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Protocol Details

Phenomenological Study of Psycho-Socio-Spiritual healing in the Context of Chronic or Life-Threatening Illness

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

09-CC-0227

Sponsoring Institute

National Institutes of Health Clinical Center (CC)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 18
Max Age: N/A

Referral Letter Required

Yes

Population Exclusion(s)

Children

Special Instructions

Currently Not Provided

Keywords

Psychosocial Functioning;
Psychosocial Stress;
Palliative Care

Recruitment Keyword(s)

Psychosocial Functioning

Condition(s)

Cancer;
Pain

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

None

Supporting Site

NIH Clinical Center

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.

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Eligibility

INCLUSION CRITERIA FOR ALL SUBGROUPS IN STUDY POPULATION 1:

1. Physician-diagnosed cancer.

2. Audio clarity subjects must be able to participate in oral interviews with sufficient speaking volume and clarity to enable clearly audible recording of the participant s verbal responses using a recorder. For example, subjects with severe hearing disability who nonetheless reads lip well are eligible for enrollment in this study.

3. Willing to have audio recording during interview subjects must be willing to have the interview recorded with a recorder during oral interviews.

4. 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.

5. Able to provide informed consent.

SUBGROUP-SPECIFIC INCLUSION CRITERIA IN STUDY POPULATION 1:

1. SFC participants who have completed healing program: have well-established, life-transforming positive psychosocio-spiritual outcome with onset > 6 months before interview

2. 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

3. CRS patients recent cardiac event, beginning rehabilitation: have willingness to participate in a series of face-to-face or telephone interviews

4. CRS patients completed initial 36-session physical rehabilitation: have positive psycho-socio-spiritual outcome with onset after cardiac event

5. NIH CC PPCS patients terminal prognosis or GVHD: positive psycho-socio-spiritual outcome with onset after disease onset or diagnosis

INCLUSION CRITERIA FOR POPULATION 2:

1. Physician-diagnosed cancer.

2. Completion of at least one of the formal programs of palliative care (CC), healing (SFC), or rehabilitation (CRS or CC).

3. No requirement for positive psychological, social, or spiritual change of any duration.

4. 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.

5. Able to provide informed consent.

SUBGROUP-SPECIFIC INCLUSION CRITERIA IN STUDY POPULATION 1:

1. SFC participants who have completed healing program: have well-established, life-transforming positive psychosocio-spiritual outcome with onset > 6 months before interview

2. 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

3. CRS patients recent cardiac event, beginning rehabilitation: have willingness to participate in a series of face-to-face or telephone interviews

4. CRS patients completed initial 36-session physical rehabilitation: have positive psycho-socio-spiritual outcome with onset after cardiac event

5. NIH CC PPCS patients terminal prognosis or GVHD: positive psycho-socio-spiritual outcome with onset after disease onset or diagnosis

EXCLUSION CRITERIA FOR THE STUDY POPULATION 1:

1. 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.

2. 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).

3. 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.

EXCLUSION CRITERIA FOR POPULATION 2:

1. 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.

2. 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).


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Citations:

Beck CT. The lived experience of postpartum depression: a phenomenological study. Nurs Res. 1992 May-Jun;41(3):166-70.

Beck CT. Teetering on the edge: a substantive theory of postpartum depression. Nurs Res. 1993 Jan-Feb;42(1):42-8.

Beck CT, Gable RK. Postpartum Depression Screening Scale: development and psychometric testing. Nurs Res. 2000 Sep-Oct;49(5):272-82.

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Contacts:

Principal Investigator

Referral Contact

For more information:

Ann M. Berger, M.D.
National Institutes of Health Clinical Center (CC)
BG 10-CRC RM 2-1733
10 CENTER DR
BETHESDA MD 20814
(301) 594-9767
ab363j@nih.gov

Ann M. Berger, M.D.
National Institutes of Health Clinical Center (CC)
BG 10-CRC RM 2-1733
10 CENTER DR
BETHESDA MD 20814
(301) 594-9767
ab363j@nih.gov

Patient Recruitment and Public Liaison Office
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Toll Free: 1-800-411-1222
TTY: 301-594-9774 (local),1-866-411-1010 (toll free)
Fax: 301-480-9793

prpl@mail.cc.nih.gov

Clinical Trials Number:

NCT01077414

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