A Multimedia Self-management Intervention to Prepare Family Caregivers and Patients for Lung Cancer Surgery
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 380
- 试验地点
- 1
- 主要终点
- Change in Family Caregiver Psychological Distress (as Measured by the Distress Thermometer)
研究概览
简要总结
This randomized phase III trial studies how well a multimedia self-management intervention works in preparing family caregivers and patients with stage I-III lung cancer for lung cancer surgery. The multimedia self-management intervention, Preparing for your Lung Cancer Surgery, is a nurse-led, caregiver-based, multimedia intervention that may improve patient recovery after surgery, lower caregiving burden, and improve distress and quality of life.
详细描述
PRIMARY OBJECTIVES:
I. Test the effects of the multimedia self-management (MSM) intervention on family caregivers (FCG) outcomes and cancer support services use at discharge and 3-month post-discharge, comparing intervention and attention control groups.
II. Test the effects of the MSM intervention on patient outcomes and healthcare resource use at discharge and 3-months post-discharge, comparing intervention and attention control groups.
III. Test the effects of the MSM intervention on outcome mediators at discharge and 3-months post-discharge, comparing intervention and attention control groups.
SECONDARY OBJECTIVES:
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A family member or friend identified by the patient as being the primary care provider before and after surgery
- •A patient/care recipient enrolled in the study
- •Age 21 years or older
- •Able to read or understand English
- •Patient Inclusion Criteria:
- •Diagnosis of Stage I-III non-small cell lung cancer
- •Scheduled to undergo surgery for treatment
- •A family caregiver enrolled in the study
- •Age 21 years or older
- •Able to read or understand English.
排除标准
- 未提供
研究组 & 干预措施
Group I (MSM intervention)
Patients and FCGs receive the MSM intervention consisting of videos, a handbook, and research nurse coaching over 40-60 minutes, approximately 3-7 days before surgery and within 24 hours of planned discharge. Patients and FCGs also receive research nurse support via telephone(separate sessions for FCGs and patients) over 20-30 minutes at 2 and 7 days, and 2 months post-discharge.
干预措施: Informational Intervention (Other)
Group I (MSM intervention)
Patients and FCGs receive the MSM intervention consisting of videos, a handbook, and research nurse coaching over 40-60 minutes, approximately 3-7 days before surgery and within 24 hours of planned discharge. Patients and FCGs also receive research nurse support via telephone(separate sessions for FCGs and patients) over 20-30 minutes at 2 and 7 days, and 2 months post-discharge.
干预措施: Media Intervention (Other)
Group II (Attention Control)
Patients and FCGs receive attention control intervention consisting of videos (American Cancer Society video on "Clinical Trials"), American Cancer Society print materials, and assistance from a CRA approximately 3-7 days before surgery and within 24 hours of planned discharge. Patients and FCGs also receive assistance from CRAs via telephone at 2 and 7 days, and 2 months post-discharge.
干预措施: Informational Intervention (Other)
Group II (Attention Control)
Patients and FCGs receive attention control intervention consisting of videos (American Cancer Society video on "Clinical Trials"), American Cancer Society print materials, and assistance from a CRA approximately 3-7 days before surgery and within 24 hours of planned discharge. Patients and FCGs also receive assistance from CRAs via telephone at 2 and 7 days, and 2 months post-discharge.
干预措施: Media Intervention (Other)
结局指标
主要结局
Change in Family Caregiver Psychological Distress (as Measured by the Distress Thermometer)
时间窗: Outcomes are measured at baseline, 1 month, and 3 months post-discharge. Absolute values are reported at each timeframe.
Mean caregiver psychological distress scores from baseline to 3 months post-discharge were calculated. A linear mixed-effects model was used to assess differences in psychological distress between the intervention and control arm over time. Score range: 0-10. Higher score means worse outcome.
Change in Caregiving Burden (as Measured by the Montgomery Borgatta Caregiver Burden Scale)
时间窗: Outcomes are measured at baseline, 1 month, and 3 months post-discharge. Absolute values are reported at each timeframe.
