Ignite Creation Date:
2025-12-25 @ 3:46 AM
Ignite Modification Date:
2025-12-26 @ 2:33 AM
Study NCT ID:
NCT02664402
Status:
COMPLETED
Last Update Posted:
2023-04-14
First Post:
2016-01-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Tool to Assess Psycho-Social-Spiritual Healing: Cognitive Interviewing
Sponsor:
National Institutes of Health Clinical Center (CC)
Organization:
Study Overview
Official Title:
Analysis of A Tool to Assess Psycho Social Spiritual Healing: Cognitive Interviewing
Status:
COMPLETED
Status Verified Date:
2023-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Background:
People undergo many changes when they have a life-threatening illness. Their values may change. They may have less fear of illness and death. They may become more spiritual. Researchers made a questionnaire called HEALS (Healing Experience During All Life Stressors). They want to use it to better understand these positive changes. They hope to provide better care for people with serious illnesses.
Objectives:
To develop the HEALS tool to better understand psycho-social-spiritual healing in people with serious illnesses. Also, to find out how palliative care services help people handle their illness or stress.
Eligibility:
Adults at least 18 years old at least 91 days after being diagnosed with a life-threatening illness. They must be getting:
Inpatient or outpatient palliative care at NIH Clinical Center OR
Inpatient palliative care at Suburban Hospital OR
NIH outpatient palliative care provided at Mobile Medical Care Clinic
Design:
Participants will be screened with questions to make sure they are eligible.
Participants will have 1 individual research session. This will be at the NIH Clinical Center.
Participants will be interviewed by a research team member. They will be asked about changes in a person s way of living that might happen during or after a serious illness.
Participants will be asked for their thoughts and opinions about the questions. They will be asked what ideas they may have to make the questions better.
Interviews will be audiotaped.
Participants will be asked some questions specific to their care location and team. These are to better understand how their services are helping participants.
...
People undergo many changes when they have a life-threatening illness. Their values may change. They may have less fear of illness and death. They may become more spiritual. Researchers made a questionnaire called HEALS (Healing Experience During All Life Stressors). They want to use it to better understand these positive changes. They hope to provide better care for people with serious illnesses.
Objectives:
To develop the HEALS tool to better understand psycho-social-spiritual healing in people with serious illnesses. Also, to find out how palliative care services help people handle their illness or stress.
Eligibility:
Adults at least 18 years old at least 91 days after being diagnosed with a life-threatening illness. They must be getting:
Inpatient or outpatient palliative care at NIH Clinical Center OR
Inpatient palliative care at Suburban Hospital OR
NIH outpatient palliative care provided at Mobile Medical Care Clinic
Design:
Participants will be screened with questions to make sure they are eligible.
Participants will have 1 individual research session. This will be at the NIH Clinical Center.
Participants will be interviewed by a research team member. They will be asked about changes in a person s way of living that might happen during or after a serious illness.
Participants will be asked for their thoughts and opinions about the questions. They will be asked what ideas they may have to make the questions better.
Interviews will be audiotaped.
Participants will be asked some questions specific to their care location and team. These are to better understand how their services are helping participants.
...
Detailed Description:
Background:
We identify healing in the context of chronic or life-threatening illness as a patient-reported outcome consisting of growth or benefit in psychological, social and/or spiritual dimensions representing improvement well above the patient s pre-morbidity baseline. This positive outcome often occurs despite substantial suffering during the illness, even in terminal cases. Current literature reflects numerous studies suggesting that psychological, social, and/or spiritual dimensions influence positive patient health outcomes and affects overall quality of life. This trend parallels a movement to understand how a difficult experience, such as a cancer diagnosis for example, may help facilitate positive growth, also referred to as healing. Although attention to positive growth/healing in the treatment of life limiting illness is increasing, a psychometrically sound instrument that assesses psycho-social-spiritual (PSS) growth as a means to healing does not exist. The ability to assess healing will allow improvements in programs aimed at helping individuals make positive personal changes in their health-related behavior (our larger program on healing). Content analysis of this contributes to construct validity of the assessment and brings us closer to creating a psychometrically sound measure of psycho- social spiritual healing.
This swill use cognitive interviewing to examine item performance of the NIH HEALS Assessment (healing experience during all life stressors) tool.
Objectives:
Primary Objective
* To continue with instrument development of a tool to assess an individual s progression toward psycho-social spiritual healing by evaluating the participant s understanding of questionnaire items through a cognitive interviewing technique.
* Examine differences in the understanding of questionnaire items between the three recruitment sites.
Eligibility:
* Age greater than or equal to 18 years old
* Understand and speak English
* Physician diagnosed with a life threatening illness
* 91+ days post diagnosis of life threatening illness
* Receiving inpatient or/ outpatient palliative care at NIH Clinical Center inpatient palliative Care at Suburban Hospital, and NIH outpatient palliative care provided at the Mobile Medical Care Clinic
Design:
* Exploratory descriptive study using mix-methods
* Cognitive interviews using retrospective probing in a purposive sample with three rounds of 10 for a total maximum sample of 30 participants, with the completion of content analysis after each round of 10 to inform content and clarity of question items.
We identify healing in the context of chronic or life-threatening illness as a patient-reported outcome consisting of growth or benefit in psychological, social and/or spiritual dimensions representing improvement well above the patient s pre-morbidity baseline. This positive outcome often occurs despite substantial suffering during the illness, even in terminal cases. Current literature reflects numerous studies suggesting that psychological, social, and/or spiritual dimensions influence positive patient health outcomes and affects overall quality of life. This trend parallels a movement to understand how a difficult experience, such as a cancer diagnosis for example, may help facilitate positive growth, also referred to as healing. Although attention to positive growth/healing in the treatment of life limiting illness is increasing, a psychometrically sound instrument that assesses psycho-social-spiritual (PSS) growth as a means to healing does not exist. The ability to assess healing will allow improvements in programs aimed at helping individuals make positive personal changes in their health-related behavior (our larger program on healing). Content analysis of this contributes to construct validity of the assessment and brings us closer to creating a psychometrically sound measure of psycho- social spiritual healing.
This swill use cognitive interviewing to examine item performance of the NIH HEALS Assessment (healing experience during all life stressors) tool.
Objectives:
Primary Objective
* To continue with instrument development of a tool to assess an individual s progression toward psycho-social spiritual healing by evaluating the participant s understanding of questionnaire items through a cognitive interviewing technique.
* Examine differences in the understanding of questionnaire items between the three recruitment sites.
Eligibility:
* Age greater than or equal to 18 years old
* Understand and speak English
* Physician diagnosed with a life threatening illness
* 91+ days post diagnosis of life threatening illness
* Receiving inpatient or/ outpatient palliative care at NIH Clinical Center inpatient palliative Care at Suburban Hospital, and NIH outpatient palliative care provided at the Mobile Medical Care Clinic
Design:
* Exploratory descriptive study using mix-methods
* Cognitive interviews using retrospective probing in a purposive sample with three rounds of 10 for a total maximum sample of 30 participants, with the completion of content analysis after each round of 10 to inform content and clarity of question items.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 16-CC-0056 | None | None | View |