NCT06795815

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable leukemia

Timeline
2mo left

Started Jun 2025

Shorter than P25 for not_applicable leukemia

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress85%
Jun 2025Jul 2026

First Submitted

Initial submission to the registry

January 8, 2025

Completed
20 days until next milestone

First Posted

Study publicly available on registry

January 28, 2025

Completed
5 months until next milestone

Study Start

First participant enrolled

June 30, 2025

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Last Updated

May 7, 2026

Status Verified

May 1, 2026

Enrollment Period

1 year

First QC Date

January 8, 2025

Last Update Submit

May 4, 2026

Conditions

Keywords

Advance Care PlanningGo Wish GameMedical OncologyHematologyOncologyPalliative CareExperimental Design StudyMixed Methods

Outcome Measures

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)

    1 Year

Secondary Outcomes (6)

  • ACP Engagement;

    18 Months

  • Quality of Communication;

    18 Months

  • Meaning of Life;

    18 Months

  • Impact on patients' hope

    18 Months

  • Acceptability

    18 Months

  • +1 more secondary outcomes

Study Arms (1)

Patients affected by refractory lymphomas, or leukemia or myeloma multiple or advanced solid tumors

EXPERIMENTAL
Other: Go Wish Game

Interventions

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.

Patients affected by refractory lymphomas, or leukemia or myeloma multiple or advanced solid tumors

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ≥ 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.

You may not qualify if:

  • Patients with severe cognitive impairment or serious psychiatric condition;
  • refusal to participate to the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AziendaUSL IRCCS Reggio Emilia

Reggio Emilia, Italy

RECRUITING

MeSH Terms

Conditions

LeukemiaLymphomaNeoplasmsHematologic Diseases

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Central Study Contacts

Marta Perin (Dr), PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 8, 2025

First Posted

January 28, 2025

Study Start

June 30, 2025

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

July 1, 2026

Last Updated

May 7, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will share

We share individual information about gender, age, work occupation, disease type, prognosis and time of diagnosis.

Shared Documents
STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
Access Criteria
The access will be able only to those people in terms of clinical staff, who are involved in the study

Locations