- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT03871270
The National Institutes of Health Measure of Healing Experience of All Life Stressors (NIH-HEALS)
21 augusti 2019 uppdaterad av: Ann Berger, M.D., National Institutes of Health Clinical Center (CC)
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.
Studieöversikt
Status
Avslutad
Betingelser
Detaljerad beskrivning
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.
Studietyp
Observationell
Inskrivning (Faktisk)
200
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Maryland
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Bethesda, Maryland, Förenta staterna, 20892
- National Institute of Health
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Testmetod
Icke-sannolikhetsprov
Studera befolkning
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.
Beskrivning
Inclusion Criteria:
- 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
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
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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.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
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National Institutes of Health- Healing Experience of All Life Stressors (NIH-HEALS)
Tidsram: 7 months
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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.
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7 months
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Self Integration Scale (SIS) -V2
Tidsram: 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.
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7 months
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Functional Assessment of Chronic Illness Therapy-Spiritual well being (FACIT-SP)
Tidsram: 7 months
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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.
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7 months
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Mindful Attention Awareness Scale (MAAS)
Tidsram: 7 months
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MAAS is a self report measure of trait mindfulness with 15 items.
As predicted NIH-HEALS correlated positively with MAAS.
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7 months
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The Connor-Davidson Resilience Scale (CD-RISC) (10 item version)
Tidsram: 7 months
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CD-RSIC is a 10 item self-report measure of resilience.
As predicted NIH-HEALS positively correlated with CD-RISC
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7 months
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Life Events Checklist 5 (LEC-5) (standard self-report)
Tidsram: 7 months
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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.
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7 months
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Demographic Questionnaire (DQ)
Tidsram: 7 months
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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.
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7 months
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna publikationer
- Egnew TR. The meaning of healing: transcending suffering. Ann Fam Med. 2005 May-Jun;3(3):255-62. doi: 10.1370/afm.313.
- Park 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.
- Skeath 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.
- Sloan 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.
- Young 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.
- Ameli 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.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
15 juni 2017
Primärt slutförande (Faktisk)
21 september 2017
Avslutad studie (Faktisk)
31 december 2017
Studieregistreringsdatum
Först inskickad
11 mars 2019
Först inskickad som uppfyllde QC-kriterierna
11 mars 2019
Första postat (Faktisk)
12 mars 2019
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
26 augusti 2019
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
21 augusti 2019
Senast verifierad
1 augusti 2019
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 17-CC-00125
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
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