A Computer-Based Intervention for Distance Caregivers of Parents With Advanced Cancer
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- effect of CLOSER intervention on caregiver anxiety
研究概览
简要总结
This pilot clinical trial studies the feasibility and effectiveness of a new computer-based communication intervention in supporting distance caregivers of patients with advanced lung or brain cancer. Unlike local caregivers, distance caregivers often receive little, if any, professional support and have limited communication with the oncology team. Using a computer-based communication intervention to allow distance caregivers the opportunity to participate in a physician visit, have questions and concerns addressed, and meet members of the oncology team may help reduce stress.
详细描述
PRIMARY OBJECTIVES:
I. What is the relationship of primary stressors (type and stage/grade of cancer, and patient quality of life [QOL]) and structural factors/stressors (age, gender, race, and education) with patient and caregiver psychological outcomes at baseline? II. What are the effects of the Communication with Long Distance Caregivers Offering a Supportive Electronic Resource (CLOSER) intervention on distance caregiver psychological outcomes (anxiety and distress), controlling for primary stressors (type and stage/grade of cancer, and patient quality of life), distance caregiver structural factors/stressors (caregiver age, gender, race, and employment), and baseline anxiety and distress? III. What are the effects of the CLOSER intervention on patient psychological outcomes (anxiety and distress), controlling for primary stressors (type and stage/grade of cancer, and patient quality of life), distance caregiver structural factors/stressors (caregiver age, gender, race, and employment), and baseline anxiety and distress? IV. What is the feasibility (time, cost, resources and acceptability to patients, caregivers and clinicians) of using Adobe Connect, a computer-based web communication system, with the distance caregiver, the parent with advanced cancer, and the health care providers together in a routine follow-up oncology office visit? V. What is the experience of being a distance caregiver participating in the CLOSER intervention?
OUTLINE: Participants are assigned to 1 of 2 arms.
ARM I: Participants receive usual care for 5 weeks. During the week 5 office visit, distance caregivers are not present.
ARM II: Participants receive usual care for 5 weeks. During the week 5 visit, distance caregivers virtually attend using the CLOSER intervention with computer video and audio connection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •INCLUSION CRITERIA FOR PATIENTS:
- •Having a diagnosis of advanced lung cancer or malignant brain tumor for two to six months
- •Receiving on-going care from the medical oncologist at the Seidman Cancer Center
- •Having a primary and distance caregiver involved in their care, support, and/or care planning
- •English as a primary language
- •Capacity to provide informed consent, as validated by the oncologist
- •INCLUSION CRITERIA FOR DISTANCE CAREGIVERS:
- •Family caregiver of a patient with advanced lung cancer or malignant brain tumor
- •Patient and distance caregiver perception that this caregiver's geographic location is such that precludes routine participation in medical appointments
- •English as primary language
- •Capable of providing informed consent
- •Computer ownership with internet access
排除标准
- •EXCLUSION CRITERIA FOR PATIENTS:
- •No primary caregiver
- •Enrolled in hospice
- •EXCLUSION CRITERIA FOR DISTANCE CAREGIVERS:
- •Those who routinely participate in most of the patient's medical appointments (once or more per month)
研究组 & 干预措施
Arm I (usual care)
Participants receive usual care (care from physician, physician nurse, and social worker) for 5 weeks. During the week 5 office visit, distance caregivers are not present. In the pre-physician interview patients will verbally complete the FACT, POMS-B, Tension-Anxiety subscale, Distress Thermometer. Distance caregivers will verbally complete the POMS-B, Tension-Anxiety subscale, and Distress Thermometer
干预措施: Profile of Mood States (POMS-B) (Other)
Arm I (usual care)
Participants receive usual care (care from physician, physician nurse, and social worker) for 5 weeks. During the week 5 office visit, distance caregivers are not present. In the pre-physician interview patients will verbally complete the FACT, POMS-B, Tension-Anxiety subscale, Distress Thermometer. Distance caregivers will verbally complete the POMS-B, Tension-Anxiety subscale, and Distress Thermometer
干预措施: Usual care (Procedure)
Arm I (usual care)
Participants receive usual care (care from physician, physician nurse, and social worker) for 5 weeks. During the week 5 office visit, distance caregivers are not present. In the pre-physician interview patients will verbally complete the FACT, POMS-B, Tension-Anxiety subscale, Distress Thermometer. Distance caregivers will verbally complete the POMS-B, Tension-Anxiety subscale, and Distress Thermometer
干预措施: Distress Thermometer (Other)
Arm I (usual care)
Participants receive usual care (care from physician, physician nurse, and social worker) for 5 weeks. During the week 5 office visit, distance caregivers are not present. In the pre-physician interview patients will verbally complete the FACT, POMS-B, Tension-Anxiety subscale, Distress Thermometer. Distance caregivers will verbally complete the POMS-B, Tension-Anxiety subscale, and Distress Thermometer
干预措施: Quality of Life: Functional Assessment in Cancer Therapy - (FACT) (Other)
Arm I (usual care)
Participants receive usual care (care from physician, physician nurse, and social worker) for 5 weeks. During the week 5 office visit, distance caregivers are not present. In the pre-physician interview patients will verbally complete the FACT, POMS-B, Tension-Anxiety subscale, Distress Thermometer. Distance caregivers will verbally complete the POMS-B, Tension-Anxiety subscale, and Distress Thermometer
干预措施: Tension-Anxiety Subscale (Other)
Arm II (usual care with CLOSER intervention)