Mean caregiver burden scores from baseline to 3 months post-discharge were calculated. A linear mixed-effects model was used to assess differences in burden between the intervention and control arm over time. The model included treatment arm, time, and the interaction between treatment arm and time as effects. Total burden score is calculated by summing items from 3 subscales: objective burden, subjective burden \& demand burden. Score range: 14-70. Higher score means worse outcome.
Change in Preparedness for Caregiving (as Measured by the Preparedness for Caregiving Scale)
时间窗: Outcomes are measured before surgery (baseline), 1 month, and 3 months post-discharge. Absolute values are reported at each timeframe.
Mean caregiver preparedness scores from baseline to 3 months post-discharge were calculated. A linear mixed-effects model was used to assess differences in preparedness between the intervention and control arm over time. Score range: 0-4. Higher score means better outcome.
Change in Family Caregiver Quality of Life (as Measured by the City of Hope-Quality of Life-Family (COH-QOL-Family)
时间窗: Outcomes are measured at baseline, 1 month, and 3 months post-discharge. Absolute values are reported at each timeframe.
Mean caregiver QoL scores from baseline to 3 months post-discharge were calculated. A linear mixed-effects model was used to assess differences in QoL between the intervention and control arm over time. Total QoL score is calculated by summing items from 3 subscales: physical well-being, psychological well-being, social concerns \& spiritual well-being. Score range: 0-40. Higher score means better outcome.
Number of Participants Who Used Family Caregiver Resource (as Measured by the Family Caregiver Healthcare Use Inventory)
时间窗: Outcomes are measured at discharge, 1 month, and 3 months post-discharge.
Differences in the number of caregivers who saw a support services specialist were compared between both groups using Chi-squared and Fisher's exact test.
Change in Patient Psychological Distress (as Measured by the Distress Thermometer)
时间窗: Outcomes are measured at baseline, 1 month, and 3 months post-discharge. Absolute values are reported at each timeframe.
Mean patient psychological distress scores from baseline to 3 months post-discharge were calculated. A linear mixed-effects model was used to assess differences in psychological distress between the intervention and control arm over time. Score range: 0-10. Higher score means worse outcome.
Change in Patient Quality of Life (as Measured by the Functional Assessment of Cancer Therapy-Lung - FACT-L)
时间窗: Outcomes are measured at baseline, 1 month, and 3 months post-discharge. Absolute values are reported at each timeframe.
Mean patient QoL scores from baseline to 3 months post-discharge were calculated. A linear mixed-effects model was used to assess differences in QoL between the intervention and control arm over time. Total FACT-L score is calculated by summing items from 5 subscales: physical well-being, social/family well-being, emotional well-being, functional well-being \& lung cancer subscale. Score range: 0-136. Higher score means better outcome.
Number of Participants Who Used Patient Healthcare Resource Use (Home Health Nursing Care, Urgent/ER Visits, Hospital Readmissions)
时间窗: Outcomes are measured at 1 month, and 3 months post-discharge.
Differences in the number of patients who were readmitted to the hospital for an overnight stay were compared between both groups using Chi-squared and Fisher's exact test.
次要结局
- Change in Family Caregiver Knowledge (as Measured by the Surgery-Related Knowledge Tool)(Outcomes are measured at baseline, 1 month, and 3 months post-discharge)
- Change in Family Caregiver Self-efficacy (as Measured by the Self-Efficacy Scale)(Outcomes are measured at baseline, 1 month, and 3 months post-discharge. Absolute values are reported at each timeframe.)
- Change in Patient Self-efficacy (as Measured by the Self-Efficacy Scale)(Outcomes are measured at baseline, 1 month, and 3 months post-discharge. Absolute values are reported at each timeframe.)
- Change in Family Caregiver Activation (as Measured by the FCG Activation in Transitions Tool)(Outcomes are measured at baseline, 1 month, and 3 months post-discharge. Absolute values are reported at each timeframe.)
- Change in Patient Activation (as Measured by the Patient Activation Measure)(Outcomes are measured at baseline, 1 month, and 3 months post-discharge. Absolute values are reported at each timeframe.)
- Change in Patient Knowledge (as Measured by the Surgery-Related Knowledge Tool)(Outcomes are measured at baseline, 1 month, and 3 months post-discharge)