CancerNCT01077414
Phenomenological Study of Psycho-Socio-Spiritual Healing in the Context of Chronic or Life-Threatening Illness
An observational study of Cancer and Pain, run by National Institutes of Health Clinical Center (CC) at 1 site in United States.
Trial summary
Background: A person s mental state, personal relationships, or spiritual well-being often change in many ways during or after cancer. Some of these changes can have a life-changing positive side, called psycho-socio-spiritual or PSS Healing. Read more about this study
- Who is it for?
- Ages 18 years and older
- How many people
- 37 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Sep 2009to 2 Nov 2016
- 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
Who may be able to join
- Physician-diagnosed cancer.
- Completion of at least one of the formal programs of palliative care (CC), healing (SFC), or rehabilitation (CRS or CC).
- No requirement for positive psychological, social, or spiritual change of any duration.
- English speaking and reading subjects must be proficient in English speaking and reading. The purpose of the speaking requirement is to aid interview transcription and coding processes. The purpose of the reading requirement is two-fold: (A) for completion of English text documents during enrollment, including written standard psychological exams, with minimal assistance, and (B) fluent reading of specific written text in English is necessary for the training of transcription software to perform automated transcription.
- Able to provide informed consent.
- SUBGROUP-SPECIFIC INCLUSION CRITERIA IN STUDY POPULATION 1:
Show all 11Show fewer
- SFC participants who have completed healing program: have well-established, life-transforming positive psychosocio-spiritual outcome with onset > 6 months before interview
- SFC-CUP participants who may be considered underserved in healthcare: have well-established, life-transforming positive psychosocio-spiritual outcome with onset > 6 months before interview
- CRS patients recent cardiac event, beginning rehabilitation: have willingness to participate in a series of face-to-face or telephone interviews
- CRS patients completed initial 36-session physical rehabilitation: have positive psycho-socio-spiritual outcome with onset after cardiac event
- NIH CC PPCS patients terminal prognosis or GVHD: positive psycho-socio-spiritual outcome with onset after disease onset or diagnosis
Who cannot join
- Age under 18 years. Subjects under 18 years of age are less likely to have a sufficient volume of life experience and maturity of perspective to address the full range and depth of psychological, social and spiritual issues that arise in the context of psycho-socio-spiritual healing.
- Born with the illness or diagnosed before 17 1/2 years of age. Even if the subject is at least 18 years of age at the time of the interview, the scope of this study is focused on the adult psycho-socio-spiritual response to cancer (see exclusion criterion 1 above).
- Emotional distress self-report (by the subject) that is equal to or above 3 as indicated on the Distress Thermometer instrument s 0-10 scale.
- Age under 18 years. Subjects under 18 years of age are less likely to have a sufficient volume of life experience and maturity of perspective to address the full range and depth of psychological, social and spiritual issues that arise in the context of psycho-socio-spiritual healing.
- Born with the illness or diagnosed before 17 1/2 years of age. Even if the subject is at least 18 years of age at the time of the interview, the scope of this study is focused on the adult psycho-socio-spiritual response to cancer (see exclusion criterion 1 above).
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Background:
- A person s mental state, personal relationships, or spiritual well-being often change in many ways during or after cancer. Some of these changes can have a life-changing positive side, called psycho-socio-spiritual or PSS Healing. For example, a person may feel mentally stronger or more whole than before their cancer.
- Because researchers are interested in enhancing such experiences in other cancer patients, there is interest in developing a way to measure PSS Healing that would be helpful in understanding this phenomenon.
Read more
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:
- The study design does not involve any treatment or counseling.
- Participants will be interviewed by a research team member. The one-time interview will last up to 2.25 hours and will be audiotaped and transcribed.
- Interviews will consist of an in-depth portion to assess the positive changes in relation to the illness. Participants will then be asked to identify from a list of short descriptions the ones that best reflect their personal experience of PSS Healing.
- Transcribed information will be coded and categorized according to standard research techniques.
Read the 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)
- Keywords
- Psychosocial Functioning, Psychosocial Stress, Palliative Care, Spirituality, Cancer
- Medical subject headings
- Neoplasms, Pain
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2010 (estimated)
- Study start4 Sep 2009
- Study completion2 Nov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for CancerStudies 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
- Time perspective
- Prospective
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institutes of Health Clinical Center (CC)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Ann M Cohen Berger, M.D., Principal investigator, National Institutes of Health Clinical Center (CC)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01077414
- Sponsor's protocol ID
- 090227
- Other IDs
- 09-CC-0227
- Status last verified
- 2 Nov 2016
- First submitted
- 26 Feb 2010
- Last updated
- 17 Dec 2019
- Results posted
- No
Publications
Beck CT. The lived experience of postpartum depression: a phenomenological study. Nurs Res. 1992 May-Jun;41(3):166-70.