Participants receive usual care (care from physician, physician nurse, and social worker) for 5 weeks. During the week 5 office visit, distance caregivers will use a computer-assisted intervention to be present electronically with video and audio feed to provide psychosocial support. In the pre-physician interview patients will verbally complete the FACT, POMS-B, Tension-Anxiety subscale, Distress Thermometer. Distance caregivers will verbally complete the POMS-B, Tension-Anxiety subscale, and Distress Thermometer. Up to 96 hours after the week 5 visit, patients and caregivers will be interviewed about their experience during the intervention
干预措施: Usual care (Procedure)
Arm II (usual care with CLOSER intervention)
Participants receive usual care (care from physician, physician nurse, and social worker) for 5 weeks. During the week 5 office visit, distance caregivers will use a computer-assisted intervention to be present electronically with video and audio feed to provide psychosocial support. In the pre-physician interview patients will verbally complete the FACT, POMS-B, Tension-Anxiety subscale, Distress Thermometer. Distance caregivers will verbally complete the POMS-B, Tension-Anxiety subscale, and Distress Thermometer. Up to 96 hours after the week 5 visit, patients and caregivers will be interviewed about their experience during the intervention
干预措施: computer-assisted intervention (Other)
Arm II (usual care with CLOSER intervention)
Participants receive usual care (care from physician, physician nurse, and social worker) for 5 weeks. During the week 5 office visit, distance caregivers will use a computer-assisted intervention to be present electronically with video and audio feed to provide psychosocial support. In the pre-physician interview patients will verbally complete the FACT, POMS-B, Tension-Anxiety subscale, Distress Thermometer. Distance caregivers will verbally complete the POMS-B, Tension-Anxiety subscale, and Distress Thermometer. Up to 96 hours after the week 5 visit, patients and caregivers will be interviewed about their experience during the intervention
干预措施: Distress Thermometer (Other)
Arm II (usual care with CLOSER intervention)
Participants receive usual care (care from physician, physician nurse, and social worker) for 5 weeks. During the week 5 office visit, distance caregivers will use a computer-assisted intervention to be present electronically with video and audio feed to provide psychosocial support. In the pre-physician interview patients will verbally complete the FACT, POMS-B, Tension-Anxiety subscale, Distress Thermometer. Distance caregivers will verbally complete the POMS-B, Tension-Anxiety subscale, and Distress Thermometer. Up to 96 hours after the week 5 visit, patients and caregivers will be interviewed about their experience during the intervention
干预措施: Profile of Mood States (POMS-B) (Other)
Arm II (usual care with CLOSER intervention)
Participants receive usual care (care from physician, physician nurse, and social worker) for 5 weeks. During the week 5 office visit, distance caregivers will use a computer-assisted intervention to be present electronically with video and audio feed to provide psychosocial support. In the pre-physician interview patients will verbally complete the FACT, POMS-B, Tension-Anxiety subscale, Distress Thermometer. Distance caregivers will verbally complete the POMS-B, Tension-Anxiety subscale, and Distress Thermometer. Up to 96 hours after the week 5 visit, patients and caregivers will be interviewed about their experience during the intervention
干预措施: Quality of Life: Functional Assessment in Cancer Therapy - (FACT) (Other)
Arm II (usual care with CLOSER intervention)
Participants receive usual care (care from physician, physician nurse, and social worker) for 5 weeks. During the week 5 office visit, distance caregivers will use a computer-assisted intervention to be present electronically with video and audio feed to provide psychosocial support. In the pre-physician interview patients will verbally complete the FACT, POMS-B, Tension-Anxiety subscale, Distress Thermometer. Distance caregivers will verbally complete the POMS-B, Tension-Anxiety subscale, and Distress Thermometer. Up to 96 hours after the week 5 visit, patients and caregivers will be interviewed about their experience during the intervention
干预措施: Tension-Anxiety Subscale (Other)
结局指标
主要结局
effect of CLOSER intervention on caregiver anxiety
时间窗: Up to 96 hours after week 5 visit
A two sample t-test will be conducted to compare differences in baseline to post-treatment POMS-B scores between the usual care and intervention caregiver groups
Frequency of technological errors
时间窗: Up to 96 hours after week 5 visit
Will be used to determine the feasibility of using Adobe's computer-based web communication system.
Length of time of physician office visit
时间窗: Up to 96 hours after week 5 visit
Will be used to determine the feasibility of using Adobe's computer-based web communication system.
effect of CLOSER intervention on patient distress
时间窗: Up to 96 hours after week 5 visit
A two sample t-test will be conducted to compare differences in baseline to post-treatment Distress Thermometer scores between the usual care and intervention patient groups
Primary stressors (type and stage/grade of cancer, and patient QOL)
时间窗: Baseline
Regression analysis will be run to explore the influence of primary stressors and structural factors on patient and caregiver outcomes (anxiety and distress).
effect of CLOSER intervention on caregiver distress
时间窗: Up to 96 hours after week 5 visit
A two sample t-test will be conducted to compare differences in baseline to post-treatment Distress Thermometer scores between the usual care and intervention caregiver groups
effect of CLOSER intervention on patient anxiety
时间窗: Up to 96 hours after week 5 visit
A two sample t-test will be conducted to compare differences in baseline to post-treatment POMS-B scores between the usual care and intervention patient groups
Perceived ease of use
时间窗: Up to 96 hours after week 5 visit
Will be used to determine the feasibility of using Adobe's computer-based web communication system.
次要结局
未报告次要终点