Testing the Utility of a Novel Website to Help Cancer Patients Plan for Their Future - Phase 2
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Accrual
研究概览
简要总结
This clinical trial examines a web-based tool, in partnership with Peacefully, Inc, designed to improve end-of-life planning among patients with advanced cancers. This program helps users prepare comprehensively for end-of-life (e.g., medical wishes, legal estate planning, financial planning and transfer of accounts, legacy building, and emotional support). It is expected that this web-based end-of-life planning program may reduce distress and improve end-of-life preparation among advanced cancer patients.
详细描述
OUTLINE:
Patients are randomized to 1 of 2 groups and their engagement in end-of-life planning is assessed at baseline and four weeks post-randomization.
Group I (intervention): Patients receive Peacefully's web-based tool to help with end-of-life planning on day 7.
Group II (control): Patients receive standard of care.
After completion of study, patients are followed up at 4, 12, and 24 weeks post-randomization.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of poor prognosis advanced cancer defined as locally advanced or metastatic cancer and/or disease progression following at least first line systemic therapy
- •Access to a computer or mobile device
- •The ability to provide informed consent
排除标准
- •Not fluent in English
- •Severely cognitively impaired (as measured by Short Portable Mental Status Questionnaire scores of < 6)
- •Too ill or weak to complete the interviews (as judged by the interviewer)
结局指标
主要结局
Accrual
时间窗: Up to 36 months
The number of participants enrolled during the recruitment period.
Retention rates
时间窗: Up to 36 months
The number of participants who completed all study activities.
Change in patients' engagement in advance care planning, as measured by the Decision Maker subscale of the Advance Care Planning Engagement Survey: Action Measures, from baseline to 4 weeks post-randomization
时间窗: Baseline and Week 4 post-randomization
Change in patient engagement in advance care planning will be assessed in patients using the reliable and valid Decision Maker (four items) subscale of the Advance Care Planning Engagement Survey: Action Measures. Response options include: yes=1, no=0. Questions include those asking about whether patients have engaged in a decision around advance care planning (e.g., "Have you already decided who you want your medical decision maker to be?" Individual scores can range from 0 to 4, with higher scores indicating that more decisions have been made around advance care planning. Change scores can range from -4 to +4.
Change in patients' engagement in advance care planning, as measured by the Quality of Life subscale of the Advance Care Planning Engagement Survey: Action Measures, from baseline to 24 weeks post-randomization
时间窗: Baseline and Week 24 post-randomization
Change in patient engagement in advance care planning will be assessed in patients using the reliable and valid Quality of Life (four items) subscale of the Advance Care Planning Engagement Survey: Action Measures. Response options include: yes=1, no=0. Questions include those asking about whether patients have engaged in a decision around quality of life in advance care planning (e.g., "Have you already decided whether or not certain health situations would make your life not worth living?" Individual scores can range from 0 to 4, with higher scores indicating that more decisions have been made around advance care planning as it pertains to quality of life. Change scores can range from -4 to +4.
Change in patients' engagement in advance care planning, as measured by the Decision Maker subscale of the Advance Care Planning Engagement Survey: Action Measures, from baseline to 12 weeks post-randomization
时间窗: Baseline and Week 12 post-randomization
Change in patient engagement in advance care planning will be assessed in patients using the reliable and valid Decision Maker (four items) subscale of the Advance Care Planning Engagement Survey: Action Measures. Response options include: yes=1, no=0. Questions include those asking about whether patients have engaged in a decision around advance care planning (e.g., "Have you already decided who you want your medical decision maker to be?" Individual scores can range from 0 to 4, with higher scores indicating that more decisions have been made around advance care planning. Change scores can range from -4 to +4.
Change in patients' engagement in advance care planning, as measured by the Decision Maker subscale of the Advance Care Planning Engagement Survey: Action Measures, from baseline to 24 weeks post-randomization
时间窗: Baseline and Week 24 post-randomization
Change in patient engagement in advance care planning will be assessed in patients using the reliable and valid Decision Maker (four items) subscale of the Advance Care Planning Engagement Survey: Action Measures. Response options include: yes=1, no=0. Questions include those asking about whether patients have engaged in a decision around advance care planning (e.g., "Have you already decided who you want your medical decision maker to be?" Individual scores can range from 0 to 4, with higher scores indicating that more decisions have been made around advance care planning. Change scores can range from -4 to +4.
Change in patients' engagement in advance care planning, as measured by the Quality of Life subscale of the Advance Care Planning Engagement Survey: Action Measures, from baseline to 12 weeks post-randomization
时间窗: Baseline and Week 12 post-randomization
Change in patient engagement in advance care planning will be assessed in patients using the reliable and valid Quality of Life (four items) subscale of the Advance Care Planning Engagement Survey: Action Measures. Response options include: yes=1, no=0. Questions include those asking about whether patients have engaged in a decision around quality of life in advance care planning (e.g., "Have you already decided whether or not certain health situations would make your life not worth living?" Individual scores can range from 0 to 4, with higher scores indicating that more decisions have been made around advance care planning as it pertains to quality of life. Change scores can range from -4 to +4.
