A Dyadic Approach to Cancer Care: a Feasibility and Efficacy Partner-based Exercise Study (C4C)

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.

Study Overview

• Status: Completed
• Conditions: Cancer
• Intervention / Treatment: Behavioral: Multimodal exercise

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.

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3H 2Y9
      • Physical Activity and Cancer (PAC) Lab

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Multimodal Exercise Intervention; 12-week, twice weekly partner-based multimodal exercise program	Behavioral: Multimodal exercise; Multimodal exercise programming including aerobic, resistance, balance, and flexibility exercises

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recruitment	Participant accrual as defined as the number of eligible participant dyads who consents to participate	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	Through study completion, about 2 years
Adverse Events	Adverse and serious adverse events will be recorded	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	Through study completion, about 2 years
Participant Satisfaction	Participant satisfaction will be assessed by semi-structured interviews (no min/max)	Post intervention, about 12-weeks after baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	Pre to post intervention (12-week change)
Body Mass Index (BMI)	Weight (kg) and height (m) will be used to calculate BMI	Pre to post intervention (12-week change)
Body Composition	Waist and hip circumference	Pre to post intervention (12-week change)
Resting heart rate	Resting heart rate	Pre to post intervention (12-week change)
Resting Blood Pressure	Resting systolic and diastolic blood pressure	Pre to post intervention (12-week change)
Aerobic Fitness	The 6-minute walk test will be used to assess aerobic capacity	Pre to post intervention (12-week change)
Upper Body Strength	Grip strength will be measured using a hand-held dynamometer	Pre to post intervention (12-week change)
Muscular Endurance	Lower body muscular endurance will be assessed using the 30-second sit-to-stand	Pre to post intervention (12-week change)
Balance	Balance will be assessed using the one-legged stance	Pre to post intervention (12-week change)
Flexibility	Flexibility will be assessed using the sit-and-reach and shoulder flexibility	Pre to post intervention (12-week change)
Caregiver Quality of Life	Quality of life will be assessed using the Short-Form Health Survey- SF-36. The SF-36 consists of 36 questions that cover 8 health domains/subscales (physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health). The total scale score ranges from 0 to 100 with higher values representing higher quality of life.	Pre to post intervention (12-week change)
Cancer Patient Quality of Life	Quality of life for cancer patients will be assessed using the Functional Assessment of Cancer Therapy - General survey. The combined 27-item scale provides subscale scores physical (7-items), functional (7-items), emotional (6-items), and social/family (7-items) well-being. The sum of scores on the five domains evaluates a participants' quality of life with higher scores (ranging from 0-108) denoting higher quality of life.	Pre to post intervention (12-week change)
Cancer Patient Fatigue	Fatigue will be assessed using the 13-item Functional Assessment of Chronic Illness Therapy - Fatigue survey. Scores range from 0-52 with higher scores indicating better functioning/less fatigue	Pre to post intervention (12-week change)
Self-Reported Physical Activity	Physical activity will be assessed using the Godin Leisure Time Exercise Questionnaire. Total score ranges from 0 to no maximum.	Pre to post intervention (12-week change)
General Health (EuroQol) 5 Dimension - 5 Level	Mobility, self-care, usual activities, pain/discomfort, anxiety/depression (EuroQol-5Dimension-5Level; EQ-5D-5L); higher scores indicate higher problems (range 0-1)	Pre to post intervention (12-week change)

Collaborators and Investigators

• Sponsor: Nova Scotia Health Authority
• Investigators: Principal Investigator: Melanie Keats, PhD, Dalhousie University / Nova Scotia Health

Publications and helpful links

Helpful Links

• Physical Activity and Cancer Lab website

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2023
• Primary Completion (Actual): December 31, 2024
• Study Completion (Actual): December 31, 2024

Study Registration Dates

• First Submitted: April 4, 2022
• First Submitted That Met QC Criteria: April 11, 2022
• First Posted (Actual): April 18, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 11, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Exercise; Cancer; Feasibility; Caregiver burden; Intervention; Survivor; Dyad
• Other Study ID Numbers: NSH Caring 4 Cancer Caregivers

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No