Research AwarenessAWEINCT04683510
Awareness Enhancing Interventions
A study testing Navigation - Study Specific - Researcher Voice, Navigation - Study Specific - Cancer Survivor Voice and Navigation - Research General - Researcher Voice in people with Research Awareness, run by University of Tennessee at 2 sites in United States.
Trial summary
The purpose of this study is to determine if increasing awareness and, thus, enhancing positive attitudes about research, prior to recruitment attempts, will increase participation in cancer clinical research among African American (AA) cancer survivors so that recruitment efforts can focus on the most optimal and… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Research Awareness
- What is being tested?
- Navigation - Study Specific - Researcher Voice, Navigation - Study Specific - Cancer Survivor Voice and Navigation - Research General - Researcher Voice
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,451 participants
- Where
- 2 sitesUnited States
- Study dates
- 12 Apr 2021to 31 Mar 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- African American/Black
- adults (age ≥50 years old)
- diagnosed with obesity/physical activity associated cancers that have a 70% or greater 5-year relative cancer-free survival rate multiple myeloma, localized kidney cancer and loco- regional cancers of the colorectum, female breast, prostate, endometrium, and ovary).
- 1-5 years post diagnosis
- reside in an area with wireless coverage
- In the AMPLIFI recruitment pool
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Alabama at Birmingham
Birmingham, Alabama, 35294
University of Tennessee Health Science Center
Memphis, Tennessee, 38105
About this study
Official title: Increasing Recruitment of Underrepresented Cancer Survivors With Awareness Enhancing Interventions
The purpose of this study is to determine if increasing awareness and, thus, enhancing positive attitudes about research, prior to recruitment attempts, will increase participation in cancer clinical research among African American (AA) cancer survivors so that recruitment efforts can focus on the most optimal and cost- effective approaches
Read the detailed description
In this project, 2000 AA potential AMPLIFI project participants will be randomized to the awareness-enhancing intervention (AWEI) or to the comparison condition in which they do not receive AWEI intervention but only the Adapting Multiple Behavior Interventions that Effectively Improve Cancer Survivor Health (AMPLIFI) basic recruitment strategy (No AWEI). Randomization for the AWEI Randomized Controlled Trial (RCT) will occur soon after the AMPLIFI recruitment letter is sent, and AWEI interventions will be delivered over a two-week period between the AMPLIFI recruitment invitation letter and the AMPLIFI recruitment call. Survivors randomized to AWEI intervention will be exposed to 8 different combinations of the AWEI components according to different types of strategies and type of information reflecting the survivor voice or not. Subsequent to the AMPLIFI recruitment call, a 20% random sample of cancer survivors will be surveyed over the phone to assess intervention fidelity.
- Conditions
- Research Awareness
- Being tested
- Navigation - Study Specific - Researcher Voice, Navigation - Study Specific - Cancer Survivor Voice, Navigation - Research General - Researcher Voice, Navigation - Research General - Cancer Survivor Voice, Brochure - Study Specific - Researcher Voice
- Keywords
- Cancer Survivors, African American, Awareness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Navigation - Study Specific - Researcher VoiceOther
The intervention is delivered over the telephone
Navigation - Study Specific - Cancer Survivor VoiceOther
The intervention is delivered over the telephone
Navigation - Research General - Researcher VoiceOther
The intervention is delivered over the telephone
Navigation - Research General - Cancer Survivor VoiceOther
The intervention is delivered over the telephone
Brochure - Study Specific - Researcher VoiceOther
The invention is mailed to the participant in a brochure.
Brochure - Study Specific - Cancer Survivor VoiceOther
The invention is mailed to the participant in a brochure.
Brochure - Research General - Researcher VoiceOther
The invention is mailed to the participant in a brochure.
Brochure - Research General - Cancer Survivor VoiceOther
The invention is mailed to the participant in a brochure.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | This group will receive no intervention before receiving the AMPLIFI Recruitment Call |
| Navigation | Other | After receiving recruitment letter from AMPLIFI, participant randomized to this arm will receive a phone call from a Research Specialist who will discuss the importance of research participation for cancer survivors to increase research awareness and aid in recruitment. The information will focus on the importance of research and will be delivered from the perspective of either a researcher or a cancer survivor. Receives: Other: Navigation - Study Specific - Researcher Voice; Other: Navigation - Study Specific - Cancer Survivor Voice; Other: Navigation - Research General - Researcher Voice; Other: Navigation - Research General - Cancer Survivor Voice |
| Brochure | Other | After receiving recruitment letter from AMPLIFI, participant randomized to this arm will receive a brochure which will focus on the importance of research participation for cancer survivors in order to increase research awareness and aid in recruitment. Receives: Other: Brochure - Study Specific - Researcher Voice; Other: Brochure - Study Specific - Cancer Survivor Voice; Other: Brochure - Research General - Researcher Voice; Other: Brochure - Research General - Cancer Survivor Voice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment Yield
measured by the proportion of targeted survivors who, at the time of the recruitment call, after the screening process is complete, decide to participate in AMPLIFI.
Measured: within 3 months of receiving intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2020
- Study start12 Apr 2021
- Primary completion31 Mar 2024
- Study completion31 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (42)Papers the sponsor has linked to this study.
- Other trials for Research AwarenessStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- AMPLIFI recruitment process, 1600 AA cancer survivors will be randomized to one of 8 conditions that vary by type of strategy, type of information, and type of perspective (survivor or researcher "voice") and 400 randomized to the basic recruitment strategy
- Masking
- None (open label)
- Enrolment
- 4,451 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Tennessee
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, MICHELLE Y MARTIN, University of Tennessee
- Investigators
- Michelle Y Marttin, PhD, Principal investigator, University of TennesseeMaria Pisu, PhD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04683510
- Sponsor's protocol ID
- 300002068-B
- Other IDs
- R01CA242737-01A1
- Acronym
- AWEI
- Status last verified
- Apr 2025
- First submitted
- 19 Dec 2020
- Last updated
- 4 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We will share data which will include the AMPLIFI final disposition code (recruited versus not recruited), the impact of the AWEI interventions versus the standard recruitment approach.
Publications
Bester N, Di Vito-Smith M, McGarry T, Riffkin M, Kaehler S, Pilot R, Bwire R. The Effectiveness of an Educational Brochure as a Risk Minimization Activity to Communicate Important Rare Adverse Events to Health-Care Professionals. Adv Ther. 2016 Feb;33(2):167-77. doi: 10.1007/s12325-016-0284-y. Epub 2016 Jan 23.
PubMed 26801772Beskow LM, Sandler RS, Millikan RC, Weinberger M. Patient perspectives on research recruitment through cancer registries. Cancer Causes Control. 2005 Dec;16(10):1171-5. doi: 10.1007/s10552-005-0407-2.
PubMed 16215867Wenzel JA, Mbah O, Xu J, Moscou-Jackson G, Saleem H, Sakyi K, Ford JG. A Model of Cancer Clinical Trial Decision-making Informed by African-American Cancer Patients. J Racial Ethn Health Disparities. 2015 Jun;2(2):192-9. doi: 10.1007/s40615-014-0063-x.
PubMed 25960945Doak LG, Doak CC, Meade CD. Strategies to improve cancer education materials. Oncol Nurs Forum. 1996 Sep;23(8):1305-12.
PubMed 8883075Ford JG, Howerton MW, Bolen S, Gary TL, Lai GY, Tilburt J, Gibbons MC, Baffi C, Wilson RF, Feuerstein CJ, Tanpitukpongse P, Powe NR, Bass EB. Knowledge and access to information on recruitment of underrepresented populations to cancer clinical trials. Evid Rep Technol Assess (Summ). 2005 Jun;(122):1-11. doi: 10.1037/e439572005-001. No abstract available.
PubMed 15989377Hughes TB, Varma VR, Pettigrew C, Albert MS. African Americans and Clinical Research: Evidence Concerning Barriers and Facilitators to Participation and Recruitment Recommendations. Gerontologist. 2017 Apr 1;57(2):348-358. doi: 10.1093/geront/gnv118.
PubMed 26553736Kamen CS, Quinn GP, Asare M, Heckler CE, Guido JJ, Giguere JK, Gilliland K, Liu JJ, Geer J, Delacroix SE, Morrow GR, Jacobsen PB. Multimedia psychoeducation for patients with cancer who are eligible for clinical trials: A randomized clinical trial. Cancer. 2018 Dec 1;124(23):4504-4511. doi: 10.1002/cncr.31771. Epub 2018 Oct 6.
