FIRST-Sask Study Protocol: A Remote Exercise Oncology Intervention

ConditionExercise Oncology

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age65+

SponsorUniversity of Saskatchewan

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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 design

Design model

Parallel

Treatments tested in this trial

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.

Treatment groups

37 Participants

are divided into 2 treatment groups

Group A: Intervention groupExperimental treatment 1 intervention

Group B: ControlNo intervention 0 interventions

Trial outcomes

Primary outcomes

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)

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

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