CaregiversNCT03069105
An Exploratory Study of Caregiver Burden Among Family Caregivers of Patients With Cancer
An observational study of Caregivers and Cancer, run by Saint John's Cancer Institute at 4 sites in United States.
Trial summary
This study will look at caregiver burden and the coping behavior of caregivers of patients with cancer. Through this study, the investigators will identify the relationship between cognitive dysfunction (measured as a proxy rating by the caregiver), resilience, social support, cognitive appraisal, coping behavior, and… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Caregivers, Cancer
- What is being tested?
- Questionnaire
- How many people
- 49 participants
- Where
- 4 sitesUnited States
- Study dates
- 23 Feb 2017to 28 Apr 2020
- 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: The sample for this study will consist of caregivers of persons with cancer. A convenience sampling will be used to enroll eligible caregivers.
Who may be able to join
- Age ≥ 18 years
- Self-identified primary caregiver of patients with cancer
- Co-residence with the patient
- Providing a minimum of 4 hours of direct care for at least 3 days per week
- Able to speak, read, and understand English
- Willing to participate in completion of surveys
Who cannot join
- Professional or paid caregivers
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Providence Saint Joseph Medical Center
Burbank, California, 91505
Providence Holy Cross Medical Center
Mission Hills, California, 91345
EndBrainCancer Initiative/Chris Elliott Fund
Redmond, Washington, 98052
John Wayne Cancer Institute at Providence Saint John's Health Center
Santa Monica, California, 90404
About this study
Official title: An Exploratory Study of Caregiver Burden Among Family Caregivers of Cancer Patients
This study will look at caregiver burden and the coping behavior of caregivers of patients with cancer. Through this study, the investigators will identify the relationship between cognitive dysfunction (measured as a proxy rating by the caregiver), resilience, social support, cognitive appraisal, coping behavior, and caregiver burden, anxiety, and depression among family caregivers of patients with cancer.
Read the detailed description
The goal of this study is to explore caregiver burden and the coping behavior of caregivers of patients with cancer. It has been documented that non-professional caregivers and long-term care providers to patients with cancer receive little preparation, information, or support to perform their vital role. Through this study, the investigators will identify the relationship between cognitive dysfunction, resilience, social support, cognitive appraisal, coping behavior, and caregiver burden, anxiety, and depression among family caregivers of patients with cancer. The findings of this study will direct future intervention studies to reduce caregiver burden and improve outcomes for the many individuals caring for family members with cancer.
- Conditions
- Caregivers, Cancer
- Being tested
- Questionnaire
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
Participants will complete paper and pencil or electronic questionnaires at the cancer center or in the privacy of their own homes.
| Study group | Role | What they receive |
|---|---|---|
| Family caregivers | The sample for this study will consist of caregivers of patients with cancer. Eligible subjects who agrees to participate in the research study and sign the consent form will participate by completing paper and pencil or electronic questionnaires. Receives: Other: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Caregiver Burden Score [Caregiver Reaction Assessment (CRA)]
Relation between caregiver burden subscale scores and caregiver resilience, social support, and coping
Measured: 1 year
Secondary outcomes (1)
Changes in Anxiety and Depression Score [Hospital Anxiety and Depression Scale (HADS)]
Relation between caregiver anxiety and depression score and caregiver resilience, social support, and coping
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 posted3 Mar 2017
- Study start23 Feb 2017
- Primary completion28 Apr 2020
- Study completion28 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for CaregiversStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saint John's Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marlon Garzo Saria, Saint John's Cancer Institute
- Investigators
- Santosh Kesari, MD PhD, Study chair, Saint John's Cancer InstituteMarlon G Saria, PhD RN FAAN, Principal investigator, John Wayne Cancer Institute at Providence Saint John's Health Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03069105
- Sponsor's protocol ID
- JWCI-16-1201
- Status last verified
- Nov 2020
- First submitted
- 23 Feb 2017
- Last updated
- 13 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Saria MG, Nyamathi A, Phillips LR, Stanton AL, Evangelista L, Kesari S, Maliski S. The Hidden Morbidity of Cancer: Burden in Caregivers of Patients with Brain Metastases. Nurs Clin North Am. 2017 Mar;52(1):159-178. doi: 10.1016/j.cnur.2016.10.002.
