- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03518970
Uncertainty in Illness in Palliative Care: an Intervention for Family Caregivers
Nursing Intervention to Manage Uncertainty in Illness in Palliative Care: Feasibility and Acceptability Study in Family Caregivers
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Edier M Arias, RN, MSc, PhD(c)
- Phone Number: +573134258151
- Email: emariasr@unal.edu.co
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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
|
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. |
No Intervention: Conventional care
The control group will receive the nursing care conventionally given in the health care institution
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
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
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.
|
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
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.
|
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
Time Frame: 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
|
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
Time Frame: 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
|
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
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Sonia P Carreño, RN, MSc, PhD, Universidad Nacional de Colombia
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- AVAL-O35-17
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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