Efficacy of a Proactive Approach to Death Thoughts in People With Advanced Cancer (Go-TAD)

May 21, 2024 updated by: Iris Crespo Martin, Universitat Internacional de Catalunya

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

168

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Go-TAD
the participants will receive a medical visit that will include the 4 open-ended questions comprising the Go-TAD intervention
Other: Go-TAD
The participants will receive a medical visit that will include the 4 open-ended questions comprising the Go-TAD intervention
No 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Emotional distress
Time Frame: 4 days
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.
4 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hopelessness assessed by the Beck Hopelessness Questionnaire (BHQ).
Time Frame: 4 days
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.
4 days
Doctor-patient relationship evaluated with the Patient-Doctor-Relationship Questionnaire -PDRQ-9-.
Time Frame: 4 days
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.
4 days
Quality of life related to health evaluated using the Palliative Outcome Scale (POS)
Time Frame: 4 days
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.
4 days

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical and sociodemographic variables
Time Frame: 4 days
age, gender, marital status, type of cancer, months since diagnosis.
4 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitat Internacional de Catalunya

Collaborators

Institut Català d'Oncologia
Hospital Arnau de Vilanova
Fundacion Rioja Salud

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 14, 2024

Primary Completion (Estimated)

June 1, 2025

Study Completion (Estimated)

December 21, 2025

Study Registration Dates

First Submitted

May 14, 2024

First Submitted That Met QC Criteria

May 14, 2024

First Posted (Actual)

May 20, 2024

Study Record Updates

Last Update Posted (Actual)

May 23, 2024

Last Update Submitted That Met QC Criteria

May 21, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PI22/01536

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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