Awareness Enhancing Interventions (AWEI)

October 19, 2021 updated by: MICHELLE Y MARTIN, University of Tennessee

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

2000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
    • Tennessee
      • Memphis, Tennessee, United States, 38105
        • Recruiting
        • University of Tennessee Health Science Center
        • Contact:
        • Contact:
        • Principal Investigator:
          • Michelle Y Martin, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control Group
This group will receive no intervention before receiving the AMPLIFI Recruitment Call
Other: Navigation
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
The intervention is delivered over the telephone
Other: Navigation - Study Specific - Cancer Survivor Voice
The intervention is delivered over the telephone
Other: Navigation - Research General - Researcher Voice
The intervention is delivered over the telephone
Other: Navigation - Research General - Cancer Survivor Voice
The intervention is delivered over the telephone
Other: Brochure
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
The invention is mailed to the participant in a brochure.
Other: Brochure - Study Specific - Cancer Survivor Voice
The invention is mailed to the participant in a brochure.
Other: Brochure - Research General - Researcher Voice
The invention is mailed to the participant in a brochure.
Other: Brochure - Research General - Cancer Survivor Voice
The invention is mailed to the participant in a brochure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
within 3 months of receiving intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Interest in Participating in the AMPLIFI Study
Time Frame: within 3 months of receiving intervention
proportion of survivors who express interest in participating and return the consent form to the AMPLIFI team.
within 3 months of receiving intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Tennessee

Collaborators

National Cancer Institute (NCI)
University of Alabama at Birmingham

Investigators

  • Principal Investigator: Michelle Y Marttin, PhD, University of Tennessee
  • Principal Investigator: Maria Pisu, PhD, University of Alabama at Birmingham

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 12, 2021

Primary Completion (Anticipated)

August 1, 2022

Study Completion (Anticipated)

March 30, 2023

Study Registration Dates

First Submitted

December 19, 2020

First Submitted That Met QC Criteria

December 19, 2020

First Posted (Actual)

December 24, 2020

Study Record Updates

Last Update Posted (Actual)

October 25, 2021

Last Update Submitted That Met QC Criteria

October 19, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 300002068-B
  • R01CA242737-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing 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.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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