Trial Outcomes & Findings for Impact of Therapeutic Patient Education on the Toxicity of Immune Checkpoint Inhibitors in Oncology (NCT NCT03948724)

Results Overview

The primary outcome is the occurrence of at least one immune-related adverse event (irAE) of Grade ≥3, as defined by the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0, during the 25 weeks following initiation of immune checkpoint inhibitor (ICI) treatment. This outcome is compared between the experimental group receiving Therapeutic Patient Education (TPE) and the control group receiving usual information.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

412 participants

Primary outcome timeframe

25 weeks

Results posted on

2026-08-31

Participant Flow

Participant milestones

Participant milestones
Measure	Therapeutic Patient Education Patient will receive 5 therapeutic education sessions. Therapeutic education program: Patient will have 5 educational therapy workshops. The first educational therapy workshops will be realized at cycle 1 and the last one within 25 weeks after starting treatment	Standard Care Patient will receive usual informations Usual Information: Patient receive usual informations
Overall Study STARTED	275	137
Overall Study COMPLETED	272	133
Overall Study NOT COMPLETED	3	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Therapeutic Patient Education Patient will receive 5 therapeutic education sessions. Therapeutic education program: Patient will have 5 educational therapy workshops. The first educational therapy workshops will be realized at cycle 1 and the last one within 25 weeks after starting treatment	Standard Care Patient will receive usual informations Usual Information: Patient receive usual informations
Overall Study Withdrawal by Subject	1	3
Overall Study Physician Decision	1	1
Overall Study Death	1	0

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Therapeutic Patient Education n=272 Participants Patient will receive 5 therapeutic education sessions. Therapeutic education program: Patient will have 5 educational therapy workshops. The first educational therapy workshops will be realized at cycle 1 and the last one within 25 weeks after starting treatment	Standard Care n=133 Participants Patient will receive usual informations Usual Information: Patient receive usual informations	Total n=405 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=272 Participants	0 Participants n=133 Participants	0 Participants n=405 Participants
Age, Categorical Between 18 and 65 years	113 Participants n=272 Participants	56 Participants n=133 Participants	169 Participants n=405 Participants
Age, Categorical >=65 years	159 Participants n=272 Participants	77 Participants n=133 Participants	236 Participants n=405 Participants
Sex: Female, Male Female	89 Participants n=272 Participants	47 Participants n=133 Participants	136 Participants n=405 Participants
Sex: Female, Male Male	183 Participants n=272 Participants	86 Participants n=133 Participants	269 Participants n=405 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: 25 weeks

The primary outcome is the occurrence of at least one immune-related adverse event (irAE) of Grade ≥3, as defined by the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0, during the 25 weeks following initiation of immune checkpoint inhibitor (ICI) treatment. This outcome is compared between the experimental group receiving Therapeutic Patient Education (TPE) and the control group receiving usual information.

Outcome measures

Outcome measures
Measure	Therapeutic Patient Education n=272 Participants Patient will receive 5 therapeutic education sessions. Therapeutic education program: Patient will have 5 educational therapy workshops. The first educational therapy workshops will be realized at cycle 1 and the last one within 25 weeks after starting treatment	Standard Care n=133 Participants Patient will receive usual informations Usual Information: Patient receive usual informations
Proportion of Participants With at Least One Grade ≥3 Immune-related Adverse Event (irAE) (CTCAE v5.0) Within 25 Weeks After Initiation of Immune Checkpoint Inhibitor (ICI) Treatment	24 Participants	15 Participants

SECONDARY outcome

Timeframe: 12 months

This outcome measures the total number of immune checkpoint inhibitor (ICI) injections received by each participant over the course of the study.

Outcome measures

Outcome measures
Measure	Therapeutic Patient Education n=272 Participants Patient will receive 5 therapeutic education sessions. Therapeutic education program: Patient will have 5 educational therapy workshops. The first educational therapy workshops will be realized at cycle 1 and the last one within 25 weeks after starting treatment	Standard Care n=133 Participants Patient will receive usual informations Usual Information: Patient receive usual informations
Number of Immune Checkpoint Inhibitor (ICI) Injections Received During the Study Period	9.1 injection Standard Deviation 4.3	8.9 injection Standard Deviation 4.2

SECONDARY outcome

Timeframe: 12 months

This outcome assesses patients' anxiety level using the Hospital Anxiety and Depression Scale - Anxiety subscale (HADS-A), a validated self-report instrument designed to measure the severity of anxiety symptoms in medical populations. The HADS-A subscale consists of 7 items, each scored from 0 to 3, yielding a total score ranging from 0 to 21. Minimum score: 0 (no anxiety symptoms) Maximum score: 21 (maximum anxiety severity) Interpretation: Lower scores indicate better outcomes (lower anxiety levels). Higher scores indicate worse outcomes (greater anxiety symptoms). Scores are calculated as the sum of the 7 item scores. Results will be compared between treatment groups at the specified time point.ps.

