- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05549479
Virtual Peer-support Exercise Intervention for Older Adults with Cancer
A Pilot Randomized Controlled Trial of a Virtual Peer-support Exercise Intervention for Older Adults with Cancer
Background:
By 2030, 23% of Canadians will be over 65 years of age. Two in five of these individuals will be diagnosed with cancer. Older adults have high levels of functional decline, and a cancer diagnosis adds prolonged physical sequelae to the natural aging process. Many of these effects can be mitigated by regular exercise. However, older adult cancer survivors are significantly less likely to meet current exercise guidelines than their younger counterparts. As our population ages, we need to develop effective, scalable interventions that support health in older adult cancer survivors. The objective of this study is to determine the feasibility and preliminary effectiveness of a virtually delivered peer exercise intervention with qualified exercise professional (QEP) support for older adult cancer survivors.
Methods:
Participants will include older adult cancer survivors who are cleared for exercise, have consistent access to the internet, and currently take part in less than 150 minutes of exercise per week. All participants will be matched with a partner, given a peer support guide, and information on current exercise guidelines. In addition to being matched with a peer, dyads in the intervention group will have weekly virtual sessions with a QEP for 10 weeks. Participants in the control group will independently support their partner around exercise for 10 weeks.
Outcomes:
Participants will be assessed at 3 time points. The primary outcome is feasibility. This will be measured by assessing recruitment, retention, adherence rates to the intervention, and participant acceptability and satisfaction. Secondary effectiveness outcomes include exercise volume, social support, quality of life, physical function, and physical activity enjoyment.
Impact:
If effective, this will be the first virtual peer-based exercise intervention for older adult cancer survivors. Findings will inform future methods aimed at increasing exercise in older adults.
Study Overview
Status
Intervention / Treatment
Detailed Description
METHODS
Research Questions:
Research Question 1 (primary). Is a virtually-delivered, peer matching exercise intervention supported by qualified exercise professionals (QEP) feasible for older adult cancer survivors? Research Question 2. Do older adult cancer survivors who participate in a virtually-delivered peer matching exercise intervention with QEP support have improved levels of social support compared to those matched with a peer only? Research Question 3. Do older adult cancer survivors who participate in a virtually-delivered peer matching exercise intervention with QEP support have improved levels of physical activity behaviour, health-related quality of life and physical functioning compared to those who are matched with a peer only?
Study Design:
This is a two-arm pilot randomized controlled trial with blinded outcome assessment. The protocol and study methods adhere to the CONSORT extension for randomized pilot trials. The Hamilton Integrated Research Ethics Board will approve this study. Dyads will be randomized (1:1) to the Intervention (AgeMatchPLUS) or control (AgeMatch) groups prior to baseline assessment. Group allocation will be centrally randomized using a web platform (https://www.randomizer.org/) by a graduate student external to the research team. A Research Assistant will assign group allocation in the order participants complete an initial demographics questionnaire and are matched with a peer for the study.
Intervention:
Peer Matching. A Research Assistant will match all participants into dyads based on evidence-informed criteria. To be matched, females must be in the same time zone and diagnosed with the same type of cancer. Matched peers will be introduced to each other by a Research Assistant via zoom after baseline data collection. All participants will be given a peer support guide that provides tips for supporting their exercise partner, an infographic on exercise guidelines for older cancer survivors and a Fitbit Inspire 2©. Partners will independently communicate and support each other around exercise for the duration of the study.
Intervention Group (AgeMatchPLUS). This group will have dyads participate in weekly virtual sessions with a QEP for 10 weeks. Each session will last up to 1 hour. The QEP (i.e., registered kinesiologist) will provide a tailored exercise program, focusing on aerobic activity with both participants in the dyad based on personal circumstances, cancer-related characteristics, side effects, current fitness level, and personal preferences. Overall, content discussed at the sessions will include a review of the exercise program, barriers to exercise participation, achievement of goals, and adverse events. For four weeks following the 10-week intervention, the QEP will be available for consultation (labelled "tapering" period) as needed by participants in this group. This tapering period is important to understand strategies to successfully taper older adults from an exercise trial. Also, during the tapering period, participants in this group will receive two supportive emails from the QEP encouraging ongoing maintenance of exercise and social support.
