Awareness Enhancing Interventions

NCT04683510 | Completed Results DMC

• 2 other identifiers: 300002068-BR01CA242737-01A1
• Study Type: interventional
• Target: 4,451
• Locations: 1 country
• Sites: 2

Brief 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 cost- effective approaches

Conditions

Research Awareness

Keywords

Cancer Survivors; African American; Awareness

Outcome Measures

Primary Outcomes (1)

• 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.

  within 3 months of receiving intervention

Study Arms (3)

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.

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.

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

Interventions

Navigation - Study Specific - Researcher Voice OTHER

The intervention is delivered over the telephone

Navigation

Navigation - Study Specific - Cancer Survivor Voice OTHER

The intervention is delivered over the telephone

Navigation

Navigation - Research General - Researcher Voice OTHER

The intervention is delivered over the telephone

Navigation

Navigation - Research General - Cancer Survivor Voice OTHER

The intervention is delivered over the telephone

Navigation

Brochure - Study Specific - Researcher Voice OTHER

The invention is mailed to the participant in a brochure.

Brochure

Brochure - Study Specific - Cancer Survivor Voice OTHER

The invention is mailed to the participant in a brochure.

Brochure

Brochure - Research General - Researcher Voice OTHER

The invention is mailed to the participant in a brochure.

Brochure

Brochure - Research General - Cancer Survivor Voice OTHER

The invention is mailed to the participant in a brochure.

Brochure

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• years post diagnosis
• reside in an area with wireless coverage
• In the AMPLIFI recruitment pool

Sponsors & Collaborators

• University of Tennessee: lead
• National Cancer Institute (NCI): collaborator
• University of Alabama at Birmingham: collaborator

Study Sites (2)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

University of Tennessee Health Science Center

Memphis, Tennessee, 38105, United States

Location

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Results Point of Contact

• Title: Principle investigator
• Organization: University of Tennessee Health Science Center

mmart126@uthsc.edu

(901)448-2383

Study Officials

• Michelle Y Marttin, PhD

  University of Tennessee

  PRINCIPAL INVESTIGATOR

• Maria Pisu, PhD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director: Center for Innovation in Health Equity Research

Model Details: 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

Study Record Dates

• First Submitted: December 19, 2020
• First Posted: December 24, 2020
• Study Start: April 12, 2021
• Primary Completion: March 31, 2024
• Study Completion: March 31, 2025
• Last Updated: May 4, 2025
• Results First Posted: May 4, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: All data will be shared once all primary outcomes papers have been published (consonant with the NIH definition of "timely fashion") but no later than within one year of the completion of the funded study.
• Access Criteria: The access to the data will be granted to investigators working in an organization with a Federal Wide Assurance (FWA). Before access is granted, individuals must provide a copy of their Institutional Review Board (IRB) approval to use the data to answer their specific study questions. Individuals in receipt of data must produce proof of human subjects and HIPAA training. All datasets will conform to the "Standards for Privacy of Individually Identifiable Health Information" rule of HIPAA. In order to maintain HIPAA compliance, we will provide a limited-use dataset (i.e., stripped of identifying information). Requesting users will be required to sign a data-use sharing agreement. Although not immediately precluded, data deemed to be "sensitive" will be added to limited use datasets only after careful consideration. Resulting publications must credit the funding for this grant.

Locations

US (2)