Partner4Exercise Randomized Controlled Trial (P4E RCT)

McMaster University

Status and phase: Begins enrollment this month; Phase 3; Phase 2

Conditions: Cancer

Treatments: Behavioral: Peer matching; Behavioral: Quailfied Exercise Professional (QEP) Support

Study type: Interventional

Funder types: Other

Identifiers

NCT07408128

P4E2

Details and patient eligibility

About

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.

Full description

Background:

By 2030, 23% of Canadians will be over 65 years of age. Two in five of these individuals will be diagnosed with cancer during their lifetime. Older adults have high levels of functional decline and morbidity, 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 adults with cancer are significantly less likely to meet current exercise guidelines compared to their younger counterparts. Additionally, psychological symptoms from fewer social interactions leads to decreased quality of life (QOL) among older adults with cancer. Our previous work demonstrated that peer-based exercise interventions improve exercise levels and physical outcomes in younger adult populations. However, there is little research on peer-based interventions to promote exercise in older adults and in cancer populations alone, and no literature among older cancer populations. As our population ages, there is a need to develop effective, scalable interventions that support health in older adults with cancer.

Research Aims:

The primary aim of this study is to determine if older adults with cancer who participate in a virtually delivered peer matching exercise intervention with qualified exercise professional (QEP) support have improved exercise volume, social support, QOL, frailty, and physical activity enjoyment compared to those who are matched with a peer only and a usual care group receiving no intervention. We will also examine the cost effectiveness of the intervention over 6-months and the mechanisms of an effective peer match qualitatively.

Methods:

There are two parts to this study. Part 1 is a three-arm randomized controlled trial. Participants will include older adults (over 65 years) living with or beyond a cancer diagnosis (any type or stage of cancer) who are cleared for exercise and have access to an internet-connected device. Participants will be randomized to 3 groups: 1) PartnerMatchPLUS: peer support plus tailored QEP virtual support for 10 weeks, 2) PartnerMatch: peer support only for 10 weeks, or 3) Control: usual care (no intervention). Dyads in both the PartnerMatchPLUS and PartnerMatch groups will be matched with a partner, given a peer support guide, information on current exercise guidelines, and a Fitbit, and be asked to support each other around exercise for 10 weeks. Descriptive statistics will be reported for each group and an Analysis of Covariance (ANCOVA) will be used to determine between group differences across timepoints. In Part 2 participants will complete a virtual 1-on-1 interview to determine key elements and mechanisms of the peer-based intervention.

Expected Outcomes:

Participants will be assessed at 4 times: baseline, post-intervention (10 weeks post baseline), posttapering (14 weeks post baseline) and 6-months follow-up (26 weeks post baseline). The primary effectiveness outcome is device measured exercise volume at post-intervention. Secondary effectiveness outcomes include self-report exercise volume, social support, QOL, frailty, physical activity enjoyment, and costeffectiveness.

Impact:

Our team includes experts in oncology, rehabilitation, social support, aging, and statistics. If effective, this will be the first virtual peer-based exercise intervention for older adult cancer survivors. Project findings will inform future methods aimed to increase exercise in older adults through accessible exercise supports.

Enrollment: 183 estimated patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 1) English speaking;
• 2) older adults (>60 years);
• 3) living beyond a cancer diagnosis (any type or stage of cancer at any stage of treatment);
• 4) living in Canada;
• 5) have been medically cleared for exercise; and
• 6) have consistent access to an internet-connected device.

Exclusion criteria

• 1) self-report any chronic condition, cognitive impairment, or injury that prevents participation in independent moderate intensity exercise,
• 2) do not pass medical clearance via the GAQ46, or
• 3) had recent (in the last 4 weeks) or have planned surgery of any kind (including reconstructive surgery) in the next 6 months

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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183 participants in 3 patient groups

PartnerMatchPLUS

Experimental group

Description:

This group will have dyads take part together in weekly virtual sessions with a qualified exercise professional (QEP) for 10 weeks. Sessions will last 1 hour. The 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 by the intervention end. A standardized guide will be used to deliver weekly sessions, personalized to participants' goals. Content discussed at sessions will include informational support (benefits of exercise), tangible assistance (suggestions for an exercise program), emotional support (overcoming barriers), and esteem support (encouragement). For four weeks following the 10-week intervention, the QEP will be available for consultation to answer questions as needed.

Treatment:

Behavioral: Quailfied Exercise Professional (QEP) Support

Behavioral: Peer matching

PartnerMatch

Active Comparator group

Description:

Dyads in this group will independently communicate and support each other around exercise for 10 weeks. They will not have contact with the study QEP during the intervention or tapering period. They will be asked to check in with their partner at least once per week but otherwise will structure their communication (mode and frequency) with their matched peer. After the final assessment time point, dyads in this group will be offered a single virtual session with the study QEP to discuss exercise-related questions. They will be asked to document any exercise-related questions that come up during the study period to be answered during the QEP session.

Treatment:

Behavioral: Peer matching

Usual Care

No Intervention group

Description:

Participants in this group will receive no intervention. They will not be introduced to a partner and will not communicate with the study QEP throughout the project. They will be offered a single session with the study QEP after the final assessment (and asked to track questions).