Severe Chronic IllnessNIH-HEALSNCT03871270
The National Institutes of Health Measure of Healing Experience of All Life Stressors
An observational study of Severe Chronic Illness, run by National Institutes of Health Clinical Center (CC) at 1 site in United States.
Trial summary
NIH-Healing Experience in All Life Stressors (NIH-HEALS) is a 35 item self-report questionnaire developed by the NIH Clinical Center Pain and Palliative care. It assesses an individual's mechanisms for coping as a means to reach "healing" during life's difficult situations and/or life limiting challenges. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Severe Chronic Illness
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jun 2017to 31 Dec 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: All patients had a history of a serious chronic illness and were already involved in experimental treatments and research projects for the study and treatment of their particular disease at the NIH Clinical Center.
Who may be able to join
- Age of 18 or above
- The ability to read and write in English
- The presence or history of a serious and/or life-threatening disease
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institute of Health
Bethesda, Maryland, 20892
About this study
Official title: The National Institutes of Health Measure of Healing Experience of All Life Stressors (NIH-HEALS): Factor Analysis and Validation
NIH-Healing Experience in All Life Stressors (NIH-HEALS) is a 35 item self-report questionnaire developed by the NIH Clinical Center Pain and Palliative care. It assesses an individual's mechanisms for coping as a means to reach "healing" during life's difficult situations and/or life limiting challenges. The factorial structure of the tool has been recently re-examined with 200 patients. The three main factors are: Connection (including religious, spiritual, interpersonal), Reflection/ Introspection, and Trust/Acceptance.
Read the detailed description
At the Clinical Center Pain and Palliative Care Service (PPCS) we have developed a pscyho-social-spiritual measure, the Healing Experience in all Life Stressors (HEALS), that focuses on the healing experience in people with severe and life limiting illness. We have validated this tool further in order to be able to identify those individuals who may benefit from additional interventions to cope with their illness and even assist them in reaching a healing experience that is possible even in the midst of their unfavorable circumstances. Identification of vulnerable individuals as well individuals who do have transformative experience after being diagnosed with severe and life limiting illness, has far-reaching impact on the quality of patient care for the very sick patients.
- Conditions
- Severe Chronic Illness
- Keywords
- healing, spiritual, psycho-social-spiritual, growth, chronic illness, patient care
- Medical subject headings
- Chronic Disease
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 |
|---|---|---|
| Participants | Those with severe chronic illnesses, which included but were not limited to various forms of advanced cancer, blood dyscrasias, graft vs. host disease, and rare genetic conditions. |
What is being measured
The primary outcome is the main question the study is designed to answer.
National Institutes of Health- Healing Experience of All Life Stressors (NIH-HEALS)
Based on our validation study (Ameli et.al., 2018), we now propose a 35-item, three-factor NIH-HEALS as a measure of psycho-social-spiritual healing. These three factors include: Connection, Reflection \& Introspection, and Trust \& Acceptance.
Measured: 7 months
Self Integration Scale (SIS) -V2
SIS is an 18 item self report measure with 2 factors: Healed and Co-dependent. As predicted NIH-HEALS positively correlated with the Healed and negative correlated with the Co-dependent factors.
Measured: 7 months
Functional Assessment of Chronic Illness Therapy-Spiritual well being (FACIT-SP)
FACIT-SP is a 12 item self report that measures spiritual well being and is a part of the larger FACIT measurement system (www.FACIT.org). A 3 factor structure has been reported with cancer patients and include meaning, peace, and faith. As predicted, NIH-HEALS correlated positively with these 3 factors.
Measured: 7 months
Mindful Attention Awareness Scale (MAAS)
MAAS is a self report measure of trait mindfulness with 15 items. As predicted NIH-HEALS correlated positively with MAAS.
Measured: 7 months
The Connor-Davidson Resilience Scale (CD-RISC) (10 item version)
CD-RSIC is a 10 item self-report measure of resilience. As predicted NIH-HEALS positively correlated with CD-RISC
Measured: 7 months
Life Events Checklist 5 (LEC-5) (standard self-report)
LEC-5 is a 17 item self-report measure designed to screen for potentially traumatic events in a respondent's lifetime. The LEC-5 assesses exposure to 16 events known to potentially result in PTSD or distress and includes one additional item assessing any other extraordinarily stressful event not captured in the first 16 items.
