Palliative CareNCT02664402
Tool to Assess Psycho-Social-Spiritual Healing: Cognitive Interviewing
An observational study of Palliative Care and Critical Illness, run by National Institutes of Health Clinical Center (CC) at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Palliative Care, Critical Illness
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jan 2017to 5 Jan 2017
- Phase
- Observational
- 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
Study population: A purposive sample of 30 participants were recruited from patients with scheduled appointments at the palliative care clinic or inpatients at 3 locations: l)Mobile Medical Care, Rockville, MD, 2) Suburban Hospital, Bethesda, MD, 3)NIH Clinical Center, Bethesda, MD.
Who may be able to join
- Adults age greater than or equal to 18 years. The instrument under study for validation in this protocol is a self-assessment specifically designed for adult populations. Adults above the age of 18 are able to use logic, deductive reasoning, think more about the world / environment and has an understanding and ability to apply abstract ideas, which are all necessary for retrospective cognitive processes
- Understand and speak English
- Oriented to person, time and place at time of interview
- Physician diagnosed with 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
Who cannot join
- Patients with known brain metastases will be excluded because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of the assessment questions
- Inability to provide informed consent
- Inability to meet inclusion criteria
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
Official title: Analysis of A Tool to Assess Psycho Social Spiritual Healing: Cognitive Interviewing
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.
Read more
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.
...
Read the 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.
- Conditions
- Palliative Care, Critical Illness
- Keywords
- Palliative Care, Pain, Community Health, Natural History
- Medical subject headings
- Critical Illness, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Adults | English speaking, physician diagnosed with a life threatening illness. |
What is being measured
The primary outcome is the main question the study is designed to answer.
NIH HEALS Assessment
Newly developed 49-item questionnaire being evaluated for participant understanding of each item included in questionnaire.
Measured: Present
Secondary outcomes (1)
Risk Assessment for Barriers to Palliative Care
Questions from this assessment will help healthcare providers complete a needs assessment with the patient and caregiver in order to better understand patient needs and to identify barriers to using palliative care in a low-income population
Measured: present
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2016 (estimated)
- Study start5 Jan 2017
- Primary completion5 Jan 2017
- Study completion5 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Palliative CareStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institutes of Health Clinical Center (CC)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Ann M Cohen Berger, M.D., Principal investigator, National Institutes of Health Clinical Center (CC)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02664402
- Sponsor's protocol ID
- 160056
- Other IDs
- 16-CC-0056
- Status last verified
- Apr 2023
- First submitted
- 26 Jan 2016
- Last updated
- 14 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Egnew TR. The meaning of healing: transcending suffering. Ann Fam Med. 2005 May-Jun;3(3):255-62. doi: 10.1370/afm.313.
PubMed 15928230Denz-Penhey H, Murdoch C. Personal resiliency: serious diagnosis and prognosis with unexpected quality outcomes. Qual Health Res. 2008 Mar;18(3):391-404. doi: 10.1177/1049732307313431.
PubMed 18235162Lyckholm LJ, Coyne PJ, Kreutzer KO, Ramakrishnan V, Smith TJ. Barriers to effective palliative care for low-income patients in late stages of cancer: report of a study and strategies for defining and conquering the barriers. Nurs Clin North Am. 2010 Sep;45(3):399-409. doi: 10.1016/j.cnur.2010.03.007. Epub 2010 May 10.
PubMed 20804885
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of A Tool to Assess Psycho Social Spiritual Healing: Cognitive Interviewing
- ClinicalTrials.gov ID
- NCT02664402
- Acronym / sponsor ID
- 160056
- Conditions
- Palliative Care, Critical Illness
- Keywords
- Palliative Care, Pain, Community Health, Natural History
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- National Institutes of Health Clinical Center (CC)US National Institutes of Health
- Study start
- 5 Jan 2017 (actual)
- Primary completion
- 5 Jan 2017 (actual)
- Study completion
- 5 Jan 2017 (actual)
- First posted
- 27 Jan 2016 (estimated)
- 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:
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adults | – | –English speaking, physician diagnosed with a life threatening illness. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A purposive sample of 30 participants were recruited from patients with scheduled appointments at the palliative care clinic or inpatients at 3 locations: l)Mobile Medical Care, Rockville, MD, 2) Suburban Hospital, Bethesda, MD, 3)NIH Clinical Center, Bethesda, MD.
Key inclusion criteria (6 listed)
- Adults age greater than or equal to 18 years. The instrument under study for validation in this protocol is a self-assessment specifically designed for adult populations. Adults above the age of 18 are able to use logic, deductive reasoning, think more about the world / environment and has an understanding and ability to apply abstract ideas, which are all necessary for retrospective cognitive processes
- Understand and speak English
- Oriented to person, time and place at time of interview
- Physician diagnosed with life threatening illness
- 91+ days post diagnosis of life threatening illness
Key exclusion criteria (3 listed)
- Patients with known brain metastases will be excluded because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of the assessment questions
- Inability to provide informed consent
- Inability to meet inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
NIH HEALS Assessment
Time frame: Present
Newly developed 49-item questionnaire being evaluated for participant understanding of each item included in questionnaire.
1 secondary outcome
Risk Assessment for Barriers to Palliative Care
Time frame: present
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2023.
- Background: PubMed 15928230Egnew TR. The meaning of healing: transcending suffering. Ann Fam Med. 2005 May-Jun;3(3):255-62. doi: 10.1370/afm.313.
- Background: PubMed 18235162Denz-Penhey H, Murdoch C. Personal resiliency: serious diagnosis and prognosis with unexpected quality outcomes. Qual Health Res. 2008 Mar;18(3):391-404. doi: 10.1177/1049732307313431.
- Background: PubMed 20804885Lyckholm LJ, Coyne PJ, Kreutzer KO, Ramakrishnan V, Smith TJ. Barriers to effective palliative care for low-income patients in late stages of cancer: report of a study and strategies for defining and conquering the barriers. Nurs Clin North Am. 2010 Sep;45(3):399-409. doi: 10.1016/j.cnur.2010.03.007. Epub 2010 May 10.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
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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.
Ann M Cohen Berger, M.D. principal investigator
National Institutes of Health Clinical Center (CC)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Palliative Care and Critical Illness, run by National Institutes of Health Clinical Center (CC) at 1 site in United States.
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 6 inclusion and 3 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: finished, as of the sponsor's last update on 14 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NIH HEALS Assessment (time frame: Present). 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 NCT02664402, which also lists 3 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 Apr 2023.