The National Institutes of Health Measure of Healing Experience of All Life Stressors (NIH-HEALS)

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.

Study Overview

• Status: Completed
• Conditions: Severe Chronic Illness

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 Type: Observational
• Enrollment (Actual): 200

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Bethesda, Maryland, United States, 20892
      • National Institute Of Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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	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.	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.	7 months

Collaborators and Investigators

• Sponsor: National Institutes of Health Clinical Center (CC)

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 15, 2017
• Primary Completion (Actual): September 21, 2017
• Study Completion (Actual): December 31, 2017

Study Registration Dates

• First Submitted: March 11, 2019
• First Submitted That Met QC Criteria: March 11, 2019
• First Posted (Actual): March 12, 2019

Study Record Updates

• Last Update Posted (Actual): August 26, 2019
• Last Update Submitted That Met QC Criteria: August 21, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: chronic illness; growth; healing; patient care; spiritual; psycho-social-spiritual
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Chronic Disease
• Other Study ID Numbers: 17-CC-00125

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No