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Completed

NCT Number: NCT05333016

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Physical Activity and Cancer (PAC) Lab

Halifax, Nova Scotia, B3H 2Y9, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Multimodal exercise

Behavioral

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

Primary outcomes

  1. Recruitment

    Time frame: Through study completion, about 2 years

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

  2. Intervention Adherence

    Time frame: Through study completion, about 2 years

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

  3. Adverse Events

    Time frame: Through study completion, about 2 years

    Adverse and serious adverse events will be recorded

  4. Attrition

    Time frame: Through study completion, about 2 years

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

  5. Participant Satisfaction

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

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

Secondary outcomes

  1. Caregiver Burden

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

    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)

  2. Body Mass Index (BMI)

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

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

  3. Body Composition

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

    Waist and hip circumference

  4. Resting heart rate

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

    Resting heart rate

  5. Resting Blood Pressure

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

    Resting systolic and diastolic blood pressure

  6. Aerobic Fitness

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

    The 6-minute walk test will be used to assess aerobic capacity

  7. Upper Body Strength

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

    Grip strength will be measured using a hand-held dynamometer

  8. Muscular Endurance

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

    Lower body muscular endurance will be assessed using the 30-second sit-to-stand

  9. Balance

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

    Balance will be assessed using the one-legged stance

  10. Flexibility

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

    Flexibility will be assessed using the sit-and-reach and shoulder flexibility

  11. Caregiver Quality of Life

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

    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.

  12. Cancer Patient Quality of Life

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

    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.

  13. Cancer Patient Fatigue

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

    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

  14. Self-Reported Physical Activity

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

    Physical activity will be assessed using the Godin Leisure Time Exercise Questionnaire. Total score ranges from 0 to no maximum.

  15. General Health (EuroQol) 5 Dimension - 5 Level

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

    Mobility, self-care, usual activities, pain/discomfort, anxiety/depression (EuroQol-5Dimension-5Level; EQ-5D-5L); higher scores indicate higher problems (range 0-1)

Sponsors and collaborators

Lead sponsor

Nova Scotia Health Authority

Other

Registry information

Acronym: C4C

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Apr 18, 2022
Registry last updated
Feb 13, 2025

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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