Efficacy of a Proactive Approach to Death Thoughts in People with Advanced Cancer

NCT ID: NCT06420609

Last Updated: 2025-04-01

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 168 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-14
• Study Completion Date: 2025-12-21

Brief Summary

The aim of this study is to demonstrate the efficacy of a proactive intervention to approach death thoughts among people with advanced cancer compared to usual care (the reactive approach) via a feasible approach with previous indicators of efficacy: Go-TAD (Give the Opportunity to Talk about Death). The benefits of the intervention will be evaluated in terms of: reduction of emotional distress and hopelessness and improvement the doctor-patient relationship, as well as improvement of quality of life for the patient. A Phase II randomized controlled mixed methods clinical trial (RCT) will be carried out within 4 Palliative Care units of tertiary care hospitals in Catalonia. Participants will be persons with advanced cancer defined according to the criteria of the American Society of Clinical Oncology. Participants will be randomly assigned to an intervention group or control group. In the intervention group, the participants will receive a medical visit that will include the 4 open-ended questions comprising the Go-TAD intervention, while the control group will receive usual care. Between 24 and 96 hours later, a researcher from outside the center will assess study outcome measures. To strengthen the study conclusions, a qualitative study will be carried out in which the experiences of the participants in the intervention group and of their professionals who administered the Go-TAD will be explored in depth.

Conditions

Death; Advanced Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Go-TAD

the participants will receive a medical visit that will include the 4 open-ended questions comprising the Go-TAD intervention

Group Type: EXPERIMENTAL

Go-TAD

Intervention Type: OTHER

The participants will receive a medical visit that will include the 4 open-ended questions comprising the Go-TAD intervention

CONTROL

the participants will receive a medical visit that will include the 4 open-ended questions comprising hobbies and other personal themes, but not death.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Go-TAD

The participants will receive a medical visit that will include the 4 open-ended questions comprising the Go-TAD intervention

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. patients with advanced cancer defined according to ASCO (American Society of Clinical Oncology) criteria referred for the initial palliative care (PC) consultation.

2. age over 18 years

3. ECOG 0-3 (functionality status)

4. outpatients and inpatients

5. patients who can sign the informed consent

6. patients with the ability to maintain a conversation

Exclusion Criteria

1. patients with acute symptoms that may affect their consciousness.

2. patients with any uncontrolled symptoms that prevent collaboration in the study assessed according to clinical judgment

3. moderate or severe cognitive impairment assessed according to clinical judgment

4. patients included in another incompatible clinical trial

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institut Català d'Oncologia

OTHER

Sponsor Role: collaborator

Hospital Arnau de Vilanova

OTHER

Sponsor Role: collaborator

Fundacion Rioja Salud

OTHER

Sponsor Role: collaborator

Universitat Internacional de Catalunya

OTHER

Sponsor Role: lead

Responsible Party

Iris Crespo Martin

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Universitat Internacional de Catalunya

Sant Cugat del Vallès, Barcelona, Spain

Countries

Spain

References

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

PMID: 15482713 (View on PubMed)

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Reference Type: BACKGROUND

PMID: 30688146 (View on PubMed)

Julia-Torras J, Garcia-Salanova A, Monforte-Royo C, Jimeno Ariztia M, Balaguer A, Crespo I. Impact of proactively inviting people with advanced cancer to talk about the end of life: a randomised clinical trial protocol. BMJ Open. 2025 Jul 13;15(7):e104195. doi: 10.1136/bmjopen-2025-104195.

Reference Type: DERIVED

PMID: 40659391 (View on PubMed)

Other Identifiers

PI22/01536

Identifier Type: -

Identifier Source: org_study_id