Clinical trial NCT02211092: Feasibility Study of a Home-based Physical Activity Intervention for Family Caregivers of People With Advanced Cancer
Official title: Development and Pilot Testing of a Home-Based Physical Activity Intervention for Family Caregivers of People With Advanced Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Self Care
Family Caregivers
Keywords: Family Caregivers
Advanced Cancer
Palliative Care
Support
Self Care
Physical Activity
Lead sponsor: Jewish General Hospital
Sponsor class: OTHER
Collaborators: name: McGill University
name: Canadian Institutes of Health Research (CIHR)
First posted: 2014-08-07
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to develop an individually tailored home-based physical activity intervention for family caregivers of people with advanced cancer and assess the feasibility of a future randomized controlled trial (RCT) to test the effects of this intervention.

Detailed description: Families play an essential role in the care of people with advanced cancer and usually undertake caregiving responsibilities for patients at home. While caregiving is often rewarding, the physical and emotional demands of caregiving have significant impacts on caregivers' health, including a wide range of emotional responses and high levels of fatigue. Caregivers' own health is important and their ability to continue to provide care also necessitates that their self-care needs are met. However, few supportive interventions have been developed specifically to address these needs. One way of doing so may be increasing physical activity. The physical and psychological benefits of physical activity are well documented. A lifestyle approach to physical activity can be tailored to the needs, preferences, and circumstances of the individual and is therefore a logical way to address some of the self-care needs of caregivers within the context of their personal caregiving situation. The main objectives of this pilot study are to develop an individually tailored home-based physical activity intervention for family caregivers of people with advanced cancer and assess the feasibility of a future randomized controlled trial to test the effect of this intervention on caregivers' positive and negative affect, fatigue, and overall self-rated health.

Eligibility criteria: Inclusion Criteria:

* 18 years of age or older
* able to speak and read English
* involved in the care of a person with advanced cancer (stage III or IV) at home

Exclusion Criteria:

* already participating in physical activity more than three days a week and 30 minutes or more per session as assessed by self-report
* a current mental illness that has been treated with medication for \<8 weeks or that the caregiver intends to initiate medication for during the period of the intervention
* any major physical health problem that would prevent caregivers from participating in the intervention as assessed by the Physical Activity Readiness Questionnaire (PAR-Q)

Primary outcomes:
measure: Rate of recruitment
timeFrame: 9 months of running feasibility trial
measure: Number of participants who drop out
timeFrame: 9 months of running feasibility trial
measure: Number of items complete on the outcome questionnaires
timeFrame: Baseline, 6, 9, and 12 weeks
measure: Rate of adherence to individual physical activity plans
timeFrame: 12 weeks
measure: Level of and change in physical activity levels
timeFrame: 12 weeks
measure: Level of adherence to physical activity intervention
timeFrame: 12 weeks
measure: Level of adherence to intervention delivery
timeFrame: 12 weeks
Secondary outcomes:
measure: Caregivers' perception of the acceptability of the intervention
timeFrame: 12 weeks
measure: Caregivers' perception of benefits and/or risks of intervention
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Jewish General Hospital
state: Quebec
Study officials:
affiliation: McGill University; Jewish General Hospital
name: Jamie L Penner, RN, PhD(c)
role: PRINCIPAL_INVESTIGATOR
affiliation: McGill University; Jewish General Hospital
name: S Robin Cohen, PhD
role: PRINCIPAL_INVESTIGATOR
References: