Hematopoietic and Lymphatic System NeoplasmGUIDENCT06484595
Clinical Trial Navigation to Increase Participation and Diversity in Cancer Clinical Trials
A study testing Best Practice and Patient Navigation in people with Hematopoietic and Lymphatic System Neoplasm and Malignant Solid Neoplasm, run by Fred Hutchinson Cancer Center at 1 site in United States.
Trial summary
This clinical trial evaluates a clinical trial navigation intervention to help increase participation and diversity in cancer clinical trials. Cancer clinical trials are an important part of the development of treatments, and improved patient care and outcomes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hematopoietic and Lymphatic System Neoplasm, Malignant Solid Neoplasm
- What is being tested?
- Best Practice and Patient Navigation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Sep 2024to 26 Jan 2026
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients ≥ 18 years of age
- Identified as potentially eligible for an open clinical trial by clinical trial pre-screening
- Have ≥ 1 health related social need, defined by
- Food insecurity, housing instability, transportation challenges, or financial instability documented in the Supportive Cancer Care Questionnaire in Epic Electronic Medical Record (EPIC), OR
- Concerns about insurance, cost of trial, additional trial visits, travel, transportation, childcare/eldercare, OR unable to take time off work, etc., as documented by clinical trial pre-screening (CTPS) or provider, OR
- Medicaid insurance (including Medicaid pending) documented in EPIC, OR
- Respond affirmatively (yes, maybe, possibly, I think so, etc.) to the social needs screening question asked by our Research Coordinator: "During your cancer treatment, are you interested in assistance with transportation, food, housing, financial resources, or other barriers to treatment?"
- Able to speak English
Who cannot join
- Unable to speak English
- Children, adolescents, and teens under the age of 18 years
- Patients participating on clinical trials providing financial navigation, such as clinicaltrials.gov identifier (CT ID): NCT04960787
- Patients refusing to sign Health Insurance Portability and Accountability Act (HIPAA) authorization
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: Guiding Participation Toward Understanding, Inclusion, Diversity, and Equity for Cancer Clinical Trials (GUIDE) Pilot Trial
This clinical trial evaluates a clinical trial navigation intervention to help increase participation and diversity in cancer clinical trials. Cancer clinical trials are an important part of the development of treatments, and improved patient care and outcomes. Despite this, only a small number of cancer patients participate in clinical trials. There are many different items that contribute to low clinical trial participation, including health-related social needs (HRSN) and financial burden. Guiding participation toward understanding, inclusion, diversity, and equity for cancer clinical trials (GUIDE), is a program that uses a trained clinical trial navigator, or "Guide", to work with identified potential cancer clinical trial patients to help them recognize and remove HRSN and financial barriers preventing clinical trial participation. A clinical trial navigation intervention, like GUIDE, may help increase participation and diversity in cancer clinical trials.
Read the detailed description
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients meet with a clinical trial navigator to understand activities involved with clinical trials, identify financial barriers to clinical trial participation, and review available financial resources. Patients receive ongoing access to the Guide for up to 6 months. Patients also receive standard of care (SOC) supportive care services.
ARM II: Patients receive SOC supportive care services.
- Being tested
- Best Practice, Patient Navigation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Best PracticeOther
Also called standard of care, standard therapy
Receive SOC supportive care services
Patient NavigationBehavioural
Also called Patient Navigator Program
Receive clinical trial navigator guide services
| Study group | Role | What they receive |
|---|---|---|
| ARM I (Clinical trial navigator, SOC) | Experimental | Patients meet with a clinical trial navigator to understand activities involved with clinical trials, identify financial barriers to clinical trial participation, and review available financial resources. Patients receive ongoing access to the Guide via a check in meeting once monthly for up to 6 months. Patients also receive SOC supportive care services. Receives: Other: Best Practice; Behavioral: Patient Navigation |
| Arm II (SOC) | Active comparator | Patients receive SOC supportive care services. Receives: Other: Best Practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant perceptions of the intervention (acceptability, appropriateness, feasibility)
Acceptability, appropriateness, and feasibility of the intervention will be assessed as potential themes in the qualitative interviews with patients in the GUIDE intervention arm of the trial.
Measured: At 6 months
Secondary outcomes (4)
Staff time and effort to deliver intervention
This is the time spent by the Guide with patients, preparing for patient visits, and delivering the intervention.
Measured: At 6 months
Participant time costs
This is the time spent by patients on all activities related to the cancer clinical trial and with the Guide.
Measured: At 6 months
Overhead
Overhead costs are defined as the indirect expenses associated with delivering the GUIDE intervention. This includes the facility costs, measured using the facilities and administration rate, as well as non-clinical equipment and supplies needed to deliver the intervention. Observation-based costs accrued over the intervention delivery period will be averaged and standardized to US 2024 dollars.
