Caregiver BurdenNCT02501785
Caregiver Burden Within the Ambulatory Extended Recovery (AXR) Patient Population
An observational study of Caregiver Burden, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
The purpose of this study is to understand the level of caregiver burden related to caring for a patient who goes home within the first 24 hours following surgery. As the caregiver they are providing care to a family member, friend, or neighbor. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Caregiver Burden
- What is being tested?
- Caregiver Reaction Assessment (CRA) and The Caregiver Quality of Life - Cancer (CQOLC)
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 47 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2015to Aug 2018
- Phase
- Observational
- 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
Study population: Patients and caregivers will be recruited prior to the patient's scheduled surgery during a clinic visit within the four target services. (Breast, Gynecology, Head and Neck, and Urology
Who may be able to join
- Caregiver/patient pairs undergoing surgery for an indication tracked within the Breast, Gynecology, Head and Neck, and Urology AXR program
- English speaking
- Patients willing to provide demographic, surgical, and outcome information
- Caregivers willing to provide demographic, socioeconomic, and caregiver experience information
- Caregivers willing to complete the caregiver burden measurement scales
Who cannot join
- Patients undergoing surgery within the AXR pathway that do not have a caregiver
- Non-English speaking patients or caregivers
- Patients unwilling to provide demographic and surgical information
- Caregivers unwilling to provide demographic, socioeconomic, or caregiver experience information or unwilling to complete the caregiver burden measurement scales
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
About this study
The purpose of this study is to understand the level of caregiver burden related to caring for a patient who goes home within the first 24 hours following surgery. As the caregiver they are providing care to a family member, friend, or neighbor. Even when not formally trained, the care they provide is important to the patient's recovery. Providing care in this manner can be stressful. This study will help us understand what aspects of the patient's recovery are most difficult for the caregiver.
- Conditions
- Caregiver Burden
- Being tested
- Caregiver Reaction Assessment (CRA), The Caregiver Quality of Life - Cancer (CQOLC)
- Keywords
- Quality of Life, Patient care givers, 15-145, Ambulatory Extended Recovery
- Medical subject headings
- Caregiver Burden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Caregiver Reaction Assessment (CRA)Behavioural
The Caregiver Quality of Life - Cancer (CQOLC)Behavioural
| Study group | Role | What they receive |
|---|---|---|
| patient and caregivers | This is a prospective cohort study. Four questionnaires will be used to collect data from caregivers: demographic and socioeconomic data will be collected from the caregiver before the patient's surgery, and caregiver burden information will be collected 15 (+/- 3) days after surgery. Receives: Behavioral: Caregiver Reaction Assessment (CRA); Behavioral: The Caregiver Quality of Life - Cancer (CQOLC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Caregiver Reaction Assessment (CRA) score
in the AXR patient population. Burden will be defined as both a total CRA score and sub scores and will be summarized using descriptive statistics. CRA total score of 72 and subscale scores of 3 or greater will be used to indicate high levels of caregiver
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2015 (estimated)
- Study startJun 2015
- Primary completionAug 2018
- Study completionAug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Caregiver BurdenStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mindy Sovel, MPH, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02501785
- Sponsor's protocol ID
- 15-145
- Status last verified
- Aug 2018
- First submitted
- 9 Jul 2015
- Last updated
- 14 Aug 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Caregiver Burden Within the Ambulatory Extended Recovery (AXR) Patient Population
- ClinicalTrials.gov ID
- NCT02501785
- Acronym / sponsor ID
- 15-145
- Conditions
- Caregiver Burden
- Keywords
- Quality of Life, Patient care givers, 15-145, Ambulatory Extended Recovery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- Jun 2015 (actual)
- Primary completion
- Aug 2018 (actual)
- Study completion
- Aug 2018 (actual)
- First posted
- 17 Jul 2015 (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 understand the level of caregiver burden related to caring for a patient who goes home within the first 24 hours following surgery. As the caregiver they are providing care to a family member, friend, or neighbor. Even when not formally trained, the care they provide is important to the patient's recovery. Providing care in this manner can be stressful. This study will help us understand what aspects of the patient's recovery are most difficult for the caregiver.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patient and caregivers | – | Behavioral: Caregiver Reaction Assessment (CRA), Behavioral: The Caregiver Quality of Life - Cancer (CQOLC)This is a prospective cohort study. Four questionnaires will be used to collect data from caregivers: demographic and socioeconomic data will be collected from the caregiver before the patient's surgery, and caregiver burden information will be collected 15 (+/- 3) days after surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients and caregivers will be recruited prior to the patient's scheduled surgery during a clinic visit within the four target services. (Breast, Gynecology, Head and Neck, and Urology
Key inclusion criteria (5 listed)
- Caregiver/patient pairs undergoing surgery for an indication tracked within the Breast, Gynecology, Head and Neck, and Urology AXR program
- English speaking
- Patients willing to provide demographic, surgical, and outcome information
- Caregivers willing to provide demographic, socioeconomic, and caregiver experience information
- Caregivers willing to complete the caregiver burden measurement scales
Key exclusion criteria (4 listed)
- Patients undergoing surgery within the AXR pathway that do not have a caregiver
- Non-English speaking patients or caregivers
- Patients unwilling to provide demographic and surgical information
- Caregivers unwilling to provide demographic, socioeconomic, or caregiver experience information or unwilling to complete the caregiver burden measurement scales
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 |
|---|---|---|
| Caregiver Reaction Assessment (CRA) | Behavioural | patient and caregivers |
| The Caregiver Quality of Life - Cancer (CQOLC) | Behavioural | patient and caregivers |
Primary outcome
Caregiver Reaction Assessment (CRA) score
Time frame: 1 year
in the AXR patient population. Burden will be defined as both a total CRA score and sub scores and will be summarized using descriptive statistics. CRA total score of 72 and subscale scores of 3 or greater will be used to indicate high levels of caregiver
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 14 Aug 2018.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
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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.
Mindy Sovel, MPH principal investigator
Memorial Sloan Kettering Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Caregiver Burden, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
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 5 inclusion and 4 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 14 Aug 2018. 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 United States. 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?
Caregiver Reaction Assessment (CRA) score (time frame: 1 year). 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 14 Aug 2018.