilitation/early survivorship. Ultimately, the findings from this study aim to inform future implementation strategies, optimize integration processes, and improve patient outcomes by translating evidence-based practices into sustainable, real-world cancer care settings.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Physical Activity & Cancer Lab Research Coordinator
- 전화번호: 902-473-2035
- 이메일: excancer@nshealth.ca
연구 연락처 백업
- 이름: Physical Activity & Cancer Lab Research Manager
- 전화번호: 902-473-1022
- 이메일: debbie.wright@nshealth.ca
연구 장소
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Nova Scotia
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Halifax, Nova Scotia, 캐나다, B3H 2Y9
- Physical Activity & Cancer Lab
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수석 연구원:
- Melanie Keats, PhD
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연락하다:
- Physical Activity & Cancer Lab Research Coordinator
- 전화번호: 902-473-2035
- 이메일: excancer@nshealth.ca
-
연락하다:
- Physical Activity & Cancer Lab Research Manager
- 전화번호: 902-473-1022
- 이메일: debbie.wright@nshealth.ca
-
-
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Have received a cancer diagnosis (inclusive of primary, recurrent; and/or metastatic disease);
- Over the age of 19 years;
- Able to participate in mild levels of activity as a minimum;
- Be pretreatment, or receiving active cancer treatment, or have received cancer treatment within the past six months and are still under active oncology care, or beyond six months if they continue to be under active oncology care;
- Able to provide informed written consent in English; and
- Have access to internet service and a device that can support video calling (for online programs).
Exclusion Criteria:
- Severe cognitive, physical, psychiatric, or uncontrolled medical condition(s) resulting in an inability to provide consent and/or safely participate in the study.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위화되지 않음
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Pre-treatment (Prehabilitation)
Participants preparing for surgery, a minimum 3-week prehabilitation intervention will be implemented to optimize physical functioning prior to the surgical procedure.
Supervised exercise sessions will be delivered 2-3 times per week throughout the pre-surgical intervention, with participants encouraged to engage in 30 minutes of walking on non-supervised days.
Individuals undergoing neoadjuvant therapy will continue participating in the exercise program up to the date of surgery, up to a maximum duration of 12 weeks of supervised exercise programming.
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PRE-TREATMENT: Frequency: 2-3 supervised exercise sessions/week (45-60 min/session) with 30 minutes of walking on non-supervised days. Intensity: Rating of Perceived Exertion (RPE) 5-7/10. Type: Multimodal (aerobic + resistance training). Time: 3 to 12 weeks of supervised exercise. ON TREATMENT: Frequency: 2 supervised exercise sessions/week (45-60 min/session) with 30 minutes of walking on non-supervised days. Intensity: RPE 3-5/10. Type: Multimodal (aerobic + resistance training). Time: 12 weeks of supervised exercise. POST-TREATMENT: Frequency: 3 supervised exercise sessions/week (45-60 min/session) for the first 4 weeks; 2 supervised + 1 independent exercise sessions per week for the next 4 weeks; 1 supervised + 2 independent exercise session for the next 4 weeks; 3 independent exercise sessions for the final 4 weeks + 30 minutes of walking on non-supervised days. Intensity: RPE 5-7/10. Type: Multimodal (aerobic + resistance training). Time: 16 weeks tapered exercise program. |
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실험적: Active Treatment
Participants receiving adjuvant therapy who are not scheduled for surgery, as well as those who have recovered from surgery, will be enrolled in a 12-week exercise intervention.
Supervised sessions will be delivered 2 times per week and an independent walking program of 30 minutes/day on non-supervised exercise days will be encouraged.
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PRE-TREATMENT: Frequency: 2-3 supervised exercise sessions/week (45-60 min/session) with 30 minutes of walking on non-supervised days. Intensity: Rating of Perceived Exertion (RPE) 5-7/10. Type: Multimodal (aerobic + resistance training). Time: 3 to 12 weeks of supervised exercise. ON TREATMENT: Frequency: 2 supervised exercise sessions/week (45-60 min/session) with 30 minutes of walking on non-supervised days. Intensity: RPE 3-5/10. Type: Multimodal (aerobic + resistance training). Time: 12 weeks of supervised exercise. POST-TREATMENT: Frequency: 3 supervised exercise sessions/week (45-60 min/session) for the first 4 weeks; 2 supervised + 1 independent exercise sessions per week for the next 4 weeks; 1 supervised + 2 independent exercise session for the next 4 weeks; 3 independent exercise sessions for the final 4 weeks + 30 minutes of walking on non-supervised days. Intensity: RPE 5-7/10. Type: Multimodal (aerobic + resistance training). Time: 16 weeks tapered exercise program. |
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실험적: Post-Treatment (Rehabilitation/Early Survivorship)
Participants who have completed treatment will engage in a progressively tapered exercise program.
