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FIRST-Sask Study Protocol: A Remote Exercise Oncology Intervention (FIRST-Sask)

28 maj 2026 uppdaterad av: Schroder Sattar, University of Saskatchewan

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.

Studieöversikt

Status

Har inte rekryterat ännu

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Beräknad)

37

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Äldre vuxen

Tar emot friska volontärer

Nej

Beskrivning

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.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Stödjande vård
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Enda

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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.
Beteende: 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.
Inget ingripande: Control
Participants in the control arm will receive no intervention.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Feasibility (measurement by recruitment rate, adherence rate, retention rate, outcome capture rate)
Tidsram: 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%).
At Week 12 (end-of-intervention)
Acceptability of program (measured using survey and open-ended interview)
Tidsram: 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
At Week 12 (end-of-intervention)

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Cardiovascular endurance, measured using the 2-Minute Step Test and reported as the number of steps completed in two minutes.
Tidsram: 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.
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)
Tidsram: 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.
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.
Tidsram: At baseline and at Week 12 (end-of-intervention)
Lower limb strength will be measured assessed using 30-second sit-stand.
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.
Tidsram: At baseline and at Week 12 (end-of-intervention)
Balance will be assessed using the Single-leg Stance test.
At baseline and at Week 12 (end-of-intervention)

Andra resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
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.
Tidsram: At baseline and at Week 12 (end-of-intervention)
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.
At baseline and at Week 12 (end-of-intervention)

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

University of Saskatchewan

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Beräknad)

1 maj 2026

Primärt slutförande (Beräknad)

30 mars 2027

Avslutad studie (Beräknad)

30 juli 2027

Studieregistreringsdatum

Först inskickad

7 maj 2026

Först inskickad som uppfyllde QC-kriterierna

28 maj 2026

Första postat (Faktisk)

1 juni 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

1 juni 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

28 maj 2026

Senast verifierad

1 maj 2026

Mer information

Termer relaterade till denna studie

Andra studie-ID-nummer

  • BIO 5554
  • SHRF 6794 (Annat bidrag/finansieringsnummer: Saskatchewan Health Research Foundation)

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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