Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:57 PM
Ignite Modification Date:
2025-12-24 @ 6:57 PM
NCT ID:
NCT03344757
Eligibility Criteria:
Inclusion Criteria:
1. ≥ 18 years of age;
2. Hispanic/Latino self-identification;
3. Spanish speakers (including bilinguals who express interest in a Spanish-based psychosocial intervention);
4. Primary diagnosis of localized Prostate Cancer (T1-T3, N0, M0);
5. Surgical or radiation treatment (e.g., external beam, brachytherapy, proton) within minimum of 4 months and maximum of 72-months;
6. Some patients with prior inpatient psychiatric treatment for severe mental illness or overt signs of severe psychopathology (e.g., psychosis) may be enrolled, per P.I. discretion, based on a case-by-case review;
7. Willingness to be randomized and followed for approximately12 months.
Exclusion Criteria:
1. History of non-skin cancer within the last 2 years.
2. Prior inpatient psychiatric treatment for severe mental illness or overt signs of severe psychopathology (e.g., psychosis) within the past six months, as these conditions can interfere with adequate participation in our experimental conditions may be exclusionary, per P.I. discretion, based on a case-by-case review;
3. Active alcohol dependence within the past six months may be exclusionary, per P.I. discretion, based on a case-by-case review;
4. Active substance dependence within the past six months may be exclusionary, per P.I. discretion, based on a case-by-case review; and
5. Acute or chronic immune system medical conditions, medications or conditions that impact immune and endocrine function (e.g., Chronic Fatigue Syndrome (CFS), Lupus, rheumatoid arthritis, Hepatitis C, or immunosuppressive treatment requiring conditions), per PI discretion based on a case by case review.
6. Individuals scoring \>3 on the SPMSQ will be excluded or per PI discretion based on a case by case review.
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Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT03344757
Study Brief:
Protocol Section:
NCT03344757