Ta strona została przetłumaczona automatycznie i dokładność tłumaczenia nie jest gwarantowana. Proszę odnieść się do angielska wersja za tekst źródłowy.

From Exercise Oncology Research to Clinical Practice (PAC ICare)

3 czerwca 2026 zaktualizowane przez: Melanie Keats

Bridging the Gap Between Exercise Oncology Research and Its Implementation in Clinical Practice

Building on previous research that shows the benefits of exercise, this study aims to find out how best to implement exercise in real-world settings. The study will assess the feasibility and acceptability of an embedding an automated referral tool and an exercise professional into standard cancer care impacts clinician referral and patient uptake of exercise programming. The study will assess how effective the exercise program is at improving patients' physical health, quality of life, symptom management, and overall wellbeing during different stages of their cancer journey (e.g., before treatment, on treatment, after treatment).

Przegląd badań

Status

Jeszcze nie rekrutacja

Warunki

Interwencja / Leczenie

Szczegółowy opis

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.

Typ studiów

Interwencyjne

Zapisy (Szacowany)

500

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

  • Nazwa: Physical Activity & Cancer Lab Research Coordinator
  • Numer telefonu: 902-473-2035
  • E-mail: excancer@nshealth.ca

Kopia zapasowa kontaktu do badania

Lokalizacje studiów

  • Kanada
    • Nova Scotia
      • Halifax, Nova Scotia, Kanada, B3H 2Y9
        • Physical Activity & Cancer Lab
        • Główny śledczy:
          • Melanie Keats, PhD
        • Kontakt:
          • Physical Activity & Cancer Lab Research Coordinator
          • Numer telefonu: 902-473-2035
          • E-mail: excancer@nshealth.ca
        • Kontakt:

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Nie

Opis

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.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie podtrzymujące
  • Przydział: Nielosowe
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: 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.
Inny: Exercise

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.
Eksperymentalny: 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.
Inny: Exercise

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.
Eksperymentalny: 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.
Inny: Exercise

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.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Implementation [Reach]
Ramy czasowe: 12 months, 24 months, 36 months
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.
12 months, 24 months, 36 months
Implementation [Adoption]
Ramy czasowe: 12 months, 24 months, 36 months
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.
12 months, 24 months, 36 months
Implementation Outcomes
Ramy czasowe: 6 months, 12 months, 18 months, 24 months, 30 months, 36 months
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).
6 months, 12 months, 18 months, 24 months, 30 months, 36 months
Implementation [Maintenance]
Ramy czasowe: 12 months, 24 months, 36 months
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.
12 months, 24 months, 36 months
Implementation [Cost Effectiveness]
Ramy czasowe: 36 months
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).
36 months

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Effectiveness [Quality of Life]
Ramy czasowe: Baseline, 12 weeks, 16 weeks
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.
Baseline, 12 weeks, 16 weeks
Effectiveness [Physical Activity]
Ramy czasowe: Baseline, 12 weeks, 16 weeks
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.
Baseline, 12 weeks, 16 weeks
Effectiveness [Symptom Burden]
Ramy czasowe: Baseline, 12 weeks, 16 weeks
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).
Baseline, 12 weeks, 16 weeks
Effectiveness [Participant Satisfaction]
Ramy czasowe: 12 weeks, 16 weeks
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.
12 weeks, 16 weeks
Effectiveness [Physical Fitness]
Ramy czasowe: Baseline, 12 weeks, 16 weeks
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).
Baseline, 12 weeks, 16 weeks
Effectiveness [Functional Capacity]
Ramy czasowe: Baseline, 12 weeks
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).
Baseline, 12 weeks
Effectiveness [Treatment Related Complications]
Ramy czasowe: Baseline, 12 weeks
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).
Baseline, 12 weeks

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Melanie Keats

Współpracownicy

Queen Elizabeth II Health Sciences Centre

Śledczy

  • Główny śledczy: Melanie Keats, PhD, Dalhousie University and Nova Scotia Health

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Szacowany)

1 września 2026

Zakończenie podstawowe (Szacowany)

1 września 2029

Ukończenie studiów (Szacowany)

1 grudnia 2029

Daty rejestracji na studia

Pierwszy przesłany

28 maja 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

3 czerwca 2026

Pierwszy wysłany (Rzeczywisty)

9 czerwca 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

9 czerwca 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

3 czerwca 2026

Ostatnia weryfikacja

1 czerwca 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • PAC ICare

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

TAK

Opis planu IPD

At the conclusion of the study, individual participant data (IPD) will be anonymized by removing all personally identifiable information and assigned unique codes to protect participant confidentiality. The de-identified dataset will be stored securely on a password-protected Nova Scotia Health server with access limited to authorized research personnel. Data will be made available to other researchers through a controlled access data repository (to be determined), under data sharing agreements that specify permissible uses and ensure compliance with ethical and legal standards. A detailed data dictionary and accompanying documentation will be provided to facilitate secondary analyses.

Ramy czasowe udostępniania IPD

IPD data will be made available within 6 months following the publication of the main study results.

Kryteria dostępu do udostępniania IPD

Access to study IPD will be limited to qualified researchers engaging in independent scientific research. Researchers must submit a formal protocol detailing their research goals and methodology and the research must fall under the boundaries of the informed consent originally provided by the study participants. A Data Transfer Agreement (DTA) may also be required.

Typ informacji pomocniczych dotyczących udostępniania IPD

  • PROTOKÓŁ BADANIA
  • SOK ROŚLINNY
  • ICF
  • ANALITYCZNY_KOD

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

Subskrybuj