Change in advance care planning engagement: conversations discussing EoL care, living will, HCP, and DNR orders with doctors, from baseline to 4 weeks post-randomization
时间窗: Baseline and Week 4 post-randomization
Engagement in ACP with doctors will be assessed in patients. This outcome will consist of documentation of ACP conversations using the investigators' previously utilized 8-item measure of discussing EoL care, living will, HCP, and DNR orders with family (4 items) and doctors (4 items). Scores for the doctor subscale are computed by summing together the total number of ACP topic discussed with the patient's doctors. Scores can range from 0 to 4, with higher scores indicating increases in engagement in ACP conversations with doctors.
Change in patients' engagement in advance care planning, as measured by the Quality of Life subscale of the Advance Care Planning Engagement Survey: Action Measures, from baseline to 4 weeks post-randomization
时间窗: Baseline and Week 4 post-randomization
Change in patient engagement in advance care planning will be assessed in patients using the reliable and valid Quality of Life (four items) subscale of the Advance Care Planning Engagement Survey: Action Measures. Response options include: yes=1, no=0. Questions include those asking about whether patients have engaged in a decision around quality of life in advance care planning (e.g., "Have you already decided whether or not certain health situations would make your life not worth living?" Individual scores can range from 0 to 4, with higher scores indicating that more decisions have been made around advance care planning as it pertains to quality of life. Change scores can range from -4 to +4.
Change in advance care planning engagement: conversations discussing EoL care, living will, HCP, and DNR orders with family members and loved ones, from baseline to 24 weeks post-randomization
时间窗: Baseline and Week 24 post-randomization
Engagement in ACP with family members and loved ones will be assessed in patients. This outcome will consist of documentation of ACP conversations using the investigators' previously utilized 8-item measure of discussing EoL care, living will, HCP, and DNR orders with family (4 items) and doctors (4 items). Scores for the family subscale are computed by summing together the total number of ACP topic discussed with the patient's family members and loved ones. Scores can range from 0 to 4, with higher scores indicating increases in engagement in ACP conversations with family members and loved ones.
Change in advance care planning engagement: conversations discussing EoL care, living will, HCP, and DNR orders with doctors, from baseline to 24 weeks post-randomization
时间窗: Baseline and Week 24 post-randomization
Engagement in ACP with doctors will be assessed in patients. This outcome will consist of documentation of ACP conversations using the investigators' previously utilized 8-item measure of discussing EoL care, living will, HCP, and DNR orders with family (4 items) and doctors (4 items). Scores for the doctor subscale are computed by summing together the total number of ACP topic discussed with the patient's doctors. Scores can range from 0 to 4, with higher scores indicating increases in engagement in ACP conversations with doctors.
Change in advance care planning engagement: conversations discussing EoL care, living will, HCP, and DNR orders with family members and loved ones, from baseline to 4 weeks post-randomization
时间窗: Baseline and Week 4 post-randomization
Engagement in ACP with family members and loved ones will be assessed in patients. This outcome will consist of documentation of ACP conversations using the investigators' previously utilized 8-item measure of discussing EoL care, living will, HCP, and DNR orders with family (4 items) and doctors (4 items). Scores for the family subscale are computed by summing together the total number of ACP topic discussed with the patient's family members and loved ones. Scores can range from 0 to 4, with higher scores indicating increases in engagement in ACP conversations with family members and loved ones.
Change in advance care planning engagement: conversations discussing EoL care, living will, HCP, and DNR orders with family members and loved ones, from baseline to 12 weeks post-randomization
时间窗: Baseline and Week 12 post-randomization
Engagement in ACP with family members and loved ones will be assessed in patients. This outcome will consist of documentation of ACP conversations using the investigators' previously utilized 8-item measure of discussing EoL care, living will, HCP, and DNR orders with family (4 items) and doctors (4 items). Scores for the family subscale are computed by summing together the total number of ACP topic discussed with the patient's family members and loved ones. Scores can range from 0 to 4, with higher scores indicating increases in engagement in ACP conversations with family members and loved ones.
Change in advance care planning engagement: completion of advance directives, from baseline to 12 weeks post-randomization
时间窗: Baseline and Week 12 post-randomization
Completion of advance directives will be assessed by asking patients whether they completed a do-not-resuscitate order, a living will, and/or identified a health care proxy; data will be verified through the patient's electronic health record. Change in these numbers will be assessed at baseline and post-intervention. Scores are computed by summing together the total number of advance directives completed. Scores can range from 0 to 3, with higher scores indicating increases in completion of advance directives. Change scores can range from -3 to +3.
