CompletedNot Applicable

Tool to Assess Psycho-Social-Spiritual Healing: Cognitive Interviewing

United States30 participantsStarted 2017-01-05

Plain-language summary

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. ...

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

* 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

NIH HEALS Assessment

Timeframe: Present

Trial details

NCT IDNCT02664402

SponsorNational Institutes of Health Clinical Center (CC)

Sponsor typeNIH

Study typeOBSERVATIONAL

Primary completion2017-01-05

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