MIND-WELL: A Dyadic Intervention for Lung Cancer Survivors and Family Caregivers During Transition
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Recruitment Rate Assessed Using Study Recruitment Records
研究概览
简要总结
Lung cancer patients often go through more than one type of treatment, such as chemotherapy, radiation, and immunotherapy. These treatments can lead to several transition periods, which may increase stress and leave some needs unmet for patients and their family caregivers. The purpose of this study is to find out whether a program that includes mindfulness (stress reduction) and education is helpful, acceptable, and practical for lung cancer patients and their family caregivers. We also want to learn if this program helps them feel better prepared during these transitions.
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
- •Non-healthy adults:
- •Inclusion Criteria: Lung cancer patients aged 18 years or older who are currently receiving or scheduled to initiate active treatment, including those diagnosed with small cell or non-small cell lung cancer (Stage I-IV)
排除标准
- •Lung cancer patients who are under 18 years of age or unable to read and speak English will be excluded. Individuals with known severe psychiatric illness (e.g., active psychosis or acute psychiatric instability) or severe physical illness that would prevent meaningful participation in the intervention activities, as determined during the eligibility screening process, will be excluded
- •Healthy adults:
- •Inclusion Criteria: Family caregivers aged 18 years or older who are providing any type of support (physical, emotional, social, financial) to the lung cancer patients
- •Exclusion Criteria: Family caregivers who are under 18 years of age or unable to read and speak English will be excluded. Individuals with severe psychiatric illness (e.g., active psychosis or acute psychiatric instability) or severe physical illness that would prevent meaningful participation in the intervention activities, as determined during the eligibility screening process, will be excluded
研究组 & 干预措施
Intervention Group
Participants (patient-caregiver dyad together) will take part in 6 Zoom sessions over approximately 6-8 weeks. Each session will last up to 1 hour and will be scheduled at a convenient time. Sessions will be led by trained study staff and include mindfulness (stress reduction) practices, educational content, and dyadic activities. Topics include stress management, physical activity, sleep, nutrition, and communication. The intervention has two components: (1) mindfulness-based stress reduction, and (2) wellness preparation education using the Symptom Management and Survivorship Handbook.
干预措施: MIND-WELL Intervention (MINDfulness-based Intervention for Navigation of Dyadic WELLness and Education During Transitions) (Behavioral)
Comparison Group
Participants will receive an educational information packet. A study team member will conduct brief check-in phone calls at weeks 2, 4, and 6.
结局指标
主要结局
Recruitment Rate Assessed Using Study Recruitment Records
时间窗: through study completion, an average of 1.5 year
Number of participants enrolled divided by the number of eligible participants approached for participation
Retention Rate Assessed Using Study Completion Records
时间窗: through study completion, an average of 1.5 year
Number of enrolled participants who completed the study through the final assessment divided by the number enrolled
Intervention Adherence Assessed Using Intervention Tracking Records
时间窗: through study completion, an average of 1.5 year
Number/proportion of prescribed intervention activities or sessions completed according to the intervention protocol
Session Attendance Assessed Using Intervention Attendance Logs
时间窗: through study completion, an average of 1.5 year
Number and percentage of scheduled intervention sessions attended by each
Participant Satisfaction Assessed by the Client Satisfaction Questionnaire Adapted to Internet-Based Interventions (CSQ-I)
时间窗: Week 8
Participant satisfaction with the intervention will be assessed using the Client Satisfaction Questionnaire adapted to Internet-based interventions (CSQ-I). Scores from all 8 items are summed to produce a total score ranging from 8 to 32, with higher scores indicating greater satisfaction with the intervention.
Intervention Acceptability Assessed by Post-Intervention Interview
时间窗: Week 8
Intervention acceptability will be assessed through a semi-structured post-intervention interview exploring participants' experiences with the intervention, including perceived usefulness, satisfaction, and recommendations for improvement.
次要结局
- Dyadic Coping Assessed by the Dyadic Coping Inventory (DCI)(Baseline, Week 8, Week 12)
- Perceived Stress Assessed by the Perceived Stress Scale-10 (PSS-10)(Baseline, Week 8, Week 12)
- Symptom Burden Assessed by the Edmonton Symptom Assessment System-Revised (ESAS-r)(Baseline, Week 8, Week 12)
- Cigarette Smoking Status Assessed Using Questions From the Behavioral Risk Factor Surveillance System (BRFSS)(Baseline, Week 8, Week 12)
- Smokeless Tobacco Use Assessed Using Questions From the Behavioral Risk Factor Surveillance System (BRFSS)(Baseline, Week 8, and Week 12)
- Electronic Cigarette or Vaping Product Use Assessed Using Questions From the Behavioral Risk Factor Surveillance System (BRFSS)(Baseline, Week 8, and Week 12)
- Smoking Cessation Attempt Assessed Using Questions From the Behavioral Risk Factor Surveillance System (BRFSS)(Baseline, Week 8, and Week 12)
- Alcohol Use Frequency Assessed Using Questions From the Behavioral Risk Factor Surveillance System (BRFSS)(Baseline, Week 8, and Week 12)
- Average Number of Alcoholic Drinks Assessed Using Questions From the Behavioral Risk Factor Surveillance System (BRFSS)(Baseline, Week 8, and Week 12)
- Physical Activity Assessed Using Questions From the Behavioral Risk Factor Surveillance System (BRFSS)(Baseline, Week 8, and Week 12)
- Sleep Quality Assessed by the Pittsburgh Sleep Quality Index (PSQI)(Baseline, Week 8, and Week 12)
- Diet Quality Assessed by the Mini-Eating Assessment Tool (Mini-EAT)(Baseline, Week 8, and Week 12)