Measured: 7 months
Demographic Questionnaire (DQ)
DQ collected information on gender, age, ethnicity, race, marital status, religious affiliation, education, employment status, medical diagnosis, length of illness, severity of illness, psychiatric co-morbidity, perceived stress level, perceived level of social support, overall health status, and overall quality of life.
Measured: 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2019
- Study start15 Jun 2017
- Primary completion21 Sep 2017
- Study completion31 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Severe Chronic IllnessStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institutes of Health Clinical Center (CC)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Principal investigator, Ann Berger, M.D., National Institutes of Health Clinical Center (CC)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03871270
- Sponsor's protocol ID
- 17-CC-00125
- Acronym
- NIH-HEALS
- Status last verified
- Aug 2019
- First submitted
- 11 Mar 2019
- Last updated
- 26 Aug 2019
- Results posted
- No
- Data monitoring committee
- 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 15928230Park CL. Making sense of the meaning literature: an integrative review of meaning making and its effects on adjustment to stressful life events. Psychol Bull. 2010 Mar;136(2):257-301. doi: 10.1037/a0018301.
PubMed 20192563Skeath P, Norris S, Katheria V, White J, Baker K, Handel D, Sternberg E, Pollack J, Groninger H, Phillips J, Berger A. The nature of life-transforming changes among cancer survivors. Qual Health Res. 2013 Sep;23(9):1155-67. doi: 10.1177/1049732313499074. Epub 2013 Jul 17.
PubMed 23863850Sloan DH, BrintzenhofeSzoc K, Kichline T, Baker K, Pinzon JP, Tafe C, Li L, Cheng MJ, Berger A. An assessment of meaning in life-threatening illness: development of the Healing Experience in All Life Stressors (HEALS). Patient Relat Outcome Meas. 2017 Feb 16;8:15-21. doi: 10.2147/PROM.S118696. eCollection 2017.
PubMed 28243158Young WC, Nadarajah SR, Berger AM. Supportive medical care in life-threatening illness: A pilot study. Palliat Support Care. 2016 Dec;14(6):680-685. doi: 10.1017/S147895151600033X. Epub 2016 May 24.
PubMed 27215292Ameli R, Sinaii N, Luna MJ, Cheringal J, Gril B, Berger A. The National Institutes of Health measure of Healing Experience of All Life Stressors (NIH-HEALS): Factor analysis and validation. PLoS One. 2018 Dec 12;13(12):e0207820. doi: 10.1371/journal.pone.0207820. eCollection 2018.
PubMed 30540764
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The National Institutes of Health Measure of Healing Experience of All Life Stressors (NIH-HEALS): Factor Analysis and Validation
- ClinicalTrials.gov ID
- NCT03871270
- Acronym / sponsor ID
- NIH-HEALS / 17-CC-00125
- Conditions
- Severe Chronic Illness
- Keywords
- healing, spiritual, psycho-social-spiritual, growth, chronic illness, patient care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- National Institutes of Health Clinical Center (CC)US National Institutes of Health
- Study start
- 15 Jun 2017 (actual)
- Primary completion
- 21 Sep 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 12 Mar 2019 (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.
NIH-Healing Experience in All Life Stressors (NIH-HEALS) is a 35 item self-report questionnaire developed by the NIH Clinical Center Pain and Palliative care. It assesses an individual's mechanisms for coping as a means to reach "healing" during life's difficult situations and/or life limiting challenges. The factorial structure of the tool has been recently re-examined with 200 patients. The three main factors are: Connection (including religious, spiritual, interpersonal), Reflection/ Introspection, and Trust/Acceptance.
Detailed description
At the Clinical Center Pain and Palliative Care Service (PPCS) we have developed a pscyho-social-spiritual measure, the Healing Experience in all Life Stressors (HEALS), that focuses on the healing experience in people with severe and life limiting illness. We have validated this tool further in order to be able to identify those individuals who may benefit from additional interventions to cope with their illness and even assist them in reaching a healing experience that is possible even in the midst of their unfavorable circumstances. Identification of vulnerable individuals as well individuals who do have transformative experience after being diagnosed with severe and life limiting illness, has far-reaching impact on the quality of patient care for the very sick patients.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants | – | –Those with severe chronic illnesses, which included but were not limited to various forms of advanced cancer, blood dyscrasias, graft vs. host disease, and rare genetic conditions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients had a history of a serious chronic illness and were already involved in experimental treatments and research projects for the study and treatment of their particular disease at the NIH Clinical Center.
