Living Well on Androgen Deprivation Therapy: A Comprehensive Approach to Prostate Cancer Survivorship
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Change from baseline in participant's quality of life on the Functional Assessment of Chronic Illnesses Therapy (FACT-P)
研究概览
简要总结
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.
详细描述
- Purpose:
The overarching goal of the Living Well project is to maintain or improve quality of life for people with prostate cancer on androgen deprivation therapy (ADT) and their partners by providing the couples with the tools to promote confidence and motivation to remain both physically and psychosocially healthy and intimate. The primary objective is to determine the effect of our comprehensive community-based survivorship program on psychosocial health of people with PCa on ADT and their partners. Secondarily we intend to explore the impact of the program on biomarkers associated with the metabolic syndrome often observed in men on ADT, the program's operational and perceived (by patients and partners) impact of the program. 2. Hypothesis:
- The intervention group will show a larger magnitude of improvement on measures of QOL, fatigue, and intimacy, ultimately leading to increased benefit when compared to the control group.
- We believe through the engagement of peer volunteers that compliance and adherence to positive lifestyle changes will be higher on the intervention group when compared to the control group.
- Justification:
ADT has offered people with prostate cancer (PCa) improved curative outcomes when combined with local radiation therapy and has been fundamental in controlling disease for those with a biochemical recurrence or metastatic disease. Due to its effectiveness, ADT is offered to up to 50% of people with PCa.
ADT reduces the occurrence of metastases by lowering testosterone levels. Unfortunately, decreased testosterone can lead to hot flashes, diminished libido, erectile dysfunction, depression, diminished muscle strength, reduced bone mineral density, increased fat mass, and increased cholesterol levels. This conglomerate of secondary effects can lead to osteoporosis, cardiovascular disease, stroke, and diabetes. Poor lifestyle habits can further aggravate these secondary effects of ADT therapy. Being overweight may increase the risk of mortality from PCa. However, the increase in vascular disease and diabetes seems to be more strongly correlated with death than the cancer itself. Those with pre-existing cardiac problems and receiving ADT, have a 75% chance of dying from cardiovascular disease rather than PCa.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- — 至 80 Years（Child, Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Change from baseline in participant's quality of life on the Functional Assessment of Chronic Illnesses Therapy (FACT-P)
时间窗: Baseline, 6 months, 12 months and 24 months
Functional Assessment of Chronic Illnesses Therapy is a quality of life questionnaire for patients.with prostate cancer.
Change from baseline in patient's partner quality of life on the Quality of Life Scale (QOLS)
时间窗: Baseline, 6 months,12 months, 24 months
The Quality of Life Scale is a quality of life questionnaire that will be used for participants partners.
Change from baseline in fatigue on the Functional Assessment of Chronic Illnesses Therapy- Fatigue (FACIT-fatigue)
时间窗: Baseline, 6 months, 12 months, 24 months
The Functional Assessment of Chronic Illnesses Therapy is a measure of fatigue. This outcome will be tested for both participants and their partners.
次要结局
- Change from baseline in intimacy on the Dyadic Adjustment Scale (DAS)(Baseline, 6 months, 12 months, 24 months)