Phenomenological Study of Psycho-Socio-Spiritual Healing in the Context of Chronic or Life-Threatening Illness
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ClinicalTrials.gov Identifier: NCT01077414 |
Recruitment Status :
Completed
First Posted : March 1, 2010
Last Update Posted : December 17, 2019
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Tracking Information | ||||
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First Submitted Date | February 26, 2010 | |||
First Posted Date | March 1, 2010 | |||
Last Update Posted Date | December 17, 2019 | |||
Study Start Date | September 4, 2009 | |||
Primary Completion Date | Not Provided | |||
Current Primary Outcome Measures | Not Provided | |||
Original Primary Outcome Measures | Not Provided | |||
Change History | ||||
Current Secondary Outcome Measures | Not Provided | |||
Original Secondary Outcome Measures | Not Provided | |||
Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title | Phenomenological Study of Psycho-Socio-Spiritual Healing in the Context of Chronic or Life-Threatening Illness | |||
Official Title | Phenomenological Study of Psycho-Socio-Spiritual Healing in the Context of Chronic or Life-Threatening Illness | |||
Brief Summary | Background:
Objective: - To determine and categorize the characteristics of PSS Healing, which could lead to development of a psychometric instrument to measure it. Eligibility: - Adults who have cancer or have had cancer that was diagnosed after the age of 18 and who have had at least one strong positive emotional or mental change in relation to the cancer (e.g., relationships with others, spiritual well-being or faith, thoughts about the meaning of life, reactions to stress). Design:
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Detailed Description | 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 (Kearney 2000). In previous phenomenological studies, qualitative descriptions of healing and the processes by which it develops have not been structured in categories suitable for the development of a fully validated and standardized psychometric instrument. Also, the relationship of healing to psychometrically measurable constructs such as posttraumatic growth, resilience, coping, and acceptance is not clear. Objective: This program is to provide (1) a qualitative model of healing-related processes, (2) phenomenological categories of healing suitable for a psychometric instrument development, (3) the relationship of healing to other relevant constructs such as trauma, coping, and adult development, and (4) questionnaire items for healing assessment and (5) software tools that greatly increase the qualitative analysis speed and rigor of phenomenological category building. Study populations: Two populations of subjects who have experienced a life-threatening disease or serious chronic illness (cancer or cardiac disease) will be recruited from three sites. The first population (50 subjects) are individuals with exemplary healing experiences (life-transforming positive outcomes connected to illness along psychological, social and/or spiritual dimensions) or in the early stages of healing-related processes. In-depth interview data from these subjects will empirically help identify endpoint markers and process pathways of profound healing. The second population (400 subjects) consists of current or past participants in structured healing or medical rehabilitation programs. In a written interview, these participants will qualitatively evaluate questionnaire items for identifying readiness for and progress toward healing using their first-hand, illness-related experience. Design: This protocol has a qualitative, phenomenological, natural history design similar to identifying features of a medical syndrome or psychological disorder. It has two formats of data collection: in-depth individual interviews of the exemplary healing population, and self-administered written interviews for current participants in formal healing or rehabilitation programs. In-depth interview sessions have 2 1/4-hour duration with three components: a 50-minute, in depth phenomenological interview, a 30-minute short-statement interview (how subjects view healing-related short questionnaire statements), and a 25-minute related-constructs interview (how their positive outcomes, may be related to personality). Interview and short-statement analyses consist of standard qualitative methodologies including transcription, memo-writing, coding, categorization, and modeling. Outcome measures: None (non-interventional) |
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Study Type | Observational | |||
Study Design | Time Perspective: Prospective | |||
Target Follow-Up Duration | Not Provided | |||
Biospecimen | Not Provided | |||
Sampling Method | Not Provided | |||
Study Population | Not Provided | |||
Condition |
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Intervention | Not Provided | |||
Study Groups/Cohorts | Not Provided | |||
Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status | Completed | |||
Actual Enrollment |
37 | |||
Original Estimated Enrollment |
30 | |||
Study Completion Date | November 2, 2016 | |||
Primary Completion Date | Not Provided | |||
Eligibility Criteria |
SUBGROUP-SPECIFIC INCLUSION CRITERIA IN STUDY POPULATION 1:
INCLUSION CRITERIA FOR POPULATION 2:
SUBGROUP-SPECIFIC INCLUSION CRITERIA IN STUDY POPULATION 1:
EXCLUSION CRITERIA FOR THE STUDY POPULATION 1:
EXCLUSION CRITERIA FOR POPULATION 2:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers | No | |||
Contacts | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number | NCT01077414 | |||
Other Study ID Numbers | 090227 09-CC-0227 |
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Has Data Monitoring Committee | Not Provided | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | National Institutes of Health Clinical Center (CC) | |||
Study Sponsor | National Institutes of Health Clinical Center (CC) | |||
Collaborators | Not Provided | |||
Investigators |
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PRS Account | National Institutes of Health Clinical Center (CC) | |||
Verification Date | November 2, 2016 |