Mobilized Psychoeducation and Skills Based Intervention (Pep-Pal) for Caregivers of Patients With Advanced Illness
2020年7月31日 更新者：University of Colorado, Denver
A Pilot Study of a Mobilized Psychoeducation and Skills Based Intervention (Pep-Pal) for Caregivers of Patients With Advanced Illness
The proposed project is a pilot study of the Pep-Pal (Psychoeducation and Skills Based Intervention) versus a treatment as usual control group.
A total of 60 caregivers; including caregivers of patients with HSCT (Hematopoietic Stem Cell Transplantation), caregivers enrolled in Phase I clinical trials, and caregivers of patients with advanced cancer (Stage III, solid tumor) will be enrolled in this study.
The investigators do not expect different outcomes from these three groups, rather these populations are selected to optimize recruitment within a short time frame.
The caregivers will be randomized to either treatment as usual or Pep-Pal intervention.
研究概览
详细说明
The proposed project is a pilot study of the Pep-Pal intervention versus a treatment as usual control group.
A total of 60 caregivers; caregivers of patients with HSCT, caregivers of patients enrolled in phase I oncology trials, and caregivers of patients with advanced cancer (Stage IV, solid tumor) will be enrolled in this study.
The investigators do not expect different outcomes from these three groups, rather these populations are selected to optimize recruitment within a short time frame.
The caregivers will be randomized to either treatment as usual or Pep-Pal intervention.
The proposed study population is based on prior research indicating that caregivers of patients receiving HSCT, caregivers of patients enrolled in phase I oncology trials, and caregivers of patients with advanced cancer experience significant distress.
In addition, an initial study of caregivers of patients receiving allogeneic-HSCT were able to benefit from a brief, cognitive behavioral stress management treatment approach.
A study examining distress in phase I oncology clinical trial patient caregivers highlighted the need for more support for this significantly distressed population.
Furthermore, initial results of the qualitative development study for Pep-Pal yielded support for a mobilized platform delivery of resources for caregivers to manage distress because they acknowledged many barriers to engaging in in-person treatment to manage distress.
研究类型
介入性
注册 (实际的)
69
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Colorado
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Aurora、Colorado、美国、80045
- University of Colorado, Denver
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 85年 (成人、年长者)
接受健康志愿者
是的
有资格学习的性别
全部
描述
Inclusion Criteria:
- Women and men ≥ 18 years of age of any ethnicity
- Must endorse a moderate level of anxiety (e.g. Score above an 8 on the Hospital and Anxiety Depression Scale (HADS))
- Speak and read in English
- Caregiver of a patient with auto HSCT who are moving forward with bone marrow transplant or have receive a bone marrow transplant
- Caregiver of a patient in a Phase I Clinical Trial
- Caregiver of a patient diagnosed with advanced cancer (stage III or stage IV)
- No Cognitive or psychiatric conditions prohibiting participation
- Must meet criteria for being a primary caregiver, defined as, the person in the patient's life who is primarily responsible for care decisions, emotionally invested in the patient's care, provides instrumental care such as transportation for a patient receiving auto-HSCT, enrolled in a phase I oncology clinical trial, or of a patient diagnosed with advanced cancer (stage IV, solid tumor).
- Have a computer, smartphone, or tablet with internet access
Exclusion Criteria:
- Caregivers below the age of 18
- Score below an 8 on the Hospital and Anxiety Depression Scale (HADS)
- Cannot speak and read in English
- Patient does not receive a bone marrow transplant
- Patient is not enrolled in a Phase I clinical trial
- Patient is not diagnosed with Stage III or Stage IV cancer
- Cognitive conditions prohibiting participation
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Pep-Pal + Treatment as Usual
If the caregiver is assigned to the Pep-Pal intervention condition, the RA will provide access to the mobilized website (passcode) through an email.
Caregivers will be instructed to watch each session at least once.
It will be recommended that caregivers watch one to two new sessions per week so that they can have enough time to practice the skills between sessions.
In addition, they will be told that they can go back and watch the sessions for review as many times as they like.
Full participation will be defined as watching at least 7/9 sessions (75% of program) based on previous criteria for similar intervention completion in a prior trial with advanced cancer patients.
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Pep-Pal is designed to complement the utilization of other resources, provide support when no other resources can be obtained, or provide support in the interim until greater resources can be obtained.
In this way, Pep-Pal is a resource for our most hard to reach caregivers.
