Cancer Caregivers of Older AdultsNCT02099526
Older Cancer Caregiver Needs Post Hospital Discharge
An observational study of Cancer Caregivers of Older Adults, run by Duke University at 1 site in United States.
Trial summary
The goals of the study are to investigate the needs of older (age 60+) caregivers caring for adults with cancer at 1-week and 2 weeks following hospital discharge and to explore strategies that may assist caregivers in their home caregiving needs. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cancer Caregivers of Older Adults
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2014to Jun 2015
- 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: Subjects include 30 informal caregivers and cancer patients dyads. Patients have been admitted to either the hematological malignancy unit, or the non-hematological malignancy unit for treatment of cancer, or treatment-related/cancer-related complications.
Who may be able to join
- Caregiver must speak English
- Caregiver must be at least 60 years of age
- Patients must be 18 years of age or older \& speak English
- Patients must have been admitted to either the 9100 or 9300 oncology unit for treatment of cancer, or treatment-related/cancer-related complications
- Patients must be discharged home to participate in the study
Who cannot join
- Dyads who received hospice referral prior to the care recipient's discharge
- Patient must not have any diagnosis of dementia in their medical records, or any cognitive impairment as assessed by hospital providers (physicians and nurses)
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27710
About this study
Official title: Needs of Older Caregivers of Adults With Cancer In the First 2 Weeks Following Hospital Discharge
The goals of the study are to investigate the needs of older (age 60+) caregivers caring for adults with cancer at 1-week and 2 weeks following hospital discharge and to explore strategies that may assist caregivers in their home caregiving needs. This study will explore how these needs vary based on caregiver spirituality and relationship with the care recipient.
The study will enroll cancer patients and their caregivers admitted to 9100 and 9300, which are the hematological and non-hematological malignancy units at Duke University Medical Center (DUMC) respectively. Results of this study will lay the groundwork for creating tailored interventions for caregivers that are compatible to their preferences and more responsive to their needs.
Read the detailed description
Baseline demographic data about the caregiver and patient will be collected at patient beside prior to hospital discharge. Qualitative interviews will be conducted with the cancer caregivers in their home at 1-week after their loved one was discharged from the hospital, and at 2-weeks after discharge from the hospital. This study utilizes a qualitative descriptive design.
- Conditions
- Cancer Caregivers of Older Adults
- Keywords
- cancer, caregiver, caregiving, care give, elderly, older adults, unmet needs, post-discharge, cancer symptoms
- Medical subject headings
- Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Unmet cancer caregiver needs
Explore the needs (e.g., psychosocial) of older adults caring for a loved one with cancer at home during the first and second weeks after hospital discharge, and determine how these needs vary by spirituality and relationship to the care recipient.
Measured: 1 week after patient discharge from hospital
Caregiver strategies assisting in caregiving role
Identify the strategies used by older caregivers during the first and second weeks after hospital discharge, and determine how these strategies vary by spirituality and relationship to the care recipient.
Measured: 1 week after patient discharge from hospital
Caregiver decision making in seeking assistance for cancer patient
Describe the preferences of support and assistance (e.g., family/friends) of older caregivers in caring for a loved one with cancer at home during the first and second weeks after hospital discharge, and determine how these preferences vary by spirituality and relationship to the care recipient.
Measured: 1 week after patient discharge from hospital
Secondary outcomes (1)
Caregiver needs and preferences vary with time
Explore whether caregiver needs and preferences vary with time (1 week versus 2 weeks post hospital discharge).
Measured: 2 weeks after patient discharge from the hospital
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2014 (estimated)
- Study startJun 2014
- Primary completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer Caregivers of Older AdultsStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe 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
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- The Reed Foundation, Ruth Landes Memorial Research Fund
- Responsible party
- Sponsor
- Investigators
- Cristina Hendrix, DNS, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02099526
- Sponsor's protocol ID
- Pro00051203
- Status last verified
- Jan 2015
- First submitted
- 26 Mar 2014
- Last updated
- 23 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Needs of Older Caregivers of Adults With Cancer In the First 2 Weeks Following Hospital Discharge
- ClinicalTrials.gov ID
- NCT02099526
- Acronym / sponsor ID
- Pro00051203
- Conditions
- Cancer Caregivers of Older Adults
- Keywords
- cancer, caregiver, caregiving, care give, elderly, older adults, unmet needs, post-discharge
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- The Reed Foundation, Ruth Landes Memorial Research Fund
- Study start
- Jun 2014
- Primary completion
- Jun 2015 (actual)
- First posted
- 31 Mar 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 goals of the study are to investigate the needs of older (age 60+) caregivers caring for adults with cancer at 1-week and 2 weeks following hospital discharge and to explore strategies that may assist caregivers in their home caregiving needs. This study will explore how these needs vary based on caregiver spirituality and relationship with the care recipient.
The study will enroll cancer patients and their caregivers admitted to 9100 and 9300, which are the hematological and non-hematological malignancy units at Duke University Medical Center (DUMC) respectively. Results of this study will lay the groundwork for creating tailored interventions for caregivers that are compatible to their preferences and more responsive to their needs.
Detailed description
Baseline demographic data about the caregiver and patient will be collected at patient beside prior to hospital discharge. Qualitative interviews will be conducted with the cancer caregivers in their home at 1-week after their loved one was discharged from the hospital, and at 2-weeks after discharge from the hospital. This study utilizes a qualitative descriptive design.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects include 30 informal caregivers and cancer patients dyads. Patients have been admitted to either the hematological malignancy unit, or the non-hematological malignancy unit for treatment of cancer, or treatment-related/cancer-related complications.
Key inclusion criteria (5 listed)
- Caregiver must speak English
- Caregiver must be at least 60 years of age
- Patients must be 18 years of age or older \& speak English
- Patients must have been admitted to either the 9100 or 9300 oncology unit for treatment of cancer, or treatment-related/cancer-related complications
- Patients must be discharged home to participate in the study
Key exclusion criteria (2 listed)
- Dyads who received hospice referral prior to the care recipient's discharge
- Patient must not have any diagnosis of dementia in their medical records, or any cognitive impairment as assessed by hospital providers (physicians and nurses)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Unmet cancer caregiver needs
Time frame: 1 week after patient discharge from hospital
Explore the needs (e.g., psychosocial) of older adults caring for a loved one with cancer at home during the first and second weeks after hospital discharge, and determine how these needs vary by spirituality and relationship to the care recipient.
Caregiver strategies assisting in caregiving role
Time frame: 1 week after patient discharge from hospital
Identify the strategies used by older caregivers during the first and second weeks after hospital discharge, and determine how these strategies vary by spirituality and relationship to the care recipient.
Caregiver decision making in seeking assistance for cancer patient
Time frame: 1 week after patient discharge from hospital
Describe the preferences of support and assistance (e.g., family/friends) of older caregivers in caring for a loved one with cancer at home during the first and second weeks after hospital discharge, and determine how these preferences vary by spirituality and relationship to the care recipient.
1 secondary outcome
Caregiver needs and preferences vary with time
Time frame: 2 weeks after patient discharge from the hospital
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 23 Jul 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.
Cristina Hendrix, DNS principal investigator
Duke University
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 Cancer Caregivers of Older Adults, run by Duke University 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 2 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 23 Jul 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 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?
Unmet cancer caregiver needs (time frame: 1 week after patient discharge from hospital). The study lists 3 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 23 Jul 2015.