NextSteps: A Supportive Care Program For Advanced Cancer Patients and Their Caregivers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 242
- 试验地点
- 1
- 主要终点
- Patient and Caregiver Depression
研究概览
简要总结
This study seeks to test the efficacy of a psychosocial intervention to empower advanced cancer patients and their caregivers and improve their quality of life (QOL). The program, called NextSTEPS, provides skills training in six domains that are central to patient and caregiver QOL: self-care, stress management, symptom management, effective communication, problem-solving, and social support.
详细描述
In this study, 200 advanced cancer patients who are within one month of treatment initiation (baseline) and their caregivers will complete baseline surveys and be randomized to NextSTEPS or a usual medical care (UMC) condition. In addition to UMC, patients and caregivers in the NextSTEPS condition will each receive an intervention manual and six weekly 45-minute telephone counseling sessions with a trained interventionist. Patients and caregivers in both the NextSTEPS and UMC conditions will complete follow-up surveys at 8 weeks (primary endpoint), and 4 and 6 months post-baseline (secondary endpoints).
The specific aims are to:
- Determine the impact of NextSTEPS on patient physical and emotional QOL, palliative care utilization, and satisfaction with care relative to UMC. We hypothesize that at 8 weeks (2 months), and 4 and 6 months, patients in NextSTEPS will have less symptom burden, less emotional distress, greater palliative care utilization, and greater satisfaction with care relative to patients in UMC.
- Determine the impact of NextSTEPS on caregiver self-care, physical and emotional QOL, and satisfaction with care. We hypothesize that at 8 weeks, and 4 and 6 months, caregivers in NextSTEPS will report more self-care, better physical QOL, less emotional distress, and greater satisfaction with care relative to caregivers in UMC.
Secondary/exploratory aims and hypotheses are to:
Examine the effects of the NextSTEPS intervention on Self Determination Theory (SDT) constructs. We hypothesize that NextSTEPS will enhance patient and caregiver competence, autonomy, and relatedness.
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
- 是
入选标准
- •Patient has stage 3A, 3B, or 4 NSLC or extensive stage SCLC and is within one month of treatment initiation OR patient has Stage 4 GI cancer and is within one month of treatment initiation
- •patient is spending more than 50% of time out of bed on a daily basis as measured by an ECOG Performance Status rating of level 0, 1, or 2
- •patient has stable brain metastases and no limitation on hepatic or renal function
- •patient has a spouse/partner other or close family member who he/she defines as the primary caregiver
- •patient and caregiver are age 18 years or older
- •patient and caregiver have the ability to read and understand English at a sixth grade level, as determined by ability to understand the consent form
- •patient and caregiver can provide informed consent
排除标准
- •patient or caregiver is deaf or has significant hearing impairment and thus cannot use the telephone
- •patient is currently enrolled in hospice.
研究组 & 干预措施
NextSteps Intervention
Patients and caregivers will each receive their own tailored manual and six weekly 45-minute telephone calls that correspond to the manual, delivered by a Masters level trained interventionist.
干预措施: NextSteps (Behavioral)
Usual Medical Care
UMC consists of standard oncologic care for the patient from the point of diagnosis of advanced cancer.
结局指标
主要结局
Patient and Caregiver Depression
时间窗: 2 months
Patient Reported Outcomes Measurement Information System Depression 6 item Short form
Patient and Caregiver Anxiety
时间窗: 2 months
Patient Reported Outcomes Measurement Information System Anxiety 6 item Short form
次要结局
- Patient and Caregiver Satisfaction with Care(2 months, 4 months, and 6 months)
- Patient and Caregiver Depression(4 and 6 months)
- Patient Symptom Burden(2 months, 4 months, and 6 months)
- Patient and Caregiver Anxiety(4 and 6 months)
研究者
Hoda Badr
Dr.
Baylor College of Medicine