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

Cancer Clinical Trial

— C4C  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05333016
• Other study ID #: NSH Caring 4 Cancer Caregivers
• Status: Recruiting
• Phase: N/A
• Start date: January 15, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: March 2024
• Source: Nova Scotia Health Authority
• Contact: Melanie Keats, PhD
• Phone: 902-494-7173
• Email: melanie.keats[@]dal.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer

Intervention

Behavioral:
• Multimodal exercise
Multimodal exercise programming including aerobic, resistance, balance, and flexibility exercises

Locations

Country	Name	City	State
Canada	Physical Activity and Cancer (PAC) Lab	Halifax	Nova Scotia

Sponsors (1)

Lead Sponsor	Collaborator
Nova Scotia Health Authority

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recruitment	Participant accrual as defined as the number of eligible participant dyads who consents to participate	Through study completion, about 2 years
Primary	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
Primary	Adverse Events	Adverse and serious adverse events will be recorded	Through study completion, about 2 years
Primary	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
Primary	Participant Satisfaction	Participant satisfaction will be assessed by semi-structured interviews (no min/max)	Post intervention, about 12-weeks after baseline
Secondary	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)
Secondary	Body Mass Index (BMI)	Weight (kg) and height (m) will be used to calculate BMI	Pre to post intervention (12-week change)
Secondary	Body Composition	Waist and hip circumference	Pre to post intervention (12-week change)
Secondary	Resting heart rate	Resting heart rate	Pre to post intervention (12-week change)
Secondary	Resting Blood Pressure	Resting systolic and diastolic blood pressure	Pre to post intervention (12-week change)
Secondary	Aerobic Fitness	The 6-minute walk test will be used to assess aerobic capacity	Pre to post intervention (12-week change)
Secondary	Upper Body Strength	Grip strength will be measured using a hand-held dynamometer	Pre to post intervention (12-week change)
Secondary	Muscular Endurance	Lower body muscular endurance will be assessed using the 30-second sit-to-stand	Pre to post intervention (12-week change)
Secondary	Balance	Balance will be assessed using the one-legged stance	Pre to post intervention (12-week change)
Secondary	Flexibility	Flexibility will be assessed using the sit-and-reach and shoulder flexibility	Pre to post intervention (12-week change)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)

External Links

•   Physical Activity and Cancer Lab website