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NCT Number: NCT07617220

FIRST-Sask Study Protocol: 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.

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Key information

Conditions

Exercise Oncology

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Feasibility (measurement by recruitment rate, adherence rate, retention rate, outcome capture rate)

    Time frame: 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%).

  2. Acceptability of program (measured using survey and open-ended interview)

    Time frame: 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 outcomes

  1. Cardiovascular endurance, measured using the 2-Minute Step Test and reported as the number of steps completed in two minutes.

    Time frame: 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.

  2. Upper limb muscle strength, measured using hand grip dynamometry and reported as maximal grip strength (in kilograms)

    Time frame: 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.

  3. 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.

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

    Lower limb strength will be measured assessed using 30-second sit-stand.

  4. Balance, measured using the Single-Leg Stance Test and reported as the duration a participant can maintain single-leg standing.

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

    Balance will be assessed using the Single-leg Stance test.

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.

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Principle Investigator

CONTACT

[email protected]

1-306-337-3817

Sponsors and collaborators

Lead sponsor

University of Saskatchewan

Other

Registry information

Official study title

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

Acronym: FIRST-Sask

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 1, 2026
Registry last updated
Jun 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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