Malignant NeoplasmNCT03943082
Impact of Phone Call About Financial Reimbursement Program on Access to Cancer Clinical Trials
A study testing Cancer Educational Materials, Follow-Up Care and Questionnaire in people with Malignant Neoplasm and Hematopoietic and Lymphoid Cell Neoplasm, run by University of California, San Francisco at 2 sites in United States.
Trial summary
This trial studies how well a follow-up phone call regarding financial reimbursement program (FRP) works in improving cancer patients' access to therapeutic cancer clinical trials. Follow-up phone call intervention regarding FRP may improve recruitment of cancer patients to cancer therapeutic clinical trials. Read more about this study
- Who is it for?
- Ages 7 years and older
- Conditions the study is for
- Malignant Neoplasm, Hematopoietic and Lymphoid Cell Neoplasm
- What is being tested?
- Cancer Educational Materials, Follow-Up Care and Questionnaire
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 252 participants
- Where
- 2 sitesUnited States
- Study dates
- 8 Apr 2019to 26 Oct 2021
- 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 7 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- COHORT A:
- Eligible patients to be randomized for the iMPACT study must:
- Carry a diagnosis of cancer
- Patient is considered potentially eligible for a cancer therapeutic clinical trial (TCT) and is being offered an opportunity to sign an informed consent document for the cancer TCT
- Eligible patients to receive FRP (these documents will be requested by Lazarex Foundation, however research coordinator at site can help patient collect documents):
- Have a household income =< 700% of the 2018 Health and Human Services (HHS) Poverty Guidelines
- Willing to provide proof of household income. Acceptable proof of income documents are: first two pages of signed copy of income tax return, or if a return is not filed, a copy of the most recent pay stub, unemployment check, Supplemental Security Income (SSI), Social Security Disability (SSD), or public assistance benefit notification. If a patient is not employed, they must submit a signed letter stating their current financial situation
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
USC / Norris Comprehensive Cancer Center
Los Angeles, California, 90033
University of California, San Francisco
San Francisco, California, 94143
About this study
Official title: A Pilot Feasibility Study for Improving Patient Access to Cancer Clinical Trials (iMPACT): A Financial Reimbursement Program for Patients in Cancer Therapeutic Clinical Trials
This trial studies how well a follow-up phone call regarding financial reimbursement program (FRP) works in improving cancer patients' access to therapeutic cancer clinical trials. Follow-up phone call intervention regarding FRP may improve recruitment of cancer patients to cancer therapeutic clinical trials.
Read the detailed description
There are limited financial models that address the economic hardship associated with clinical research participation and how it might restrict clinical research access. The Lazarex Foundation offers a financial reimbursement program (FRP) to help patients and caregivers cover the out-of-pocket costs associated with clinical trial participation for almost ten years.
iMPACT is a pilot study to assess the overall feasibility of conducting a multi-center trial of the Lazarex sliding scale FRP among sociodemographically diverse patients of all cancer types enrolling/potentially enrolling in therapeutic clinical trials (TCTs). The study will formalize informing patients or parents/legal guardians of patients about the Lazarex sliding-scale FRP in order to evaluate whether operationalizing intensive follow-up about the Lazarex FRP improves recruitment to cancer TCTs.
All patients or parents/legal guardians of patients will be offered information about the FRP at initial time of TCT discussion/consent for the iMPACT study, however, participants will be randomized 1:1 to receive an additional follow-up call about the FRP or no follow-up call (usual care). Participants who are randomized to usual care will be provided a phone number for the Lazarex Foundation that they or their parent or legal guardian may contact directly. Therefore all patients or parents/legal guardians of patients in the study have access to FRP eligibility assessment through the Lazarex Foundation.
Participants or parents/legal guardians of participants will be surveyed at baseline (time of consent to iMPACT) and interviewed 30 days after consent to iMPACT. If a participant enrolls in a therapeutic clinical trial, he/she will also be given an additional survey after TCT participation and interviewed up to 90 days after TCT participation.
- Being tested
- Cancer Educational Materials, Follow-Up Care, Questionnaire
- Medical subject headings
- Neoplasms, Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cancer Educational MaterialsBehavioural
Receive FRP brochure
Follow-Up CareOther
Receive follow-up phone call
QuestionnaireBehavioural
Also called Questionnaires
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Cohort A : Usual Care (FRP Only) | Active comparator | Patients or parents/legal guardians of patients receive FRP brochure at the time of iMPACT consent. Receives: Behavioral: Cancer Educational Materials; Behavioral: Questionnaire |
| Cohort A: Usual Care + Intervention (FRP + Follow-up) | Experimental | Patients or parents/legal guardians of patients receive FRP brochure at the time of iMPACT consent and a follow-up phone call on day 3 after iMPACT consent. Receives: Behavioral: Cancer Educational Materials; Other: Follow-Up Care; Behavioral: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients who sign consent to improving Patient Access to Cancer Clinical Trials (iMPACT) study among patients who are offered enrollment
The point estimate and 95% confidence interval (CI) of the proportion will be obtained within each site, furthermore, by cancer type and by phase of the clinical trial within each site.
Measured: Up to 90 days after therapeutic clinical trial (TCT) participation
Secondary outcomes (1)
Proportion of patients who sign consent for cancer TCT as well as by cancer type and phase of clinical trial within each arm
Two-sample proportion test between two arms will be used between two arms within each site. The point estimate and 95% confidence interval (CI) of the proportion will be obtained within each site by cancer type and by phase of the clinical trial.