PubMed 1584660Beck CT. Teetering on the edge: a substantive theory of postpartum depression. Nurs Res. 1993 Jan-Feb;42(1):42-8.
PubMed 8424067Beck CT, Gable RK. Postpartum Depression Screening Scale: development and psychometric testing. Nurs Res. 2000 Sep-Oct;49(5):272-82. doi: 10.1097/00006199-200009000-00006.
PubMed 11009122
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phenomenological Study of Psycho-Socio-Spiritual Healing in the Context of Chronic or Life-Threatening Illness
- ClinicalTrials.gov ID
- NCT01077414
- Acronym / sponsor ID
- 090227
- Keywords
- Psychosocial Functioning, Psychosocial Stress, Palliative Care, Spirituality, Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- National Institutes of Health Clinical Center (CC)US National Institutes of Health
- Study start
- 4 Sep 2009
- Study completion
- 2 Nov 2016
- First posted
- 1 Mar 2010 (estimated)
- 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.
Background:
- A person s mental state, personal relationships, or spiritual well-being often change in many ways during or after cancer. Some of these changes can have a life-changing positive side, called psycho-socio-spiritual or PSS Healing. For example, a person may feel mentally stronger or more whole than before their cancer.
- Because researchers are interested in enhancing such experiences in other cancer patients, there is interest in developing a way to measure PSS Healing that would be helpful in understanding this phenomenon.
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:
- The study design does not involve any treatment or counseling.
- Participants will be interviewed by a research team member. The one-time interview will last up to 2.25 hours and will be audiotaped and transcribed.
- Interviews will consist of an in-depth portion to assess the positive changes in relation to the illness. Participants will then be asked to identify from a list of short descriptions the ones that best reflect their personal experience of PSS Healing.
- Transcribed information will be coded and categorized according to standard research techniques.
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)
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Physician-diagnosed cancer.
- Completion of at least one of the formal programs of palliative care (CC), healing (SFC), or rehabilitation (CRS or CC).
- No requirement for positive psychological, social, or spiritual change of any duration.
- English speaking and reading subjects must be proficient in English speaking and reading. The purpose of the speaking requirement is to aid interview transcription and coding processes. The purpose of the reading requirement is two-fold: (A) for completion of English text documents during enrollment, including written standard psychological exams, with minimal assistance, and (B) fluent reading of specific written text in English is necessary for the training of transcription software to perform automated transcription.
- Able to provide informed consent.
Key exclusion criteria (5 listed)
- Age under 18 years. Subjects under 18 years of age are less likely to have a sufficient volume of life experience and maturity of perspective to address the full range and depth of psychological, social and spiritual issues that arise in the context of psycho-socio-spiritual healing.
- Born with the illness or diagnosed before 17 1/2 years of age. Even if the subject is at least 18 years of age at the time of the interview, the scope of this study is focused on the adult psycho-socio-spiritual response to cancer (see exclusion criterion 1 above).
- Emotional distress self-report (by the subject) that is equal to or above 3 as indicated on the Distress Thermometer instrument s 0-10 scale.
- Age under 18 years. Subjects under 18 years of age are less likely to have a sufficient volume of life experience and maturity of perspective to address the full range and depth of psychological, social and spiritual issues that arise in the context of psycho-socio-spiritual healing.
- Born with the illness or diagnosed before 17 1/2 years of age. Even if the subject is at least 18 years of age at the time of the interview, the scope of this study is focused on the adult psycho-socio-spiritual response to cancer (see exclusion criterion 1 above).
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
Not reported in the source record.
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 17 Dec 2019.
- Background: PubMed 1584660Beck CT. The lived experience of postpartum depression: a phenomenological study. Nurs Res. 1992 May-Jun;41(3):166-70.
- Background: PubMed 8424067Beck CT. Teetering on the edge: a substantive theory of postpartum depression. Nurs Res. 1993 Jan-Feb;42(1):42-8.
- Background: PubMed 11009122Beck CT, Gable RK. Postpartum Depression Screening Scale: development and psychometric testing. Nurs Res. 2000 Sep-Oct;49(5):272-82. doi: 10.1097/00006199-200009000-00006.
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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.
Ann M Cohen Berger, M.D. principal investigator
National Institutes of Health Clinical Center (CC)
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 Cancer and Pain, 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 11 inclusion and 5 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 17 Dec 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01077414, which also lists 3 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 17 Dec 2019.