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From Exercise Oncology Research to Clinical Practice (PAC ICare)

3 giugno 2026 aggiornato da: 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).

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Stimato)

500

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

  • Nome: Physical Activity & Cancer Lab Research Coordinator
  • Numero di telefono: 902-473-2035
  • Email: excancer@nshealth.ca

Backup dei contatti dello studio

Luoghi di studio

  • Canada
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 2Y9
        • Physical Activity & Cancer Lab
        • Investigatore principale:
          • Melanie Keats, PhD
        • Contatto:
          • Physical Activity & Cancer Lab Research Coordinator
          • Numero di telefono: 902-473-2035
          • Email: excancer@nshealth.ca
        • Contatto:

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Terapia di supporto
  • Assegnazione: Non randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Altro: 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.
Sperimentale: 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.
Altro: 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.
Sperimentale: 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.
Altro: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Implementation [Reach]
Lasso di tempo: 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]
Lasso di tempo: 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
Lasso di tempo: 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]
Lasso di tempo: 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]
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Effectiveness [Quality of Life]
Lasso di tempo: 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]
Lasso di tempo: 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]
Lasso di tempo: 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]
Lasso di tempo: 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]
Lasso di tempo: 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]
Lasso di tempo: 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]
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Melanie Keats

Collaboratori

Queen Elizabeth II Health Sciences Centre

Investigatori

  • Investigatore principale: Melanie Keats, PhD, Dalhousie University and Nova Scotia Health

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 settembre 2026

Completamento primario (Stimato)

1 settembre 2029

Completamento dello studio (Stimato)

1 dicembre 2029

Date di iscrizione allo studio

Primo inviato

28 maggio 2026

Primo inviato che soddisfa i criteri di controllo qualità

3 giugno 2026

Primo Inserito (Effettivo)

9 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

9 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

3 giugno 2026

Ultimo verificato

1 giugno 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • PAC ICare

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano 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.

Periodo di condivisione IPD

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

Criteri di accesso alla condivisione 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.

Tipo di informazioni di supporto alla condivisione IPD

  • STUDIO_PROTOCOLLO
  • LINFA
  • ICF
  • CODICE_ANALITICO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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