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

NCT03518970 | Unknown

• 1 other identifier: AVAL-O35-17
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Uncertainty; Advanced Cancer; Family Members; Quality of Life

Keywords

uncertainty; caregivers; palliative care; nursing; Hospice and Palliative Care Nursing

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• 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

• 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

Study Arms (2)

Nursing intervention

EXPERIMENTAL

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

Conventional care

NO INTERVENTION

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

Interventions

Nursing intervention 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.

Nursing intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidad Nacional de Colombia: lead

Related Publications (8)

• Northouse L, Kershaw T, Mood D, Schafenacker A. Effects of a family intervention on the quality of life of women with recurrent breast cancer and their family caregivers. Psychooncology. 2005 Jun;14(6):478-91. doi: 10.1002/pon.871.

  PMID: 15599947 BACKGROUND

• Moore G, Collins A, Brand C, Gold M, Lethborg C, Murphy M, Sundararajan V, Philip J. Palliative and supportive care needs of patients with high-grade glioma and their carers: a systematic review of qualitative literature. Patient Educ Couns. 2013 May;91(2):141-53. doi: 10.1016/j.pec.2012.11.002. Epub 2012 Dec 5.

  PMID: 23218925 BACKGROUND

• Henson LA, Higginson IJ, Daveson BA, Ellis-Smith C, Koffman J, Morgan M, Gao W; BuildCARE. 'I'll be in a safe place': a qualitative study of the decisions taken by people with advanced cancer to seek emergency department care. BMJ Open. 2016 Nov 2;6(11):e012134. doi: 10.1136/bmjopen-2016-012134.

  PMID: 27807085 BACKGROUND

• Sparla A, Flach-Vorgang S, Villalobos M, Krug K, Kamradt M, Coulibaly K, Szecsenyi J, Thomas M, Gusset-Bahrer S, Ose D. Individual difficulties and resources - a qualitative analysis in patients with advanced lung cancer and their relatives. Patient Prefer Adherence. 2016 Oct 3;10:2021-2029. doi: 10.2147/PPA.S110667. eCollection 2016.

  PMID: 27757022 BACKGROUND

• Chiou CP, Chung YC. Effectiveness of multimedia interactive patient education on knowledge, uncertainty and decision-making in patients with end-stage renal disease. J Clin Nurs. 2012 May;21(9-10):1223-31. doi: 10.1111/j.1365-2702.2011.03793.x. Epub 2011 Aug 26.

  PMID: 21883569 BACKGROUND

• Scott AM, Martin SC, Stone AM, Brashers DE. Managing multiple goals in supportive interactions: using a normative theoretical approach to explain social support as uncertainty management for organ transplant patients. Health Commun. 2011 Jul-Aug;26(5):393-403. doi: 10.1080/10410236.2011.552479. Epub 2011 Jun 29.

  PMID: 21409670 BACKGROUND

• Borneman T, Sun V, Williams AC, Fujinami R, Del Ferraro C, Burhenn PS, Irish T, Zachariah F, van Zyl C, Buga S. Support for Patients and Family Caregivers in Lung Cancer: Educational Components of an Interdisciplinary Palliative Care Intervention. J Hosp Palliat Nurs. 2015 Aug;17(4):309-318. doi: 10.1097/NJH.0000000000000165.

  PMID: 26640416 BACKGROUND

• Bristowe K, Carey I, Hopper A, Shouls S, Prentice W, Caulkin R, Higginson IJ, Koffman J. Patient and carer experiences of clinical uncertainty and deterioration, in the face of limited reversibility: A comparative observational study of the AMBER care bundle. Palliat Med. 2015 Oct;29(9):797-807. doi: 10.1177/0269216315578990. Epub 2015 Mar 31.

  PMID: 25829443 BACKGROUND

MeSH Terms

Interventions

Methods

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Sonia P Carreño, RN, MSc, PhD

  Universidad Nacional de Colombia

  STUDY DIRECTOR

Central Study Contacts

Edier M Arias, RN, MSc, PhD(c)

CONTACT

+573134258151; emariasr@unal.edu.co

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: the participants in this study won't know if they are in the intervention group or in the control group
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 15, 2018
• First Posted: May 8, 2018
• Study Start: August 1, 2018
• Primary Completion: December 1, 2018
• Study Completion: March 1, 2019
• Last Updated: May 14, 2018

Record last verified: 2018-05