Evaluation of the Effect of Psycho-oncological Intervention on Well-being of Patients With Advanced Prostate Cancer on LHRH Analogs and Their Partners. A Randomized Controlled Pilot Study.
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- Ipsen
- 入组人数
- 6
- 试验地点
- 3
- 主要终点
- Sufficient interest in participation
研究概览
简要总结
The purpose of the protocol, is to assess the feasibility of conducting a larger trial to evaluate the effect of a psychological intervention on the well-being of patients on luteinizing hormone-releasing hormone (LHRH) analogs in the treatment of prostate cancer and their partners.
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
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed diagnosis of prostate cancer on biopsy
- •Locally advanced or metastasised prostate cancer in need of hormonal treatment.
- •On LHRH analogue treatment for a minimum of 5 months (at inclusion)
- •Having a female partner
- •Patients and their partner are able to fill out questionnaires, attend group sessions and give consent
排除标准
- •Serious psychiatric difficulties
- •Life expectancy < 12 months
结局指标
主要结局
Sufficient interest in participation
时间窗: Up to the end of 16 weeks of the intervention period
Determined by achievement of all of the following: * Number of participants (couples) recruited in 18 months in the participating centres. Achieved by recruitment of 50 couples. * Number of participants (couples) informed personally about the study consent to participate. To be achieved by 20% of couples. * Number of participants in group 1 that attend at least 70% of the sessions. To be achieved by 80% of participants.
Preliminary improvement in well-being
时间窗: After the intervention period of 16 weeks
Improved - Group 1 improve more than group 2 on at least one of the outcome measures (includes HADS, EORTC QLQ-C30 or Maudsley Marital Questionnaire). Worsened - Group 1 should not worsen more than group 2 on any of the outcome measures.
次要结局
- Change in quality of life questionnaire QLQ-PR25 scores(Baseline(T0), after the intervention period of 16 weeks (T1) and 1 year (T2))
- Difference in relationship satisfaction (Maudsley Marital Questionnaire)(Baseline (T0), after the intervention period of 16 weeks (T1) and 1 year (T2))
- Difference between level of depression and anxiety (HADS)(Baseline (T0) and 1 year (T2))
- Change in quality of life questionnaire QLQ-C30 scores(Baseline (T0), after the intervention period of 16 weeks (T1) and 1 year (T2))
- Change in Hospital Anxiety and Depression Scale (HADS) scores(Baseline (T0), after the intervention period of 16 weeks (T1))