A Randomised Single Blinded Trial Assessing the Impact of Routine Distress Screening and Personalised Interventions on Quality of Life and Distress in Cancer patients Undergoing Radiotherapy.
试验速览
- 阶段
- 2/3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Anticipating that routine distress screening and timely interventions will significantly reduce the
研究概览
简要总结
This prospective, single-institution, randomized controlled study aims to evaluate the impact of routine distress screening using the NCCN Distress Thermometer and Problem List, followed by tailored interventions, on quality of life (QoL) and psychological distress in cancer patients undergoing definitive radiotherapy at Dr. B. Borooah Cancer Institute, Guwahati.
Two groups will be studied
Arm A (Intervention) Patients will undergo weekly distress screening. If distress scores are greater than or equal to 5, timely psychosocial and supportive interventions will be provided.
Arm B (Control) Patients will receive standard care without routine distress screening, with support offered only if requested or deemed necessary by clinicians.
QoL will be assessed in both groups at baseline and at the end of treatment using the EORTC QLQ-C30 tool. The primary objective is to assess the effectiveness of distress screening and intervention in reducing distress; secondary objectives include identifying common causes of distress and comparing QoL between groups.
A total of 200 patients (100 per group) will be recruited through purposive and stratified random sampling based on cancer type using random number table. The estimated statistical power is 90%, and data will be analyzed using appropriate statistical tests in RStudio or SPSS. Psychosocial adverse events will be monitored throughout.
Expected outcomes include reduced distress levels, improved QoL, and identification of common distress factors. If effective, the study will support integrating routine distress screening into standard cancer care protocols, possibly through EMR systems. Limitations include single-center bias and absence of long-term follow-up. Future plans involve multicentric validation and long-term impact assessment.
Study duration Nearly18 months including recruitment, intervention, follow-up, and analysis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 81.00 Year(s)（—）
- 性别
- All
入选标准
- •Newly diagnosed cancer patients planned for definitive or upfront radiotherapy or chemoradiotherapy at Dr B Borooah Cancer Institute.
- •Performance Status: ECOG Performance Status of 0-2
- •Patients must be willing to provide informed consent for participation in the study.
排除标准
- •Exclusion Criteria: o ECOG Performance Status greater than or equal to
- •o Age less than or equal to 18 years.
- •o Diagnosis of depression or mood disorder, and patients on antidepressants and anti-psychotics from before o Patients who have previously undergone neoadjuvant chemotherapy, surgery, or radiotherapy.
- •o Treated with palliative intent.
- •o Patients who do not provide informed consent to participate in the study.
结局指标
主要结局
Anticipating that routine distress screening and timely interventions will significantly reduce the
时间窗: At the start of radiotherapy, weekly and at the end of radiotherapy.
psychological and practical challenges faced by cancer patients.
时间窗: At the start of radiotherapy, weekly and at the end of radiotherapy.
次要结局
- Factors influencing distress among(patients will be identified which will help us to develop prophylactic measures for these group of patients)
- Additionally, expecting to see improved quality of life scores in the screening group compared(to the standard care group.)
研究者
Mouchumee Bhattacharyya
Dr. B. Borooah Cancer Institute