NCT05509751

Brief Summary

Phase 2 randomized controlled study using a waitlist control group. The study also has a single arm pre-post test 12-week chair-based exercise arm for those who have received the geriatric assessment in the older adults with cancer clinic (geriatric oncology clinic). Study Duration 2.5 years Study Agent/ Intervention/ Procedure Comprehensive Geriatric Assessment and Management (GAM) combined with online chair-based exercise (CBE) and health education for 12 weeks.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable lung-cancer

Timeline
6mo left

Started Oct 2023

Typical duration for not_applicable lung-cancer

Geographic Reach
1 country

2 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress85%
Oct 2023Dec 2026

First Submitted

Initial submission to the registry

August 15, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 22, 2022

Completed
1.1 years until next milestone

Study Start

First participant enrolled

October 1, 2023

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2026

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Expected
Last Updated

April 28, 2026

Status Verified

April 1, 2026

Enrollment Period

2.4 years

First QC Date

August 15, 2022

Last Update Submit

April 27, 2026

Conditions

Keywords

comprehensive geriatric assessmentchair-based exercisehealth education

Outcome Measures

Primary Outcomes (2)

  • Feasability of the study

    What is the feasibility of implementation of the study? Feasibility will be measured by recruitment rate which will be the proportion of eligible patients and support persons who agree to enroll in the study, collected from our recruitment log) and measured in percentage with range 0-100. Feasibility of retention will be measured proportion of participants who complete the study data collection, collected from our study log), range 0-100. Feasibility of data outcome collection will be the percentage of patients who have complete data collection (collected from our study log), range 0-100. Feasibility of the study will be defined as recruitment of \>60% of all eligible older adults; retention of \>80% of the dyads; and 3) capture of outcome data of 80% or more.

    12 weeks

  • Acceptability of the intervention and the study

    What is the acceptability of the intervention and study? Acceptability will be measured by 1) adherence to the intervention and 2) satisfaction. Adherence to the intervention= 1) adherence to the geriatric assessment recommendations (collected through chart review) and expressed as percentage of recommendations received and implemented by the patient, range 0-100. 2) Adherence to online classes will be measured through the number of sessions missed as documented in the intervention log. A 5-item Likert scale satisfaction with the study scale ranging from very satisfied to very unsatisfied and satisfied and very Satisfied= satisified. Acceptability will be defined as 1) adherence to the intervention of \>85% of participants adhering to at least 80% of the classes and recommendations; 2) satisfaction by 80% of participants.

    12 weeks

Secondary Outcomes (9)

  • Effect intervention on Physical function

    12 weeks

  • Effect intervention on Grip strength

    12 weeks

  • Effect intervention on Life space Mobility

    12 weeks

  • Effect intervention on Physical Activity

    12 weeks

  • Effect intervention on number of self-reported Falls

    12 weeks

  • +4 more secondary outcomes

Study Arms (3)

Intervention group

ACTIVE COMPARATOR

geriatric assessment (GAM) and remote exercise and education prior to and during curative/adjuvant or first/second line palliative chemotherapy /immunotherapy or targeted therapy

Behavioral: GAM, exercise, health education

Waitlist control group

NO INTERVENTION

Wait list, receiving standard of care and option to receive intervention after treatment.

single arm pre-post test study for participants recruited from geriatric oncology clinic

EXPERIMENTAL

They will receive the 12 week virtual chair-based exercise and health education intervention except no geriatric assessment

Behavioral: online chair-based exercise combined with health education

Interventions

geriatric assessment, exercise and health education

Also known as: Comprehensive Geriatric Assessment and Management (GAM) combined with online chair-based exercise (CBE) and health education for 12 weeks.
Intervention group

online chair-based exercise and health education for 12 weeks

single arm pre-post test study for participants recruited from geriatric oncology clinic

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Aged 65+ years.
  • Diagnosed with lung, gastrointestinal (GI) , breast, Gynecologic or Genitourinary (GU) cancer or lymphoma who are referred for chemotherapy or immunotherapy and have not received \> 4 weeks of systemic treatment.
  • \) Have a physician estimated life expectancy of \>6 months. 5) Be physically inactive (no more than 90 min moderate to vigorous activity per week as per GLTEQ and do not currently meet the recommended physical activity volume of 90 min of aerobic exercise/week).
  • \) Able to speak and understand English. 7) Able to give informed consent. 8) Are considered safe to participate in the weekly classes as per their treating oncologist.
  • Eligible support persons are:
  • Identified by the older adult as their support person.
  • Aged 18 years and over.
  • Able to speak and understand English.
  • Able to give informed consent.

You may not qualify if:

  • Severe neuropsychiatric abnormalities (e.g., moderate-severe dementia) per the treating physician; and
  • Clinic visit with a geriatrician in the previous 12 months (they have already received part of the intervention).
  • Chest tube in-situ.
  • Not able to give informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Princess Margaret Cancer Centre

Toronto, Ontario, M5G2C4, Canada

Location

Sunybrook Health Sciences Centre, Odette Cancer Centre

Toronto, Ontario, Canada

Location

Related Publications (1)

  • Jebanesan N, Alibhai SMH, Santa Mina D, Jones J, Legacy N, Freeman L, Smith A, Cobbing S, Vadali N, Lo S, Godhwani K, Nasiri F, Antonio M, Stephens D, Pitters E, Bennie F, Stephens A, Papadakos J, Cerullo L, Zjadewicz M, Jang R, Eng L, Krzyzanowska M, Matthew A, Durbano S, Mehta R, Menjak I, Emmenegger U, Sattar S, Sun V, Ladham K, Puts M. Supporting older adults with cancer and their support person through geriatric assessment and remote exercise and education: The SOAR study protocol. J Geriatr Oncol. 2025 Apr;16(3):102194. doi: 10.1016/j.jgo.2025.102194. Epub 2025 Feb 5.

MeSH Terms

Conditions

Lung NeoplasmsUrogenital NeoplasmsBreast NeoplasmsLymphomaHealth Education

Interventions

ExerciseGeriatric AssessmentTherapeutics

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesNeoplasms by Histologic TypeLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesAdherence InterventionsMedication AdherencePatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaData CollectionEpidemiologic MethodsInvestigative TechniquesHealth StatusDemographyPopulation CharacteristicsHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationEpidemiologic MeasurementsPublic HealthEnvironment and Public Health

Study Officials

  • Martine Puts, RN PhD

    University of Toronto

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The study statistician will be blinded to group allocation
Purpose
SUPPORTIVE CARE
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 15, 2022

First Posted

August 22, 2022

Study Start

October 1, 2023

Primary Completion

March 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

April 28, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations