A Randomized Intervention for Cardiovascular and Lifestyle Risk Factors in Prostate Cancer Patients

RADICAL PC

Principal Investigator: Dr. Margot Davis,  Department of Medicine, Vancouver General Hospital, UBC

Purpose: This research aims to:

1. Explore why some men with prostate cancer develop cardiovascular disease, and in particular, determine whether one type of treatment for prostate cancer called Androgen Deprivation Therapy (ADT) contributes to the risk of cardiovascular disease, and
2. Whether the risk of cardiovascular disease can be reduced in men with prostate cancer.

Who: All newly diagnosed prostate cancer patients diagnosed within the last year, or those who have recently started or will be starting on Androgen Deprivation Therapy (ADT) or hormone therapy.

What is Involved: Eligible patients will be followed in an observational registry, or randomized between either standard treatment or extra care from a cardiologist (including prescriptions for cardiac medications). Research clinic visits at enrollment, 1 year, 2 years, and study closeout. Randomized arm will also have telephone visits at 3, 6, 18, and 36 months after enrollment.

Project Funder: Population Health Research Institute, Hamilton General Hospital

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TrueNTH Global Registry – Prostate Cancer Outcomes

Principal Investigator: Dr. Larry Goldenberg,  Professor Department of Urologic Sciences, UBC Research Investigator with VCH Research Institute

Purpose: This project aims to improve the physical and mental health of men treated for prostate cancer by  establishing a  global registry. The overarching aim of this project is to significantly improve quality of care and the attendant patien-t­centred outcomes in men with localised prostate cancer.

Who: All newly diagnosed prostate cancer patients who have completed electronic Patient Reported Outcomes (ePROs) at their urology clinic visit.

What is Involved: Responses to the ePRO questionnaires will anonymized and uploaded to the global registry, along with diagnosis and treatment details.

Project Funder: Movember Foundation

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TEMPO: A web-based, psychosocial and physical activity self-management program for prostate cancer

Principal Investigator: Dr. Larry Goldenberg,  Professor Department of Urologic Sciences, UBC Research Investigator with VCH Research Institute

Purpose:  TEMPO is a dyadic, Tailored, web-based, psychosocial and physical activity self-Management Programme that aims to provide coping-skills training and an in-home exercise program to meet the needs of men with prostate cancer and their caregivers.

Who: Men who have received treatment for prostate cancer within the past 24 months or are scheduled to receive treatment in the near future. Eligible men must also have a primary caregiver who is willing to participate in the study.

What is involved: Patients and caregivers will be asked to use TEMPO for a period of 7-10 weeks. This includes educational materials, videos, and interactive worksheets to help manage the challenges they face as a result of cancer. 

Project Funder: Prostate Cancer Canada

Website: https://tempo.truenth.ca/

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RADICAL-PC: A Randomized, Controlled Trial of a Systematic Approach to Modifying Cardiovascular and Lifestyle risk factors in Men with a New Diagnosis of Prostate Cancer

Principal Investigator: Dr. Margot Davis, Clinical Assistant Professor, Department of Cardiology, UBC Research Investigator with VCH Research Institute

Purpose:  To identify factors associated with the development of cardiovascular disease in men with prostate cancer, and to determine whether lifestyle modification with additional cardiovascular care improve physical, cognitive and cardiovascular function in prostate cancer patients.

Who: Men aged ≥45 diagnosed with prostate cancer that is either:

• New (diagnosed within the past year), or
• Treated with androgen deprivation therapy for the first time within the past 6 months, or
• To be treated with androgen deprivation therapy for the first time within one month.

What is involved: Eligible patients will be randomized between either 1) standard treatment or 2) extra care from a cardiologist (including prescriptions for cardiac medications). Research clinic visits will be performed at enrollment, 1 year, 2 years, and at study completion. Research coordinators will also contact participants by telephone at 3, 6, 18, and 36 months after enrollment..

Project Funder: Population Health Research Centre (PHRI).

Clinicaltrials.gov: NCT03127631

PC360º – Prostate Cancer Survivorship 360º

Principal Investigator: Dr. Larry Goldenberg,  Professor Department of Urologic Sciences, UBC Research Investigator with VCH Research Institute

Purpose: This is a collaboration-based initiative involving prostate cancer and survivorship researchers from three Canadian prostate centers with the goal of identifying and tracking unmet supportive care needs of patients with localized prostate cancer, and responding to these needs through survivorship care. There are two aspects to the study:

PC360-IS – Prostate Cancer 360º – Information Systems

This involves the a registry of prostate cancer patients across Canada. Participation involves responses to the electronic Patient Reported Outcomes (ePROs), completed at each urology clinic appointment, being anonymized and uploaded to the registry database, along with diagnosis and treatment information.

