- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06795815
The Implementation of the Go Wish Game to Promote Advance Care Planning in Onco- Hematologic Disease (OHGW-ACP)
The Implementation of the Go Wish Game to Promote Advance Care Planning in Onco-hematologic Disease (Onco-hema Go Wish-ACP): Intervention Set up and Multicentre Feasibility Trial
This is a mixed-method, device-free and drug-free multicenter interventional study. The study aims at facilitating end-of-life conversations within the doctor-patient relationship through the use of the Go Wish Game (GWG) and supporting patients, their caregivers and healthcare professionals to complete Advance Care Panning documentation.
The GWG helps people clarify and identify their priorities, should they be affected by a chronic, disabling and potentially non-healing illness. In fact, the GWG consists of a small deck of cards, and on each card is a concrete action or situation that may be important to a person at the end of life.
The "Onco-hema Go wish-ACP" project aims to evaluate the feasibility of a Go Wish Game-based intervention with patients with refractory lymphoma, leukemia or multiple myeloma or advanced solid tumors with prognosis > 3 months.
In terms of secondary objectives, the study aims to.
- Evaluate and compare the intervention with hematology and oncology patients in terms of: - Other feasibility indicators; Involvement in CCP pathways; Quality of communication; Meaning of life; Impact on hope; through a series of questionnaires administered to patients and caregivers involved in the intervention
- Qualitatively assess the acceptability of the intervention in terms of recruitment and delivery with patients and caregivers through semi-structured interviews and with professionals through Focus Groups (FGs).
- To analyze the clinical records of enrolled patients in terms of: values and preferences; awareness of prognosis; end-of-life choices and shared decision-making on treatment decisions.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Marta Perin (Dr), PhD
- Phone Number: +39 3463576133
- Email: marta.perin@ausl.re.it
Study Contact Backup
- Name: Andrea Fusco, MSc
- Phone Number: +39 3409136595
- Email: andrea.fusco@ausl.re.it
Study Locations
-
-
-
Reggio Emilia, Italy
- Recruiting
- AziendaUSL IRCCS Reggio Emilia
-
Contact:
- Marta Perin
- Phone Number: 3463576133
- Email: marta.perin@ausl.re.it
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- ≥ 18 years age; diagnosed with refractory lymphomas, or leukemia or multiple myeloma or advanced solid tumors and estimated prognosis > 3 months;
- able to communicate in Italian and
- to give written consent to the study.
Exclusion Criteria:
- Patients with severe cognitive impairment or serious psychiatric condition;
- refusal to participate to the study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Patients affected by refractory lymphomas, or leukemia or myeloma multiple or advanced solid tumors
|
The Go Wish Game (GWG) provides a simple tool, composed by 35 cards to identify individual priorities. GWG is welcomed as a first step in clarifying values and personal thoughts linked to the end of life. The GWG discussion will be divided into two meetings. During the first one, the physician instructs the patients and their caregivers on how the GWG works. The patient will be invited to divide the cards into three sets, labeling the content of the cards within each set as: Very important;more or less important and not important. This will be the base for the second meeting. During the second meeting - scheduled within one week - each category of card sets will be discussed with patients and their caregivers. The identification of the most relevant wishes or priorities of each patient will be incorporated into the individual therapeutic plan and the patient will be offered the option to make a formal ACP in the following 4 weeks. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Intervention Feasibility
Time Frame: 1 Year
|
We will evaluate the feasibility of the intervention. Feasibility will be investigated by:
4. proportion of enrolled patients that will complete the ACP document (after participating in all the planned GWG discussions) |
1 Year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
ACP Engagement;
Time Frame: 18 Months
|
We will further assess and compare the intervention within hemato-oncological and oncological patients in terms of: 1. ACP engagement: we will use the 4-item ACP Engagement (4-item ACP-E) questionnaire |
18 Months
|
|
Quality of Communication;
Time Frame: 18 Months
|
We will further assess and compare the intervention within hemato-oncological and oncological patients in terms of: 2. Quality of communication: we will use the 19-item Quality of Communication (QOC) questionnaire |
18 Months
|
|
Meaning of Life;
Time Frame: 18 Months
|
We will further assess and compare the intervention within hemato-oncological and oncological patients in terms of: 3. Meaning of life: we will use the Meaning in Life scale (MLS) |
18 Months
|
|
Impact on patients' hope
Time Frame: 18 Months
|
We will further assess and compare the intervention within hemato-oncological and oncological patients in terms of: 4. Impact on patients' hope: we will use the Hope Herth Index (HHI) |
18 Months
|
|
Acceptability
Time Frame: 18 Months
|
5. Acceptability of intervention in terms of recruitment and intervention delivery will be further investigated by: semi-structured interviews with patients and caregivers and FG with HPs who applied the GWG. . |
18 Months
|
|
ACP documentation
Time Frame: 18 Months
|
We will analyze the ACP documentation of patients enrolled to qualitatively investigate the congruence and relations between the priorities defined during the GWG meetings and the decisions written in the care plan
|
18 Months
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- OHGW-ACP
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ANALYTIC_CODE
- CSR
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.
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