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Protocol Details

Analysis of A Tool to Assess Psycho Social Spiritual Healing: Cognitive Interviewing

This study is NOT currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

16-CC-0056

Sponsoring Institute

National Institutes of Health Clinical Center (CC)

Recruitment Detail

Type: Completed Study; data analyses ongoing
Gender: Male & Female
Min Age: 18
Max Age: N/A

Referral Letter Required

No

Population Exclusion(s)

Non-English Speaking;
Children

Keywords

Palliative Care;
Pain;
Community Health;
Natural History

Recruitment Keyword(s)

None

Condition(s)

Palliative Care;
Critical Illness

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

None

Supporting Site

NIH Clinical Center

Background:

People undergo many changes when they have a life-threatening illness. Their values may change. They may have less fear of illness and death. They may become more spiritual. Researchers made a questionnaire called HEALS (Healing Experience During All Life Stressors). They want to use it to better understand these positive changes. They hope to provide better care for people with serious illnesses.

Objectives:

To develop the HEALS tool to better understand psycho-social-spiritual healing in people with serious illnesses. Also, to find out how palliative care services help people handle their illness or stress.

Eligibility:

Adults at least 18 years old at least 91 days after being diagnosed with a life-threatening illness. They must be getting:

Inpatient or outpatient palliative care at NIH Clinical Center OR

Inpatient palliative care at Suburban Hospital OR

NIH outpatient palliative care provided at Mobile Medical Care Clinic

Design:

Participants will be screened with questions to make sure they are eligible.

Participants will have 1 individual research session. This will be at the NIH Clinical Center.

Participants will be interviewed by a research team member. They will be asked about changes in a person s way of living that might happen during or after a serious illness.

Participants will be asked for their thoughts and opinions about the questions. They will be asked what ideas they may have to make the questions better.

Interviews will be audiotaped.

Participants will be asked some questions specific to their care location and team. These are to better understand how their services are helping participants.

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Eligibility

INCLUSION CRITERIA:

- Adults age greater than or equal to 18 years. The instrument under study for validation in this protocol is a self-assessment specifically designed for adult populations. Adults above the age of 18 are able to use logic, deductive reasoning, think more about the world / environment and has an understanding and ability to apply abstract ideas, which are all necessary for retrospective cognitive processes

- Understand and speak English

- Oriented to person, time and place at time of interview

- Physician diagnosed with life threatening illness

- 91+ days post diagnosis of life threatening illness

- Receiving inpatient or outpatient palliative care at NIH Clinical Center, inpatient palliative Care at Suburban Hospital, and NIH outpatient palliative care provided at the Mobile Medical Care Clinic

EXCLUSION CRITERIA:

- Patients with known brain metastases will be excluded because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of the assessment questions

-Inability to provide informed consent

-Inability to meet inclusion criteria


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Citations:

Egnew TR. The meaning of healing: transcending suffering. Ann Fam Med. 2005 May-Jun;3(3):255-62.

Denz-Penhey H, Murdoch C. Personal resiliency: serious diagnosis and prognosis with unexpected quality outcomes. Qual Health Res. 2008 Mar;18(3):391-404. doi: 10.1177/1049732307313431.

Lyckholm LJ, Coyne PJ, Kreutzer KO, Ramakrishnan V, Smith TJ. Barriers to effective palliative care for low-income patients in late stages of cancer: report of a study and strategies for defining and conquering the barriers. Nurs Clin North Am. 2010 Sep;45(3):399-409. doi: 10.1016/j.cnur.2010.03.007. Epub 2010 May 10.

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Contacts:

Principal Investigator

Referral Contact

For more information:

Ann M. Cohen 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. Cohen 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

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: TTY Users Dial 7-1-1
ccopr@nih.gov

Clinical Trials Number:

NCT02664402

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