Measured: At 6 months
Amount of money provided to participants for reimbursement of trial-related expenses
The amount of money provided to participants for reimbursement of trial-related expenses.
Measured: At 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2024
- Study start23 Sep 2024
- Primary completion26 Jan 2026
- Study completion26 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematopoietic and Lymphatic System NeoplasmStudies of the same condition, open and under way.
- More trials run by Fred Hutchinson Cancer CenterThe 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
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fred Hutchinson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Andy Hill Cancer Research Endowment (CARE) Fund, National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Jason Mendoza, MD, MPH, Principal investigator, Fred Hutch/University of Washington Cancer Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06484595
- Sponsor's protocol ID
- RG1124291
- Other IDs
- NCI-2024-04530, P30CA015704
- Acronym
- GUIDE
- Status last verified
- May 2026
- First submitted
- 21 Jun 2024
- Last updated
- 18 May 2026
- 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 18 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Guiding Participation Toward Understanding, Inclusion, Diversity, and Equity for Cancer Clinical Trials (GUIDE) Pilot Trial
- ClinicalTrials.gov ID
- NCT06484595
- Acronym / sponsor ID
- GUIDE / RG1124291
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Fred Hutchinson Cancer CenterUniversity, hospital or other
- Collaborators
- Andy Hill Cancer Research Endowment (CARE) Fund, National Cancer Institute (NCI)
- Study start
- 23 Sep 2024 (actual)
- Primary completion
- 26 Jan 2026 (actual)
- Study completion
- 26 Jan 2026 (actual)
- First posted
- 3 Jul 2024 (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 clinical trial evaluates a clinical trial navigation intervention to help increase participation and diversity in cancer clinical trials. Cancer clinical trials are an important part of the development of treatments, and improved patient care and outcomes. Despite this, only a small number of cancer patients participate in clinical trials. There are many different items that contribute to low clinical trial participation, including health-related social needs (HRSN) and financial burden. Guiding participation toward understanding, inclusion, diversity, and equity for cancer clinical trials (GUIDE), is a program that uses a trained clinical trial navigator, or "Guide", to work with identified potential cancer clinical trial patients to help them recognize and remove HRSN and financial barriers preventing clinical trial participation. A clinical trial navigation intervention, like GUIDE, may help increase participation and diversity in cancer clinical trials.
Detailed description
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients meet with a clinical trial navigator to understand activities involved with clinical trials, identify financial barriers to clinical trial participation, and review available financial resources. Patients receive ongoing access to the Guide for up to 6 months. Patients also receive standard of care (SOC) supportive care services.
ARM II: Patients receive SOC supportive care services.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ARM I (Clinical trial navigator, SOC) | Experimental | Other: Best Practice, Behavioral: Patient NavigationPatients meet with a clinical trial navigator to understand activities involved with clinical trials, identify financial barriers to clinical trial participation, and review available financial resources. Patients receive ongoing access to the Guide via a check in meeting once monthly for up to 6 months. Patients also receive SOC supportive care services. |
| Arm II (SOC) | Active comparator | Other: Best PracticePatients receive SOC supportive care services. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients ≥ 18 years of age
- Identified as potentially eligible for an open clinical trial by clinical trial pre-screening
- Have ≥ 1 health related social need, defined by
- Able to speak English
Key exclusion criteria (4 listed)
- Unable to speak English
- Children, adolescents, and teens under the age of 18 years
- Patients participating on clinical trials providing financial navigation, such as clinicaltrials.gov identifier (CT ID): NCT04960787
- Patients refusing to sign Health Insurance Portability and Accountability Act (HIPAA) authorization
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 |
|---|---|---|
| Best PracticeAlso: standard of care, standard therapyReceive SOC supportive care services | Other | ARM I (Clinical trial navigator, SOC), Arm II (SOC) |
| Patient NavigationAlso: Patient Navigator ProgramReceive clinical trial navigator guide services | Behavioural | ARM I (Clinical trial navigator, SOC) |
Primary outcome
Participant perceptions of the intervention (acceptability, appropriateness, feasibility)
Time frame: At 6 months
Acceptability, appropriateness, and feasibility of the intervention will be assessed as potential themes in the qualitative interviews with patients in the GUIDE intervention arm of the trial.
4 secondary outcomes
Staff time and effort to deliver intervention
Time frame: At 6 months
Participant time costs
Time frame: At 6 months
Overhead
Time frame: At 6 months
Amount of money provided to participants for reimbursement of trial-related expenses
Time frame: At 6 months
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 18 May 2026.
- 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.
Jason Mendoza, MD, MPH 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 Best Practice and Patient Navigation in people with Hematopoietic and Lymphatic System Neoplasm and Malignant 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 8 inclusion and 4 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 18 May 2026. 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?
Participant perceptions of the intervention (acceptability, appropriateness, feasibility) (time frame: At 6 months). 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 18 May 2026.