Clinical trial · Interventional
Living Well on Androgen Deprivation Therapy
Living Well on Androgen Deprivation Therapy: A Comprehensive Approach to Prostate Cancer Survivorship
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): It was deemed not enough funding and the initial funding returned and study withdrawn (never opened and no recruitment happened.
Summary
Brief summary (as posted)
Approximately half of men treated for prostate cancer will be offered hormone deprivation therapy during their cancer experience. The secondary effects of this treatment can result in osteoporosis, cardiovascular disease, stroke, diabetes, and diminished sexual health. To promote healthy lifestyle choices for couples and maintain their intimacy and emotional health we propose the Living Well, an innovative program that combines nutrition, physical activity, and sexual health initiatives in one integrated service. This project will be piloted at the Vancouver Island Centre with an expected 100 patients over 1 year. Over a six month period both the experimental and control groups will have access to a workbook (designed for men with prostate cancer and on hormone deprivation therapy) and sexual health counseling. The experimental group will also have access to an exercise and a nutritional program and support by volunteers to keep motivated. Assessment will look at quality of life, physical factors, and biomarkers associated with secondary disease.
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 Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Exercise Sessions | Behavioral | — | UNRESOLVED |
| Nutrition Education | Behavioral | — | UNRESOLVED |
| Peer Support Volunteer | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Intervention
- description
- The intervention arm will receive sexual health counselling, exercise sessions, nutrition education, and will be assigned a peer support volunteer.
- interventionNames
- Behavioral: Exercise Sessions
- Behavioral: Nutrition Education
- Behavioral: Peer Support Volunteer
- type
- NO_INTERVENTION
- label
- Control
- description
- The control group will receive sexual health counseling.
Primary outcomes (3)
- measure
- Change from baseline in participant's quality of life on the Functional Assessment of Chronic Illnesses Therapy (FACT-P)
- timeFrame
- Baseline, 6 months, 12 months and 24 months
Eligibility
Eligibility (as posted)
- Sex
- Male
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * All prostate cancer patients registered with BCCA-VIC or referred by an urologist that are prescribed to receive androgen deprivation in their care plan (not currently on hormone therapy) * Must provide written, informed consent * Must be able to understand, speak, read and write English, and have the cognitive capacity to complete written questionnaires * Must be deemed ready to become more physically active, as determined by the PAR-Q+ and, if required, screened by a Canadian Society for Exercise Physiology Certified Exercise Physiologist® (CSEP-CEP) or medical doctor. * Must be willing and able to attend the introductory meeting with the Prostate Centre nurse (baseline measurement recordings), 8 weeks of supervised exercise, 4 monthly nutrition meetings, two sexual health meetings (which includes measurement recording sessions at 6 months), and follow up at 12 and 24 months * Must have access to a telephone * Must be able to commit to the full 6 month intervention period of the study (i.e. no scheduled, extended absences) and follow up at 12 and 24 months. This does not preclude any participants from withdrawing from the study at any point. * Must have greater than 12 months life expectancy Exclusion Criteria: * Prior invasive malignancy (except non-melanomatous skin cancer) or superficial bladder cancer unless disease free for a minimum of 5 years \[for example, carcinoma in situ of the oral cavity is permissible\] * Previous hormone therapy within the past 5 years * Participants who do not meet the following PAR-Q+(26, 27) criteria will be excluded from the study: * Must not have a YES response to Q2 on pg1: Do you feel pain in your chest at rest, during your daily activities of living, OR when you do physical activity? * Must not have a YES response to Q7 on pg 1: Has your doctor ever said that you should only do medically supervised physical activity? * Must not have YES response to any sub-questions on pages 2-3 related to musculoskeletal conditions, diabetes, heart disease, mental health problems or learning difficulties, pulmonary conditions, spinal cord injury, stroke unless clearance is provided by a CSEP-CEP . A CSEP-CEP will only provide clearance to a positive response if upon further query it is determined that the participant is asymptomatic and the benefits of light to moderate intensity exercise outweigh any foreseeable health and injury risks. In such cases where the CSEP-CEP makes a professional determination that the foreseeable risks may outweigh the benefits of exercise or the participant does not know the necessary details of his or her own medical condition, then the participant will need to obtain clearance via the physician referral letter. * PARQ+ form must be signed and dated within 6 months of entry into study * More than 80 years of age
References
Publications (0)
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