Measured: At day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2019
- Study start8 Apr 2019
- Primary completion26 Oct 2021
- Study completion26 Oct 2021
Why it stopped: Accrual for Feasibility Met
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant NeoplasmStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 252 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Lazarex Cancer Foundation
- Responsible party
- Sponsor
- Investigators
- Hala Borno, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03943082
- Sponsor's protocol ID
- 189819
- Other IDs
- NCI-2019-00171
- Status last verified
- Nov 2021
- First submitted
- 7 May 2019
- Last updated
- 16 Nov 2021
- Results posted
- No
- Data monitoring committee
- 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 16 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Feasibility Study for Improving Patient Access to Cancer Clinical Trials (iMPACT): A Financial Reimbursement Program for Patients in Cancer Therapeutic Clinical Trials
- ClinicalTrials.gov ID
- NCT03943082
- Acronym / sponsor ID
- 189819
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Accrual for Feasibility Met
- Enrolment
- 252 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Lazarex Cancer Foundation
- Study start
- 8 Apr 2019 (actual)
- Primary completion
- 26 Oct 2021 (actual)
- Study completion
- 26 Oct 2021 (actual)
- First posted
- 9 May 2019 (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 follow-up phone call regarding financial reimbursement program (FRP) works in improving cancer patients' access to therapeutic cancer clinical trials. Follow-up phone call intervention regarding FRP may improve recruitment of cancer patients to cancer therapeutic clinical trials.
Detailed description
There are limited financial models that address the economic hardship associated with clinical research participation and how it might restrict clinical research access. The Lazarex Foundation offers a financial reimbursement program (FRP) to help patients and caregivers cover the out-of-pocket costs associated with clinical trial participation for almost ten years.
iMPACT is a pilot study to assess the overall feasibility of conducting a multi-center trial of the Lazarex sliding scale FRP among sociodemographically diverse patients of all cancer types enrolling/potentially enrolling in therapeutic clinical trials (TCTs). The study will formalize informing patients or parents/legal guardians of patients about the Lazarex sliding-scale FRP in order to evaluate whether operationalizing intensive follow-up about the Lazarex FRP improves recruitment to cancer TCTs.
All patients or parents/legal guardians of patients will be offered information about the FRP at initial time of TCT discussion/consent for the iMPACT study, however, participants will be randomized 1:1 to receive an additional follow-up call about the FRP or no follow-up call (usual care). Participants who are randomized to usual care will be provided a phone number for the Lazarex Foundation that they or their parent or legal guardian may contact directly. Therefore all patients or parents/legal guardians of patients in the study have access to FRP eligibility assessment through the Lazarex Foundation.
Participants or parents/legal guardians of participants will be surveyed at baseline (time of consent to iMPACT) and interviewed 30 days after consent to iMPACT. If a participant enrolls in a therapeutic clinical trial, he/she will also be given an additional survey after TCT participation and interviewed up to 90 days after TCT participation.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort A : Usual Care (FRP Only) | Active comparator | Behavioral: Cancer Educational Materials, Behavioral: QuestionnairePatients or parents/legal guardians of patients receive FRP brochure at the time of iMPACT consent. |
| Cohort A: Usual Care + Intervention (FRP + Follow-up) | Experimental | Behavioral: Cancer Educational Materials, Other: Follow-Up Care, Behavioral: QuestionnairePatients or parents/legal guardians of patients receive FRP brochure at the time of iMPACT consent and a follow-up phone call on day 3 after iMPACT consent. |
Who may qualify
- Ages
- 7 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Eligible patients to be randomized for the iMPACT study must:
- Eligible patients to receive FRP (these documents will be requested by Lazarex Foundation, however research coordinator at site can help patient collect documents):
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Cancer Educational MaterialsReceive FRP brochure | Behavioural | Cohort A : Usual Care (FRP Only), Cohort A: Usual Care + Intervention (FRP + Follow-up) |
| Follow-Up CareReceive follow-up phone call | Other | Cohort A: Usual Care + Intervention (FRP + Follow-up) |
| QuestionnaireAlso: QuestionnairesAncillary studies | Behavioural | Cohort A : Usual Care (FRP Only), Cohort A: Usual Care + Intervention (FRP + Follow-up) |
Primary outcome
Proportion of patients who sign consent to improving Patient Access to Cancer Clinical Trials (iMPACT) study among patients who are offered enrollment
Time frame: Up to 90 days after therapeutic clinical trial (TCT) participation
The point estimate and 95% confidence interval (CI) of the proportion will be obtained within each site, furthermore, by cancer type and by phase of the clinical trial within each site.
1 secondary outcome
Proportion of patients who sign consent for cancer TCT as well as by cancer type and phase of clinical trial within each arm
Time frame: At day 30
Results and safety
The study was stopped early (reason given: Accrual for Feasibility Met). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2021.
- 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.
Hala Borno, MD principal investigator
University of California, San Francisco
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cancer Educational Materials, Follow-Up Care and Questionnaire in people with Malignant Neoplasm and Hematopoietic and Lymphoid Cell Neoplasm, run by University of California, San Francisco at 2 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 7 inclusion and 0 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: stopped early, as of the sponsor's last update on 16 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 was stopped early (reason given: Accrual for Feasibility Met). 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?
Proportion of patients who sign consent to improving Patient Access to Cancer Clinical Trials (iMPACT) study among patients who are offered enrollment (time frame: Up to 90 days after therapeutic clinical trial (TCT) participation). 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 16 Nov 2021.