The Impact of a Standardised Initial Contact by a Psycho-oncological Counsellor on Anxiety and Depression, Quality of Life and the Use of Psycho-oncological Support in Cancer Patients: A Patient-initiated Multicentre Randomised Controlled Study - the Psycho-oncological Initial Contact Study (PICS)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 148
- 试验地点
- 10
- 主要终点
- Change in anxiety and depression
研究概览
简要总结
When diagnosed with cancer, patients or their relatives may, if they wish, on the recommendation of the treatment team and/or in cases of high stress, seek psycho-oncological support.
This study investigates whether an initial consultation with a psycho-oncological specialist reduces anxiety and depression, improves quality of life, and whether patients subsequently make greater use of support services.
Participants will be randomised, meaning they will be assigned to groups at random to ensure that the results are comparable. In the intervention group, participants will receive a detailed initial consultation with a psycho-oncology specialist and standard treatment. In the control group, participants receive standard treatment. To gather results, questionnaires are administered at regular intervals (at the start, after 3 and 6 months). The study lasts a total of 6 months.
The study was developed by patients. It is being conducted simultaneously at several hospitals.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with an oncological disease diagnosed within the last 3 months with planned or ongoing systemic oncologic treatment (e.g. chemotherapy, immunotherapy, hormone therapy) or a planned or ongoing radiotherapy
- •Patient is ≥18 years of age and legally competent
- •Patients must have understood and signed the study information and the informed consent form
- •Patients are willing and able to complete scheduled follow-up evaluations / questionnaires as described in the informed consent
- •No previous contact with psycho-oncological services
排除标准
- •Documented severe functional impairment according to the ECOG Performance Status (ECOG 3-4)
- •Patients receiving or planned to receive treatments associated with a severe risk of toxicity (e.g., CAR-T cell therapy, myeloablative therapy)
- •Insufficient language skills in German
- •Inability to give informed consent
- •Refusal to participate in the study, unsigned informed consent
研究组 & 干预措施
Standard
Participants in the Control Arm will receive current standard of care psycho- oncological support according to local processes.
干预措施: Standard (Other)
Initial psycho-oncological contact
Participants in the Intervention Arm will be contacted by a psycho-oncological counsellor. The study intervention is a 45 minutes initial psycho-oncological counselling and 3 months follow-up contact.
干预措施: initial psycho-oncological contact (Other)
结局指标
主要结局
Change in anxiety and depression
时间窗: 6 months follow-up
Change in anxiety and depression from study entry to the 6 months follow-up survey, measured using a summary measure of the entire HADS
次要结局
- Change in anxiety and depression components(6 months follow-up)
- Change in quality of life(6 months follow-up)
- Change in quality-of-life components(6 months follow-up)
- Change in patient's global distress(6 months follow-up)
- Use of psycho-oncological support(6 months follow-up)
- Reasons for seeking or not seeking psycho-oncological support(6 months follow-up)