Exercise OncologyFIRST-SaskNCT07617220
FIRST-Sask Study Protocol: A Remote Exercise Oncology Intervention
A study testing FIRST-Sask Study (Feasibility & acceptabIlity of canceR exerciSe inTervention - a Saskatchewan study) in people with Exercise Oncology, run by University of Saskatchewan.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Exercise Oncology
- What is being tested?
- FIRST-Sask Study (Feasibility & acceptabIlity of canceR exerciSe inTervention - a Saskatchewan study)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- No sites listed yet
- Study dates
- May 2026to 30 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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 informed consent;
- physically suitable to participate by research personnel based on PAR-Q and physical performance screening.
Who cannot join
- 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 metastases.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: FIRST-Sask Study Protocol: A Randomized Controlled Trial of a Remote Exercise Oncology Intervention
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.
- Conditions
- Exercise Oncology
- Being tested
- FIRST-Sask Study (Feasibility & acceptabIlity of canceR exerciSe inTervention - a Saskatchewan study)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FIRST-Sask Study (Feasibility & acceptabIlity of canceR exerciSe inTervention - a Saskatchewan study)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | 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. Receives: Behavioral: FIRST-Sask Study (Feasibility & acceptabIlity of canceR exerciSe inTervention - a Saskatchewan study) |
| Control | No intervention | Participants in the control arm will receive no intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%).
Measured: At Week 12 (end-of-intervention)
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
Measured: At Week 12 (end-of-intervention)
Secondary outcomes (4)
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.
Measured: At baseline and at Week 12 (end-of-intervention)
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.
Measured: At baseline and at Week 12 (end-of-intervention)
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.
Measured: At baseline and at Week 12 (end-of-intervention)
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.
Measured: At baseline and at Week 12 (end-of-intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2026
- Study startMay 2026 (estimated)
- Primary completion30 Mar 2027 (estimated)
- Study completion30 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Exercise OncologyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 37 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Saskatchewan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Schroder Sattar, University of Saskatchewan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07617220
- Sponsor's protocol ID
- BIO 5554
- Other IDs
- SHRF 6794
- Acronym
- FIRST-Sask
- Status last verified
- May 2026
- First submitted
- 7 May 2026
- Last updated
- 1 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FIRST-Sask Study Protocol: A Randomized Controlled Trial of a Remote Exercise Oncology Intervention
- ClinicalTrials.gov ID
- NCT07617220
- Acronym / sponsor ID
- FIRST-Sask / BIO 5554
- Conditions
- Exercise Oncology
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 37 participants (estimated)
- Lead sponsor
- University of SaskatchewanUniversity, hospital or other
- Study start
- May 2026 (estimated)
- Primary completion
- 30 Mar 2027 (estimated)
- Study completion
- 30 Jul 2027 (estimated)
- First posted
- 1 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: FIRST-Sask Study (Feasibility & acceptabIlity of canceR exerciSe inTervention - a Saskatchewan study)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. |
| Control | No intervention | –Participants in the control arm will receive no intervention. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (3 listed)
- 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 metastases.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FIRST-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. | Behavioural | Intervention group |
Primary outcome
Feasibility (measurement by recruitment rate, adherence rate, retention rate, outcome capture rate)
Time frame: At Week 12 (end-of-intervention)
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%).
Acceptability of program (measured using survey and open-ended interview)
Time frame: At Week 12 (end-of-intervention)
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
4 secondary outcomes
Cardiovascular endurance, measured using the 2-Minute Step Test and reported as the number of steps completed in two minutes.
Time frame: At baseline and at Week 12 (end-of-intervention)
Upper limb muscle strength, measured using hand grip dynamometry and reported as maximal grip strength (in kilograms)
Time frame: At baseline and at Week 12 (end-of-intervention)
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.
Time frame: At baseline and at Week 12 (end-of-intervention)
Balance, measured using the Single-Leg Stance Test and reported as the duration a participant can maintain single-leg standing.
Time frame: At baseline and at Week 12 (end-of-intervention)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing FIRST-Sask Study (Feasibility & acceptabIlity of canceR exerciSe inTervention - a Saskatchewan study) in people with Exercise Oncology, run by University of Saskatchewan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Principle Investigator (1-306-337-3817, schroder.sattar@usask.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility (measurement by recruitment rate, adherence rate, retention rate, outcome capture rate) (time frame: At Week 12 (end-of-intervention)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2026.