Palliative Care for Elderly Outpatients

March 6, 2024 updated by: University of Florida
Our long-term goal is to improve spiritual care outcomes for elderly patients with cancer. The study team will use a spiritual intervention, Dignity Therapy (DT), to help these patients maintain pride, find spiritual comfort, enhance continuity of self, and ultimately make meaning of their life threatening illness.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The study team propose a 3 arm pre/posttest, RCT with a 4-step (approximately 12 months per step), stepped-wedge design to compare effects of usual outpatient palliative care (usual care) and usual care along with either nurse-led or chaplain-led DT on patient outcomes, cancer prognosis awareness. The study team will assign 6 outpatient palliative care sites to usual care during the first-step, and randomly assign two sites per step to begin and continue DT led by either a nurse or a chaplain during each of the next 3 steps. During the usual care steps, 280 patients will complete pretest measures and satisfaction with palliative spiritual care services, receive usual palliative care, and complete posttest measures. During the experimental steps as part of routine palliative care service delivery, 280 patients will complete pretest measures, receive nurse-led or chaplain-led DT, and complete posttest measures. Using mixed level analysis with site, provider (nurse, chaplain) and time (step) included in the model, the study team will compare the usual care and each of the DT groups for effects on dignity impact, existential tasks, and cancer prognosis awareness and explore the moderating effects of physical symptoms and spiritual distress. The study team will also determine the effect of usual care and DT on the patient's satisfaction with palliative spiritual care services and the report of the patient's unmet spiritual needs.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
579

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Yingwei Yao, PhD
  • Phone Number: (352) 273-6524
  • Email: y.yao@ufl.edu

Study Locations

  • United States
    • Florida
      • Gainesville, Florida, United States, 32611
        • University of Florida

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

55 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. cancer diagnosis (receiving cancer therapy or cancer control care)
  2. receiving outpatient palliative care
  3. age 55 years or older
  4. able to speak and read English
  5. physically able to complete the study (Palliative Performance Scale [PPS]>50, suggesting a mean in life expectancy of 53 days at the time of enrollment since each patient is expected to participate in the study for 28-42 days maximum [4-6 weeks]).

Exclusion Criteria:

  1. legally blind
  2. cognitively unable to complete study measures (Mini Mental Status Exam [MMSE] does not correctly spell the word world backwards)
  3. history of psychosis (medical record review)
  4. Patient Dignity Inventory score that indicates their distress level falls outside the remaining quota for a given step (quota is 50% of sample/site/step with low distress ≤ 2 problems rated >2 & 50% with high distress ≥ 3 problems rated >2)
  5. Spiritual distress score that indicates their distress level falls outside the remaining quota for a given step (quota is 50% of sample/site/step with low distress ≤ 2 problems rated >2 & 50% with high distress ≥ 3 problems rated >2)
  6. are participating in another psychosocial intervention study that is focused on concepts similar to the proposed study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: usual outpatient palliative care
During the usual care steps, patients will receive usual outpatient palliative care
Behavioral: Usual care
Palliative care nurses usually see patients each clinic visit to assess vital signs, function, symptoms, and to provide patient and family education. They document findings and interventions in the electronic health record (EHR). Whereas usual care for palliative care chaplaincy in the outpatient setting varies by site, chaplaincy care for usual care patients in this study will follow the usual practice for inpatient palliative care chaplaincy, which is to visit all new referrals to the clinic and assess their spiritual and religious needs. This assessment is then memorialized in a spiritual treatment plan documented in the EHR.
Experimental: Dignity Therapy - Nurse Led
During the experimental steps as part of routine palliative care service delivery, patients receive nurse-led DT.
Behavioral: Dignity Therapy - Nurse Led
The nurse-led intervention involves three sessions, each of which follows a set process. The standardize approach to the delivery of the intervention facilitates a personal process of reflection and recognition that allows the patient to make meaning of their experience.
Experimental: Dignity Therapy - Chaplain Led
During the experimental steps as part of routine palliative care service delivery, patients will receive chaplain-led DT.
Behavioral: Dignity Therapy - Chaplain Led
The chaplain-led DT intervention involves three sessions, each of which follows a set process. The standardize approach to the delivery of the intervention facilitates a personal process of reflection and recognition that allows the patient to make meaning of their experience.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Dignity Impact Scale
Time Frame: 5 weeks
Our primary outcome measure is a 7-item Dignity Impact Scale. The items are scored on a 5-point scale from 'strongly disagree' (1) to 'strongly agree' (5). The scores can range from 7 to 35 with higher scores representing better outcome.
5 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Preparation
Time Frame: 5 weeks
Preparation for death subscale taken from the QUAL-E, a measure designed to evaluate quality of life and to assess the effectiveness of interventions targeted to improve the quality of life at the end of life. Scores range from 4 to 20 with higher scores representing better outcomes.
5 weeks
Completion
Time Frame: 5 weeks
Life completion subscale taken from the QUAL-E, a measure designed to evaluate quality of life and to assess the effectiveness of interventions targeted to improve the quality of life at the end of life. Scores range from 7 to 35 with higher scores representing better outcomes.
5 weeks
Peaceful Awareness
Time Frame: 5 weeks
We measured peaceful awareness with the 2 items: terminal illness awareness and peaceful awareness questionnaire. The first focused on terminal illness acknowledgement (TIA) in which patients rated their current health status as 1) relatively healthy, 2) seriously but not terminally ill, or 3) seriously and terminally ill. The second item focused on the frequency of feeling deep inner peace or harmony, which was rated on a 6-point Likert scale ranging from 1) never or almost never to 6) many times a day. Scores of at least 3 on each of the two items defined positive peaceful awareness, a dichotomous measure.
5 weeks
Treatment Preference
Time Frame: 5 weeks
We measured treatment preferences with a single item from the standardized and validated Hypothetical Advanced Care Planning Scenario (H-CAP-S) that assesses treatment preferences.
5 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Florida

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Northwestern University
Emory University
University of California, San Francisco
Rush University
Healthcare Chaplaincy

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Diana J Wilkie, PhD, University of Florida
  • Study Director: Tammi Quest, MD, Emory University
  • Principal Investigator: George Fitchett, PhD, Rush University
  • Study Director: Michael Rabow, MD, University of California, San Francisco
  • Principal Investigator: Linda Emanuel, MD/PhD, Northwestern University
  • Study Director: Marvin Delgado, MD, MD Anderson

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 26, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 31, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 31, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 26, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 5, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 6, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 4, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 6, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRB201601190-N
  • OCR17893 (Other Identifier: UF OnCore)
  • 5R01CA200867-05 (U.S. NIH Grant/Contract)
  • PRO00002457 (Other Identifier: UFIRST Proposal)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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