Clinical trial · Interventional
Quality of Life and Supportive Care Preferences Following Radiation Therapy in Prostate Cancer Survivors
NCT02704377CI-TRIAL-00069636completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This pilot clinical trial studies quality of life and supportive care preferences following radiation therapy in prostate cancer survivors. Studying quality of life and supportive care preferences in patients undergoing radiation therapy may help identify the effects of treatment on patients with prostate cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Carcinoma | Prostate Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Dual X-ray Absorptiometry | Procedure | — | UNRESOLVED |
| Laboratory Biomarker Analysis | Other | — | UNRESOLVED |
| Quality-of-Life Assessment | Other | — | UNRESOLVED |
| Questionnaire Administration | Other | — | UNRESOLVED |
| Undergo HRV and wear accelerometer to assess therapy complications | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Supportive care (quality of life, supportive care preferences)
- description
- Participants complete questionnaires about quality of life and preferences for supportive care treatment, wear accelerometerundergo heart rate variability(HRV) testing over 10-15 minutes while both lying down and standing, complete a walking test, wear an accelerometer for a period of 1 week, and undergo a single Dual X-ray Absorptiometry (iDXA) scan over 10 minutes. Other interventions include: Laboratory Biomarker Analysis, Quality-of-Life Assessments, and othe Questionnaire Administration.
- interventionNames
- Other: Undergo HRV and wear accelerometer to assess therapy complications
- Procedure: Dual X-ray Absorptiometry
- Other: Laboratory Biomarker Analysis
- Other: Quality-of-Life Assessment
- Other: Questionnaire Administration
Primary outcomes (3)
- measure
- Develop an understanding of the impacts of prostate cancer on HRQL measured by the SF-36
- timeFrame
- Baseline
- description
- Significance tests for the difference between treatment groups on all primary outcomes will be conducted. Data will be individually standardized by covariates such as age, disease stage and grade, time on treatment values and will be evaluated using an analysis of co-variance statistical mode. Descriptive statistics for the feasibility measures will be calculated prospectively throughout the trial.
Eligibility
Eligibility (as posted)
- Sex
- Male
Show eligibility criteria text
Inclusion Criteria: * English speaking * Diagnosis of prostate cancer * Treatment with primary radiation (brachytherapy or external beam therapy), radiation + androgen deprivation therapy (ADT) or salvage prostatectomy * Body mass index (BMI) (26 - 40 kg/m\^2) * Treating oncologist consent * Ambulatory or able to engage in walking for at least 45 minutes per intervention visit * Sedentary lifestyle, as engaging in less than 100 minutes structured aerobic walking, cycling or swimming per week Exclusion Criteria: * Poor diagnosis or other cancer * Severe heart or systemic disease: evidence of documented myocardial infarction, chronic unstable angina, symptomatic congestive heart failure, uncontrolled hypertension * Severe musculoskeletal disease: severe muscle or joint disorders due to disease or trauma, amputations, or any condition that significantly impair physical capabilities, as defined by the physician * Non-ambulatory * Concurrent diagnosis of organic brain syndrome, dementia, mental retardation, or significant sensory deficit * Major mental illness (e.g., schizophrenia, major depressive disorder) * Unwilling to give consent
References
Publications (0)
Data not yet available
No reference posted for this study.