This program will involve supervised sessions 3 times per week during the initial four weeks, followed by 2 sessions per week for the subsequent four weeks, and 1 session per week for the remaining 12 weeks.
Participants will be encouraged to walk 30 minutes/day on non-supervised exercise days.
The final four weeks will emphasize the transition toward independent exercise participation, incorporating self-monitoring strategies and mid-month (week 14) check-in to address any emerging concerns and support appropriate adjustments to the program.
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PRE-TREATMENT: Frequency: 2-3 supervised exercise sessions/week (45-60 min/session) with 30 minutes of walking on non-supervised days. Intensity: Rating of Perceived Exertion (RPE) 5-7/10. Type: Multimodal (aerobic + resistance training). Time: 3 to 12 weeks of supervised exercise. ON TREATMENT: Frequency: 2 supervised exercise sessions/week (45-60 min/session) with 30 minutes of walking on non-supervised days. Intensity: RPE 3-5/10. Type: Multimodal (aerobic + resistance training). Time: 12 weeks of supervised exercise. POST-TREATMENT: Frequency: 3 supervised exercise sessions/week (45-60 min/session) for the first 4 weeks; 2 supervised + 1 independent exercise sessions per week for the next 4 weeks; 1 supervised + 2 independent exercise session for the next 4 weeks; 3 independent exercise sessions for the final 4 weeks + 30 minutes of walking on non-supervised days. Intensity: RPE 5-7/10. Type: Multimodal (aerobic + resistance training). Time: 16 weeks tapered exercise program. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Implementation [Reach]
기간: 12 months, 24 months, 36 months
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Guided by the RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance) framework, Reach will be assessed across each intervention phase by tracking participant accrual (number of consenting participants divided by the number of referrals) and by monitoring the representativeness of consenting participants by comparing demographic and relevant characteristics (i.e., age, ethnicity, socioeconomic status, and disease status) of the sample against the broader target population.
Reasons for study refusal will also be documented.
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12 months, 24 months, 36 months
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Implementation [Adoption]
기간: 12 months, 24 months, 36 months
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Guided by the RE-AIM framework Adoption will be examined across each intervention phase by documenting the total number of clinician referrals received annually as well as the characteristics of referring clinicians, including their roles (e.g., oncologist, oncology nurse, nurse navigator).
A representative sample of non-referring clinicians will be interviewed to explore any underlying psychological and/or environmental barriers/facilitators to referring patients to exercise programming.
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12 months, 24 months, 36 months
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Implementation Outcomes
기간: 6 months, 12 months, 18 months, 24 months, 30 months, 36 months
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Guided by the RE-AIM framework, Implementation outcomes will be assessed across each intervention phase and will include feasibility (i.e., intervention adherence, consent, refusal, and completion rates, percentage of missing data), acceptability (semi-structured interviews with a representative sub-sample of patients who decline participation, consent to participate, and those who complete or withdraw prematurely from the study), and fidelity of intervention protocol delivery (i.e., adherence to exercise prescription, and program components; quality of instructor delivery; participant engagement and responsiveness to home-based walking).
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6 months, 12 months, 18 months, 24 months, 30 months, 36 months
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Implementation [Maintenance]
기간: 12 months, 24 months, 36 months
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Guided by the RE-AIM framework Maintenance will be assessed across each intervention phase by evaluating the sustainability of exercise practices at the organizational and individual levels over time.
Data collection will include quantitative metrics (e.g., referral rates, completion rates) and qualitative interviews with stakeholders to explore contextual facilitators and barriers.
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12 months, 24 months, 36 months
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Implementation [Cost Effectiveness]
기간: 36 months
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The EQ-5D-5L (EuroQol 5-Dimension, 5-Level questionnaire) will be used to examine the cost effectiveness across each intervention phase (pre-treatment, active treatment, post-treatment).
