NCT05333016

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable cancer

Timeline
Completed

Started Jan 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 4, 2022

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 18, 2022

Completed
9 months until next milestone

Study Start

First participant enrolled

January 15, 2023

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

February 13, 2025

Status Verified

February 1, 2025

Enrollment Period

2 years

First QC Date

April 4, 2022

Last Update Submit

February 11, 2025

Conditions

Cancer

Keywords

CancerCaregiver burdenSurvivorDyadExerciseInterventionFeasibility

Outcome Measures

Primary Outcomes (5)

  • 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 Outcomes (15)

  • Caregiver Burden

    Pre to post intervention (12-week change)

  • Body Mass Index (BMI)

    Pre to post intervention (12-week change)

  • Body Composition

    Pre to post intervention (12-week change)

  • Resting heart rate

    Pre to post intervention (12-week change)

  • Resting Blood Pressure

    Pre to post intervention (12-week change)

  • +10 more secondary outcomes

Study Arms (1)

Multimodal Exercise Intervention

EXPERIMENTAL

12-week, twice weekly partner-based multimodal exercise program

Behavioral: Multimodal exercise

Interventions

Multimodal exerciseBEHAVIORAL

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

Multimodal Exercise Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • + 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)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Physical Activity and Cancer (PAC) Lab

Halifax, Nova Scotia, B3H 2Y9, Canada

Location

Related Links

MeSH Terms

Conditions

NeoplasmsCaregiver BurdenMotor Activity

Condition Hierarchy (Ancestors)

Stress, PsychologicalBehavioral SymptomsBehavior

Study Officials

  • Melanie Keats, PhD

    Dalhousie University / Nova Scotia Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Affiliated Scientist

Study Record Dates

First Submitted

April 4, 2022

First Posted

April 18, 2022

Study Start

January 15, 2023

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

February 13, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)