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

28 de mayo de 2026 actualizado por: 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.

Descripción general del estudio

Estado

Aún no reclutando

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Estimado)

37

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto Mayor

Acepta Voluntarios Saludables

No

Descripción

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.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Cuidados de apoyo
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: 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.
Conductual: 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.
Sin intervención: Control
Participants in the control arm will receive no intervention.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Feasibility (measurement by recruitment rate, adherence rate, retention rate, outcome capture rate)
Periodo de tiempo: 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)
Periodo de tiempo: 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)

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Cardiovascular endurance, measured using the 2-Minute Step Test and reported as the number of steps completed in two minutes.
Periodo de tiempo: 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)
Periodo de tiempo: 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.
Periodo de tiempo: 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.
Periodo de tiempo: 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)

Otras medidas de resultado

Medida de resultado
Medida Descripción
Periodo de tiempo
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.
Periodo de tiempo: 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)

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

University of Saskatchewan

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

1 de mayo de 2026

Finalización primaria (Estimado)

30 de marzo de 2027

Finalización del estudio (Estimado)

30 de julio de 2027

Fechas de registro del estudio

Enviado por primera vez

7 de mayo de 2026

Primero enviado que cumplió con los criterios de control de calidad

28 de mayo de 2026

Publicado por primera vez (Actual)

1 de junio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

1 de junio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

28 de mayo de 2026

Última verificación

1 de mayo de 2026

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • BIO 5554
  • SHRF 6794 (Otro número de subvención/financiamiento: Saskatchewan Health Research Foundation)

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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