CancerNCT05244915
A Supportive Care Intervention for Older Caregivers of Older Adults with Advanced Cancer
A study testing Experimental (Delphi Surveys), Experimental (Focus Groups) and Qualitative interviews in people with Cancer, run by University of Rochester at 1 site in United States.
Trial summary
This project assesses the feasibility of utilizing the geriatric assessment as a tool to identify distressed older caregivers of older adults with cancer. The investigator will engage key stakeholders including older caregivers of older adults with cancer, experts in geriatric oncology and primary care physicians to… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- Experimental (Delphi Surveys), Experimental (Focus Groups) and Qualitative interviews
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Dec 2021to 11 Aug 2023
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Patient Inclusion Criteria
- Patient and caregiver be aged 65 or older
- Patient with a diagnosis of solid tumor malignancy or lymphoma, any stage
- Patients who have initiated a new line of treatment (surgery, radiation therapy, chemotherapy, immunotherapy, or targeted therapy) OR are being considered for new line of treatment (surgery, radiation therapy, chemotherapy, immunotherapy, or targeted therapy).
- Patients and caregivers must be able to provide informed consent, or if it is determined that they do not have decision-making capacity, a patient-designated health care proxy must sign consent per institutional University of Rochester and Research Subject Review Board policies on consent for incapacitated/decisionally impaired subjects.
Patient Exclusion Criteria
- Patient or caregiver is less than 65 years of age
- Patient and caregivers who do not have decision-making capacity (decisionally or cognitively impaired) AND do NOT have a previously designated health care proxy available to sign consent.
Caregiver Inclusion Criteria
- Caregivers enrolled in phase I
- Patient and caregiver have completed a GA
Caregiver Exclusion Criteria
- Patient and caregiver have not completed a GA
Stakeholder Inclusion Criteria
- Member of SCOREboard Community Advisory Board
- Aged 65 years or older
- Has been a family member, partner, friend or caregiver to an older adult with cancer
Stakeholder Exclusion Criteria • None
Geriatric Oncology Expert Inclusion Criteria
- Members of the Cancer and Aging Research Group
- Primary care physicians who care for older adults
Geriatric Oncology Expert Exclusion Criteria
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Development and Feasibility of a Supportive Care Intervention for Older Caregivers of Older Adults with Advanced Cancer
This project assesses the feasibility of utilizing the geriatric assessment as a tool to identify distressed older caregivers of older adults with cancer. The investigator will engage key stakeholders including older caregivers of older adults with cancer, experts in geriatric oncology and primary care physicians to develop and pilot a supportive care intervention to improve outcomes in older caregivers.
Read the detailed description
Older caregivers of older adults with cancer (described here-on as "older caregivers") are at high risk for increased burden and negative physical and psychological outcomes. Despite this, identification of older caregivers at risk for burden remains a challenge and evaluation of supportive care interventions and guidelines for this population remains limited. Health outcomes of older adults with cancer and their caregivers are inter-related and it is important to evaluate and support the health of both. The geriatric assessment (GA) is a valuable tool to evaluate health and age-related conditions (e.g., physical and cognitive function) of older adults with cancer and guide supportive care. Identifying older adults with age-related conditions can help to identify caregivers who are at increased risk for the negative impacts of caregiving. This project seeks to gather preliminary data on the health of older caregivers and to develop and pilot high priority supportive care interventions for this population. The investigator will examine the feasibility of utilizing the GA as a tool to identify distressed older caregivers. The investigator will engage key stakeholders including, older caregivers and older adults with cancer, experts in geriatric oncology and primary care physicians to develop and pilot a supportive care intervention to improve outcomes in older caregivers.
- Conditions
- Cancer
- Being tested
- Experimental (Delphi Surveys), Experimental (Focus Groups), Qualitative interviews
- Keywords
- Cancer, Geriatric Assessment
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental (Delphi Surveys)Other
The Delphi method, a process used to arrive at a group opinion or decision by surveying a panel of experts, will be used with experts in geriatric oncology to develop a supportive care management intervention for older caregivers of older adults with cancer.
Experimental (Focus Groups)Other
Focus group qualitative interviews will be conducted with key stakeholders consisting of older adults with cancer and their caregivers.
Qualitative interviewsOther
Qualitative interviews will be conducted with older caregivers of older adults with cancer to inquire about their experience with caregiving and unmet supportive care needs.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Participants will receive a geriatric assessment which consists of validated questionnaires that are used to assess health status of older adults with cancer. Based on participant responses, tailored recommendations will be provided. Receives: Other: Experimental (Delphi Surveys); Other: Experimental (Focus Groups); Other: Qualitative interviews |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants who enroll and complete the GA
Percentage of participants who were approached, enrolled in the study and completed the GA will be determined.
Measured: 8 weeks per participant
Time for caregivers to complete the GA
Time to complete the GA per caregiver will be determined by summing the time to complete self-administered and clinic portions of GA.
