Prostate Cancer Clinical Trial
— NurseNedOfficial title:
Virtualizing Survivorship: Implementing a More Timely and Comprehensive Model of Follow-up Care: Effectiveness Evaluation Phase
The purpose of this non-randomized control trial is to evaluate the effectiveness of a virtual nurse-led survivorship clinic for prostate cancer (PCa) survivors. Through this trial, investigators will compare pre-determined survivorship outcomes of men receiving care via traditional specialist-led PCa virtual care model (Specialist Ned) to those receiving care via the newly-proposed nurse-led PCa virtual care model (Nurse Ned). In total, it is anticipated that a maximum of 600 men (300 in control arm; 300 in intervention arm) across five clinical sites (3 in Ontario; 1 in Alberta; and 1 in Nova Scotia) will be enrolled into this trial and will be followed for 12 months.
Status | Recruiting |
Enrollment | 600 |
Est. completion date | September 30, 2024 |
Est. primary completion date | September 30, 2024 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. 18 years of age or older 2. Completed curative-intent treatment 3. Receiving PCa survivorship care at University Health Network (UHN), Trillium Health Partners (THP), Niagara Health System (NHS), Prostate Cancer Centre - Calgary (PCCC), or Queen Elizabeth II Health Sciences Centre (QEII HSC)-affiliated hospital 4. Low risk of recurrence as determined by their treatment specialist 5. Adequate English ability (or a caregiver willing to provide translation) to complete study activities as determined by research assistant 6. Have an email address (or be able to use the email address of a caregiver) Exclusion Criteria: Patients with metastatic PCa are not eligible to participate in this research. |
Country | Name | City | State |
---|---|---|---|
Canada | University Health Network (Princess Margaret Hospital) | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
University Health Network, Toronto | Niagara Health System, Queen Elizabeth II Health Sciences Centre, Rockyview General Hospital, Trillium Health Partners |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Changes in unmet needs | Assessed by Cancer Survivors' Unmet Needs (CaSUN) questionnaire. The questionnaire is a 42-item instrument that captures the current needs of a cancer survivor, such as medical care, quality of life, emotional and relationship needs and their current view of life. | Measured at Baseline, 6 months, 1 year | |
Secondary | Changes to Participant's Health Status | Assessed by the EQ5D-5L questionnaire. This questionnaire contains 6 questions which assess the patient's health status by understanding how they feel about their mobility, self-care, usual activities, pain/discomfort and levels of anxiety or depression. | Measured at Baseline, 6 months, 1 year | |
Secondary | Changes in Prostate Cancer health related quality of life | Assessed by the Expanded Prostate Cancer Index Composite Short Form (EPIC-26). The questionnaire is a 13-item instrument that captures the side effects and symptoms that might affect the quality of life in patients with prostate cancer patients. | Measured at Baseline, 6 months, 1 year | |
Secondary | Changes in overall health related quality of life | Assessed by the Functional Assessment of Cancer Therapy for Prostate Cancer patients (FACT-P). This questionnaire is a 39-item instrument that assesses the quality of health-related well-being for patients with prostate cancer. | Measured at Baseline, 6 months, 1 year | |
Secondary | Changes in Psychological Wellbeing | Assessed by the General Health Questionnaire (GHQ-12). This questionnaire contains 12-questions that ask prostate cancer patients how they have been feeling in the past weeks. | Measured at Baseline, 6 months, 1 year | |
Secondary | Changes in willingness to self-manage | Assessed by the Patient Activation Measure Questionnaire (PAM-13). This questionnaire is a 13-item instrument that quantifies a patient's readiness to engage in their own self-management. | Measured at Baseline and 1 year | |
Secondary | Changes to satisfaction with care | Assessed by the Care Satisfaction Questionnaire. This questionnaire is an 11-item instrument used to quantify experience and acceptability of follow-up care. | Measured at Baseline and 1 year | |
Secondary | Changes in health behaviours | Assessed by the Health Behaviour Questionnaire. This questionnaire is used to determine participant health practices (e.g. smoking, fitness, alcohol consumption). | Measured at Baseline and 1 year |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05613023 -
A Trial of 5 Fraction Prostate SBRT Versus 5 Fraction Prostate and Pelvic Nodal SBRT
|
Phase 3 | |
Recruiting |
NCT05540392 -
An Acupuncture Study for Prostate Cancer Survivors With Urinary Issues
|
Phase 1/Phase 2 | |
Recruiting |
NCT05156424 -
A Comparison of Aerobic and Resistance Exercise to Counteract Treatment Side Effects in Men With Prostate Cancer
|
Phase 1/Phase 2 | |
Completed |
NCT03177759 -
Living With Prostate Cancer (LPC)
|
||
Completed |
NCT01331083 -
A Phase II Study of PX-866 in Patients With Recurrent or Metastatic Castration Resistant Prostate Cancer
|
Phase 2 | |
Recruiting |
NCT05540782 -
A Study of Cognitive Health in Survivors of Prostate Cancer
|
||
Active, not recruiting |
NCT04742361 -
Efficacy of [18F]PSMA-1007 PET/CT in Patients With Biochemial Recurrent Prostate Cancer
|
Phase 3 | |
Completed |
NCT04400656 -
PROState Pathway Embedded Comparative Trial
|
||
Completed |
NCT02282644 -
Individual Phenotype Analysis in Patients With Castration-Resistant Prostate Cancer With CellSearch® and Flow Cytometry
|
N/A | |
Recruiting |
NCT06037954 -
A Study of Mental Health Care in People With Cancer
|
N/A | |
Recruiting |
NCT06305832 -
Salvage Radiotherapy Combined With Androgen Deprivation Therapy (ADT) With or Without Rezvilutamide in the Treatment of Biochemical Recurrence After Radical Prostatectomy for Prostate Cancer
|
Phase 2 | |
Recruiting |
NCT05761093 -
Patient and Physician Benefit/ Risk Preferences for Treatment of mPC in Hong Kong: a Discrete Choice Experiment
|
||
Completed |
NCT04838626 -
Study of Diagnostic Performance of [18F]CTT1057 for PSMA-positive Tumors Detection
|
Phase 2/Phase 3 | |
Recruiting |
NCT03101176 -
Multiparametric Ultrasound Imaging in Prostate Cancer
|
N/A | |
Completed |
NCT03290417 -
Correlative Analysis of the Genomics of Vitamin D and Omega-3 Fatty Acid Intake in Prostate Cancer
|
N/A | |
Active, not recruiting |
NCT00341939 -
Retrospective Analysis of a Drug-Metabolizing Genotype in Cancer Patients and Correlation With Pharmacokinetic and Pharmacodynamics Data
|
||
Completed |
NCT01497925 -
Ph 1 Trial of ADI-PEG 20 Plus Docetaxel in Solid Tumors With Emphasis on Prostate Cancer and Non-Small Cell Lung Cancer
|
Phase 1 | |
Recruiting |
NCT03679819 -
Single-center Trial for the Validation of High-resolution Transrectal Ultrasound (Exact Imaging Scanner ExactVu) for the Detection of Prostate Cancer
|
||
Completed |
NCT03554317 -
COMbination of Bipolar Androgen Therapy and Nivolumab
|
Phase 2 | |
Completed |
NCT03271502 -
Effect of Anesthesia on Optic Nerve Sheath Diameter in Patients Undergoing Robot-assisted Laparoscopic Prostatectomy
|
N/A |