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FIRST-Sask Study Protocol: A Remote Exercise Oncology Intervention

FIRST-Sask Study Protocol: A Randomized Controlled Trial of a Remote Exercise Oncology Intervention

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07617220
Acronym
FIRST-Sask
Enrollment
37
Registered
2026-06-01
Start date
2026-05-01
Completion date
2027-07-30
Last updated
2026-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Exercise Oncology

Brief 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.

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.

Sponsors

University of Saskatchewan
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No

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 informed consent; * physically suitable to participate by research personnel based on PAR-Q and physical performance screening.

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 metastases.

Design outcomes

Primary

MeasureTime frameDescription
Feasibility (measurement by recruitment rate, adherence rate, retention rate, outcome capture rate)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)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

Secondary

MeasureTime frameDescription
Cardiovascular endurance, measured using the 2-Minute Step Test and reported as the number of steps completed in two minutes.At baseline and at Week 12 (end-of-intervention)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.
Upper limb muscle strength, measured using hand grip dynamometry and reported as maximal grip strength (in kilograms)At baseline and at Week 12 (end-of-intervention)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.
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.At baseline and at Week 12 (end-of-intervention)Lower limb strength will be measured assessed using 30-second sit-stand.
Balance, measured using the Single-Leg Stance Test and reported as the duration a participant can maintain single-leg standing.At baseline and at Week 12 (end-of-intervention)Balance will be assessed using the Single-leg Stance test.

Contacts

CONTACTPrinciple Investigator
schroder.sattar@usask.ca1-306-337-3817

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 2, 2026