Feasibility Study of a Home-based Physical Activity Intervention for Family Caregivers of People With Advanced Cancer
Development and Pilot Testing of a Home-Based Physical Activity Intervention for Family Caregivers of People With Advanced Cancer
2 other identifiers
interventional
28
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Nov 2013
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2013
CompletedFirst Submitted
Initial submission to the registry
August 5, 2014
CompletedFirst Posted
Study publicly available on registry
August 7, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2015
CompletedMarch 31, 2015
March 1, 2015
1.3 years
August 5, 2014
March 30, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (7)
Rate of recruitment
Frequency counts of the number of participants recruited from each of the recruitment sites will be conducted and the overall rate of recruitment will be calculated. This criterion for advancing to a full RCT will be met if the estimated sample size required for a full RCT can likely be recruited in 2 years.
9 months of running feasibility trial
Number of participants who drop out
Frequency counts for the number of participants who drop out of both the experimental and control group will be conducted and the percentage rate of attrition in each group will be calculated. This criterion for advancing to a full RCT will be met if less than 30% of participants dropped out of the experimental or control group.
9 months of running feasibility trial
Number of items complete on the outcome questionnaires
To assess acceptability of outcome questionnaires and feasibility of data collection procedures for a full RCT, descriptive statistics (frequency counts) of complete versus incomplete items as well as the expected versus actual completion dates will be conducted at baseline, and week 6, 9, and 12 for both the experimental and control group on the following outcome measures: Positive and Negative Affect Schedule (PANAS); Lee Fatigue Scale (LFS); General Self-Rated Health question. This criterion for advancing to a full RCT will be met if less than 10% of items on each of the questionnaires are missing and less than 10% of participants are missing any one item on each of the questionnaires.
Baseline, 6, 9, and 12 weeks
Rate of adherence to individual physical activity plans
The number of weeks that participants were able to engage in physical activity levels at or above their retrospective baseline physical activity level in relation to the number of weeks that they were in the study will be calculated. Rate of adherence will be calculated for individual participants and the mean and median rate of adherence will be calculated for the experimental group. The proportion of participants that were able to engage in physical activity at or above their retrospective baseline level of physical activity 0-25%, 26-50%, 51-75%, and 76-100% of the time will be calculated. Qualitative data will also be collected and analyzed to explore what factors influence adherence to the individual physical activity plans. This criterion for advancing to a full RCT will be met if the rate of adherence to the individual PA plans is greater than or equal to 75%.
12 weeks
Level of and change in physical activity levels
The mean number of Metabolic Equivalent Task (MET) hours per week that participants engaged in physical activity as well as the number of minutes per week that participants engaged in light, moderate, and vigorous intensity PA for each of the experimental and control groups will be calculated.
12 weeks
Level of adherence to physical activity intervention
The number of weeks that each participant missed receiving the intervention will be calculated. In addition, qualitative data will be collected to assess the pattern of missed weeks for each participant including the reasons that any weeks were missed.
12 weeks
Level of adherence to intervention delivery
An intervention fidelity audit will be conducted. The percentage of audited participants that engaged in each of the main components of intervention delivery (i.e pre-baseline home visit, baseline home visit, and weekly telephone calls) will be calculated. In addition, the percentage of individual intervention delivery criteria items that were met in each component will be calculated for each audited participant.
12 weeks
Secondary Outcomes (2)
Caregivers' perception of the acceptability of the intervention
12 weeks
Caregivers' perception of benefits and/or risks of intervention
12 weeks
Study Arms (2)
Physical activity intervention
EXPERIMENTALA 12 week individually tailored home-based physical activity program with goal-setting, a physical activity self-monitoring technique, and weekly telephone calls provided by the intervener for coaching and support.
Usual care
OTHERAccess to usual community resources but no active lifestyle coaching.
Interventions
A 12 week individually tailored home-based physical activity program with goal-setting, a physical activity self-monitoring technique, and weekly telephone calls provided by the intervener for coaching and support.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Jewish General Hospitallead
- McGill Universitycollaborator
- Canadian Institutes of Health Research (CIHR)collaborator
Study Sites (1)
Jewish General Hospital
Montreal, Quebec, H3T 1E2, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jamie L Penner, RN, PhD(c)
McGill University; Jewish General Hospital
- PRINCIPAL INVESTIGATOR
S Robin Cohen, PhD
McGill University; Jewish General Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Nursing Doctoral Candidate
Study Record Dates
First Submitted
August 5, 2014
First Posted
August 7, 2014
Study Start
November 1, 2013
Primary Completion
March 1, 2015
Study Completion
March 1, 2015
Last Updated
March 31, 2015
Record last verified: 2015-03