- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04020679
The Goals of Care Initiative (GOCI)
A Hybrid Implementation-effectiveness Stepped Wedge Cluster Randomised Controlled Trial to Determine the Effectiveness of the Goals of Care Initiative
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Manchester, United Kingdom, M20 4BX
- The Christie NHS Foundation Trust
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Undergoing, or being considered for, systemic treatment from one of the cluster teams.
- 18+ years.
- Able to give written consent.
- Able to understand verbal and written English.
Exclusion Criteria:
• Patient is not being considered for Systemic Anti-Cancer Treatment.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Sequential Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control arm
Participants will not receive GOCI materials
|
|
Experimental: Intervention
Participants will receive GOCI materials and clinicians will receive training.
|
Can-GUIDE will provide videos on a number of SDM topics including interviews with patients and clinicians discussing patient involvement in SDM and how goal conversations can inform the decision making process.
Furthermore, there will be instructional videos on how to complete the Goal conversations sheet.
Accompanying the videos will be interactive elements which will help users consider the types of questions that they wish to ask their clinical teams.
The goal conversation sheet allows patients to list their goals and priorities that they wish to bring up in the consultation with their clinical teams.
The Goals of Care (GOC) tool is a communication aid for clinicians to summarise goals of care discussions such as those facilitated by the goals conversation sheet.
The completed tool will then be logged onto the Electronic Patient Record (EPR) and is then disseminated to other HCPs involved in the patients care.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
SDM-Q-9
Time Frame: Immediately following intervention
|
Patient involvement in decision making will be measured using the SDM-Q-9 questionnaire.
The questionnaire contains nine items with respondents scoring on a six point scale (0 represents completely disagree to 5 which represents completely disagree) how much they agree with the presented statement.
The highest score attainable, 45, represents the highest level of perceived Shared Decision Making and 0 represents no perceived involvement in Shared Decision Making.
|
Immediately following intervention
|
Decision Conflict Scale
Time Frame: Immediately following intervention
|
Patient satisfaction with decision and overall decision conflict will be measured using the Ottawa Decisional Conflict Scale. The scale consists of 16 items with patients scoring themselves on a five point scale (0, Strongly Agree - 4, Strongly Disagree). The scale includes five subscales: uncertainty, support, values, informed, effective decision. The total score and subscale scores are calculated by dividing the sum of the items by the number of items within that subscale and multiplying by twenty five (scored range from 0 to 100; 0 score indicates no decisional conflict, 100 indicates extremely high decisional conflict). This scale evaluates the quality of decision as outlined within internationally recognised guidelines to establish the effectiveness of decision aids. Furthermore, some of the subscales address evaluating the quality of the decision process (feeling informed about the options, clarity of values). |
Immediately following intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Decision Self Efficacy Scale
Time Frame: Immediately following intervention, then at 6 weeks and 12 weeks.
|
A patient's ability to make a decision about treatment (or decision self-efficacy) will be measured using the Ottawa Decision Self-Efficacy scale.
The scale consists of 11 items where patients score themselves on a five point scale (0, not at all confident - 4, Very confident); high score indicates greater decision self-efficacy.
The total score provides a global rating of self confidence in the patient's ability to engage with decision making regarding their treatment.
The total score is calculated by summing the 11 items, dividing by 11 and then multiply by 25.
|
Immediately following intervention, then at 6 weeks and 12 weeks.
|
EQ-5D-5L
Time Frame: Immediately following intervention, then at 6 weeks and 12 weeks.
|
EQ-5D is a standardised instrument for use as a measure of health outcome and it provides a simple descriptive profile and a single index value for health status that can be used in the clinical and economic evaluation of health care as well as in population health surveys. The EuroQoL 5-level version (EQ-5D-5L) will be assessed to provide a preference based measure of health-related quality-of-life which will enable us to calculate a quality adjusted life-year (QALY) for use in the cost-effectiveness analysis. The preference weights to estimate utility values and QALYs will be those recommended by NICE at the time of data analysis. Participants are asked to choose a statement which best relates to their current experience relating to the following health domains: mobility, self-care, ability to carry out usual activities, pain/discomfort, anxiety/depression. |
Immediately following intervention, then at 6 weeks and 12 weeks.
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Janelle Yorke, PhD, University of Manchester
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 18_CPCR_17
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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.
Clinical Trials on Chemotherapy Effect
-
Hospices Civils de LyonCompletedChemotherapy Effect | G-CHOP Chemotherapy | R-CHOP ChemotherapyFrance
-
GCS Ramsay Santé pour l'Enseignement et la RechercheRecruitingChemotherapy EffectFrance
-
West Cancer CenterPfizer; Emory UniversityCompletedChemotherapy EffectUnited States
-
Namik Kemal UniversityCompleted
-
Animated Dynamics, Inc.Purdue UniversityNot yet recruitingCancer | Chemotherapy EffectUnited States
-
Rennes University HospitalNot yet recruitingChemotherapy Effect | AplasiaFrance
-
Groupe Hospitalier Paris Saint JosephHopital Antoine BeclereCompletedCancer | Chemotherapy EffectFrance
-
Udayana UniversityUnknown
-
Sutter HealthUnknownChemotherapy Effect | Chemotherapeutic Toxicity | FastingUnited States
-
Milton S. Hershey Medical CenterCompletedChemotherapy Effect | Chemotherapeutic Toxicity | Chemotherapeutic Agent ToxicityUnited States
Clinical Trials on Goals of Care Initiative
-
University of North Carolina, Chapel HillNational Institute on Aging (NIA)CompletedDementiaUnited States
-
Memorial Sloan Kettering Cancer CenterCompleted
-
Icahn School of Medicine at Mount SinaiPatient-Centered Outcomes Research InstituteCompletedMelanoma | Glioblastoma | Colorectal Cancer | Cancer of Pancreas | Cancer of Stomach | Head or Neck Cancer | Stage III | Esophageal | Stage IV | Lung Cancers | Pancreatic Cancers | Primary Stage IV HepatobiliaryUnited States
-
Jewish General HospitalRecruiting
-
VA Office of Research and DevelopmentCompletedSchizophrenia | Bipolar Disorder | Major Depressive Disorder | Cardiovascular Disease Risk | Chronic Affective DisordersUnited States
-
VA Office of Research and DevelopmentCompletedSchizophrenia | Schizoaffective Disorder | Bipolar Disorder | Major Depressive Disorder | Cardiovascular Disease RiskUnited States
-
The Hospital for Sick ChildrenHamilton Health Sciences Corporation; London Health Sciences Centre; Children...Completed
-
San Diego State UniversityNational Institute on Minority Health and Health Disparities (NIMHD); Family...RecruitingLow Back Pain | Chronic Pain | Chronic Low-back Pain | Neck PainUnited States
-
Lawson Health Research InstituteUnknown