PubMed 28189161Saria MG, Courchesne N, Evangelista L, Carter J, MacManus DA, Gorman MK, Nyamathi AM, Phillips LR, Piccioni D, Kesari S, Maliski S. Cognitive dysfunction in patients with brain metastases: influences on caregiver resilience and coping. Support Care Cancer. 2017 Apr;25(4):1247-1256. doi: 10.1007/s00520-016-3517-3. Epub 2016 Dec 5.
PubMed 27921222
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Study of Caregiver Burden Among Family Caregivers of Cancer Patients
- ClinicalTrials.gov ID
- NCT03069105
- Acronym / sponsor ID
- JWCI-16-1201
- Conditions
- Caregivers, Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Saint John's Cancer InstituteUniversity, hospital or other
- Study start
- 23 Feb 2017 (actual)
- Primary completion
- 28 Apr 2020 (actual)
- Study completion
- 28 Apr 2020 (actual)
- First posted
- 3 Mar 2017 (actual)
- 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.
This study will look at caregiver burden and the coping behavior of caregivers of patients with cancer. Through this study, the investigators will identify the relationship between cognitive dysfunction (measured as a proxy rating by the caregiver), resilience, social support, cognitive appraisal, coping behavior, and caregiver burden, anxiety, and depression among family caregivers of patients with cancer.
Detailed description
The goal of this study is to explore caregiver burden and the coping behavior of caregivers of patients with cancer. It has been documented that non-professional caregivers and long-term care providers to patients with cancer receive little preparation, information, or support to perform their vital role. Through this study, the investigators will identify the relationship between cognitive dysfunction, resilience, social support, cognitive appraisal, coping behavior, and caregiver burden, anxiety, and depression among family caregivers of patients with cancer. The findings of this study will direct future intervention studies to reduce caregiver burden and improve outcomes for the many individuals caring for family members with cancer.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Family caregivers | – | Other: QuestionnaireThe sample for this study will consist of caregivers of patients with cancer. Eligible subjects who agrees to participate in the research study and sign the consent form will participate by completing paper and pencil or electronic questionnaires. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The sample for this study will consist of caregivers of persons with cancer. A convenience sampling will be used to enroll eligible caregivers.
Key inclusion criteria (6 listed)
- Age ≥ 18 years
- Self-identified primary caregiver of patients with cancer
- Co-residence with the patient
- Providing a minimum of 4 hours of direct care for at least 3 days per week
- Able to speak, read, and understand English
Key exclusion criteria (1 listed)
- Professional or paid caregivers
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 |
|---|---|---|
| QuestionnaireParticipants will complete paper and pencil or electronic questionnaires at the cancer center or in the privacy of their own homes. | Other | Family caregivers |
Primary outcome
Changes in Caregiver Burden Score [Caregiver Reaction Assessment (CRA)]
Time frame: 1 year
Relation between caregiver burden subscale scores and caregiver resilience, social support, and coping
1 secondary outcome
Changes in Anxiety and Depression Score [Hospital Anxiety and Depression Scale (HADS)]
Time frame: 1 year
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 13 Nov 2020.
- Background: PubMed 28189161Saria MG, Nyamathi A, Phillips LR, Stanton AL, Evangelista L, Kesari S, Maliski S. The Hidden Morbidity of Cancer: Burden in Caregivers of Patients with Brain Metastases. Nurs Clin North Am. 2017 Mar;52(1):159-178. doi: 10.1016/j.cnur.2016.10.002.
- Background: PubMed 27921222Saria MG, Courchesne N, Evangelista L, Carter J, MacManus DA, Gorman MK, Nyamathi AM, Phillips LR, Piccioni D, Kesari S, Maliski S. Cognitive dysfunction in patients with brain metastases: influences on caregiver resilience and coping. Support Care Cancer. 2017 Apr;25(4):1247-1256. doi: 10.1007/s00520-016-3517-3. Epub 2016 Dec 5.
- Individual participant dataSharing planned: No
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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.
Santosh Kesari, MD PhD study chair
Saint John's Cancer Institute
Marlon G Saria, PhD RN FAAN principal investigator
John Wayne Cancer Institute at Providence Saint John's Health Center
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Caregivers and Cancer, run by Saint John's Cancer Institute at 4 sites 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 6 inclusion and 1 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 13 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
Changes in Caregiver Burden Score [Caregiver Reaction Assessment (CRA)] (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03069105, which also lists 2 linked publications.
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 13 Nov 2020.