Key inclusion criteria (3 listed)
- Age of 18 or above
- The ability to read and write in English
- The presence or history of a serious and/or life-threatening disease
Key exclusion criteria (0 listed)
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
National Institutes of Health- Healing Experience of All Life Stressors (NIH-HEALS)
Time frame: 7 months
Based on our validation study (Ameli et.al., 2018), we now propose a 35-item, three-factor NIH-HEALS as a measure of psycho-social-spiritual healing. These three factors include: Connection, Reflection \& Introspection, and Trust \& Acceptance.
Self Integration Scale (SIS) -V2
Time frame: 7 months
SIS is an 18 item self report measure with 2 factors: Healed and Co-dependent. As predicted NIH-HEALS positively correlated with the Healed and negative correlated with the Co-dependent factors.
Functional Assessment of Chronic Illness Therapy-Spiritual well being (FACIT-SP)
Time frame: 7 months
FACIT-SP is a 12 item self report that measures spiritual well being and is a part of the larger FACIT measurement system (www.FACIT.org). A 3 factor structure has been reported with cancer patients and include meaning, peace, and faith. As predicted, NIH-HEALS correlated positively with these 3 factors.
Mindful Attention Awareness Scale (MAAS)
Time frame: 7 months
MAAS is a self report measure of trait mindfulness with 15 items. As predicted NIH-HEALS correlated positively with MAAS.
The Connor-Davidson Resilience Scale (CD-RISC) (10 item version)
Time frame: 7 months
CD-RSIC is a 10 item self-report measure of resilience. As predicted NIH-HEALS positively correlated with CD-RISC
Life Events Checklist 5 (LEC-5) (standard self-report)
Time frame: 7 months
LEC-5 is a 17 item self-report measure designed to screen for potentially traumatic events in a respondent's lifetime. The LEC-5 assesses exposure to 16 events known to potentially result in PTSD or distress and includes one additional item assessing any other extraordinarily stressful event not captured in the first 16 items.
Demographic Questionnaire (DQ)
Time frame: 7 months
DQ collected information on gender, age, ethnicity, race, marital status, religious affiliation, education, employment status, medical diagnosis, length of illness, severity of illness, psychiatric co-morbidity, perceived stress level, perceived level of social support, overall health status, and overall quality of life.
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 26 Aug 2019.
- 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 20192563Park CL. Making sense of the meaning literature: an integrative review of meaning making and its effects on adjustment to stressful life events. Psychol Bull. 2010 Mar;136(2):257-301. doi: 10.1037/a0018301.
- Background: PubMed 23863850Skeath P, Norris S, Katheria V, White J, Baker K, Handel D, Sternberg E, Pollack J, Groninger H, Phillips J, Berger A. The nature of life-transforming changes among cancer survivors. Qual Health Res. 2013 Sep;23(9):1155-67. doi: 10.1177/1049732313499074. Epub 2013 Jul 17.
- Background: PubMed 28243158Sloan DH, BrintzenhofeSzoc K, Kichline T, Baker K, Pinzon JP, Tafe C, Li L, Cheng MJ, Berger A. An assessment of meaning in life-threatening illness: development of the Healing Experience in All Life Stressors (HEALS). Patient Relat Outcome Meas. 2017 Feb 16;8:15-21. doi: 10.2147/PROM.S118696. eCollection 2017.
- Background: PubMed 27215292Young WC, Nadarajah SR, Berger AM. Supportive medical care in life-threatening illness: A pilot study. Palliat Support Care. 2016 Dec;14(6):680-685. doi: 10.1017/S147895151600033X. Epub 2016 May 24.
- Results publication: PubMed 30540764Ameli R, Sinaii N, Luna MJ, Cheringal J, Gril B, Berger A. The National Institutes of Health measure of Healing Experience of All Life Stressors (NIH-HEALS): Factor analysis and validation. PLoS One. 2018 Dec 12;13(12):e0207820. doi: 10.1371/journal.pone.0207820. eCollection 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Severe Chronic 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 3 inclusion and 0 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 26 Aug 2019. 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?
National Institutes of Health- Healing Experience of All Life Stressors (NIH-HEALS) (time frame: 7 months). The study lists 7 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 NCT03871270, which also lists 6 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 26 Aug 2019.