Control Condition (AgeMatch): Dyads in this group will independently communicate and support each other around exercise for 10 weeks. They will not have contact with the QEP during the intervention or tapering period and will structure their communication (mode and frequency) with their matched peer.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ontario
-
Hamilton, Ontario, Canada, L8S1C7
- McMaster University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- English speaking
- Older adult (>60 years)
- Living with or beyond a cancer diagnosis (any type or stage of cancer at any stage of treatment)
- Living in Canada
- Medically cleared for exercise
- Have consistent access to an internet-connected device with webcam
- Currently take part in less than 150 minutes of MVPA per week
Exclusion Criteria:
- Self-report any contraindications to exercise
- Had recent (in the last 4 weeks) or have planned surgery of any kind (including reconstructive surgery) in the next 3 months.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention Group (AgeMatchPLUS).
|
Participants will be matched with a peer based on evidence informed criteria.
Partners will independently communicate and support each other around exercise for the duration of the study.
Dyads will participate in weekly virtual sessions with a QEP for 10 weeks.
Each session will last up to 1 hour.
The QEP (i.e., registered kinesiologist) will provide a tailored exercise program, focusing on aerobic activity for both individuals in the dyad based on personal circumstances, cancer-related characteristics, side effects, current fitness level (consistent with home-based exercise strategies), and personal preferences.
|
|
Active Comparator: Control Condition (AgeMatch):
|
Participants will be matched with a peer based on evidence informed criteria.
Partners will independently communicate and support each other around exercise for the duration of the study.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Recruitment rate
Time Frame: 10 weeks
|
The percentage of eligible individuals who expressed interest in the study that enrolled
|
10 weeks
|
|
Retention rate
Time Frame: 10 weeks
|
The percentage of enrolled participants who completed the intervention
|
10 weeks
|
|
Adherence rate
Time Frame: 10 weeks
|
The percentage of total sessions attended and tracked using weekly logs
|
10 weeks
|
|
Participant Satisfaction
Time Frame: 10 weeks
|
7 points Likert satisfaction scale
|
10 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Exercise volume
Time Frame: 10 weeks
|
Fitbit Inspire
|
10 weeks
|
|
Exercise volume
Time Frame: 14 weeks
|
Fitbit Inspire
|
14 weeks
|
|
Exercise volume
Time Frame: 10 weeks
|
Godin Leisure Time Exercise Questionnaire (higher scores represent higher volume of exercise)
|
10 weeks
|
|
Exercise volume
Time Frame: 14 weeks
|
Godin Leisure Time Exercise Questionnaire (higher scores represent higher volume of exercise)
|
14 weeks
|
|
Social support
Time Frame: 10 weeks
|
Social Support Survey (0-7 scale; higher scores indicate higher levels of social support)
|
10 weeks
|
|
Social support
Time Frame: 14 weeks
|
Social Support Survey (0-7 scale; higher scores indicate higher levels of social support)
|
14 weeks
|
|
Health-related quality of life
Time Frame: 10 weeks
|
Eq-5d-3L (5 dimensions each with a 3 level scale; lower scores indicate higher levels of quality of life)
|
10 weeks
|
|
Health-related quality of life
Time Frame: 14 weeks
|
Eq-5d-3L (5 dimensions each with a 3 level scale; lower scores indicate higher levels of quality of life)
|
14 weeks
|
|
Self-report physical functioning
Time Frame: 10 weeks
|
Patient Specific Functional Scale (10 point scale; higher scores represent higher quality of life)
|
10 weeks
|
|
Self-report physical functioning
