Clinical trial NCT03871270: The National Institutes of Health Measure of Healing Experience of All Life Stressors
Official title: The National Institutes of Health Measure of Healing Experience of All Life Stressors (NIH-HEALS): Factor Analysis and Validation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Severe Chronic Illness
Keywords: healing
spiritual
psycho-social-spiritual
growth
chronic illness
patient care
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
First posted: 2019-03-12
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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. 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.

Eligibility criteria: 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

Primary outcomes:
measure: National Institutes of Health- Healing Experience of All Life Stressors (NIH-HEALS)
timeFrame: 7 months
measure: Self Integration Scale (SIS) -V2
timeFrame: 7 months
measure: Functional Assessment of Chronic Illness Therapy-Spiritual well being (FACIT-SP)
timeFrame: 7 months
measure: Mindful Attention Awareness Scale (MAAS)
timeFrame: 7 months
measure: The Connor-Davidson Resilience Scale (CD-RISC) (10 item version)
timeFrame: 7 months
measure: Life Events Checklist 5 (LEC-5) (standard self-report)
timeFrame: 7 months
measure: Demographic Questionnaire (DQ)
timeFrame: 7 months
Secondary outcomes:
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: National Institute of Health
state: Maryland
Study officials:
References:
citation: Egnew TR. The meaning of healing: transcending suffering. Ann Fam Med. 2005 May-Jun;3(3):255-62. doi: 10.1370/afm.313.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.