Supportive and Survivorship Care Program for Cancer Patients: a Cluster Randomized Controlled Pilot Study Among Breast and Gynaecological Cancer Patients
试验速览
- 阶段
- 不适用
- 入组人数
- 226
- 试验地点
- 1
- 主要终点
- Change in quality of life from baseline across all time points between the intervention and control study arm
研究概览
简要总结
In Singapore, cancer patients are not consistently assessed for unmet survivorship care needs and systematically identified for subsequent referral to useful care services. To address this gap, a preliminary multidisciplinary program is developed to (i) routinely screen and identify cancer patients with high distress levels, and (ii) provide appropriate care referrals after a systematic review by a supportive care nurse.
This study hypothesized that breast and gynecological cancer patients receiving timely screening for distress and appropriate supportive care services will report better improvement in quality of life as compared to non-recipients under usual care. This pilot study then aims to evaluate:
(i) The effectiveness of the program on a patient level in improving the quality of life and the symptom burden of patients requiring further supportive services.
(ii) The feasibility of the program's implementation on a health-system level among breast and gynaecological cancer patients in the outpatient oncology clinics at a specialty cancer centre.
详细描述
A cluster randomized controlled trial will be conducted at the National Cancer Centre Singapore (NCCS) over a period of 2 years. Eligible participants and their caregivers where applicable will be recruited and followed-up for a period of 12 months. Patients in the intervention arm will receive routine distress screening and referral to a supportive care nurse service where necessary; whereas patients in the control arm will receive usual care.
Patients' quality of life will be assessed by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) and compared longitudinally between both study arms at a 3-months interval. Additionally, physical and psychological symptom distress levels will be compared using the Rotterdam Symptom Checklist (RSCL).
For patients who receive symptom-specific services, additional questionnaires will be completed before and after they have received the service. They include the following: Multi-dimensional Fatigue Symptom Inventory-Short Form (MFSI-SF) for fatigue, Patient Neurotoxicity Questionnaire (PNQ) for neuropathy, Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog v3.0) for cognitive function, and Patient-Reported Arthralgia Inventory (PRAI) for arthralgia.
An economic evaluation will be conducted using healthcare resource utilization and cost data gathered from health records and surveys including the Work Productivity and Activity Impairment (WPAI) questionnaire. Process outcomes of the program delivery will also be obtained to assess its feasibility by monitoring the referral patterns to supportive care nurse and adherence to screening or appointments. Lastly, patient satisfaction and clinicians acceptability of the program will be assessed via questionnaires.
Results from this study on the program's feasibility and effectiveness among breast and gynecological cancer patients are crucial to highlight potential implementation barriers and utility for patients before extending to other cancer types. Furthermore, results can shed a light on the program's scalability for future integration into routine care. This compelling initiative will contribute to the institution of integrated and coordinated rehabilitative and specialized clinics services to address supportive and survivorship needs of cancer patients across the continuum in the long run.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Confirmed diagnosis of breast or gynaecological cancer ascertained by clinical documentation
- •Newly diagnosed patients receiving subsequent follow-up care in NCCS
- •Able to read and understand English or Chinese
- •Capable of providing informed consent
排除标准
- •Physically or mentally incapable of providing verbal / written consent
- •Patients under active care by the palliative care team
结局指标
主要结局
Change in quality of life from baseline across all time points between the intervention and control study arm
时间窗: Once at baseline and every 3 months for a period of 12 months
The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ-C30) assesses cancer patients' health-related quality of life for the past week. The global quality of life status scale will be used and it is scored from 0 to 100 where a higher score is indicative of better functioning.
次要结局
- Proportion of patients who achieve a clinically significant improvement or deterioration in quality of life between the intervention and control study arm(12 months post recruitment)
- Physical and psychological symptom distress levels between the intervention and control study arm(Once at baseline and every 3 months for a period of 12 months)
- Quality of life of caregivers providing care to patients in the intervention study arm(12 months post recruitment)
- Fatigue levels(Baseline and 3 months after)
- Severity of neuropathy(Baseline and 3 months after)
- Cognitive function(Baseline and 3 months after)
- Work productivity(9 months and 12 months post recruitment)
- Extent of healthcare resource utilization(Throughout 12 months of follow-up period)
- Severity of arthralgia(Baseline and 3 months after)
- Satisfaction levels of patients in the intervention study arm(12 months post recruitment)
研究者
Alexandre Chan
Associate Professor
National University of Singapore