## Protocol Section
### Identification Module
**NCT ID:** NCT06420609

**Acronym:** Go-TAD

**Brief Title:** Efficacy of a Proactive Approach to Death Thoughts in People With Advanced Cancer

**Official Title:** Efficacy of a Proactive Approach to Death Thoughts in People With Advanced Cancer: a Randomized Clinical Trial

#### Organization Study ID Info
**ID:** PI22/01536
#### Organization
**Class:** OTHER
**Full Name:** Universitat Internacional de Catalunya
### Status Module
#### Completion Date
**Date:** 2025-12-21

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-23

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-21

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2025-06

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05-14

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-14
**Study First Submit QC Date:** 2024-05-14
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** Institut Català d'Oncologia

**Class:** OTHER

**Name:** Hospital Arnau de Vilanova

**Class:** OTHER

**Name:** Fundacion Rioja Salud

#### Lead Sponsor

**Class:** OTHER

**Name:** Universitat Internacional de Catalunya

#### Responsible Party

**Investigator Affiliation:** Universitat Internacional de Catalunya

**Investigator Full Name:** Iris Crespo Martin

**Investigator Title:** Principal investigator

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**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 Module

**Conditions:**

- Death

- Advanced Cancer

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** SINGLE

**Masking Description:** This study proposes a randomized controlled clinical trial (RCT) with a stepped-wedge design, in which 6 palliative care units from second and third level hospitals in Spain will collaborate. The six units will contribute with both experimental and control participants, starting with the recruitment of the control group participants and subsequently starting the intervention group. The time at which they will transition to the intervention will be chosen at random. The centers will be randomized to know at what point in the study they should begin the intervention and each center will be informed of the number of patients they should include in each of the groups. The clusters correspond to the different palliative care units that participate in the study. Six sequences will be carried out, seven periods with 4 patients in each period. Patients will be different in each of the periods.

**Who Masked:**

- PARTICIPANT

**Primary Purpose:** SUPPORTIVE_CARE

#### Enrollment Info

**Count:** 168

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

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

**Intervention Names:**

- Other: Go-TAD

**Label:** Go-TAD

**Type:** EXPERIMENTAL

#### Arm Group 2

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

**Label:** CONTROL

**Type:** NO_INTERVENTION

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Go-TAD

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

**Name:** Go-TAD

**Type:** OTHER

### Outcomes Module

#### Other Outcomes

**Description:** age, gender, marital status, type of cancer, months since diagnosis.

**Measure:** Clinical and sociodemographic variables

**Time Frame:** 4 days

#### Primary Outcomes

**Description:** The main outcome will be emotional distress, which will be evaluated using an instrument validated and developed in the context of palliative care in Spain, the Emotional Distress Detection (DME) questionnaire. This questionnaire is characterized by the simplicity and ease of application and the short application time, given that it only consists of 4 items. The first three items are questions with answers in the format of a visual numerical scale from 0 to 10, in which the state of mind and the perception of coping with the situation are evaluated, and another that records the presence or absence of concerns. The last question is based on the observation, by the healthcare professional, of the presence of external signs of emotional distress. The DME gives a total score (0 to 20) made up of the sum of the scores of the first three items, one of them in reverse format, with the highest scores indicating greater discomfort.

**Measure:** Emotional distress

**Time Frame:** 4 days

#### Secondary Outcomes

**Description:** Hopelessness will be assessed with the Beck Hopelessness Questionnaire (BHQ). This validated and widely used questionnaire in palliative care research originally consists of 20 items that were reduced to 7 items with true/false responses in a brief version specially adapted to the area of palliative care. The total score ranges from 0 to 7, with higher scores indicating a higher level of hopelessness.

**Measure:** Hopelessness assessed by the Beck Hopelessness Questionnaire (BHQ).

**Time Frame:** 4 days

**Description:** The quality of the doctor-patient relationship from the patient's perspective will be evaluated with the Patient-Doctor-Relationship Questionnaire -PDRQ-9-. This questionnaire consists of 9 items with a 5-point Likert-type response format and has been previously used in the field of palliative care. The total score ranges between 9-45, with higher scores indicating a better relationship between doctor and patient.

