Truthful Information on Chemotherapy and Its Impact on Chemotherapy at the End of Life (HIPPOCRATE)

April 30, 2021 updated by: Assistance Publique - Hôpitaux de Paris

Impact of a Truthful Information Concerning Chemotherapy on Chemotherapy Prescription at the End of Life : a Randomized Controlled Study in Non-curable Lung Cancer Patients

Patients with metastatic cancer have a substantial symptom burden and may receive aggressive care at the end of life. There is evidence that the use of chemotherapy near the end of life is not related to its likelihood of providing benefit and the overuse of aggressive anticancer therapies near the end of life may result in more toxicity than clinical benefit. Moreover, proposing new lines of treatment after successive therapeutic failures may be a way of avoiding discussion of prognosis and advance care planning. It has been proposed that systems not providing overly aggressive care near the end of life would be the ones in which less than 10% of patients receive chemotherapy in the last 14 days of life. Presently the first consultation between patient and oncologist is ruled in France by the first "Plan Cancer" and the "Dispositif d'annonce" (announcement planning). Oncologists are supposed to explain the diagnosis of cancer and to present a treatment plan. In routine practice for metastatic non curable cancer patients, chemotherapy is presented as the leading therapy and its side effects are explained. The use of chemotherapy has been associated with the worsening of two major competitive life-threatening conditions for cancer patients: cachexia and thrombo-embolic events. Nevertheless the risk of worsening both those conditions is hardly explained in routine practice.

This study proposes to examine in a monocentric interventional prospective randomized trial, the impact of a particular way for the oncologist to present chemotherapy at the diagnosis stage on the easiness of timely chemotherapy interruption at the end of life. The main objective is to determine whether or not the explanation of the potential role of anticancer chemotherapy in worsening life-threatening conditions impacts the proportion of patients receiving chemotherapy in the last 30 days of life compared with usual presentation. Secondary objectives are to determine the impact of this communication strategy on overall survival and other indicators of aggressiveness of care and palliative care resources use.

The hypothesis is that the intervention will allow 15% of patients receiving anticancer therapy during the last 30 days of life, as compared to 30% in the control group.

The investigators expect that the intervention evaluated in this study will reduce the rate of patients receiving chemotherapy during the last 30 days of life hopefully improving the quality of end of life care. A secondary objective is overall survival and this study will therefore verify that the intervention arm is not associated with poorer overall survival. But more probably investigators expect patients in the intervention arm to have an improved overall survival mainly link to a decrease in harms due to chemotherapy given near the end of life and to better palliative care. In effect the hypothesis is that showing the life-threatening risks associated with chemotherapy and thus reducing for patients the importance of this treatment will leave room for improved palliative care as shown notably by earlier and more frequent referral to palliative care specialists. If this trial is positive, it will prove the capital role of patient-doctor communication in cancer care and that few differences in communication strategy could improve end of life care and maybe even survival. The impact on the oncology community would be major since the intervention could be easily transposed in all practices at no additional cost. It would also emphasize the importance of communication skills and human relationship in the very technical field of medical oncology.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

123

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75014
        • Hôpital Cochin

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • stage IV lung cancer, histologically proven
  • > 18 years old
  • diagnosed during the last 8 weeks
  • systemic therapy indicated

Exclusion Criteria:

  • prior systemic therapy for metastatic disease
  • comorbidity not compatible with the inclusion according to the investigator
  • patient has not given its non-objection or not being able to give
  • patient unaffiliated or not beneficiary of a social security scheme

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
Active Comparator: Standard of information
Information on chemotherapy as done in routine practice following national and international guidelines
Behavioral: Standard of information
Experimental: Truthful information on chemotherapy risks
Information on the potential role of anticancer chemotherapy in worsening life-threatening conditions
Behavioral: Truthful information on chemotherapy risks
One of two trained oncologist will meet the patient and inform him following an interview-guideline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of patients receiving chemotherapy in the last 30 days of life
Time Frame: from date of inclusion until death, assessed up to 1 year
from date of inclusion until death, assessed up to 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient knowledge of the goals of care assessed by questionnaire
Time Frame: 1 month after information
1 month after information
Patient knowledge of the goals of care assessed by questionnaire
Time Frame: 6 months after information
6 months after information
Number of survivals
Time Frame: at 1 year
at 1 year
Number of appeals to palliative care
Time Frame: from date of inclusion until death, assessed up to 1 year
Use of palliative care resources
from date of inclusion until death, assessed up to 1 year
Number of onco-palliative meetings
Time Frame: from date of inclusion until death, assessed up to 1 year
from date of inclusion until death, assessed up to 1 year
Number of use of emergency room, intensive care unit and hospice service in the last month of life
Time Frame: from date of inclusion until death, assessed up to 1 year
from date of inclusion until death, assessed up to 1 year
Number of unscheduled hospitalizations
Time Frame: from date of inclusion until death, assessed up to 1 year
from date of inclusion until death, assessed up to 1 year
Number of chemotherapy cycles received
Time Frame: from date of inclusion until death, assessed up to 1 year
from date of inclusion until death, assessed up to 1 year
Number of days spent in acute care
Time Frame: from date of inclusion until death, assessed up to 1 year
from date of inclusion until death, assessed up to 1 year
Number of days spent in conventional oncology hospital
Time Frame: from date of inclusion until death, assessed up to 1 year
from date of inclusion until death, assessed up to 1 year
Place of death
Time Frame: at death
at death

Collaborators and Investigators

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

Sponsor

Assistance Publique - Hôpitaux de Paris

Collaborators

National Cancer Institute, France
Recherche Clinique Paris Descartes Necker Cochin Sainte Anne

Investigators

  • Study Chair: Olivier HUILLARD, MD, PhD, Assistance Publique - Hôpitaux de Paris
  • Principal Investigator: Francois GOLDWASSER, MD, PhD, Assistance Publique - Hôpitaux de Paris

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 (Actual)

July 15, 2016

Primary Completion (Actual)

October 15, 2020

Study Completion (Actual)

October 15, 2020

Study Registration Dates

First Submitted

November 11, 2015

First Submitted That Met QC Criteria

November 13, 2015

First Posted (Estimate)

November 17, 2015

Study Record Updates

Last Update Posted (Actual)

May 3, 2021

Last Update Submitted That Met QC Criteria

April 30, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • K141201
  • 2015-A01135-44 (Registry Identifier: ID-RCB)

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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