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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-01

Study Completion Date

2019-03-01

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.

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Detailed Description

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Conditions

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Uncertainty Advanced Cancer Family Members Quality of Life

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

the participants in this study won't know if they are in the intervention group or in the control group

Study Groups

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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

Group Type EXPERIMENTAL

Nursing intervention

Intervention Type OTHER

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.

Conventional care

The control group will receive the nursing care conventionally given in the health care institution

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Nursing intervention

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.

Intervention Type OTHER

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No