Telephone-Based Mindfulness CBT for Patients in Community Settings With Advanced Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Feasibility as measured by study attrition which will be assessed by patients who do not complete the post-assessment.
研究概览
简要总结
This study examines the feasibility and acceptability of an open trial of mindfulness-based Cognitive Behavioral Therapy intervention delivered via telephone to men and women age 21 and older with a diagnosis of advanced cancer. Potential participants (N=35) will be recruited via letter from their oncologist at community-based clinics (N=18) and those served at the Duke Cancer Institute in Durham who live more than 60 miles away (N=17). Following informed consent, participants will be asked to complete assessments (e..g., examining their pain, anxiety, depression, fatigue, and engagement in valued activity). They will then receive 4 weekly 50-minute telephone sessions with a study therapist and practice skills learned in session at home. After completing the 4 sessions, they will complete a post-treatment assessment. Data analyses will examine the feasibility and acceptability of the study by assessing participant engagement, and will examine changes in key psychological variables (e.g., pain, anxiety, depression, fatigue, and valued activity) from baseline to post-treatment.
详细描述
Individuals with advanced cancers often experience significant symptom burden including pain, fatigue, and psychological distress, all while facing acceptance of the meaning of their advanced disease. Evidence-based behavioral interventions have been developed to alleviate this multiple symptom burden but are understudied and the treatments that are available are often not easily accessed by patients most in need in community-based settings. The current study examines the feasibility and acceptability of an open trial of mindfulness-based Cognitive Behavioral Therapy intervention delivered via telephone to men and women age 21 and older with a diagnosis of advanced cancer. Potential participants (N=35) will be recruited via letter from their oncologist at community-based clinics (N=18) and those served at the Duke Cancer Institute in Durham who live more than 60 miles away (N=17). Following informed consent, participants will be asked to complete assessments (e..g., examining their pain, anxiety, depression, fatigue, and engagement in valued activity). They will then receive 4 weekly 50-minute telephone sessions with a study therapist and practice skills learned in session at home. After completing the 4 sessions, they will complete a post-treatment assessment. Data analyses will examine the feasibility and acceptability of the study by assessing participant engagement, and will examine changes in key psychological variables (e.g., pain, anxiety, depression, fatigue, and valued activity) from baseline to post-treatment. There is minimal risk related to confidentiality of data and the possibility of feeling uncomfortable in the study. All study contacts will be conducted by trained study staff and supervised by the PI; a licensed clinical psychologist. Participant tracking data will be stored online via REDCAP and accessed only by study staff, participant assessment data will be collected and stored online via REDCap, and audio recordings of study telephone sessions will be stored on Duke servers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •being at least 21 years of age
- •a diagnosis of stage IV cancer in the past 3 years
- •being able to speak/read English
排除标准
- •visual or hearing impairment that would prevent ability to engage in the telephone session or study materials
- •presence of a severe unmanaged psychiatric condition (i.e., psychotic disorder or episode) or a psychiatric condition (e.g., suicidal intent) that would contraindicate safe participation in the study as indicated by the medical chart, treating oncologist, or interactions with the medical/study staff.
研究组 & 干预措施
Cognitive Behavioral Mutli-Symptom management(CBT)
Learn to manage distress, fatigue, and/or pain via Cognitive Behavioral Multi-Symptom Management(CBT). Four sessions will be conducted each session is approximately one hour.
干预措施: Cognitive Behavioral Mutli-Symptom management(CBT) (Behavioral)
结局指标
主要结局
Feasibility as measured by study attrition which will be assessed by patients who do not complete the post-assessment.
时间窗: 8 weeks
Feasibility will be shown by no more than 20% study attrition.
Acceptability, as measured by Client Satisfaction Questionnaire 10-item version
时间窗: 8 weeks
Acceptability will be indicated by at least 80% of the participants reporting satisfaction with the CBT protocol (mean score of 7) on the CSQ
Feasibility as measured by study accrual by meeting recruitment goal
时间窗: 8 weeks
Feasibility will be shown by meeting targeted study accrual (N=35) in the 12-month study period.
Feasibility as measured by adherence to the study protocol by number of intervention sessions completed by the participant
时间窗: 8 weeks
Feasibility will be shown by adherence to at least 75% of the intervention sessions (3/4)
次要结局
- Change in depression(Baseline and 8 weeks)
- Change in anxiety(Baseline and 8 weeks)
- Change in Acceptance(Baseline and 8 weeks)
- Change in pain(Baseline and 8 weeks)
- Change in fatigue(Baseline and 8 weeks)
- Change in Mindfulness(Baseline and 8 weeks)