Time Frame: 14 weeks
|
Patient Specific Functional Scale (10 point scale; higher scores represent higher quality of life)
|
14 weeks
|
|
Sub-max aerobic capacity
Time Frame: 10 weeks
|
Six minute walk test
|
10 weeks
|
|
Sub-max aerobic Capacity
Time Frame: 14 weeks
|
Six minute walk test
|
14 weeks
|
|
Physical functioning
Time Frame: 10 weeks
|
30 second sit to stand
|
10 weeks
|
|
Physical functioning
Time Frame: 14 weeks
|
30 second sit to stand
|
14 weeks
|
|
Enjoyment of performing physical activity
Time Frame: 10 weeks
|
Physical Activity Enjoyment Scale (7 point scale for each item; higher overall scores indicate higher enjoyment of physical activity)
|
10 weeks
|
|
Enjoyment of performing physical activity
Time Frame: 14 weeks
|
Physical Activity Enjoyment Scale (7 point scale for each item; higher overall scores indicate higher enjoyment of physical activity)
|
14 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- JST-3
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Cancer
-
Cellworks Group Inc.RecruitingCancer | Relapsed Cancer | Refractory CancerUnited States
-
Yale UniversityNational Institute of Nursing Research (NINR); The Glimpse Group IncRecruitingCancer | Adolescent Cancer | Young Adult CancerUnited States
-
University of Michigan Rogel Cancer CenterCompletedCancer Liver | Cancer Brain | Cancer Head &Neck | Cancer PelvisUnited States
-
Wake Forest University Health SciencesNational Cancer Institute (NCI); Atrium Health Wake Forest BaptistRecruitingCancer | Adolescent Cancer | Young Adult CancerUnited States
-
Vanderbilt-Ingram Cancer CenterEunice Kennedy Shriver National Institute of Child Health and Human Development... and other collaboratorsCompletedAdvanced Cancer | Relapsed Cancer | Refractory CancerUnited States
-
City of Hope Medical CenterNational Cancer Institute (NCI)CompletedStage III Pancreatic Cancer | Stage IIA Pancreatic Cancer | Stage IIB Pancreatic Cancer | Stage IV Gastric Cancer | Stage IVA Colorectal Cancer | Stage IVA Pancreatic Cancer | Stage IVB Colorectal Cancer | Stage IVB Pancreatic Cancer | Stage IIIA Gastric Cancer | Stage IIIB Gastric Cancer | Stage IIIC Gastric... and other conditionsUnited States
-
Second Affiliated Hospital of Soochow UniversityNot yet recruitingCancer | Solid Cancer
-
New Mexico Cancer Research AllianceOhio State University Comprehensive Cancer Center; H. Lee Moffitt Cancer Center...RecruitingCancer | Cancer RiskUnited States
-
Children's Hospital of PhiladelphiaCompletedCancer | Childhood CancerUnited States
-
UNICANCERRecruitingAdvanced Breast Cancer | Advanced Gastric Cancer | Advanced Urothelial Cancer | Advanced Non Small Cell Lung Cancer (NSCLC)France
Clinical Trials on Peer Matching
-
McMaster UniversityNot yet recruiting
-
Brittany L SmallsNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)RecruitingDiabetes Mellitus, Type 2United States
-
Samantha AnthonyHeart and Stroke Foundation of CanadaNot yet recruitingHeart Failure | Cardiomyopathies | Young Adults | Peer Support | Fontan Procedure | Mentorship | Heart Transplant Recipient | Peer Support and Chronic DiseaseCanada
-
Jury CandelarioMerck Sharp & Dohme LLCUnknown
-
Northern Arizona UniversityUniversity of Colorado, DenverRecruiting
-
Zhongda HospitalUnknownGlucose Metabolism Disorders | Metabolic Diseases | Endocrine System Diseases | DiabetesChina
-
Illinois Institute of TechnologyPatient-Centered Outcomes Research Institute; TrilogyCompletedMental DisordersUnited States
-
Northwestern UniversityCompletedDepressionUnited States
-
University of California, San FranciscoAmerican Academy of Family PhysiciansCompleted
-
King's College LondonGuy's and St Thomas' NHS Foundation Trust; MND Association; Marie Curie CharityCompletedMotor Neuron Disease | Amyotrophic Lateral SclerosisUnited Kingdom