Awareness Enhancing Interventions (AWEI)

University of Tennessee

Status: Completed

Conditions: Research Awareness

Treatments: Other: Navigation - Research General - Researcher Voice; Other: Navigation - Study Specific - Cancer Survivor Voice; Other: Brochure - Research General - Cancer Survivor Voice; Other: Brochure - Research General - Researcher Voice; Other: Brochure - Study Specific - Cancer Survivor Voice; Other: Navigation - Research General - Cancer Survivor Voice; Other: Brochure - Study Specific - Researcher Voice; Other: Navigation - Study Specific - Researcher Voice

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04683510

300002068-B

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

Details and patient eligibility

About

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

Full 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.

Enrollment: 4,451 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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4,451 participants in 3 patient groups

Control Group

No Intervention group

Description:

This group will receive no intervention before receiving the AMPLIFI Recruitment Call

Navigation

Other group

Description:

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.

Treatment:

Other: Navigation - Research General - Cancer Survivor Voice

Other: Navigation - Study Specific - Researcher Voice

Other: Navigation - Study Specific - Cancer Survivor Voice

Other: Navigation - Research General - Researcher Voice

Brochure

Other group

Description:

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.

Treatment:

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