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Clinical Trials/NCT03518970
NCT03518970
Unknown
Not Applicable

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

Universidad Nacional de Colombia0 sites60 target enrollmentAugust 1, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Uncertainty
Sponsor
Universidad Nacional de Colombia
Enrollment
60
Primary Endpoint
Recruitment
Last Updated
7 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
August 1, 2018
End Date
March 1, 2019
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Recruitment

Time Frame: 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

Time Frame: 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

Time Frame: 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.

Secondary Outcomes

  • 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)

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