PubMed 30291797Fouad MN, Acemgil A, Bae S, Forero A, Lisovicz N, Martin MY, Oates GR, Partridge EE, Vickers SM. Patient Navigation As a Model to Increase Participation of African Americans in Cancer Clinical Trials. J Oncol Pract. 2016 Jun;12(6):556-63. doi: 10.1200/JOP.2015.008946. Epub 2016 May 17.
PubMed 27189356Ward EM, Sherman RL, Henley SJ, Jemal A, Siegel DA, Feuer EJ, Firth AU, Kohler BA, Scott S, Ma J, Anderson RN, Benard V, Cronin KA. Annual Report to the Nation on the Status of Cancer, Featuring Cancer in Men and Women Age 20-49 Years. J Natl Cancer Inst. 2019 Dec 1;111(12):1279-1297. doi: 10.1093/jnci/djz106.
PubMed 31145458Wissing MD, Kluetz PG, Ning YM, Bull J, Merenda C, Murgo AJ, Pazdur R. Under-representation of racial minorities in prostate cancer studies submitted to the US Food and Drug Administration to support potential marketing approval, 1993-2013. Cancer. 2014 Oct 1;120(19):3025-32. doi: 10.1002/cncr.28809. Epub 2014 Jun 25.
PubMed 24965506Shenoy D, Packianathan S, Chen AM, Vijayakumar S. Do African-American men need separate prostate cancer screening guidelines? BMC Urol. 2016 May 10;16(1):19. doi: 10.1186/s12894-016-0137-7.
PubMed 27165293Ewing AT, Kalu N, Cain G, Erby LH, Ricks-Santi LJ, Tetteyfio-Kidd Telemaque E, Scott DM. Factors associated with willingness to provide biospecimens for genetics research among African American cancer survivors. J Community Genet. 2019 Oct;10(4):471-480. doi: 10.1007/s12687-019-00411-0. Epub 2019 Mar 14.
PubMed 30877487Rivers D, August EM, Sehovic I, Lee Green B, Quinn GP. A systematic review of the factors influencing African Americans' participation in cancer clinical trials. Contemp Clin Trials. 2013 Jul;35(2):13-32. doi: 10.1016/j.cct.2013.03.007. Epub 2013 Apr 1.
PubMed 23557729Rick J, Graffy J, Knapp P, Small N, Collier DJ, Eldridge S, Kennedy A, Salisbury C, Treweek S, Torgerson D, Wallace P, Madurasinghe V, Hughes-Morley A, Bower P. Systematic techniques for assisting recruitment to trials (START): study protocol for embedded, randomized controlled trials. Trials. 2014 Oct 25;15:407. doi: 10.1186/1745-6215-15-407.
PubMed 25344684Treweek S, Lockhart P, Pitkethly M, Cook JA, Kjeldstrom M, Johansen M, Taskila TK, Sullivan FM, Wilson S, Jackson C, Jones R, Mitchell ED. Methods to improve recruitment to randomised controlled trials: Cochrane systematic review and meta-analysis. BMJ Open. 2013 Feb 7;3(2):e002360. doi: 10.1136/bmjopen-2012-002360. Print 2013.
PubMed 23396504
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Increasing Recruitment of Underrepresented Cancer Survivors With Awareness Enhancing Interventions
- ClinicalTrials.gov ID
- NCT04683510
- Acronym / sponsor ID
- AWEI / 300002068-B
- Conditions
- Research Awareness
- Keywords
- Cancer Survivors, African American, Awareness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4,451 participants (actual)
- Lead sponsor
- University of TennesseeUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), University of Alabama at Birmingham
- Study start
- 12 Apr 2021 (actual)
- Primary completion
- 31 Mar 2024 (actual)
- Study completion
- 31 Mar 2025 (actual)
- First posted
- 24 Dec 2020 (actual)
- Results
- Posted 4 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine if increasing awareness and, thus, enhancing positive attitudes about research, prior to recruitment attempts, will increase participation in cancer clinical research among African American (AA) cancer survivors so that recruitment efforts can focus on the most optimal and cost- effective approaches
Detailed description
In this project, 2000 AA potential AMPLIFI project participants will be randomized to the awareness-enhancing intervention (AWEI) or to the comparison condition in which they do not receive AWEI intervention but only the Adapting Multiple Behavior Interventions that Effectively Improve Cancer Survivor Health (AMPLIFI) basic recruitment strategy (No AWEI). Randomization for the AWEI Randomized Controlled Trial (RCT) will occur soon after the AMPLIFI recruitment letter is sent, and AWEI interventions will be delivered over a two-week period between the AMPLIFI recruitment invitation letter and the AMPLIFI recruitment call. Survivors randomized to AWEI intervention will be exposed to 8 different combinations of the AWEI components according to different types of strategies and type of information reflecting the survivor voice or not. Subsequent to the AMPLIFI recruitment call, a 20% random sample of cancer survivors will be surveyed over the phone to assess intervention fidelity.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- AMPLIFI recruitment process, 1600 AA cancer survivors will be randomized to one of 8 conditions that vary by type of strategy, type of information, and type of perspective (survivor or researcher "voice") and 400 randomized to the basic recruitment strategy
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –This group will receive no intervention before receiving the AMPLIFI Recruitment Call |
| Navigation | Other | Other: Navigation - Study Specific - Researcher Voice, Other: Navigation - Study Specific - Cancer Survivor Voice, Other: Navigation - Research General - Researcher Voice, Other: Navigation - Research General - Cancer Survivor VoiceAfter receiving recruitment letter from AMPLIFI, participant randomized to this arm will receive a phone call from a Research Specialist who will discuss the importance of research participation for cancer survivors to increase research awareness and aid in recruitment. The information will focus on the importance of research and will be delivered from the perspective of either a researcher or a cancer survivor. |
| Brochure | Other | Other: Brochure - Study Specific - Researcher Voice, Other: Brochure - Study Specific - Cancer Survivor Voice, Other: Brochure - Research General - Researcher Voice, Other: Brochure - Research General - Cancer Survivor VoiceAfter receiving recruitment letter from AMPLIFI, participant randomized to this arm will receive a brochure which will focus on the importance of research participation for cancer survivors in order to increase research awareness and aid in recruitment. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- African American/Black
- adults (age ≥50 years old)
- diagnosed with obesity/physical activity associated cancers that have a 70% or greater 5-year relative cancer-free survival rate multiple myeloma, localized kidney cancer and loco- regional cancers of the colorectum, female breast, prostate, endometrium, and ovary).
- 1-5 years post diagnosis
- reside in an area with wireless coverage
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 |
|---|---|---|
| Navigation - Study Specific - Researcher VoiceThe intervention is delivered over the telephone | Other | Navigation |
| Navigation - Study Specific - Cancer Survivor VoiceThe intervention is delivered over the telephone | Other | Navigation |
| Navigation - Research General - Researcher VoiceThe intervention is delivered over the telephone | Other | Navigation |
| Navigation - Research General - Cancer Survivor VoiceThe intervention is delivered over the telephone | Other | Navigation |
| Brochure - Study Specific - Researcher VoiceThe invention is mailed to the participant in a brochure. | Other | Brochure |
| Brochure - Study Specific - Cancer Survivor VoiceThe invention is mailed to the participant in a brochure. | Other | Brochure |
| Brochure - Research General - Researcher VoiceThe invention is mailed to the participant in a brochure. | Other | Brochure |
| Brochure - Research General - Cancer Survivor VoiceThe invention is mailed to the participant in a brochure. | Other | Brochure |
Primary outcome
Recruitment Yield
Time frame: within 3 months of receiving intervention
measured by the proportion of targeted survivors who, at the time of the recruitment call, after the screening process is complete, decide to participate in AMPLIFI.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 26801772Bester N, Di Vito-Smith M, McGarry T, Riffkin M, Kaehler S, Pilot R, Bwire R. The Effectiveness of an Educational Brochure as a Risk Minimization Activity to Communicate Important Rare Adverse Events to Health-Care Professionals. Adv Ther. 2016 Feb;33(2):167-77. doi: 10.1007/s12325-016-0284-y. Epub 2016 Jan 23.
- Background: PubMed 16215867Beskow LM, Sandler RS, Millikan RC, Weinberger M. Patient perspectives on research recruitment through cancer registries. Cancer Causes Control. 2005 Dec;16(10):1171-5. doi: 10.1007/s10552-005-0407-2.
- Background: PubMed 25960945Wenzel JA, Mbah O, Xu J, Moscou-Jackson G, Saleem H, Sakyi K, Ford JG. A Model of Cancer Clinical Trial Decision-making Informed by African-American Cancer Patients. J Racial Ethn Health Disparities. 2015 Jun;2(2):192-9. doi: 10.1007/s40615-014-0063-x.
- Background: PubMed 8883075Doak LG, Doak CC, Meade CD. Strategies to improve cancer education materials. Oncol Nurs Forum. 1996 Sep;23(8):1305-12.
- Background: PubMed 15989377Ford JG, Howerton MW, Bolen S, Gary TL, Lai GY, Tilburt J, Gibbons MC, Baffi C, Wilson RF, Feuerstein CJ, Tanpitukpongse P, Powe NR, Bass EB. Knowledge and access to information on recruitment of underrepresented populations to cancer clinical trials. Evid Rep Technol Assess (Summ). 2005 Jun;(122):1-11. doi: 10.1037/e439572005-001. No abstract available.
- Background: PubMed 26553736Hughes TB, Varma VR, Pettigrew C, Albert MS. African Americans and Clinical Research: Evidence Concerning Barriers and Facilitators to Participation and Recruitment Recommendations. Gerontologist. 2017 Apr 1;57(2):348-358. doi: 10.1093/geront/gnv118.
- Background: PubMed 30291797Kamen CS, Quinn GP, Asare M, Heckler CE, Guido JJ, Giguere JK, Gilliland K, Liu JJ, Geer J, Delacroix SE, Morrow GR, Jacobsen PB. Multimedia psychoeducation for patients with cancer who are eligible for clinical trials: A randomized clinical trial. Cancer. 2018 Dec 1;124(23):4504-4511. doi: 10.1002/cncr.31771. Epub 2018 Oct 6.
- Background: PubMed 27189356Fouad MN, Acemgil A, Bae S, Forero A, Lisovicz N, Martin MY, Oates GR, Partridge EE, Vickers SM. Patient Navigation As a Model to Increase Participation of African Americans in Cancer Clinical Trials. J Oncol Pract. 2016 Jun;12(6):556-63. doi: 10.1200/JOP.2015.008946. Epub 2016 May 17.
- Background: PubMed 31145458Ward EM, Sherman RL, Henley SJ, Jemal A, Siegel DA, Feuer EJ, Firth AU, Kohler BA, Scott S, Ma J, Anderson RN, Benard V, Cronin KA. Annual Report to the Nation on the Status of Cancer, Featuring Cancer in Men and Women Age 20-49 Years. J Natl Cancer Inst. 2019 Dec 1;111(12):1279-1297. doi: 10.1093/jnci/djz106.
- Background: PubMed 24965506Wissing MD, Kluetz PG, Ning YM, Bull J, Merenda C, Murgo AJ, Pazdur R. Under-representation of racial minorities in prostate cancer studies submitted to the US Food and Drug Administration to support potential marketing approval, 1993-2013. Cancer. 2014 Oct 1;120(19):3025-32. doi: 10.1002/cncr.28809. Epub 2014 Jun 25.
- Background: PubMed 27165293Shenoy D, Packianathan S, Chen AM, Vijayakumar S. Do African-American men need separate prostate cancer screening guidelines? BMC Urol. 2016 May 10;16(1):19. doi: 10.1186/s12894-016-0137-7.
- Background: PubMed 30877487Ewing AT, Kalu N, Cain G, Erby LH, Ricks-Santi LJ, Tetteyfio-Kidd Telemaque E, Scott DM. Factors associated with willingness to provide biospecimens for genetics research among African American cancer survivors. J Community Genet. 2019 Oct;10(4):471-480. doi: 10.1007/s12687-019-00411-0. Epub 2019 Mar 14.
- Individual participant dataSharing planned: Yes. We will share data which will include the AMPLIFI final disposition code (recruited versus not recruited), the impact of the AWEI interventions versus the standard recruitment approach.
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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.
Michelle Y Marttin, PhD principal investigator
University of Tennessee
Maria Pisu, PhD principal investigator
University of Alabama at Birmingham
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Navigation - Study Specific - Researcher Voice, Navigation - Study Specific - Cancer Survivor Voice and Navigation - Research General - Researcher Voice in people with Research Awareness, run by University of Tennessee 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 6 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: finished, as of the sponsor's last update on 4 May 2025. 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?
Yes. Results are posted in the registry (first posted 4 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Recruitment Yield (time frame: within 3 months of receiving intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04683510, which also lists 42 linked publications.
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 4 May 2025.