FIRST-Sask Study Protocol: A Remote Exercise Oncology Intervention

NCT07617220 | Not Yet Recruiting

• 2 other identifiers: BIO 5554SHRF 6794
• Study Type: interventional
• Target: 37
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Exercise Oncology

Outcome Measures

Primary Outcomes (2)

• 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%).

  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

  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.

  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)

  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.

  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.

  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.

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

Study Arms (2)

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.

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.

Interventions

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

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.

Intervention group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Saskatchewan: lead

Central Study Contacts

Principle Investigator

CONTACT

1-306-337-3817; schroder.sattar@usask.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 7, 2026
• First Posted: June 1, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): March 30, 2027
• Study Completion (Estimated): July 30, 2027
• Last Updated: June 1, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share