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NCT Number: NCT07408128

Partner4Exercise Randomized Controlled 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.

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Key information

Conditions

Cancer Behavior Motor Activity Neoplasms

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

McMaster University

Hamilton, Ontario, L8S1C7, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Peer Matching

Behavioral

A 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

Behavioral

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. 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.

Primary outcomes

  1. Change in exercise volume

    Time frame: Post intervention (10-weeks post baseline)

    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.

Secondary outcomes

  1. Change in exercise volume

    Time frame: Post-tapering (14 weeks post baseline)

    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.

  2. Change in exercise volume

    Time frame: 6 months follow-up (26 weeks post-baseline)

    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.

  3. Change in level of perceived social support

    Time frame: Post-intervention (10 weeks post baseline)

    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.

  4. Change in level of perceived social support

    Time frame: Post-tapering (14 weeks post baseline)

    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.

  5. Change in level of perceived social support

    Time frame: 6 month follow up (26 weeks post baseline)

    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.

  6. Change in frailty levels

    Time frame: Post-intervention (10 weeks post baseline)

    The Geriatric 8 Questionnaire (G8) will assess participant frailty levels. The G8 consists of 8 items: food intake, weight loss, mobility, psychological status, body mass index, medication number, and self-perception of health. The 8 items provide a total score ranging from 0 (frailty) to 17 (no impairment). A score of ≤14 indicates frailty. The G8 has been validated in cancer survivors. Higher scores represent lower levels of frailty.

  7. Change in frailty levels

    Time frame: Post-tapering (14 weeks post baseline)

    The Geriatric 8 Questionnaire (G8) will assess participant frailty levels. The G8 consists of 8 items: food intake, weight loss, mobility, psychological status, body mass index, medication number, and self-perception of health. The 8 items provide a total score ranging from 0 (frailty) to 17 (no impairment). A score of ≤14 indicates frailty. The G8 has been validated in cancer survivors. Higher scores represent lower levels of frailty.

  8. Change in frailty levels

    Time frame: 6 months follow up (26 weeks post baseline)

    The Geriatric 8 Questionnaire (G8) will assess participant frailty levels. The G8 consists of 8 items: food intake, weight loss, mobility, psychological status, body mass index, medication number, and self-perception of health. The 8 items provide a total score ranging from 0 (frailty) to 17 (no impairment). A score of ≤14 indicates frailty. The G8 has been validated in cancer survivors. Higher scores represent lower levels of frailty.

  9. Change in quality of life (QOL)

    Time frame: Post-intervention (10 weeks post baseline)

    The SF-12 will be used to measure QOL. The SF-12 is a self-administered questionnaire including 12 items addressing eight health domains (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health). Higher scores represent higher levels of QOL.

  10. Change in quality of life (QOL)

    Time frame: Post-tapering (14 weeks post baseline)

    The SF-12 will be used to measure QOL. The SF-12 is a self-administered questionnaire including 12 items addressing eight health domains (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health). Higher scores represent higher levels of QOL.

  11. Change in quality of life (QOL)

    Time frame: 6 month follow up (26 weeks post baseline)

    The SF-12 will be used to measure QOL. The SF-12 is a self-administered questionnaire including 12 items addressing eight health domains (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health). Higher scores represent higher levels of QOL.

  12. Change in quality of life (QOL)

    Time frame: Post-intervention (10 weeks post baseline)

    The EQ-5D-3L will be used to measure QOL. The EQ-5D-3L includes a 3-level scale assessing five dimensions of health (mobility, self-care, activities, pain, and anxiety/depression), and a visual analogue scale where users rate their perception of current health on a scale of 0-10 (worst to best imaginable health). It is reliable and valid for individuals with cancer. Higher scores represent higher levels of QOL.

  13. Change in quality of life (QOL)

    Time frame: Post-tapering (14 weeks post baseline)

    The EQ-5D-3L will be used to measure QOL. The EQ-5D-3L includes a 3-level scale assessing five dimensions of health (mobility, self-care, activities, pain, and anxiety/depression), and a visual analogue scale where users rate their perception of current health on a scale of 0-10 (worst to best imaginable health). It is reliable and valid for individuals with cancer. Higher scores represent higher levels of QOL.

  14. Change in quality of life (QOL)

    Time frame: 6 months follow up (26 weeks post baseline)

    The EQ-5D-3L will be used to measure QOL. The EQ-5D-3L includes a 3-level scale assessing five dimensions of health (mobility, self-care, activities, pain, and anxiety/depression), and a visual analogue scale where users rate their perception of current health on a scale of 0-10 (worst to best imaginable health). It is reliable and valid for individuals with cancer. Higher scores represent higher levels of QOL.

  15. Change in physical activity enjoyment

    Time frame: Post-intervention (10 weeks post baseline)

    Physical activity enjoyment will be measured using the Physical Activity Enjoyment Scale (PACES). This 18-item scale assesses enjoyment of the physical activity respondents are doing on a 7-point Likert scale from 1 (I hate it) to 7 (I enjoy it). Higher scores represent greater enjoyment. The scale is valid and reliable in adults with functional limitations.

  16. Change in physical activity enjoyment

    Time frame: Post-tapering (14 weeks post baseline)

    Physical activity enjoyment will be measured using the Physical Activity Enjoyment Scale (PACES). This 18-item scale assesses enjoyment of the physical activity respondents are doing on a 7-point Likert scale from 1 (I hate it) to 7 (I enjoy it). Higher scores represent greater enjoyment. The scale is valid and reliable in adults with functional limitations.

  17. Change in physical activity enjoyment

    Time frame: 6 months follow up (26 weeks post baseline)

    Physical activity enjoyment will be measured using the Physical Activity Enjoyment Scale (PACES). This 18-item scale assesses enjoyment of the physical activity respondents are doing on a 7-point Likert scale from 1 (I hate it) to 7 (I enjoy it). Higher scores represent greater enjoyment. The scale is valid and reliable in adults with functional limitations.

Study contacts

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

Jenna Smith-Turchyn, PT, PhD

CONTACT

[email protected]

19058690599

Sponsors and collaborators

Lead sponsor

McMaster University

Other

Registry information

Official study title

Evaluating a Virtual Peer-support Exercise Intervention for Older Adults With Cancer: The Partner4Exercise Randomized Controlled Trial

Acronym: P4E RCT

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Feb 13, 2026
Registry last updated
Feb 13, 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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