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有源比较器：Treatment as Usual
Treatment as usual provides voluntary (at the caregiver's discretion) support services for the caregivers which is rarely used by the caregivers.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Evaluation of Exit Interviews
大体时间：12 weeks
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Qualitative feedback will be gathered from the first 15 Pep-Pal completer's for individual interviews (5 from Phase I group, 5 from Hematopoietic stem cell transplantation (HSCT) group, 5 from medical oncology) upon completion of the follow-up assessments at 12 weeks about usage, acceptability of content, and impressions of using Pep-Pal.
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12 weeks
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Pep-Pal Self-Report sessions at 12 Weeks
大体时间：12 weeks
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The Investigators will assess feasibility by examining recruitment, retention, as well as reasons for refusal, frequency of sessions watched and length of time spent watching each session.
Self report usage of peppal: Usage of Pep-Pal will be quantitatively assessed by asking each participant in the intervention group about their usage including frequency; how many times they watched each session and length of viewing for each session (partial or complete).
They will be asked to rate level of usage based on a Likert-scale ranging from not at all to very often for each session (0-10).
They will be asked to rank order the list of sessions from most helpful to least helpful.
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12 weeks
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Evaluation of Self-Report Caregiver reported outcomes at Baseline
大体时间：Week 1
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Hospital Anxiety and Depression Scale-Anxiety subscale (HADS-A)
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Week 1
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Evaluation of Self-report caregiver reported outcomes at 12 weeks
大体时间：Week 12
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Hospital Anxiety and Depression Scale-Anxiety subscale (HADS-A)
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Week 12
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Evaluation of Self-report caregiver reported outcomes at baseline
大体时间：Week 1
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Center for Epidemiologic Studies Depression Scale (CESD)
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Week 1
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Evaluation of Self-report caregiver reported outcomes at baseline
大体时间：Week 1
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Perceived Stress Scale (PSS)
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Week 1
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Evaluation of Self-report caregiver reported outcomes at baseline
大体时间：Week 1
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Female Sexual Function Index (FSFI)
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Week 1
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Evaluation of Self-report caregiver reported outcomes at baseline
大体时间：Week 1
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Male Sexual Health Questionnaire(MSHQ)
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Week 1
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Evaluation of Self-report caregiver reported outcomes at baseline
大体时间：Week 1
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Measure of Current Status (MOCS-A)
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Week 1
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Evaluation of Self-report caregiver reported outcomes at 12 weeks
大体时间：Week 12
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Center for Epidemiologic Studies Depression Scale (CESD)
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Week 12
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Evaluation of Self-report caregiver reported outcomes at 12 weeks
大体时间：Week 12
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Perceived Stress Scale (PSS)
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Week 12
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Evaluation of Self-report caregiver reported outcomes at 12 weeks
大体时间：Week 12
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Female Sexual Function Index (FSFI)
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Week 12
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Evaluation of Self-report caregiver reported outcomes at 12 weeks
大体时间：Week 12
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Male Sexual Health Questionnaire(MSHQ)
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Week 12
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Evaluation of Self-report caregiver reported outcomes at 12 weeks
大体时间：Week 12
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Measure of Current Status (MOCS-A)
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Week 12
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Nicole R Amoyal-Pensak, PhD、University of Colorado, Denver
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Pensak NA, Carr AL, Jones J, Mikulich-Gilbertson SK, Kutner JS, Kilbourn K, Sannes TS, Brewer BB, Kolva E, Joshi T, Laudenslager ML. A pilot study of mobilized intervention to help caregivers of oncology patients manage distress. Psychooncology. 2021 Apr;30(4):520-528. doi: 10.1002/pon.5597. Epub 2020 Dec 2.
- Carr AL, Jones J, Mikulich Gilbertson S, Laudenslager ML, Kutner JS, Kilbourn K, Sannes TS, Brewer BW, Kolva E, Joshi T, Amoyal Pensak N. Impact of a Mobilized Stress Management Program (Pep-Pal) for Caregivers of Oncology Patients: Mixed-Methods Study. JMIR Cancer. 2019 May 3;5(1):e11406. doi: 10.2196/11406.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2016年12月1日
初级完成 (实际的)
2017年11月17日
研究完成 (实际的)
2018年7月13日
研究注册日期
首次提交
2016年9月28日
首先提交符合 QC 标准的
2016年12月21日
首次发布 (估计)
2016年12月26日
研究记录更新
最后更新发布 (实际的)
2020年8月4日
上次提交的符合 QC 标准的更新
2020年7月31日
最后验证
2020年7月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
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