**Measure:** Doctor-patient relationship evaluated with the Patient-Doctor-Relationship Questionnaire -PDRQ-9-.

**Time Frame:** 4 days

**Description:** It will be evaluated using the Palliative Outcome Scale (POS). This scale has been validated with a proxy for quality of life in patients with palliative care. It consists of 12 items with multiple response format that address the physical and psychological dimensions, the information given, communication with family and friends, the meaning of life and other practical aspects related to the disease. The range of scores is 0-40, with higher scores indicating worse quality of life.

**Measure:** Quality of life related to health evaluated using the Palliative Outcome Scale (POS)

**Time Frame:** 4 days

### Eligibility Module

**Eligibility Criteria:** The inclusion criteria will be:

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

The exclusion criteria will be:

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

**Maximum Age:** 100 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### IPD Sharing Statement Module

**IPD Sharing:** NO

### References Module

#### References

**Citation:** Lee JJ, Liu DD. A predictive probability design for phase II cancer clinical trials. Clin Trials. 2008;5(2):93-106. doi: 10.1177/1740774508089279.

**PMID:** 18375647

**Citation:** Limonero JT, Mateo D, Mate-Mendez J, Gonzalez-Barboteo J, Bayes R, Bernaus M, Casas C, Lopez M, Sirgo A, Viel S. [Assessment of the psychometric properties of the Detection of Emotional Distress Scale in cancer patients]. Gac Sanit. 2012 Mar-Apr;26(2):145-52. doi: 10.1016/j.gaceta.2011.07.016. Epub 2011 Oct 26. Spanish.

**PMID:** 22033008

**Citation:** Martin-Fernandez J, del Cura-Gonzalez MI, Gomez-Gascon T, Fernandez-Lopez E, Pajares-Carabajal G, Moreno-Jimenez B. [Patient satisfaction with the patient-doctor relationship measured using the questionnaire (PDRQ-9)]. Aten Primaria. 2010 Apr;42(4):196-203. doi: 10.1016/j.aprim.2009.09.026. Epub 2010 Feb 8. Spanish.

**PMID:** 20116893

**Citation:** Serra-Prat M, Nabal M, Santacruz V, Picaza JM, Trelis J; Grupo Catalan de Estudio de la Efectividad de los Cuidados Paliativos. [Validation of the Spanish version of the Palliative Care Outcome Scale]. Med Clin (Barc). 2004 Oct 2;123(11):406-12. doi: 10.1016/s0025-7753(04)74535-2. Spanish.

**PMID:** 15482713

**Citation:** Crespo I, Monforte-Royo C, Balaguer A, Pergolizzi D, Cruz-Sequeiros C, Luque-Blanco A, Porta-Sales J. Screening for the Desire to Die in the First Palliative Care Encounter: A Proof-of-Concept Study. J Palliat Med. 2021 Apr;24(4):570-573. doi: 10.1089/jpm.2020.0276. Epub 2020 Sep 18.

**PMID:** 32945714

**Citation:** Porta-Sales J, Crespo I, Monforte-Royo C, Marin M, Abenia-Chavarria S, Balaguer A. The clinical evaluation of the wish to hasten death is not upsetting for advanced cancer patients: A cross-sectional study. Palliat Med. 2019 Jun;33(6):570-577. doi: 10.1177/0269216318824526. Epub 2019 Jan 28.

**PMID:** 30688146

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000010335

- Term: Pathologic Processes

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M6845

- Name: Death

- Relevance: HIGH

- As Found: Death

### Condition Browse Module - Meshes

- ID: D000009369

- Term: Neoplasms

- ID: D000003643

- Term: Death

### Misc Info Module

- Version Holder: 2024-05-31
