A Dyadic Approach to Cancer Care: a Feasibility and Efficacy Partner-based Exercise Study

Nova Scotia Health Authority42 enrolled

Overview

The primary goal of this study will be to assess the feasibility and acceptability of a partner-based 12-week exercise intervention for cancer caregivers and their care recipient. The researchers will also explore the preliminary effectiveness of the exercise program on caregiver burden and physical and psychological health of both the family caregiver and the care recipient.

NEED: Cancer has been characterized as a family affair, as it is a disease in which both the patient and their family members are confronted by considerable physical and psychological stressors. With an anticipated 80% increase in the average number of new cancer diagnoses by 2030 and rapidly escalating health care costs, there has been a shift to outpatient and home-based care. In doing so, family members are increasingly being called upon to participate as informal caregivers (i.e., an individual who provided uncompensated care). Despite being a key partner in the supportive care of the cancer patient, family caregivers are often inadequately prepared or supported to take on this critical role, subsequently putting their own health and well-being at risk and by extension, that of the cancer patient/survivor. Preliminary data suggests that exercise interventions show promise in mitigating caregiver burden and improving health outcomes for both the caregiver and the patient/survivor. To date, however only two studies have examined the benefit of exercise interventions on family caregiver and patient outcomes within the cancer care context. GOAL: The primary goal of this study will be to assess the feasibility and acceptability of a partner-based 12-week exercise intervention. The investigators will also explore the preliminary effectiveness of the exercise program on caregiver burden and physical and psychological health of both the family caregiver and the care recipient. WHO: Participants will include adult primary caregivers and cancer patients/survivors of all cancers and stages at any point along the cancer care trajectory. HOW: Using both surveys and participant interviews, the participant experience and impact (e.g., physical and psychological health benefits) of a 12-week, partner-based exercise intervention will be evaluated. The 12-week exercise program will include a combination of aerobic, resistance, balance, and flexibility exercises delivered in a partner-based setting twice weekly at a dedicated cancer and exercise lab.

Study Type

INTERVENTIONAL

Allocation

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Cancer

Interventions

Multimodal exerciseBEHAVIORAL

Multimodal exercise programming including aerobic, resistance, balance, and flexibility exercises

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria (all): * 18+ years * able to perform discontinuous low intensity physical activity at a minimum * able to provide informed written consent in English. Inclusion Criteria (cancer patients/survivors) \- are along any stage of the cancer continuum (i.e., pre-treatment, receiving active treatment, and up to 5 years post-treatment) Inclusion Criteria (informal caregivers) * must be currently providing physical and/or psychological support to an adult (+18 years) cancer patient/survivor * not be exceeding current Canadian physical activity guidelines (i.e., 150 minutes of moderate-to-vigorous physical activity per week) Exclusion Criteria (all): \- Patients/survivors and caregivers will be excluded from the study if they have any medical conditions that would contraindicate exercise Exclusion Criteria (informal caregivers) \- Bereaved caregivers

Locations (1)

Physical Activity and Cancer (PAC) Lab

Halifax, Nova Scotia, Canada

Outcomes

Primary Outcomes

Recruitment

Participant accrual as defined as the number of eligible participant dyads who consents to participate

Time frame: Through study completion, about 2 years

Intervention Adherence

Participant program adherence calculated as percentage of exercise sessions completed divided by total number of available exercise sessions over 12-week intervention

Time frame: Through study completion, about 2 years

Adverse Events

Adverse and serious adverse events will be recorded

Time frame: Through study completion, about 2 years

Attrition

Participant attrition calculated as percentage of patients who complete 12-week study divided by number who withdraw from study

Time frame: Through study completion, about 2 years

Participant Satisfaction

Participant satisfaction will be assessed by semi-structured interviews (no min/max)

Time frame: Post intervention, about 12-weeks after baseline

Secondary Outcomes

Caregiver Burden

Assessed by the 22-item Zarit Burden Interview (ZBI). Responses are scored on a 5-point Likert scale ranging from 0 (never) to 4 (nearly always) with the sum of scores ranging from 0 to 88 (higher scores indicate higher burden)

Time frame: Pre to post intervention (12-week change)

Body Mass Index (BMI)

Weight (kg) and height (m) will be used to calculate BMI

Time frame: Pre to post intervention (12-week change)

Data from ClinicalTrials.gov

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