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CancerC4CNCT05333016

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

A study testing Multimodal exercise in people with Cancer, run by Nova Scotia Health Authority at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cancer
What is being tested?
Multimodal exercise
Could I receive a placebo?
No, everyone receives an active treatment
How many people
42 participants
Where
1 siteCanada
Study dates
15 Jan 2023to 31 Dec 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 18+ years
  • able to perform discontinuous low intensity physical activity at a minimum
  • able to provide informed written consent in English.
  • are along any stage of the cancer continuum (i.e., pre-treatment, receiving active treatment, and up to 5 years post-treatment)
  • 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)

Who cannot join

  • Patients/survivors and caregivers will be excluded from the study if they have any medical conditions that would contraindicate exercise
  • Bereaved caregivers

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Physical Activity and Cancer (PAC) Lab

    Halifax, Nova Scotia, B3H 2Y9

Other trials in Canada

About this 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.

Read the 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.

Conditions
Cancer
Being tested
Multimodal exercise
Keywords
Cancer, Caregiver burden, Survivor, Dyad, Exercise, Intervention, Feasibility
Medical subject headings
Neoplasms, Caregiver Burden, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Multimodal exerciseBehavioural

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

Study groups in NCT05333016
Study groupRoleWhat they receive
Multimodal Exercise InterventionExperimental12-week, twice weekly partner-based multimodal exercise program
Receives: Behavioral: Multimodal exercise

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Recruitment

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

    Measured: Through study completion, about 2 years

  2. Intervention Adherence

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

    Measured: Through study completion, about 2 years

  3. Adverse Events

    Adverse and serious adverse events will be recorded

    Measured: Through study completion, about 2 years

  4. Attrition

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

    Measured: Through study completion, about 2 years

  5. Participant Satisfaction

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

    Measured: Post intervention, about 12-weeks after baseline

Secondary outcomes (15)

  1. 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)

    Measured: Pre to post intervention (12-week change)

  2. Body Mass Index (BMI)

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

    Measured: Pre to post intervention (12-week change)

  3. Body Composition

    Waist and hip circumference

    Measured: Pre to post intervention (12-week change)

  4. Resting heart rate

    Resting heart rate

    Measured: Pre to post intervention (12-week change)

  5. Resting Blood Pressure

    Resting systolic and diastolic blood pressure

    Measured: Pre to post intervention (12-week change)

  6. Aerobic Fitness

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

    Measured: Pre to post intervention (12-week change)

  7. Upper Body Strength

    Grip strength will be measured using a hand-held dynamometer

    Measured: Pre to post intervention (12-week change)

  8. Muscular Endurance

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

    Measured: Pre to post intervention (12-week change)

  9. Balance

    Balance will be assessed using the one-legged stance

    Measured: Pre to post intervention (12-week change)

  10. Flexibility

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

    Measured: Pre to post intervention (12-week change)

  11. 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.

    Measured: Pre to post intervention (12-week change)

  12. 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.

    Measured: Pre to post intervention (12-week change)

  13. 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

    Measured: Pre to post intervention (12-week change)

  14. Self-Reported Physical Activity

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

    Measured: Pre to post intervention (12-week change)

  15. 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)

    Measured: Pre to post intervention (12-week change)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Apr 2022
  2. Study start15 Jan 2023
  3. Primary completion31 Dec 2024
  4. Study completion31 Dec 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
42 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05333016
Sponsor's protocol ID
NSH Caring 4 Cancer Caregivers
Acronym
C4C
Status last verified
Feb 2025
First submitted
4 Apr 2022
Last updated
13 Feb 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Multimodal exercise in people with Cancer, run by Nova Scotia Health Authority at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recruitment (time frame: Through study completion, about 2 years). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05333016.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2025.

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