Complementary Therapies in Palliative Care (CTPC)

January 30, 2017 updated by: William Collinge, PhD, Collinge and Associates, Inc.

Palliative Care Provider Online Education in Evidence-Based Complementary Therapies

Palliative care represents one of the most rapidly expanding sectors of health care. Its rapid growth has been accompanied by widespread needs for training of multidisciplinary personnel to work with the unique set of health issues specific to its population of patients - not only those at end-of-life, but also patients with long-term, incurable, chronic and degenerative illnesses. This project will develop the first online continuing education program for palliative care personnel in the evidence-based application of complementary therapies, to enhance patient care and quality of life in the palliative care setting.

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

Palliative care represents one of the most rapidly expanding sectors of health care. Its rapid growth has been accompanied by widespread needs for training of multidisciplinary personnel to work with the unique set of health issues specific to its population of patients - not only those at end-of-life, but also patients with long-term, incurable, chronic and degenerative illnesses. Selected complementary therapies offer significant benefits for reducing suffering and improving quality of life in palliative care patients; however, there currently are no systematic educational offerings on the evidence-based application of such therapies in the palliative care setting. This project will develop the first online continuing education program for palliative care personnel in the evidence-based application of complementary therapies in the palliative care setting. The final product will consist of an interactive course with eight modules; Phase I will develop the web infrastructure for the course, and will then pilot test two modules to establish feasibility of the concept. The specific aims are as follows: Aim 1. Build a website capable of delivering an online interactive educational curriculum. Aim 2. Conduct evidence-based reviews of the literature on the application of complementary therapies to pain and dyspnea in palliative care settings. Aim 3. Incorporate the course content into a structure and form that can be effectively delivered over the website. Aim 4. Conduct peer review evaluation of content to determine fidelity of course content with available evidence. Aim 5. Recruit a multidisciplinary sample of health care personnel practicing in the field of palliative care. Aim 6. Conduct pilot testing of two modules of the program. Aim 7. Evaluate {attitudinal and} learning outcomes and user satisfaction feedback to determine feasibility of the approach. Feasibility of the approach will be determined by success in recruitment, compliance, evidence of meeting user learning objectives, and user satisfaction data. The final product to be developed is an eight-module online educational course for multidisciplinary health professionals in the evidence-based application of complementary therapies in palliative care. Commercial application will be as a continuing education program that is licensed to institutions (care facilities, hospitals, universities, colleges) as well as purchased by individual users (fee-based), with discipline-specific continuing education credits available, all administered over the internet. Impact and Innovation: This will be the first online educational program for palliative care personnel on this topic available in the US. The course will spearhead the expansion of the existing paradigm of palliative care to incorporate evidence-based integration of complementary therapies. Technological innovation includes the employment of fluid updating of content to licensees, which is a new development in online education and particularly important given the rapid rate of emergence of new data. Public health benefit: The course will aid in the improvement of quality of palliative care, benefitting potentially millions of recipients in the most rapidly expanding sector of the health care system.

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.
51

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.
  • Phase 1

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Physicians (MD, DO), physician assistant (PA), nurse practitioner (NP), registered nurse (RN), licensed practical nurse (LPN), social worker (BA/BS/BSW, MSW, PhD/DSW), psychologist (MS/MA, PhD/PsyD), counselor (MS/MA),administrator, and chaplain.
  • Must be currently active within palliative care settings.

Exclusion Criteria:

  • Professionals not actively working in palliative care settings

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: Other
  • Allocation: N/A
  • Interventional Model: Single Group 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.
Experimental: Online CE/CME course
Participant in taking the three course modules and completing pre- and post-course data collection.
Behavioral: Online CE/CME course
Educational modules of a proposed online CE/CME course, module topics consisting of acupuncture, massage, and music-related interventions

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
Change in Test Scores on Knowledge of Course Content From Baseline to 30 Days
Time Frame: Baseline, 30 days
Investigator-generated test of change in knowledge about theory, mechanisms of action, delivery, indications for use, evidence of efficacy; total of 45 multiple choice questions covering three modalities: acupuncture, massage, and music interventions. Range of total possible correct responses was from 0-45, with subscores as follows: range for acupuncture, 0-15; massage, 0-16; music interventions, 0-14. Total score is the sum of the combined subscores.
Baseline, 30 days

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
Change in Ratings of Confidence in Understanding a Modality's Safety Considerations in PC From Baseline to 30 Days
Time Frame: Baseline, 30 days
Investigator-generated scale of confidence in understanding modality safety considerations. Likert-scaled items ranging from 0-10, with 0 as lowest and 10 as highest.
Baseline, 30 days
Change in Ratings of Confidence in Making Evidence-based Recommendations for the Modality in PC Planning From Baseline to 30 Days
Time Frame: Baseline, 30 days
Investigator-generated scale of confidence in making evidence-based recommendations about the modality. Likert-scaled items ranging from 0-10, with 0 as lowest and 10 as highest.
Baseline, 30 days
Change in Ratings of Confidence in Explaining the Modality From Baseline to 30 Days
Time Frame: Baseline, 30 days
Investigator-generated scale of confidence in communicating about the modality to patients, families and colleagues in PC contexts. Likert-scaled items ranging from 0-10, with 0 as lowest and 10 as highest.
Baseline, 30 days
Perceived Course Relevance: Importance of Knowledge About Non-pharmacological Approaches
Time Frame: 30 day follow-up
Investigator-generated scale of perceived importance and relevance of course content: "How important is it for palliative care providers to know about non-pharmacological approaches to symptom management?" Likert scale ranges from 1 (not at all) to 4 (extremely).
30 day follow-up
Perceived Course Relevance: Increasing Knowledge of Non-pharmacological Approaches
Time Frame: 30 day follow-up
Investigator-generated scale of perceived importance and relevance of course content: "How relevant is the content of this course for increasing palliative care providers' knowledge of non-pharmacological approaches?" Likert scale ranges from 1 (not at all) to 4 (extremely).
30 day follow-up
Perceived Course Relevance: Potential of Course to Contribute to Improved Patient Care
Time Frame: 30 day follow-up
Investigator-generated scale of perceived importance and relevance of course content: "To what degree do you think this course could potentially contribute to improved patient care?" Likert scale ranges from 1 (not at all) to 4 (extremely).
30 day follow-up

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.
Collinge and Associates, Inc.

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.
Kozak & Associates, LLC

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: William B Collinge, PhD, MPH, Collinge and Associates, Inc.

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

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 1, 2011

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.
December 1, 2013

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.
December 1, 2013

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).
December 12, 2015

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.
December 29, 2015

First Posted (Estimate)

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.
December 31, 2015

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.
March 17, 2017

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.
January 30, 2017

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.
January 1, 2017

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.
  • R43CA157005 (U.S. NIH Grant/Contract)

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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings