CaregiverNCT03775616
Financial Navigation Program Intervention in Supporting Patients With Solid Tumors and Their Caregivers
A study testing Educational Intervention, Questionnaire Administration and Quality-of-Life Assessment in people with Caregiver and Solid Neoplasm, run by Fred Hutchinson Cancer Center at 1 site in United States.
Trial summary
This trial studies how well a financial navigation program intervention works in supporting patients with solid tumors and their caregivers. The financial navigation program intervention is an educational course about cancer treatment cost. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Caregiver, Solid Neoplasm
- What is being tested?
- Educational Intervention, Questionnaire Administration and Quality-of-Life Assessment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Nov 2017to 15 May 2019
- 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
- PATIENTS: Any solid tumor diagnosis (any stage)
- PATIENTS: Currently receiving (or completed within 6 months) chemotherapy, radiation, or hormonal therapy for cancer
- PATIENTS: In the treating physician's best estimation, has a life expectancy of 6 months or greater
- PATIENTS: Able to identify a primary caregiver who is involved in helping with the logistics, financial, or emotional aspects of his/her cancer care
- PATIENTS: English-speaking
- CAREGIVERS: Caregiver of a patient who is eligible for to participate in the study
- CAREGIVERS: English-speaking
Who cannot join
- PATIENTS: Cognitive or other impairment that would interfere with ability to understand and/or respond to questions about personal finances and paying for cancer treatment
- PATIENTS: Hematologic malignancy (e.g. multiple myeloma, lymphoma, leukemia)
- CAREGIVERS: cognitive or other impairment that would interfere with ability to understand and/or respond to questions about patient fiances and paying for cancer treatment
Trial locations and contacts
1 site in 1 country.
United States1 site
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, 98109
About this study
Official title: Development of a Comprehensive Financial Navigation Program for Patients With Cancer and Their Caregivers
This trial studies how well a financial navigation program intervention works in supporting patients with solid tumors and their caregivers. The financial navigation program intervention is an educational course about cancer treatment cost. This educational course may provide cancer patients and their caregivers with helpful information about dealing with cancer treatment cost.
Read the detailed description
Participants receive financial navigation program intervention consisting of a financial navigation video, monthly one-one financial counselling session, monthly phone or email consultation with patient navigators for 6 months and complete surveys at baseline, 3, 6, and 12 months.
- Conditions
- Caregiver, Solid Neoplasm
- Being tested
- Educational Intervention, Questionnaire Administration, Quality-of-Life Assessment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational InterventionOther
Also called Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational
Receive financial navigation program intervention
Questionnaire AdministrationOther
Ancillary studies
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Supportive (financial navigation program) | Experimental | Participants receive financial navigation program intervention consisting of a financial navigation video, monthly one-one financial counselling session, monthly phone or email consultation with patient navigators for 6 months and complete surveys at baseline, 3, 6, and 12 months. Receives: Other: Educational Intervention; Other: Questionnaire Administration; Other: Quality-of-Life Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accrual rate (number of patients and caregivers enrolled per month)
Measured: Up to 12 months
Time to accrual
Measured: Up to 12 months
Proportion of participants completing each of the 3 program components
Measured: Up to 12 months
Proportion of participants completing the entire program and 6 month follow up
Measured: Up to 6 months
Financial status assessment
Prior to and following participation in the financial navigation program, patients will complete questionnaire and provide basic information about their financial status including household income, assets, educational level, and employment status.
Measured: Up to 12 months
Financial distress assessment questionnaire
Will measure patients' level of financial distress before and after participation in various components of the program via a questionnaire that indicates financial distress based on responses
Measured: Up to 12 months
Patient advocate foundation (PAF) navigators
PAF navigators will tract all issues identified during an initial need assessment with the patients and subsequently all outcomes of any such issues.
Measured: Up to 12 months
Consumer education and training services (CENTS) financial counselors
The CENTs financial counselors will tract specific recommendations given each patient during the course of the study and share these recommendation with the investigators.
Measured: Up to 12 months
Family Reach staff feedback
Family Reach will track patients that have been granted financial assistance, and will provide any further information obtained from patients interaction.
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2018
- Study start15 Nov 2017
- Primary completion15 May 2019
- Study completion15 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CaregiverStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fred Hutchinson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Veena Shankaran, Principal investigator, Fred Hutch/University of Washington Cancer Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03775616
- Sponsor's protocol ID
- RG1001593
- Other IDs
- NCI-2018-02607, 8570
- Status last verified
- May 2019
- First submitted
- 10 Dec 2018
- Last updated
- 20 May 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Comprehensive Financial Navigation Program for Patients With Cancer and Their Caregivers
- ClinicalTrials.gov ID
- NCT03775616
- Acronym / sponsor ID
- RG1001593
- Conditions
- Caregiver, Solid Neoplasm
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Fred Hutchinson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 15 Nov 2017 (actual)
- Primary completion
- 15 May 2019 (actual)
- Study completion
- 15 May 2019 (actual)
- First posted
- 14 Dec 2018 (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 trial studies how well a financial navigation program intervention works in supporting patients with solid tumors and their caregivers. The financial navigation program intervention is an educational course about cancer treatment cost. This educational course may provide cancer patients and their caregivers with helpful information about dealing with cancer treatment cost.
Detailed description
Participants receive financial navigation program intervention consisting of a financial navigation video, monthly one-one financial counselling session, monthly phone or email consultation with patient navigators for 6 months and complete surveys at baseline, 3, 6, and 12 months.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Supportive (financial navigation program) | Experimental | Other: Educational Intervention, Other: Questionnaire Administration, Other: Quality-of-Life AssessmentParticipants receive financial navigation program intervention consisting of a financial navigation video, monthly one-one financial counselling session, monthly phone or email consultation with patient navigators for 6 months and complete surveys at baseline, 3, 6, and 12 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- PATIENTS: Any solid tumor diagnosis (any stage)
- PATIENTS: Currently receiving (or completed within 6 months) chemotherapy, radiation, or hormonal therapy for cancer
- PATIENTS: In the treating physician's best estimation, has a life expectancy of 6 months or greater
- PATIENTS: Able to identify a primary caregiver who is involved in helping with the logistics, financial, or emotional aspects of his/her cancer care
- PATIENTS: English-speaking
Key exclusion criteria (3 listed)
- PATIENTS: Cognitive or other impairment that would interfere with ability to understand and/or respond to questions about personal finances and paying for cancer treatment
- PATIENTS: Hematologic malignancy (e.g. multiple myeloma, lymphoma, leukemia)
- CAREGIVERS: cognitive or other impairment that would interfere with ability to understand and/or respond to questions about patient fiances and paying for cancer treatment
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 |
|---|---|---|
| Educational InterventionAlso: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, EducationalReceive financial navigation program intervention | Other | Supportive (financial navigation program) |
| Questionnaire AdministrationAncillary studies | Other | Supportive (financial navigation program) |
| Quality-of-Life AssessmentAlso: Quality of Life AssessmentAncillary studies | Other | Supportive (financial navigation program) |
Primary outcome
Accrual rate (number of patients and caregivers enrolled per month)
Time frame: Up to 12 months
Time to accrual
Time frame: Up to 12 months
Proportion of participants completing each of the 3 program components
Time frame: Up to 12 months
Proportion of participants completing the entire program and 6 month follow up
Time frame: Up to 6 months
Financial status assessment
Time frame: Up to 12 months
Prior to and following participation in the financial navigation program, patients will complete questionnaire and provide basic information about their financial status including household income, assets, educational level, and employment status.
Financial distress assessment questionnaire
Time frame: Up to 12 months
Will measure patients' level of financial distress before and after participation in various components of the program via a questionnaire that indicates financial distress based on responses
Patient advocate foundation (PAF) navigators
Time frame: Up to 12 months
PAF navigators will tract all issues identified during an initial need assessment with the patients and subsequently all outcomes of any such issues.
Consumer education and training services (CENTS) financial counselors
Time frame: Up to 12 months
The CENTs financial counselors will tract specific recommendations given each patient during the course of the study and share these recommendation with the investigators.
Family Reach staff feedback
Time frame: Up to 12 months
Family Reach will track patients that have been granted financial assistance, and will provide any further information obtained from patients interaction.
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 20 May 2019.
- 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.
Veena Shankaran principal investigator
Fred Hutch/University of Washington Cancer Consortium
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational Intervention, Questionnaire Administration and Quality-of-Life Assessment in people with Caregiver and Solid Neoplasm, run by Fred Hutchinson 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 7 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 20 May 2019. 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?
Accrual rate (number of patients and caregivers enrolled per month) (time frame: Up to 12 months). The study lists 9 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 20 May 2019.