Nursing Intervention to Manage Uncertainty in Illness in Palliative Care: Feasibility and Acceptability Study in Family Caregivers
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 主要终点
- Recruitment
研究概览
简要总结
Background: The increase of chronic diseases has reached an increase in the suffering of advanced diseases and an inability of health care systems to give access to the population that suffers them. In this context are people with advanced cancer who are in palliative care and the family caregivers. Uncertainty in illness in palliative care and quality of life are two concepts that are altered in the patient's family caregiver in palliative care. Objective: to examine the feasibility and acceptability of a nursing intervention to reduce the uncertainty in illness and improve the quality of life of family caregivers of patients with cancer in palliative care. Methodology: Phase II clinical trial, the ratio of recruitment, follow-up of participants as well as satisfaction with the intervention will be evaluated as primary outcomes. As secondary outcomes, the possible effect of the intervention on the uncertainty in illness and the quality of life of the family caregiver will be evaluated. This study will be carry out in a health care institution in Medellin-Colombia.
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
- Single (Participant)
盲法说明
the participants in this study won't know if they are in the intervention group or in the control group
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
- •Being the person responsible for the care of the person in palliative care most of the time
- •Being over 18 years of age;
- •Caring for a person who has a diagnosis of cancer stage IV, who is receiving palliative treatment for the disease and has an expectation longer than one month of life (determined by the physician)
- •Being able to communicate in Spanish.
排除标准
- •Being included in another institutional study of an educational nature
- •Not knowing how to read
- •Caring for another person with cancer before
- •Have a significant cognitive disability
研究组 & 干预措施
Conventional care
The control group will receive the nursing care conventionally given in the health care institution
Nursing intervention
The experimental group will receive the Nursing intervention to reduce uncertainty in illness and increase quality of life in family caregivers of patients with cancer in palliative care
干预措施: Nursing intervention (Other)
结局指标
主要结局
Recruitment
时间窗: This variable will be measured during the process of recruitment of participants in the study that will be during a period of six months.
this variable is defined as the proportion of eligible participants who agree to participate in the study, within the total of eligible participants. This variable will be measured with the Participant Recruitment Format.
Follow-up
时间窗: this variable will be measured with the participants who complete the study, it will be measured with the participants after the intervention has finished within the framework of the study that will be six months.
This variable is defined as the proportion of participants who entered the study and remained in the study until the post-intervention measurement within the total number of participants in the study. This variable will be measured with the Participation and Follow-up Format of the Participant.
Acceptability
时间窗: this variable will be measured with the participants who complete the study in the intervention group. It will be measured after the intervention within the intervention group in the frame of execution of the study that will be six months.
Refers to the perception that participants have of the intervention to address the problem presented in terms of being reasonable, adequate and convenient for its application in daily life and to meet their expectations. This variable will be measured with the Participant Satisfaction Questionnaire.
次要结局
- Quality of life(this variable will be measure before and after the intervention. The time frame of this measurement will be first at day 1 before the intervention and 5 to 7 days after the intervention)
- Uncertainty in illness(this variable will be measure before and after the intervention. The time frame of this measurement will be first at day 1 before the intervention and 5 to 7 days after the intervention)