Change in advance care planning engagement: conversations discussing EoL care, living will, HCP, and DNR orders with doctors, from baseline to 12 weeks post-randomization
时间窗: Baseline and Week 12 post-randomization
Engagement in ACP with doctors will be assessed in patients. This outcome will consist of documentation of ACP conversations using the investigators' previously utilized 8-item measure of discussing EoL care, living will, HCP, and DNR orders with family (4 items) and doctors (4 items). Scores for the doctor subscale are computed by summing together the total number of ACP topic discussed with the patient's doctors. Scores can range from 0 to 4, with higher scores indicating increases in engagement in ACP conversations with doctors.
Change in advance care planning engagement: completion of advance directives, from baseline to 24 weeks post-randomization
时间窗: Baseline and Week 24 post-randomization
Completion of advance directives will be assessed by asking patients whether they completed a do-not-resuscitate order, a living will, and/or identified a health care proxy; data will be verified through the patient's electronic health record. Change in these numbers will be assessed at baseline and post-intervention. Scores are computed by summing together the total number of advance directives completed. Scores can range from 0 to 3, with higher scores indicating increases in completion of advance directives. Change scores can range from -3 to +3.
Change in advance care planning engagement: completion of advance directives, from baseline to 4 weeks post-randomization
时间窗: Baseline and Week 4 post-randomization
Completion of advance directives will be assessed by asking patients whether they completed a do-not-resuscitate order, a living will, and/or identified a health care proxy; data will be verified through the patient's electronic health record. Change in these numbers will be assessed at baseline and post-intervention. Scores are computed by summing together the total number of advance directives completed. Scores can range from 0 to 3, with higher scores indicating increases in completion of advance directives. Change scores can range from -3 to +3.
次要结局
- Change in psychological distress, as measured by the Hospital Anxiety and Depression Scale (HADS), from baseline to 4 weeks post-randomization(Baseline and Week 4 post-randomization)
- Change in comprehensive end-of-life planning, from baseline to 12 weeks post-randomization(Baseline and Week 12 post-randomization)
- Change in psychological distress, as measured by the Hospital Anxiety and Depression Scale (HADS), from baseline to 24 weeks post-randomization(Baseline and Week 24 post-randomization)
- Change in emotional well-being, as measured by the Functional Assessment of Cancer Therapy-General (FACT-G) scale, from baseline to 4 weeks post-randomization(Baseline and Week 4 post-randomization)
- Change in social/family well-being, as measured by the Functional Assessment of Cancer Therapy-General scale, from baseline to 4 weeks post-randomization(Baseline and Week 4 post-randomization)
- Change in comprehensive end-of-life planning, from baseline to 4 weeks post-randomization(Baseline and Week 4 post-randomization)
- Change in psychological distress, as measured by the Hospital Anxiety and Depression Scale (HADS), from baseline to 12 weeks post-randomization(Baseline and Week 12 post-randomization)
- Change in comprehensive end-of-life planning, from baseline to 24 weeks post-randomization(Baseline and Week 24 post-randomization)
- Change in emotional well-being, as measured by the Functional Assessment of Cancer Therapy-General (FACT-G) scale, from baseline to 12 weeks post-randomization(Baseline and Week 12 post-randomization)
- Change in emotional well-being, as measured by the Functional Assessment of Cancer Therapy-General (FACT-G) scale, from baseline to 24 weeks post-randomization(Baseline and Week 24 post-randomization)
- Change in social/family well-being, as measured by the Functional Assessment of Cancer Therapy-General scale, from baseline to 12 weeks post-randomization(Baseline and Week 12 post-randomization)
- Change in social/family well-being, as measured by the Functional Assessment of Cancer Therapy-General scale, from baseline to 24 weeks post-randomization(Baseline and Week 24 post-randomization)
- Change in spiritual well-being, as measured by the Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being Scale (FACIT-Sp), from baseline to 4 weeks post-randomization(Baseline and Week 4 post-randomization)
- Change in spiritual well-being, as measured by the Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being Scale, from baseline to 12 weeks post-randomization(Baseline and Week 12 post-randomization)
- Change in spiritual well-being, as measured by the Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being Scale, from baseline to 24 weeks post-randomization(Baseline and Week 24 post-randomization)
- Change in financial well-being, as measured by the InCharge Financial Distress/Financial Well-Being scale, from baseline to 4 weeks post-randomization(Baseline and Week 4 post-randomization)
- Change in financial well-being, as measured by the InCharge Financial Distress/Financial Well-Being scale, from baseline to 24 weeks post-randomization(Baseline and Week 24 post-randomization)
- Change in financial well-being, as measured by the InCharge Financial Distress/Financial Well-Being scale, from baseline to 12 weeks post-randomization(Baseline and Week 12 post-randomization)