The EQ-5D-5L measures five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) of health on a 5-point scale (1=no problems - 5=extreme problems).
Responses are translated to a Health Utility Index (1=perfect health; 0=deceased).
To measure cost-effectiveness, the utility score is plotted against time (Quality Adjusted Life Years = Time (years) x Health Utility Index).
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36 months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Effectiveness [Quality of Life]
기간: Baseline, 12 weeks, 16 weeks
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Quality of life will be evaluated using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30, version 3.0).
The EORTC assesses five functional domains (physical, role, cognitive, emotional, social), three symptom scales (fatigue, pain, nausea/vomiting), six individual symptoms (dyspnea, appetite loss, sleep disturbance, constipation, diarrhea, financial impact), and a two-item global health and quality of life scale, with most items rated on a 4-point Likert scale and global scales on a 7-point scale; higher scores indicate better functioning and health for functional and global scales, but greater symptom burden for symptom scales.
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Baseline, 12 weeks, 16 weeks
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Effectiveness [Physical Activity]
기간: Baseline, 12 weeks, 16 weeks
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Self-reported physical activity will be measured using the modified Godin Leisure-Time Exercise Questionnaire, where participants recall their activity over the past week across three intensity levels (strenuous, moderate, mild), including frequency and session duration.
Total weekly moderate-to-vigorous physical activity (MVPA) will be calculated by summing minutes from moderate and strenuous activities, and a Leisure Time Physical Activity (LTPA) score will be derived by multiplying weekly strenuous exercise by 9 and moderate exercise by 5; scores of 24 or higher indicate sufficient activity, while scores of 23 or lower indicate insufficient activity.
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Baseline, 12 weeks, 16 weeks
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Effectiveness [Symptom Burden]
기간: Baseline, 12 weeks, 16 weeks
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The Edmonton Symptom Assessment System (ESAS-r) will be used to evaluate symptom burden over the past 24 hours, measuring nine core symptoms (pain, tiredness, drowsiness, nausea, appetite loss, shortness of breath, depression, anxiety, overall well-being) plus an open-ended item for additional symptoms, with each scored from 0 (none or best) to 10 (worst), and symptom severity categorized as mild (1-3), moderate (4-6), or severe (7-10).
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Baseline, 12 weeks, 16 weeks
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Effectiveness [Participant Satisfaction]
기간: 12 weeks, 16 weeks
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Participant satisfaction and program acceptability will be assessed using a 10-item self-report questionnaire.
The questionnaire covers five domains: Program & Staff Experience, Group Dynamics & Social Support, Perceived Benefits, Program Burden & Feasibility, and Future Intent & Overall Satisfaction, with two items each.
All items are rated on a 5-point Likert scale from 1 (Strongly Disagree) to 5 (Strongly Agree), and total scores (ranging from 10 to 50) indicate higher acceptability.
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12 weeks, 16 weeks
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Effectiveness [Physical Fitness]
기간: Baseline, 12 weeks, 16 weeks
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Fitness assessments will include evaluating upper body strength and endurance (modified push-up), lower body strength and endurance (30-second sit-to-stand), balance (Single Leg Stance Test), and aerobic capacity (2-minute step test).
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Baseline, 12 weeks, 16 weeks
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Effectiveness [Functional Capacity]
기간: Baseline, 12 weeks
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Functional capacity will be assessed using the ECOG Performance Status Scale, which ranges from 0 (fully active) to 5 (deceased).
The scale categorizes participants based on their daily physical restrictions, from full activity with no restrictions (Grade 0) to limited self-care and significant disability (Grade 3), total assistance (Grade 4).
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Baseline, 12 weeks
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Effectiveness [Treatment Related Complications]
기간: Baseline, 12 weeks
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Treatment-related complications will be documented using the Common Terminology Criteria for Adverse Events (CTCAE) - a standardized classification system used to identify and grade the severity of adverse events graded from 1 (mild) to 5 (life-threatening - death).
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Baseline, 12 weeks
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공동 작업자 및 조사자
스폰서
수사관
- 수석 연구원: Melanie Keats, PhD, Dalhousie University and Nova Scotia Health
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- PAC ICare
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
IPD 공유 기간
IPD 공유 액세스 기준
IPD 공유 지원 정보 유형
- 연구_프로토콜
- 수액
- ICF
- ANALYTIC_CODE
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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