Measured: 8 weeks per patient
Caregiver satisfaction with completing the GA
Caregivers will complete a questionnaire to assess satisfaction with completing the GA
Measured: 8 weeks per patient
Secondary outcomes (1)
Percentage of caregiver supportive care recommendations that are implemented by patient/caregiver physicians
Caregivers will be surveyed to determined number and types of supportive care they received from their clinical providers compared to the supportive care recommendations that were provided to their clinical providers.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2022
- Study start7 Dec 2021
- Primary completion11 Aug 2023
- Study completion11 Aug 2023
Why it stopped: Study has been closed to accrual earlier than anticipated and will not resume.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by University of RochesterThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sindhuja Kadambi, University of Rochester
- Investigators
- Sindhuja Kadambi, Principal investigator, Univ. of Rochester Wilmot Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05244915
- Sponsor's protocol ID
- UCCS21067
- Status last verified
- Feb 2024
- First submitted
- 3 Aug 2021
- Last updated
- 6 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: A complete and final study protocol will be made publicly available through the University of Rochester Cancer Center Community Oncology Research Program Research Base Protocol and Data Sharing Committee. The full protocol and data will be made publicly available no later than the publication date of the study findings from the final dataset. The protocol will include a detailed description of the study population, hypotheses tested, measurement and assessment information, data definitions and codes, and the analysis plan utilized. We will be collecting identifying information. The final dataset will be stripped of identifiers prior to release for sharing. Published papers will be made available in portable document format.
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Feasibility of a Supportive Care Intervention for Older Caregivers of Older Adults with Advanced Cancer
- ClinicalTrials.gov ID
- NCT05244915
- Acronym / sponsor ID
- UCCS21067
- Conditions
- Cancer
- Keywords
- Cancer, Geriatric Assessment
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study has been closed to accrual earlier than anticipated and will not resume.
- Enrolment
- 73 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Study start
- 7 Dec 2021 (actual)
- Primary completion
- 11 Aug 2023 (actual)
- Study completion
- 11 Aug 2023 (actual)
- First posted
- 17 Feb 2022 (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 project assesses the feasibility of utilizing the geriatric assessment as a tool to identify distressed older caregivers of older adults with cancer. The investigator will engage key stakeholders including older caregivers of older adults with cancer, experts in geriatric oncology and primary care physicians to develop and pilot a supportive care intervention to improve outcomes in older caregivers.
Detailed description
Older caregivers of older adults with cancer (described here-on as "older caregivers") are at high risk for increased burden and negative physical and psychological outcomes. Despite this, identification of older caregivers at risk for burden remains a challenge and evaluation of supportive care interventions and guidelines for this population remains limited. Health outcomes of older adults with cancer and their caregivers are inter-related and it is important to evaluate and support the health of both. The geriatric assessment (GA) is a valuable tool to evaluate health and age-related conditions (e.g., physical and cognitive function) of older adults with cancer and guide supportive care. Identifying older adults with age-related conditions can help to identify caregivers who are at increased risk for the negative impacts of caregiving. This project seeks to gather preliminary data on the health of older caregivers and to develop and pilot high priority supportive care interventions for this population. The investigator will examine the feasibility of utilizing the GA as a tool to identify distressed older caregivers. The investigator will engage key stakeholders including, older caregivers and older adults with cancer, experts in geriatric oncology and primary care physicians to develop and pilot a supportive care intervention to improve outcomes in older caregivers.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Other: Experimental (Delphi Surveys), Other: Experimental (Focus Groups), Other: Qualitative interviewsParticipants will receive a geriatric assessment which consists of validated questionnaires that are used to assess health status of older adults with cancer. Based on participant responses, tailored recommendations will be provided. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
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 |
|---|---|---|
| Experimental (Delphi Surveys)The Delphi method, a process used to arrive at a group opinion or decision by surveying a panel of experts, will be used with experts in geriatric oncology to develop a supportive care management intervention for older caregivers of older adults with cancer. | Other | Experimental |
| Experimental (Focus Groups)Focus group qualitative interviews will be conducted with key stakeholders consisting of older adults with cancer and their caregivers. | Other | Experimental |
| Qualitative interviewsQualitative interviews will be conducted with older caregivers of older adults with cancer to inquire about their experience with caregiving and unmet supportive care needs. | Other | Experimental |
Primary outcome
Percentage of participants who enroll and complete the GA
Time frame: 8 weeks per participant
Percentage of participants who were approached, enrolled in the study and completed the GA will be determined.
Time for caregivers to complete the GA
Time frame: 8 weeks per patient
Time to complete the GA per caregiver will be determined by summing the time to complete self-administered and clinic portions of GA.
Caregiver satisfaction with completing the GA
Time frame: 8 weeks per patient
Caregivers will complete a questionnaire to assess satisfaction with completing the GA
1 secondary outcome
Percentage of caregiver supportive care recommendations that are implemented by patient/caregiver physicians
Time frame: 4 weeks
Results and safety
The study was stopped early (reason given: Study has been closed to accrual earlier than anticipated and will not resume.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2025.
- Individual participant dataSharing planned: Yes. A complete and final study protocol will be made publicly available through the University of Rochester Cancer Center Community Oncology Research Program Research Base Protocol and Data Sharing Committee. The full protocol and data will be made publicly available no later than the publication date of the study findings from the final dataset. The protocol will include a detailed description of the study population, hypotheses tested, measurement and assessment information, data definitions and codes, and the analysis plan utilized. We will be collecting identifying information. The final dataset will be stripped of identifiers prior to release for sharing. Published papers will be made available in portable document format.
Related trials for Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
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.
Sindhuja Kadambi principal investigator
Univ. of Rochester Wilmot Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental (Delphi Surveys), Experimental (Focus Groups) and Qualitative interviews in people with Cancer, run by University of Rochester 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?
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: stopped early, as of the sponsor's last update on 6 Jan 2025. 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 was stopped early (reason given: Study has been closed to accrual earlier than anticipated and will not resume.). Results are not available in the source record.
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?
Percentage of participants who enroll and complete the GA (time frame: 8 weeks per participant). 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 6 Jan 2025.