Self CareNCT02211092
Feasibility Study of a Home-based Physical Activity Intervention for Family Caregivers of People With Advanced Cancer
A study testing Physical activity intervention in people with Self Care and Family Caregivers, run by Jewish General Hospital at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Self Care, Family Caregivers
- What is being tested?
- Physical activity intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2013to Mar 2015
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Development and Pilot Testing of a Home-Based Physical Activity Intervention for Family Caregivers of People With Advanced Cancer
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.
Read the 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.
- Conditions
- Self Care, Family Caregivers
- Being tested
- Physical activity intervention, Usual care
- Keywords
- Family Caregivers, Advanced Cancer, Palliative Care, Support, Self Care, Physical Activity
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical activity interventionBehavioural
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.
Usual careOther
Access to usual community resources but no active lifestyle coaching.
| Study group | Role | What they receive |
|---|---|---|
| Physical activity intervention | Experimental | 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. Receives: Behavioral: Physical activity intervention |
| Usual care | Other | Access to usual community resources but no active lifestyle coaching. Receives: Other: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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%.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12 weeks
Secondary outcomes (2)
Caregivers' perception of the acceptability of the intervention
Qualitative data will be collected during the weekly telephone calls and follow-up interviews to evaluate the acceptability of the structure, content, and process of the physical activity intervention.
This criterion for advancing to a full RCT will be met if <10% of participants report major complaints about the intervention.
Measured: 12 weeks
Caregivers' perception of benefits and/or risks of intervention
Qualitative data will be collected at the follow-up interviews to determine caregivers' overall perception of whether or not and in what ways the physical activity intervention impacted them.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2014 (estimated)
- Study startNov 2013
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Self CareStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jewish General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- McGill University, Canadian Institutes of Health Research (CIHR)
- Responsible party
- Principal investigator, Jamie Penner, RN, PhD(c), Jewish General Hospital
- Investigators
- Jamie L Penner, RN, PhD(c), Principal investigator, McGill University; Jewish General HospitalS Robin Cohen, PhD, Principal investigator, McGill University; Jewish General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02211092
- Sponsor's protocol ID
- 13-129
- Other IDs
- 003208
- Status last verified
- Mar 2015
- First submitted
- 5 Aug 2014
- Last updated
- 31 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Pilot Testing of a Home-Based Physical Activity Intervention for Family Caregivers of People With Advanced Cancer
- ClinicalTrials.gov ID
- NCT02211092
- Acronym / sponsor ID
- 13-129
- Conditions
- Self Care, Family Caregivers
- Keywords
- Family Caregivers, Advanced Cancer, Palliative Care, Support, Self Care, Physical Activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Jewish General HospitalUniversity, hospital or other
- Collaborators
- McGill University, Canadian Institutes of Health Research (CIHR)
- Study start
- Nov 2013
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 7 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Physical activity intervention | Experimental | Behavioral: Physical activity interventionA 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 | Other | Other: Usual careAccess to usual community resources but no active lifestyle coaching. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical activity interventionA 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. | Behavioural | Physical activity intervention |
| Usual careAccess to usual community resources but no active lifestyle coaching. | Other | Usual care |
Primary outcome
Rate of recruitment
Time frame: 9 months of running feasibility trial
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.
Number of participants who drop out
Time frame: 9 months of running feasibility trial
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.
Number of items complete on the outcome questionnaires
Time frame: Baseline, 6, 9, and 12 weeks
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.
Rate of adherence to individual physical activity plans
Time frame: 12 weeks
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%.
Level of and change in physical activity levels
Time frame: 12 weeks
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.
Level of adherence to physical activity intervention
Time frame: 12 weeks
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.
Level of adherence to intervention delivery
Time frame: 12 weeks
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.
2 secondary outcomes
Caregivers' perception of the acceptability of the intervention
Time frame: 12 weeks
Caregivers' perception of benefits and/or risks of intervention
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jamie L Penner, RN, PhD(c) principal investigator
McGill University; Jewish General Hospital
S Robin Cohen, PhD principal investigator
McGill University; Jewish General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical activity intervention in people with Self Care and Family Caregivers, run by Jewish General Hospital 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 3 inclusion and 3 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 31 Mar 2015. 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?
Rate of recruitment (time frame: 9 months of running feasibility trial). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Mar 2015.