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临床试验/NCT03258450
NCT03258450已完成不适用

The Feasibility and Acceptability of a Psychosocial Intervention for Advanced Colorectal Cancer Patients

Duke-NUS Graduate Medical School2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2017年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
2
主要终点
The feasibility of the intervention will be tested through enrolment rates.

研究概览

简要总结

Studies have reported about one-third to half of advanced cancer patients experience psychological distress yet the mental healthcare needs of these patients are not properly assessed and addressed. Patients with advanced colorectal cancer can face unique challenges that are stoma- or bowel-related in addition to other symptom burden such as pain, fatigue, and existential distress that have deleterious consequences on their psychological and social functioning. This pilot study aims to test an intervention for patients specifically with advanced colorectal cancer that incorporates culturally-appropriate topics. Using a randomized selection design, we will investigate the feasibility and acceptability of the intervention and obtain an initial estimate of efficacy of the intervention. This pilot study will yield useful information to inform the preparation of a larger, phase III confirmatory study.

详细描述

Cancer is the leading cause of death in Singapore and colorectal cancer is the most frequently diagnosed cancer in males and second most frequently diagnosed cancer in females, accounting for 17% and 13% of all cancers respectively. Such high incidence rates are consistent with reports of colorectal cancer being a disease of ageing and developed nations . A total of 8931 new cases of colorectal cancer were diagnosed in Singapore from 2009 and 2013, with data indicating a steep increase in incidence rate for patients aged 50 and above. Given that the number of adults aged 65 years and older to double from 2009 to 2030 (Singapore Department of Statistics), the number of colorectal cancer cases are also expected to increase.

Advanced colorectal cancer refers to stage IV cancer of the colon or rectum that cannot be cured and has metastasized to at least one distant organ or set of lymph nodes, and that will likely continue to spread, leading to end of life (National Cancer Institute). In Singapore between 2009 and 2013, approximately 25% of colorectal cancer cases were at stage IV. According to the U.S. NCI's SEER database of patients from 2004-2010, 5-year survival rates for stage IV colon and rectal cancer were 11% and 12% respectively, suggesting these patients are or will soon be managing symptoms of their disease like pain while psychologically confronting end-of-life.

The news of metastatic disease, treatment failure, and/or bleak prognosis can be demoralizing for some patients and characterized by shock, denial, anger, anxiety, and depression which can interfere with everyday living. Studies have reported about one-third to half of advanced cancer patients experience psychological distress and existential crises, yet studies indicate the needs of these patients are not properly assessed and addressed as healthcare providers tend to focus more on patients' physical problems and do not have the time and perceived competency to address emotional distress.

Colorectal cancer comes with its own set of challenges that can significantly alter patients' daily living and affect patient psychological well-being and quality of life. Bowel-related issues have been reported to present physical, psychological, and social challenges to patients and survivors. For instance, patients with surgically-created stoma as part of treatment may face complications of leakage, skin, and odour issues that can lead to anxiety, disturbance in body image, low self-esteem, and social isolation. Furthermore, clinical anecdotes have pointed toward this patient population being concerned about lifestyle factors influencing their disease progression, especially diet. Psychological care has been increasingly recognized as an important part of treatment for this population at such a vulnerable time. Psychological care aims to address patients' mood and worries as they deal with their illness and to help patients find a sense of meaning in their life despite their cancer-related suffering. Unfortunately, psychological care as part of oncology supportive/ palliative services is still very rudimentary in Singapore.

Cognitive behavioural therapy is a widely used, evidence-based therapy that focuses on cognitions, emotions, and behaviour change to address patient distress. This framework has been successfully applied in the treatment of many disorders, including anxiety disorders, depression, chronic pain, and insomnia. It is posited that psycho-behavioural interventions (PBIs) that are based on cognitive-behavioural frameworks can be designed to meet the needs of cancer patients by targeting and modifying their maladaptive thoughts about the disease and treatment (e.g., irrational beliefs, negative attitudes, unrealistic expectations) and their behaviour (e.g., maladaptive coping strategies, isolation, self-negligence). This can be done by teaching patients strategies such as cognitive restructuring, meaning-making, relaxation, activity-pacing, effective communication with others, and utilization of social support. By learning these skills, patients are expected to have increased health-related self-efficacy (i.e., belief in the capacity to manage one's health) that may act as a buffer from them prematurely adopting the "sick role". Self-efficacy can be extremely important in the context of advanced cancer as it allows patients to feel more in control of a situation that is often distressing because of the uncertainty associated with the illness. This in turn may have an effect on patient psychological well-being, symptom management, and utilization of healthcare services such as emergency department (ED) visits and inpatient hospitalizations.

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
Single (Participant)

入排标准

年龄范围
21 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 21 years or older
  • Diagnosis of stage IV colorectal cancer
  • Able and willing to attend outpatient therapy appointments
  • Speak and read English or Chinese language

排除标准

  • Serious mental illness (e.g., schizophrenia, bipolar disorder) indicated by medical records
  • Visual, hearing, or cognitive impairment that will interfere with intervention
  • Unaware they have cancer

结局指标

主要结局

The feasibility of the intervention will be tested through enrolment rates.

时间窗: Up to 8 weeks

Feasibility of the intervention will be assessed through enrolment rates, rejection rates and exclusion rates.

The acceptability of the intervention will be assessed through the Client Satisfaction Questionnaire.

时间窗: Up to 8 weeks

Acceptability of the intervention will be assessed through patient's reported satisfaction with the program, There are 12 items measuring the perceived quality of the program, usefulness of the program, satisfaction with the intervention, comfort level in working with a mental healthcare provider, likelihood of recommending the intervention to others. Five-point Likert scales will be used for the measurement.

次要结局

  • Psychological distress will be accessed through The Hospital Anxiety and Depression Scale (HADS)(Up to 8 weeks)

研究者

发起方
Duke-NUS Graduate Medical School
申办方类型
Other
责任方
Principal Investigator
主要研究者

Irene Teo

Clinical Psychologist , Assistant Professor

Duke-NUS Graduate Medical School

研究点 (2)

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