Partner4Exercise Study
ConditionCancer
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age60+
SponsorMcMaster University
About this trial
Background:
As Canada's population ages, the number of older adults facing cancer is on the rise. By 2030, 23% of Canadians will be over 65, and two in five will be diagnosed with cancer in their lifetime. This situation is compounded by many older adults experiencing functional decline and social isolation, impacting their quality of life (QOL). While regular exercise can mitigate these effects, older adults with cancer often struggle to meet exercise guidelines, leading to decreased physical and mental well-being.
Objectives:
Our study aims to evaluate the effectiveness of a novel, virtually delivered peer-based exercise intervention designed specifically for older adults with cancer.
Methods:
We will conduct a randomized trial with three groups involving older adults (65 years and older) who have a previous cancer diagnosis. Participants will be divided into three groups: one group will receive peer support along with tailored guidance from qualified exercise professionals (PartnerMatchPLUS), another group will receive peer support only (PartnerMatch), and the third group will receive usual care with no intervention. Over 10 weeks, participants will engage in a structured exercise program supported by peer matching, a peer support guide, educational materials about exercise guidelines, and a Fitbit to track their activity levels. We will assess outcomes at four time points: baseline, post intervention, post tapering, and at a six-month follow-up. Key outcomes include measured and self-reported exercise volume, social support levels, QOL, frailty, and physical activity enjoyment. In addition to these measures, we will conduct one-on-one virtual interviews to explore participants' experiences and the mechanisms that make peer support effective.
Impact:
If successful, this intervention could serve as a scalable model to encourage physical activity, promote social interaction, and ultimately enhance the psychosocial well-being of older adults with cancer.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
English speaking;
older adults (>60 years);
living beyond a cancer diagnosis (any type or stage of cancer at any stage of treatment);
living in Canada;
Disqualifiers
self-report any chronic condition, cognitive impairment, or injury that prevents participation in independent moderate intensity exercise,
do not pass medical clearance via the Get Active Questionnaire, or
had recent (in the last 4 weeks) or have planned surgery of any kind (including reconstructive surgery) in the next 6 months
Trial design
Design model
Parallel
Treatments tested in this trial
Peer matching
BehavioralA Research Coordinator (RC) will match all participants into dyads after consent and baseline data have been completed based on evidence-informed criteria. To be matched participants must be in the same time zone, same sex, and be in the same age range. Beyond these core criteria, we will match based on personal and cancer-related characteristics (i.e., type, stage, treatment status, and exercise preferences). Matched peers in the two intervention groups only (not the control group) will be introduced to each other by the RC on Zoom after randomization. Participants in these two groups will be asked to independently communicate and support their partner around exercise for the duration of the study. They will be given an evidence-based peer support guide (with information on goal setting, communicating with peers, types of support, communication preferences, and study team contact information) an infographic on activity guidelines for older adult cancer survivors, and a Fitbit Inspire.
Quailfied Exercise Professional (QEP) Support
BehavioralThe QEP will provide tailored exercise counselling for both individuals in the dyad based on personal circumstances, cancer-related characteristics, side effects, and current fitness level with an overall goal of having them meet exercise guidelines for cancer survivors. A standardized guide, used in our pilots, will be used to deliver weekly sessions, personalized to participants' goals. The QEP will have advanced training in exercise for cancer. For four weeks following the 10-week intervention, the QEP will be available for consultation ("tapering" period) to answer questions as needed.
Treatment groups
183 Participants
are divided into 3 treatment groupsGroup A: PartnerMatchPLUSExperimental treatment 2 interventions
Group B: PartnerMatchActive comparator 1 intervention
Group C: Usual CareNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Change in exercise volume
The primary effectiveness outcome is device-measured exercise volume at post-intervention follow-up. A Fitbit Inspire 3© will be used as a device-based measure of exercise volume. Fitbits will be mailed to participants to wear on the non-dominant wrist for 7 consecutive days at each assessment time point to determine average daily and weekly minutes of exercise. The RC will collect data in the online Fitbit database in participant de-identified study accounts. Higher scores represent higher levels of exercise.
Time frame
Post intervention (10-weeks post baseline)Secondary outcomes
1
Change in exercise volume
Device-measured exercise volume will also be measured post-tapering (14 weeks post baseline). A Fitbit Inspire 3© will be used as a device-based measure of exercise volume. Fitbits will be mailed to participants to wear on the non-dominant wrist for 7 consecutive days at each assessment time point to determine average daily and weekly minutes of exercise. The RC will collect data in the online Fitbit database in participant de-identified study accounts. Higher scores represent higher levels of exercise.
Time frame
Post-tapering (14 weeks post baseline)2
Change in exercise volume
Device-measured exercise volume will also be measured at 6 month follow up. A Fitbit Inspire 3© will be used as a device-based measure of exercise volume. Fitbits will be mailed to participants to wear on the non-dominant wrist for 7 consecutive days at each assessment time point to determine average daily and weekly minutes of exercise. The RC will collect data in the online Fitbit database in participant de-identified study accounts. Higher scores represent higher levels of exercise.
Time frame
6 months follow-up (26 weeks post-baseline)3
Change in level of perceived social support
An exercise-specific version of the social support survey (SSS) will assess social support. The SSS is validated in cancer survivors56 and has high construct validity. Within this survey seven dimensions of social support are assessed (listening support, emotional support, esteem support, reality confirmation, task challenge, tangible assistance, informational support). Respondents report on the number of support providers and satisfaction with each type of support on a five-point Likert scale. Higher scores represent higher levels of perceived social support.
Time frame
Post-intervention (10 weeks post baseline)4
Change in level of perceived social support
An exercise-specific version of the social support survey (SSS) will assess social support. The SSS is validated in cancer survivors56 and has high construct validity. Within this survey seven dimensions of social support are assessed (listening support, emotional support, esteem support, reality confirmation, task challenge, tangible assistance, informational support). Respondents report on the number of support providers and satisfaction with each type of support on a five-point Likert scale. Higher scores represent higher levels of perceived social support.
Time frame
Post-tapering (14 weeks post baseline)Sponsors and contacts
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Source ClinicalTrials.gov