Frequency of Cachexia in Ambulatory Cancer Patients and Psychological Burden in Both Patients and Their Primary Caregivers Who Are Referred to an Outpatient Supportive Care Clinic
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 192
- 试验地点
- 1
- 主要终点
- Cancer Cachexia
研究概览
简要总结
This trial studies the frequency of cachexia in ambulatory cancer patients and the psychological burden in patients and their primary caregivers who are referred to an outpatient supportive care clinic. Studying how often loss of appetite and/or unintentional weight loss (cachexia) occurs in patients seen in the supportive care clinic may help researchers develop new ways to lower stress in patients who suffer from loss of appetite and weight loss as well as their family caregivers.
详细描述
PRIMARY OBJECTIVE:
I. To estimate the proportion of patients with cancer cachexia, as defined by various criteria including The European Society of Clinical Nutrition and Metabolism (ESPEN) as well as an International Consensus Criteria (ICC), in a group of ambulatory patients with advanced cancer who are referred to a Supportive Care Clinic at University of Texas MD Anderson Cancer Center (UTMDACC).
SECONDARY OBJECTIVES:
I. To estimate the proportion of patients with complications anorexia (Appetite Score Edmonton Symptom Assessment Scale [ESAS] [>= 3] & Functional Assessment of Anorexia Therapy-Anorexia/Cachexia Subscale Questionnaire [FAACT-A/CS] =< 37); and the proportion of patients that have both anorexia and cancer cachexia.
II. To examine the association between symptoms of anorexia and/or cancer cachexia and the degree of symptom distress in cancer patients seen in a supportive care clinic, as measured by Edmonton Symptom Assessment Scale (ESAS - total score), Hospital Anxiety and Depression Scale (HADS), and the Functional Assessment of Anorexia Therapy-Anorexia/Cachexia Subscale (FAACT-A/CS Questionnaire) and in their primary caregivers, ESAS-Caregiver, Caregiver Quality of Life-Cancer (CQOLC), and Brief Illness Perception (Brief-IPQ) questionnaire.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •[Patient] Patients visiting the Supportive Care Clinic (SCC) for a consultation or a follow up.
- •[Patient] Patients who can identify a primary caregiver.
- •[Patient] Diagnosis of advanced cancer defined as locally advanced, recurrent, or metastatic.
- •[Patient] Be able to read and speak English.
- •[Patient] 18 years of age or older.
- •[Caregiver] Be identified or self-identified as a primary caregiver of the patient.
- •[Caregiver] Provide informed consent
- •[Caregiver] Be able to read and speak English.
- •[Caregiver] 18 years of age or older.
- •[Caregiver] Caregivers who are not able to complete the questionnaire on the day of patients' SCC visit must be willing to engage in a telephone questionnaire with research staff within 60 days of the patient's enrollment.
排除标准
- •[Patient] Refusal to participate in this study. This study requires both patient and caregiver enrollment.
- •[Patient] Patients with no caregiver or only paid caregivers.
- •[Patient] Patients with cognitive impairment as identified by research staff, treating physician or nurse (Memorial Delirium Assessment Scale score of >/= 7).
- •[Caregiver] Refusal to participate in this study. This study requires both patient and caregiver enrollment.
- •[Caregiver] Not a primary caregiver or is a paid caregiver.
- •[Caregiver] Evidence of cognitive impairment, as determined based on orientation questions pertaining to the date, day of the week, time, and place
研究组 & 干预措施
Observational (questionnaires)
Participants complete 8 questionnaires about appetite, quality of life, symptoms, history of weight loss, nutritional status, body image, and nutritional support over 30 minutes.
干预措施: Questionnaire Administration (Other)
结局指标
主要结局
Cancer Cachexia
时间窗: Day 1
Assessed by either European Society for Clinical Nutrition and Metabolism (ESPEN) includes body mass index (BMI) \< 18.5 (mandatory) or combined finding of unintentional weight loss (mandatory) and at least one of either reduced BMI or a low fat free mass index (FFMI), or International Consensus Criteria (ICC) defined as cachexia weight loss greater than 5% over 6 month period or weight loss greater than 2% showing depletion according to current bodyweight and height over an indefinite time point.
次要结局
- Caregiver Quality of Life-Cancer (CQOLC) Questionnaire(Day 1)
- Body Image Scale (BIS)(Day 1)
- Edmonton Symptom Assessment Scale (ESAS)(Day 1)
- Functional Assessment of Anorexia Therapy-Anorexia/Cachexia Subscale Questionnaire (FAACT-A/CS)(Day 1)
- Patient-Generated Subjective Global Assessment (PG-SGA-SF)(Day 1)
- Hospital Anxiety and Depression Scale (HADS) for assessment of depression and anxiety(Day 1)
- Brief Illness Perception Questionnaire (IPQ) score(Day 1)
- Perception of need for nutritional support(Day 1)