Uncertainty in Illness in Palliative Care: an Intervention for Family Caregivers

Study Overview
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Brief Summary
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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.

Official Title
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Nursing Intervention to Manage Uncertainty in Illness in Palliative Care: Feasibility and Acceptability Study in Family Caregivers

Conditions
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Uncertainty, Advanced Cancer, Family Members, Quality of Life

Intervention / Treatment
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* Other: Nursing intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This study proposes phase II in the development of randomized clinical trials for complex interventions, which refers to the development of an exploratory trial. This approach will be developed with participants randomly assigned to two groups (intervention and control) and pre-test and post-test measurements will be taken. The nursing intervention of this study is designed to be evaluated in terms of its viability, acceptability and preliminary effects in a health care institution with family caregivers of people with cancer in palliative care.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nursing intervention<br>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 | Other: Nursing intervention<br>* The intervention was built on the components of the theory of uncertainty in illness and was designed to give in a face to face meeting with the caregiver education about advanced cancer in palliative care through an educational material. Educational material: The educational booklet has the purpose of giving information to the family caregiver about palliative care. This material aims to be an easily accessible resource to understand the palliative care of the cancer patient. In addition, this booklet will be used to ensure the standardization of the intervention during the face-to-face meeting with the participants and the investigator. Face-to-face meeting: The nursing intervention has a face-to-face meeting component between the investigator and the participant. This nursing educational session will be supported by the contents of the booklet and will have the purpose of discussing the contents of the booklet and resolving doubts on the part of the family caregivers.<br>|
| No Intervention: Conventional care<br>The control group will receive the nursing care conventionally given in the health care institution | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recruitment | 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. | This variable will be measured during the process of recruitment of participants in the study that will be during a period of six months. | 
| Follow-up | 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. | 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. | 
| Acceptability | 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. | 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. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Uncertainty in illness | It is a cognitive state that is created when the individual can not adequately structure or categorize an event related to the disease due to insufficient signals to do so. the investigators will use the MISHEL UNCERTAINTY IN ILLNESS SCALE - FAMILY MEMBER FORM develop by Merle Mishel RN, PhD. This scale has 31 items with response options from 1 to 5, ranging from strongly disagree to strongly agree. This instrument in its original version has a structure of two factors. The first, Ambiguity with 19 items. The second, Complexity with 12. For populations with cancer the scale reports an alpha coefficient of between 0.77 to 0.91. The scale has a score of 31 to 150 points where the higher the score, the higher the level of uncertainty. The scale has evidence of transcultural adaptation and validity for the Colombian context. | 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 | 
| Quality of life | it is understood as the subjective perception that each subject has regarding their well-being. The scale measures the quality of life of the family caregiver of the person with cancer. In its original version it has a test-retest consistency of r = .89 and an internal consistency with an alpha value of 0.69. The scale has four dimensions, physical, psychological, social, spiritual well-being. The scale has a total of 37 items that are scored on a scale of 0 to 10, being 0 the worst result and 10 the best result. In its Spanish version it has a test-retest reliability of 0.88 and an internal consistency of 0.80. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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uncertainty, caregivers, palliative care, nursing, Hospice and Palliative Care Nursing