UncertaintyNCT03518970
Uncertainty in Illness in Palliative Care: an Intervention for Family Caregivers
A study testing Nursing intervention in people with Uncertainty and Advanced Cancer, run by Universidad Nacional de Colombia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Uncertainty, Advanced Cancer, Family Members
- What is being tested?
- Nursing intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2018to 1 Mar 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Nursing Intervention to Manage Uncertainty in Illness in Palliative Care: Feasibility and Acceptability Study in Family Caregivers
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
- Being tested
- Nursing intervention
- Keywords
- uncertainty, caregivers, palliative care, nursing, Hospice and Palliative Care Nursing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nursing interventionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Nursing intervention |
| Conventional care | No intervention | The control group will receive the nursing care conventionally given in the health care institution |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2018
- Study start1 Aug 2018 (estimated)
- Primary completion1 Dec 2018 (estimated)
- Study completion1 Mar 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for UncertaintyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Nacional de Colombia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sonia P Carreño, RN, MSc, PhD, Study director, Universidad Nacional de Colombia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03518970
- Sponsor's protocol ID
- AVAL-O35-17
- Status last verified
- May 2018
- First submitted
- 15 Apr 2018
- Last updated
- 14 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: This item will be defined after the participants agree to share this information with other researchers. Even so if the information is blinded in terms of personal information for other investigations
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.
PubMed 15599947Moore 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.
PubMed 23218925Henson 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.
PubMed 27807085Sparla 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.
PubMed 27757022Chiou 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.
PubMed 21883569Scott 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.
PubMed 21409670Borneman 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.
PubMed 26640416Bristowe 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.
PubMed 25829443
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nursing Intervention to Manage Uncertainty in Illness in Palliative Care: Feasibility and Acceptability Study in Family Caregivers
- ClinicalTrials.gov ID
- NCT03518970
- Acronym / sponsor ID
- AVAL-O35-17
- Conditions
- Uncertainty, Advanced Cancer, Family Members, Quality of Life
- Keywords
- uncertainty, caregivers, palliative care, nursing, Hospice and Palliative Care Nursing
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Universidad Nacional de ColombiaUniversity, hospital or other
- Study start
- 1 Aug 2018 (estimated)
- Primary completion
- 1 Dec 2018 (estimated)
- Study completion
- 1 Mar 2019 (estimated)
- First posted
- 8 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Nursing intervention | Experimental | Other: Nursing interventionThe 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 |
| Conventional care | No intervention | –The control group will receive the nursing care conventionally given in the health care institution |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nursing interventionThe 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. | Other | Nursing intervention |
Primary outcome
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.
2 secondary outcomes
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2018.
- Background: PubMed 15599947Northouse 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.
- Background: PubMed 23218925Moore 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.
- Background: PubMed 27807085Henson 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.
- Background: PubMed 27757022Sparla 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.
- Background: PubMed 21883569Chiou 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.
- Background: PubMed 21409670Scott 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.
- Background: PubMed 26640416Borneman 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.
- Background: PubMed 25829443Bristowe 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.
- Individual participant dataSharing planned: Undecided. This item will be defined after the participants agree to share this information with other researchers. Even so if the information is blinded in terms of personal information for other investigations
Related trials for Uncertainty
RecruitingObservational study
Lived Experiences of Women Diagnosed With HPV Infection
Human Papillomavirus Infection
Not yet recruitingPhase 2
Modulation of Stem Cell Differentiation in Individuals With High Risk Clonal Haematopoiesis
Clonal Cytopenia of Uncertain Significance, CCUS Clonal Cytopenia of Undetermined Significance
Not yet recruiting
Temporal Interference Transcranial Alternating Current Stimulation Targeting the BNST or Amygdala for Generalized Anxiety Disorder
Generalized Anxiety Disorder (GAD)
Not yet recruiting
Human-AI Uncertainty Callibration for Improved Skin Lesion Segmentation
Skin Lesions
Active, not recruiting
CANCER SCREENING PROGRAM ON UNCERTAINTY, ANTİCİPATORY ANXIETY, CANCER AWARENESS, AND E-HEALTH LITERACY IN A STROKE PATIENTS
Cancer, Stroke
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sonia P Carreño, RN, MSc, PhD study director
Universidad Nacional de Colombia
Questions about this trial
What is this clinical trial studying?
A study testing Nursing intervention in people with Uncertainty and Advanced Cancer, run by Universidad Nacional de Colombia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 May 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Edier M Arias, RN, MSc, PhD(c) (+573134258151, emariasr@unal.edu.co), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03518970, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2018.