RECRUITING

The PROACTIVE Study for Black Elders

Conditions

Musculoskeletal Pain Chronic Pain Osteoarthritis Pain, Chronic Movement Evoked Pain chronic musculoskeletal pain Black African Americans pain self-management prayer social determinants of health

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Chronic musculoskeletal pain (CMP), while a leading cause of physical disablement, is a neglected national health disparity issue in Black communities. The purpose of this study is to test a novel culturally congruent pain self-management intervention. A total of 120 persons aged 50-92, self-identifying as Black or African American having CMP will be invited to participate in this study. The primary outcome measured throughout this 3-year study is movement-evoked pain (MEP).

Official Title

Testing the Pain Relief of musculOskeletal Conditions and Arthritis Using Culturally Tailored InterVentions for Black Elders (PROACTIVE) Intervention: A Randomized Controlled Trial

Quick Facts

Study Start:2025-05-07

Study Completion:2027-10-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06512727

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.

Ages Eligible for Study:50 Years to 92 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Self-identify as being part of the Black American diaspora (Black/African American, Afro-Caribbean) 2. Age 50-92 years 3. Self-report chronic musculoskeletal pain (CMP) as defined as persistent or recurrent pain lasting 6 months or longer that arises as part of a disease or injurious process directly affecting bone(s), joint(s), muscle(s), or related soft tissue(s) 4. Self-report a chronic musculoskeletal condition (e.g., osteoarthritis, chronic low back pain) in at least one lower extremity joint (hip, knee, low back, or ankle pain) 5. Report chronic musculoskeletal symptoms: aching, stiffness, or swelling in a major lower extremity joint or low back on most days (4-5/7) of the week 6. Have (or be eligible for) a healthcare insurance plan in the state of Florida (Medicare, Medicaid, Medicare Advantage plans, Blue Cross/Blue Shield, Humana, Aetna, etc.) 7. Able to read, write, and understand English at sixth-grade level	1. Unwilling to be randomized to either study arm 2. Self-reported diagnosis of sickle cell disease or related thalassemias 3. History of major neurological event (e.g., stroke) or current neurological disease (e.g., Parkinson's disease, multiple sclerosis, epilepsy) 4. Major cardiovascular problem in the past 6 months that would cause shortness of breath and/or chest pain (e.g. myocardial infarction, coronary artery bypass graft, or valve replacement, pulmonary embolism or deep venous thrombosis) or uncontrolled Hypertension (Systolic Blood Pressure (SBP) \> 170 mmHg, Diastolic Blood Pressure (DBP) \> 90 mmHg) OR Hypotension (SBP \<90 mmHg, DBP \<60 mmHg) 5. Currently undergoing curative or palliative chemotherapy or radiation for active cancer 6. Severe physical impairment (e.g., a major activity of daily living disability requiring use of wheelchair as primary method of mobility, or unable to dress, bath, use the toilet, or transfer independently) 7. Serious mental health disorder requiring hospitalization within past 12 months 8. Severe sensory deficit (severe hearing loss or blindness)

Inclusion Criteria

Exclusion Criteria

1. Self-identify as being part of the Black American diaspora (Black/African American, Afro-Caribbean)
2. Age 50-92 years
3. Self-report chronic musculoskeletal pain (CMP) as defined as persistent or recurrent pain lasting 6 months or longer that arises as part of a disease or injurious process directly affecting bone(s), joint(s), muscle(s), or related soft tissue(s)
4. Self-report a chronic musculoskeletal condition (e.g., osteoarthritis, chronic low back pain) in at least one lower extremity joint (hip, knee, low back, or ankle pain)
5. Report chronic musculoskeletal symptoms: aching, stiffness, or swelling in a major lower extremity joint or low back on most days (4-5/7) of the week
6. Have (or be eligible for) a healthcare insurance plan in the state of Florida (Medicare, Medicaid, Medicare Advantage plans, Blue Cross/Blue Shield, Humana, Aetna, etc.)
7. Able to read, write, and understand English at sixth-grade level

1. Unwilling to be randomized to either study arm
2. Self-reported diagnosis of sickle cell disease or related thalassemias
3. History of major neurological event (e.g., stroke) or current neurological disease (e.g., Parkinson's disease, multiple sclerosis, epilepsy)
4. Major cardiovascular problem in the past 6 months that would cause shortness of breath and/or chest pain (e.g. myocardial infarction, coronary artery bypass graft, or valve replacement, pulmonary embolism or deep venous thrombosis) or uncontrolled Hypertension (Systolic Blood Pressure (SBP) \> 170 mmHg, Diastolic Blood Pressure (DBP) \> 90 mmHg) OR Hypotension (SBP \<90 mmHg, DBP \<60 mmHg)
5. Currently undergoing curative or palliative chemotherapy or radiation for active cancer
6. Severe physical impairment (e.g., a major activity of daily living disability requiring use of wheelchair as primary method of mobility, or unable to dress, bath, use the toilet, or transfer independently)
7. Serious mental health disorder requiring hospitalization within past 12 months
8. Severe sensory deficit (severe hearing loss or blindness)

Contacts and Locations

Study Contact

Staja Q Booker, PhD, RN

CONTACT

352-273-6351

bookers@ufl.edu

Fern Webb, PhD

CONTACT

904-244-9859

fern.webb@jax.ufl.edu

Principal Investigator

Staja Q Booker, PhD, RN

PRINCIPAL_INVESTIGATOR

University of Florida

Study Locations (Sites)

University of Florida

Gainesville, Florida, 32610

United States

Collaborators and Investigators

Sponsor: University of Florida

Staja Q Booker, PhD, RN, PRINCIPAL_INVESTIGATOR, University of Florida

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 Registration Dates

Study Start Date2025-05-07

Study Completion Date2027-10-01

Study Record Updates

Study Start Date2025-05-07

Study Completion Date2027-10-01

Terms related to this study

Keywords Provided by Researchers

chronic musculoskeletal pain
chronic pain
Black
African Americans
pain self-management
prayer
social determinants of health

Additional Relevant MeSH Terms

Musculoskeletal Pain
Chronic Pain
Osteoarthritis
Pain, Chronic
Movement Evoked Pain