Who: Patients who have completed primary treatment for their prostate cancer within 3 months of completing ePROs at clinic.

Overall, this study represents initial steps in uniting the country in sharing programmatic resources, data, expertise, and enthusiasm to transform survivorship care for men with prostate cancer and their families.

Funder: Prostate Cancer Canada

Clinicaltrials.gov: NCT03017456 

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INTROSPPECT – Treatment for Sexual Health and Couple Intimacy after Prostate Cancer

Principal Investigator: Dr. Lori Brotto,  Department of Obstetrics & Gynaecology, VCH Research Institute Affiliated Investigator

Purpose: We are interested in evaluating different treatment options for improving intimacy in couples after prostate cancer treatment.

Who: Couples in which (at least) one member of the couple underwent treatment for prostate cancer.

What is involved: Couples will be randomized to one of two groups: 4-weeks of a mindfulness-based group therapy program, or 4-weeks for a cognitive behavioural therapy (CBT) group therapy program. Both members of the couple will also complete 3 sets of online questionnaires which take approximately 20-30 minutes. Some honoraria will be provided to participants.

Project Funders: Movember Foundation & Prostate Cancer Canada

Clinicaltrials.gov: NCT03365518

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LPC – Living with Prostate Cancer Workshop Evaluation

Principal Investigator: Dr. David Kuhl, Professor, Department of Family Practice, UBC Vancouver Prostate Centre, Research Investigator with VCH Research Institute

Purpose: This is an evaluation to determine the effectiveness of the Prostate Cancer Supportive Care (PCSC) Program’s group therapy program, Living with Prostate Cancer (LPC).

Who: Prostate cancer patients who are willing to attend the “Living with Prostate Cancer” group therapy sessions from the PCSC Program. To be able to participate in LPC groups, men must have recently received a diagnosis of PC Stages 1 to 3, or have recently been recommended to undergo a form of treatment following a period of active surveillance.

What is involved: Participants will be asked to complete a series of questionnaires about their experience with the LPC program at various time-points.

Clinicaltrials.gov: NCT03177759

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SHRAP Evaluation Study – Critical Appraisal of the Sexual Health Rehabilitation Action Plan (SHRAP)

Principal Investigator: Dr. Stacey Elliott, Clinical Professor, Departments of Psychiatry and Urological Sciences, UBC; Research Investigator with VCH Research Institute.

Purpose: This project aims to assess the patient acceptability of, adherence to, and satisfaction with a new tool (SHRAP), whose objective is to assist patients/couples in their pathway to sexual health adaptation after prostate cancer treatments.

Who: Single or partnered men who have been diagnosed with and received primary treatment for Stage I-IV prostate cancer as well as their partners, and have attended or are scheduled to attend their first visit with a clinician of the Sexual Health Service (SHS) for the Prostate Cancer Supportive Care (PCSC) Program.

What is involved: Online questionnaires approx. 1 week, 1 month and 2 months post-receiving the SHRAP. Participants receive a gift card afterwards as a thank you for participating.

Project Funder: VCHRI research challenge

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PCSC OOP Study – Evaluating patient out-of-pocket (OOP) costs associated with attendance at a prostate cancer supportive care program

Principal Investigator: Dr. Dr. Larry Goldenberg, Professor Department of Urologic Sciences, UBC Research Investigator with VCH Research Institute.

Purpose: This project aims to assess OOP expenses borne by patients who chose to access a supportive care program for men with prostate cancer and their partners.

Who: Men who are diagnosed with PC (stage I-IV; pre- or post-treatment) and enrolled in the PCSC Program.

What is involved: One time questionnaire.

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ASGS – Active Surveillance Genetic Sampling Study 

Principal Investigator: Dr. Larry Goldenberg,  Professor Department of Urologic Sciences, UBC Research Investigator with VCH Research Institute

Purpose: To collect saliva samples from men who are currently or were previously on Active Surveillance to try and identify genetic factors that could suggest how aggressive their prostate cancer could be.

Who: Prostate cancer patients who currently meet or have previously met the traditional active surveillance criteria.

What is involved: Participants will be asked to provide a saliva sample which will be used for DNA analysis.

Project Funder: Specialized Program of Research Excellence (SPORE), Urological Research Foundation (URF), NorthShore HealthSystem

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EMMPC – A Pilot Study to Measure the Biological Effects of Exercise in Prostate Cancer

Principal Investigator: Dr. Peter Black, Department of Urologic Sciences, BC, Research Investigator with VCH Research Institute

Purpose: To help determine if a structured exercise program for prostate cancer patients prior to surgery is feasible.

Who: Prostate cancer patients who are considering a radical prostatectomy.

What is involved: Participants will be randomly assigned to either the exercise intervention (4-12 weeks) or to the control group. All participants will be asked to complete a physical activity assessment and questionnaires, and to provide biological samples before and after the intervention

Clinicaltrials.gov: NCT02481648

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Sleep Study – Feasibility of using the ARES(TM) Device to measure sleep in men with prostate cancer starting Androgen Deprivation Therapy

Principal Investigator: Dr. Larry Goldenberg, Professor UBC Department of Urologic Sciences

Purpose: This study aims to evaluate if the ARES(TM) device can be used to study the effects of Androgen Deprivation Therapy (ADT) on the sleep patterns of prostate cancer patients.

Who: Prostate cancer patients who are starting ADT, and plan to be receiving treatment for at least 6 months (with or without radiation therapy).

What is involved: Participants will be required to wear the ARES(TM) device at home to record their sleep at 3 time points: before starting ADT, and at 3 and 6 months after starting ADT. Participants will also be asked to complete a short questionnaire at each time-point. Body parameters (including weight, height, waist and neck circumferences) will also be measured. At the end of the study, participants will be asked to complete an exit phone interview to learn about their experiences using the ARES(TM) device.

Clinicaltrials.gov:  NCT02919904 

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PCSC-1 – Evaluating an Educational Intervention to Alleviate Distress in Men with Newly-Diagnosed Prostate Cancer and their Partners

Principal Investigator: Richard Wassersug, PhD, University of British Columbia

Purpose: This was an evaluation to assess if by attending the educational session “Introduction to Prostate Cancer Treatment & Primary Treatment Options”, distress is reduced in men and their partners.

Who: Recently diagnosed prostate cancer patients who were willing to attend the “Introduction to Prostate Cancer Treatment & Primary Treatment Options” education session from the PCSC Program.

What was involved: Participants were asked to complete a questionnaire before and after the session.

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Cooking Class Study – Increasing Healthy Outcomes for Prostate Cancer Survivors: An Innovative Cooking Class Intervention Feasibility Study

Principal Investigator: Dr. Carolyn Gotay, Ph.D., School of Population and Public Health, University of British Columbia

Purpose: To determine if nutrition education alleviates the uncomfortable side effects of prostate cancer treatment and reduces further cancer risk.

Who: Prostate Cancer patients and their partners who were interested in participating in a cooking class study together.

What was involved: Participants were asked to attend six weekly two-hour group classes taught by a nutrition educator and a professional chef, and to complete questionnaires before and after the intervention.

Funder: Canadian Cancer Society Research Institute

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TrueNTH (True North) Peer Navigation

Principal Investigator: Dr. Arminee Kazanjian, School of Population and Public Health, University of British Columbia

Purpose: We have developed a peer navigation program where trained peer ‘navigators’, who are either prostate cancer survivors or their caregivers, will help prostate cancer patients and caregivers navigate their journey through cancer care, from the point of diagnosis to treatment and beyond.

Who: Prostate Cancer patients diagnosed at least four weeks ago, or their caregivers who are able to use the internet for basic tasks.

What was involved: Participants were matched with a peer navigator – either man with prostate cancer (for prostate cancer survivors) or  a caregiver (for caregivers of prostate cancer patients). The peer navigator provided emotional, practical, and informational support. Participants were asked to complete questionnaires throughout the study.

Funders: Prostate Cancer Canada & Movember Foundation

Website: https://peernavigation.truenth.ca/

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TrueNTH ADT – An Evaluation of the Androgen Deprivation Therapy (ADT) Educational Program: A True NTH Initiative

Principal Investigator: Richard Wassersug, PhD, University of British Columbia

Purpose: This study aimed to assist us in providing better recommendations for prostate cancer patients on how to manage the side effects of ADT, and maintaining a strong relationship with their partner while on ADT.

Who: Prostate Cancer patients and their partners who participated in the PCSC Program’s ADT Educational Program wre eligible to take part in this evaluation.

What was involved: This research study involved completing a set of questionnaires before the first session of the ADT Educational Program, and two months later.

Funders: Prostate Cancer Canada

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TrueNTH Lifestyle – Prostate Cancer Canada’s True NTH Lifestyle Management Program – Physical Activity, Nutrition and Wellness Initiatives

Principal Investigator: Kristen Campbell, PhD, UBC Research Investigator with VCH Research Institute

Purpose: This study aimed to provide a wellness intervention for prostate cancer survivors – a multi-faceted health care program that will improve quality of life and recovery post treatment.

Who: Prostate cancer patients who were medically safe to engage in light to moderate exercise.

What was involved: A 12-week exercise and education program whereby participants underwent a baseline assessment and then attended three supervised exercise sessions per week with bi-weekly education seminars.

Funders: Prostate Cancer Canada

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