Clinical trial NCT05333016: A Dyadic Approach to Cancer Care: a Feasibility and Efficacy Partner-based Exercise Study
Official title: A Dyadic Approach to Cancer Care: a Feasibility and Efficacy Partner-based Exercise Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Keywords: Cancer
Caregiver burden
Survivor
Dyad
Exercise
Intervention
Feasibility
Lead sponsor: Nova Scotia Health Authority
Sponsor class: OTHER
First posted: 2022-04-18
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Recruitment
timeFrame: Through study completion, about 2 years
measure: Intervention Adherence
timeFrame: Through study completion, about 2 years
measure: Adverse Events
timeFrame: Through study completion, about 2 years
measure: Attrition
timeFrame: Through study completion, about 2 years
measure: Participant Satisfaction
timeFrame: Post intervention, about 12-weeks after baseline
Secondary outcomes:
measure: Caregiver Burden
timeFrame: Pre to post intervention (12-week change)
measure: Body Mass Index (BMI)
timeFrame: Pre to post intervention (12-week change)
measure: Body Composition
timeFrame: Pre to post intervention (12-week change)
measure: Resting heart rate
timeFrame: Pre to post intervention (12-week change)
measure: Resting Blood Pressure
timeFrame: Pre to post intervention (12-week change)
measure: Aerobic Fitness
timeFrame: Pre to post intervention (12-week change)
measure: Upper Body Strength
timeFrame: Pre to post intervention (12-week change)
measure: Muscular Endurance
timeFrame: Pre to post intervention (12-week change)
measure: Balance
timeFrame: Pre to post intervention (12-week change)
measure: Flexibility
timeFrame: Pre to post intervention (12-week change)
measure: Caregiver Quality of Life
timeFrame: Pre to post intervention (12-week change)
measure: Cancer Patient Quality of Life
timeFrame: Pre to post intervention (12-week change)
measure: Cancer Patient Fatigue
timeFrame: Pre to post intervention (12-week change)
measure: Self-Reported Physical Activity
timeFrame: Pre to post intervention (12-week change)
measure: General Health (EuroQol) 5 Dimension - 5 Level
timeFrame: Pre to post intervention (12-week change)
Other outcomes:
Locations:
city: Halifax
country: Canada
facility: Physical Activity and Cancer (PAC) Lab
state: Nova Scotia
Study officials:
affiliation: Dalhousie University / Nova Scotia Health
name: Melanie Keats, PhD
role: PRINCIPAL_INVESTIGATOR
References: