Awareness Enhancing Interventions

Not Applicable

Completed

• Conditions: Research Awareness
• Interventions: Other: Navigation - Study Specific - Researcher Voice; Other: Brochure - Study Specific - Researcher Voice; Other: Brochure - Study Specific - Cancer Survivor Voice; Other: Navigation - Study Specific - Cancer Survivor Voice; Other: Brochure - Research General - Researcher Voice; Other: Navigation - Research General - Researcher Voice; Other: Navigation - Research General - Cancer Survivor Voice; Other: Brochure - Research General - Cancer Survivor Voice

• Registration Number: NCT04683510
• Lead Sponsor: University of Tennessee

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

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 Timeline

• Study First Submitted: 2020-12-19
• Study First Submitted QC: 2020-12-19
• Study First Posted: 2020-12-24
• Study Start: 2021-04-12
• Primary Completion: 2024-03-31
• Study Completion: 2025-03-31
• Results First Submitted: 2025-03-31
• Status Verified: 2025-04
• Results First Submitted QC: 2025-04-17
• Last Update Submitted: 2025-04-17
• Results First Posted: 2025-05-04
• Last Update Posted: 2025-05-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4451

Inclusion Criteria

• 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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Brochure	Brochure - Study Specific - Cancer Survivor Voice	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.
Navigation	Navigation - Study Specific - Researcher Voice	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.
Navigation	Navigation - Study Specific - Cancer Survivor Voice	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.
Brochure	Brochure - Research General - Researcher Voice	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.
Navigation	Navigation - Research General - Cancer Survivor Voice	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.
Navigation	Navigation - Research General - Researcher Voice	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.
Brochure	Brochure - Study Specific - Researcher Voice	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.
Brochure	Brochure - Research General - Cancer Survivor Voice	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.

Primary Outcome Measures

Name	Time	Method
Recruitment Yield	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.

Trial Locations

Locations (2)

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States

University of Tennessee Health Science Center; 🇺🇸 Memphis, Tennessee, United States