18 and older, male only, with Prostate Neoplasm or Genital Neoplasms, Male. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Change in Symptom Burden as Measure by EPIC-S.Primary· Baseline, Month 3, Month 6, Month 12
Symptom Burden will be measured using the 5-item sexual domain of the Expanded Prostate Cancer Index Composite (EPIC) - Short Form (EPIC-S). All items are transformed to a 0-100 scale and averaged to calculate the domain summary scores, where higher scores indicate better functioning and less bother.
Change in HRQoL as Measured by the FACT Questionnaire.Primary· Baseline, Month 3, Month 6, Month 12
HRQoL will be measured using Functional Assessment of Cancer Therapy - Prostate (FACT-P) including 4 domains of the FACT-General (FACT-G). The questionnaire has 39 items, with the total score ranging from 0-156. Higher scores indicate better function.
Change in Symptom Burden as Measure by EPIC-UIN.Primary· Baseline, Month 3, Month 6, Month 12
Symptom Burden will be measured using the 9-item urinary domain of the Expanded Prostate Cancer Index Composite (EPIC) - Short Form (EPIC-UIN). All items are transformed to a 0-100 scale and averaged to calculate the domain summary scores, where higher scores indicate better functioning and less bother.
Change in HRQoL as Measured by the PROMIS Fatigue QuestionnairePrimary· Baseline, Month 3, Month 6, Month 12
HRQoL will be measured using Patient-Reported Outcome Measurement Information System (PROMIS) short form for Fatigue Questionnaire. The PROMIS Fatigue measure generates t-scores with a mean of 50 and a standard deviation of 10. Scores typically range from approximately 30 to 80. Higher scores indicate greater fatigue.
Change in HRQoL as Measured by the PROMIS Pain QuestionnairePrimary· Baseline, Month 3, Month 6, Month 12
HRQoL will be measured using the PROMIS short form for Pain Interference Questionnaire. The items are item banks, and scoring is done via a computer adaptive test (CAT), which utilizes item response theory (IRT) to calculate a score that is then transformed into a T-score with a mean of 50 and a standard deviation of 10. Scores typically range from approximately 30 to 80. Items are administered in an iterative approach where subsequent items are calibrated on prior ones. Once standard error reaches 2 or less, the CAT stops administering items. Higher scores indicate greater pain interference.
Change in Stress Management Skills as Measured by MOCS-ASecondary· Baseline, Month 3, Month 6, Month 12
Stress management skills will be measured using the Measure of Current Status Part A (MOCS-A) Questionnaire. MOCS-A is a 13-item questionnaire with a total score ranging from 0 - 52 with the higher score indicating greater stress management skills.
Change in Prostate Cancer-specific Psychological Distress as Measured by MAX-PC - Section I-IISecondary· Baseline, Month 3, Month 6, Month 12
Psychological distress will be measured using the Memorial Anxiety Scale for Prostate Cancer Patients (MAX-PC) Questionnaire. The MAX-PC sections I-II is a 14-item questionnaire with a total score ranging from 0-42 with the higher score indicating increased distress.
Change in Prostate Cancer-specific Psychological Distress as Measured by MAX-PC - Section IIISecondary· Baseline, Month 3, Month 6, Month 12
Psychological distress will be measured using the Memorial Anxiety Scale for Prostate Cancer Patients (MAX-PC) Questionnaire. The MAX-PC section III is a 4-item questionnaire with a total score ranging from 0-12 with the lower score indicating increased distress.
Change in Interpersonal Function as Measured the SIP QuestionnaireSecondary· Baseline, Month 3, Month 6, Month 12
Sickness Impact Profile (SIP) is a 20-item questionnaire responded with a yes or no. The total number of yes responses will be scored as 1 point with the total score ranging from 0-20 with the higher score indicating poor interpersonal function.
The purpose of this study is to look at the effects of a 10-week stress management in-person group program. The program will study emotions, stress, and stress management techniques (such as relaxation and coping techniques) on quality of life, distress, depression, and physical health in Spanish- speaking, Hispanic/Latino men diagnosed with Prostate Cancer (PC).
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University of Miami
Last refreshed: 11 September 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03344757.