NCT07635589

Brief Summary

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).

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for not_applicable cancer

Timeline
40mo left

Started Sep 2026

Typical duration for not_applicable cancer

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 28, 2026

Completed
12 days until next milestone

First Posted

Study publicly available on registry

June 9, 2026

Completed
3 months until next milestone

Study Start

First participant enrolled

September 1, 2026

Expected
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2029

3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2029

Last Updated

June 9, 2026

Status Verified

June 1, 2026

Enrollment Period

3 years

First QC Date

May 28, 2026

Last Update Submit

June 3, 2026

Conditions

Keywords

CancerExerciseImplementation ScienceMixed-MethodsEffectiveness-ImplementationCost Effectiveness

Outcome Measures

Primary Outcomes (5)

  • Implementation [Reach]

    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]

    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

    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]

    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]

    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

Secondary Outcomes (7)

  • Effectiveness [Quality of Life]

    Baseline, 12 weeks, 16 weeks

  • Effectiveness [Physical Activity]

    Baseline, 12 weeks, 16 weeks

  • Effectiveness [Symptom Burden]

    Baseline, 12 weeks, 16 weeks

  • Effectiveness [Participant Satisfaction]

    12 weeks, 16 weeks

  • Effectiveness [Physical Fitness]

    Baseline, 12 weeks, 16 weeks

  • +2 more secondary outcomes

Study Arms (3)

Pre-treatment (Prehabilitation)

EXPERIMENTAL

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.

Other: Exercise

Active Treatment

EXPERIMENTAL

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.

Other: Exercise

Post-Treatment (Rehabilitation/Early Survivorship)

EXPERIMENTAL

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.

Other: Exercise

Interventions

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.

Active TreatmentPost-Treatment (Rehabilitation/Early Survivorship)Pre-treatment (Prehabilitation)

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • Severe cognitive, physical, psychiatric, or uncontrolled medical condition(s) resulting in an inability to provide consent and/or safely participate in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Physical Activity & Cancer Lab

Halifax, Nova Scotia, B3H 2Y9, Canada

Location

MeSH Terms

Conditions

NeoplasmsMotor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Melanie Keats, PhD

    Dalhousie University and Nova Scotia Health

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Physical Activity & Cancer Lab Research Coordinator

CONTACT

Physical Activity & Cancer Lab Research Manager

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Consenting cancer patients will undergo comprehensive screening and triage to a personalized exercise intervention tailored to their baseline health status (low, moderate, high risk) and treatment phase (pre-treatment, active treatment, post-treatment), ensuring that the exercise program is appropriately customized to their individual needs and clinical condition.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 28, 2026

First Posted

June 9, 2026

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

September 1, 2029

Study Completion (Estimated)

December 1, 2029

Last Updated

June 9, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
Time Frame
IPD data will be made available within 6 months following the publication of the main study results.
Access Criteria
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.
More information

Locations