Clinical trial NCT03518970: Uncertainty in Illness in Palliative Care: an Intervention for Family Caregivers
Official title: Nursing Intervention to Manage Uncertainty in Illness in Palliative Care: Feasibility and Acceptability Study in Family Caregivers
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Uncertainty
Advanced Cancer
Family Members
Quality of Life
Keywords: uncertainty
caregivers
palliative care
nursing
Hospice and Palliative Care Nursing
Lead sponsor: Universidad Nacional de Colombia
Sponsor class: OTHER
First posted: 2018-05-08
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: SUPPORTIVE_CARE

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.


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

Primary outcomes:
measure: Recruitment
timeFrame: This variable will be measured during the process of recruitment of participants in the study that will be during a period of six months.
measure: Follow-up
timeFrame: 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.
measure: Acceptability
timeFrame: 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:
measure: Uncertainty in illness
timeFrame: 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
measure: Quality of life
timeFrame: 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
Other outcomes:
Locations:
Study officials:
affiliation: Universidad Nacional de Colombia
name: Sonia P Carreño, RN, MSc, PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.