ClinicalTrials.gg
Not yet recruitingNCT07617220FIRST-SaskUpdated Jun 1, 2026

FIRST-Sask Study Protocol: A Remote Exercise Oncology Intervention

An interventional study of FIRST-Sask Study (Feasibility & acceptabIlity of canceR exerciSe inTervention - a Saskatchewan study) in Exercise Oncology, sponsored by University of Saskatchewan. Not yet recruiting. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2026-06-01.

Sponsored by University of Saskatchewan · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
37
Allocation
Randomized
Ages
65 Years and older
Sex
All
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Study summary

Older adults undergoing cancer treatment experience substantial treatment-related burden and reduced quality of life (QoL). Exercise is an effective supportive care intervention, but access is limited in rural and geographically dispersed settings. Evidence on flexible delivery models that accommodate patient preferences and real-world constraints remains scarce.

This study seeks to evaluate the feasibility and acceptability of a hybrid exercise program for older adults with cancer in rural settings and to obtain preliminary efficacy estimates to inform a larger trial. This randomized controlled trial tests a 12-week, multimodal exercise intervention co-designed with patient partners. The program uses a hybrid delivery model with options (in-person, remote, or combined formats) based on preference, geography, season, and alignment with routine travel (e.g. clinic visits). Older adults (≥65) with breast, lung, prostate, colorectal, or hematologic cancers are recruited using a multipronged strategy. Assessments at baseline and 12 weeks include cardiovascular endurance, upper and lower limb strength, balance, and QoL. Feasibility and acceptability will be examined via recruitment, retention, adherence, exit surveys and interviews. Exercise prescription will follow FITT principles. Adherence, dose modifications, and fidelity will be monitored using standardized procedures. Analyses will follow an intention-to-treat approach, with between-group and over-time effects estimated using generalized linear and mixed-effects models. This study will inform the development of a scalable exercise rehabilitation model to improve equitable access to supportive care in rural settings.

02

Conditions studied

  • Exercise Oncology
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In context

Lead sponsor

University of Saskatchewan is the lead sponsor of 243 studies on the registry; 34 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
65 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • confirmed diagnosis of any type of cancer (except non-melanoma skin cancer);
  • having received cancer treatment within the past 12 months;
  • self-identifying as rural resident; or residing in areas outside of the city of Saskatoon or Regina;
  • age ≥65;
  • ability to communicate in English;
  • ability to provide ;
  • physically suitable to participate by research personnel based on PAR-Q and physical performance screening.

Exclusion criteria

Exclusion Criteria:

  • persistent light-headedness during physical activity of or syncopal episodes within the past month;
  • other comorbidities or musculoskeletal complications that preclude participation in the exercise programs as deemed by the exercise interventionist;
  • unstable bone .
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
37 participants (estimated)

Study arms

  • Experimental
    Intervention group

    The online exercise sessions will be delivered via Zoom, led by 2 certified exercise trainers. The program will span 12 weeks, with 2 sessions per week. Each session will be 60 min in duration and will include: warm-up (breathing exercise and joint mobility, 5 min); circuit-style training encompassing aerobic, balance, and resistance training (45-50 min), and cool-down. Individual progressions will be titrated based on abilities. Exercise intensity will be monitored using the 10-point Borg Rating of Perceived Exertion (RPE) scale. To provide some form of flexibility within this study, participants who would like to occasionally attend some of their sessions in-person will have option to informing the trainers 48 hours in advance to arrange an in-person session.

    Behavioral: FIRST-Sask Study (Feasibility & acceptabIlity of canceR exerciSe inTervention - a Saskatchewan study)

  • No intervention
    Control

    Participants in the control arm will receive no intervention.

Interventions

  • BehavioralFIRST-Sask Study (Feasibility & acceptabIlity of canceR exerciSe inTervention - a Saskatchewan study)

    The 12- week intervention entails 2x weekly synchronous exercise sessions, delivered via Zoom and facilitated by two certified exercise trainers. Each session is 60 min in duration and includes multimodal exercises.

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What researchers measure

Primary outcomes

  1. Feasibility (measurement by recruitment rate, adherence rate, retention rate, outcome capture rate)

    Feasibility of the intervention will be measured using attendance rate (attending ≥50% of sessions), adherence rate (adhering to ≥50% of the prescribed exercises), retention rate (≥50%), and outcome capture (≥80%).

    Time frame: At Week 12 (end-of-intervention)

  2. Acceptability of program (measured using survey and open-ended interview)

    Acceptability will be assessed using the CSQ-8 tool that assesses satisfactory level about the program. It contains 8 items, each item is scored from 1 to 4. Higher scores indicate greater satisfaction. There will also be open-ended questions to share feedback as well as recommendations for improvement for further participants, their perceived benefits about the program regarding quality of life and general well-being, and likelihood to recommend it to other cancer survivors. The optional exit interview with provide participants with opportunity to share in more depth about their experiences, and

    Time frame: At Week 12 (end-of-intervention)

Secondary outcomes

  1. Cardiovascular endurance, measured using the 2-Minute Step Test and reported as the number of steps completed in two minutes.

    Cardiovascular endurance will be assessed using the 2-min Step Test, a validated measure of cardiovascular endurance. For online assessment, participants will be instructed to stand perpendicular to the camera (i.e., with their side and either the left or right leg facing the camera); the number of steps completed by the leg facing the camera during the 2-minute test will be recorded.

    Time frame: At baseline and at Week 12 (end-of-intervention)

  2. Upper limb muscle strength, measured using hand grip dynamometry and reported as maximal grip strength (in kilograms)

    Upper limb muscle strength will be measured using hand grip strength test with a Jamar dynamometer, which is considered the gold standard for measuring grip strength.

    Time frame: At baseline and at Week 12 (end-of-intervention)

  3. Lower limb muscle strength, measured using the 30-Second Sit-to-Stand Test and reported as the number of full sit-to-stand repetitions completed in 30 seconds.

    Lower limb strength will be measured assessed using 30-second sit-stand.

    Time frame: At baseline and at Week 12 (end-of-intervention)

  4. Balance, measured using the Single-Leg Stance Test and reported as the duration a participant can maintain single-leg standing.

    Balance will be assessed using the Single-leg Stance test.

    Time frame: At baseline and at Week 12 (end-of-intervention)

Other outcomes

  1. Health-related quality of life, measured using the 30-item EORTC QLQ-C30 and reported as domain and symptom scores reflecting physical, social, emotional, and cognitive functioning, symptom burden, and overall quality of life.

    Health-related quality of life will be measured using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30). The EORTC QLQ-C30 is a 30-item questionnaire that generates scores transformed to a 0-100 scale for functional domains, symptom domains, and global health status/quality of life. Higher scores on the functional and global health status/quality of life scales indicate better functioning and quality of life, whereas higher scores on the symptom scales indicate greater symptom burden and worse outcomes.

    Time frame: At baseline and at Week 12 (end-of-intervention)

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Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 1, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07617220
Responsible party
Schroder Sattar (Associate Professor, University of Saskatchewan) — Principal investigator
First posted
Jun 1, 2026
Start date
May 2026 (estimated)
Primary completion
Mar 30, 2027 (estimated)
Completion
Jul 30, 2027 (estimated)
Last update
Jun 1, 2026

Study contacts

Principle Investigator
Contact
schroder.sattar@usask.ca
1-306-337-3817

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.

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