The Implementation of the Go Wish Game to Promote Advance Care Planning in Onco- Hematologic Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-99
SponsorAzienda USL Reggio Emilia - IRCCS
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
≥ 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.
Disqualifiers
Patients with severe cognitive impairment or serious psychiatric condition;
refusal to participate to the study
Trial design
Design model
Single group
Treatments tested in this trial
Go Wish Game
Other interventionThe 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.
Treatment groups
75 Participants
are divided into 1 treatment groupGroup A: Patients affected by refractory lymphomas, or leukemia or myeloma multiple or advanced solid tumorsExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Intervention Feasibility
We will evaluate the feasibility of the intervention. Feasibility will be investigated by: 1. proportion of patients who will accept to participate among those screened/eligible who received the proposal to participate; 2. proportion of enrolled patients who will withdraw from the study after the first GWG discussion among the enrolled patients; 3, percentage proportion of enrolled patients who will attend all the planned GWG discussions; 4\. proportion of enrolled patients that will complete the ACP document (after participating in all the planned GWG discussions)
Time frame
1 YearSecondary outcomes
1
ACP Engagement;
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
Time frame
18 Months2
Quality of Communication;
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
Time frame
18 Months3
Meaning of Life;
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)
Time frame
18 Months4
Impact on patients' hope
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)
Time frame
18 MonthsSponsors and contacts
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Source ClinicalTrials.gov