Outcome measures

Outcome measures
Measure	Therapeutic Patient Education n=156 Participants Patient will receive 5 therapeutic education sessions. Therapeutic education program: Patient will have 5 educational therapy workshops. The first educational therapy workshops will be realized at cycle 1 and the last one within 25 weeks after starting treatment	Standard Care n=72 Participants Patient will receive usual informations Usual Information: Patient receive usual informations
Anxiety Level Assessed by the Hospital Anxiety and Depression Scale (HADS-A)	4.8 score on a scale Standard Deviation 3.4	5.1 score on a scale Standard Deviation 3.6

SECONDARY outcome

Timeframe: 12 months

This outcome evaluates patients' overall quality of life using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30), a validated cancer-specific instrument assessing multiple dimensions of quality of life. The Global Health Status/Quality of Life scale of the EORTC QLQ-C30 is based on 2 items, each scored from 1 to 7. Raw scores are linearly transformed to a 0-100 scale according to the EORTC scoring manual. Minimum score (transformed): 0 Maximum score (transformed): 100 Interpretation: Higher scores indicate better outcomes (better overall quality of life and global health status). Lower scores indicate worse outcomes (poorer quality of life). The final score is calculated by averaging the item scores and applying a linear transformation to a 0-100 scale. Results will be compared between treatment groups at the specified time point.

Outcome measures

Outcome measures
Measure	Therapeutic Patient Education n=162 Participants Patient will receive 5 therapeutic education sessions. Therapeutic education program: Patient will have 5 educational therapy workshops. The first educational therapy workshops will be realized at cycle 1 and the last one within 25 weeks after starting treatment	Standard Care n=75 Participants Patient will receive usual informations Usual Information: Patient receive usual informations
Global Health Status/Quality of Life Assessed by Thethe European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Questionnaire	70.8 score on a scale Standard Deviation 20.3	64.8 score on a scale Standard Deviation 22.3

SECONDARY outcome

Timeframe: 12 months

his outcome assesses patients' depression level using the Hospital Anxiety and Depression Scale - Depression subscale (HADS-D), a validated self-report instrument designed to measure the severity of depressive symptoms in medical populations. The HADS-D subscale consists of 7 items, each scored from 0 to 3, yielding a total score ranging from 0 to 21. Minimum score: 0 (no depressive symptoms) Maximum score: 21 (maximum depression severity) Interpretation: Lower scores indicate better outcomes (lower levels of depression). Higher scores indicate worse outcomes (greater depressive symptoms).

Outcome measures

Outcome measures
Measure	Therapeutic Patient Education n=155 Participants Patient will receive 5 therapeutic education sessions. Therapeutic education program: Patient will have 5 educational therapy workshops. The first educational therapy workshops will be realized at cycle 1 and the last one within 25 weeks after starting treatment	Standard Care n=72 Participants Patient will receive usual informations Usual Information: Patient receive usual informations
Depressionlevel Assessed by the Hospital Anxiety and Depression Scale (HADS-A)	4.0 score on a scale Standard Deviation 3.6	4.8 score on a scale Standard Deviation 4.3

Adverse Events

Therapeutic Patient Education

Serious events: 0 serious events

Other events: 81 other events

Deaths: 4 deaths

Standard Care

Serious events: 0 serious events

Other events: 34 other events

Deaths: 4 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Therapeutic Patient Education n=275 participants at risk Patient will receive 5 therapeutic education sessions. Therapeutic education program: Patient will have 5 educational therapy workshops. The first educational therapy workshops will be realized at cycle 1 and the last one within 25 weeks after starting treatment	Standard Care n=137 participants at risk Patient will receive usual informations Usual Information: Patient receive usual informations
Musculoskeletal and connective tissue disorders Articula pain	8.4% 23/275 • Number of events 27 • 12 months Auto immune toxicity	5.1% 7/137 • Number of events 7 • 12 months Auto immune toxicity
Skin and subcutaneous tissue disorders Prurit	6.9% 19/275 • Number of events 22 • 12 months Auto immune toxicity	3.6% 5/137 • Number of events 5 • 12 months Auto immune toxicity
Endocrine disorders auto immune disorders	14.2% 39/275 • Number of events 44 • 12 months Auto immune toxicity	16.1% 22/137 • Number of events 32 • 12 months Auto immune toxicity

Additional Information

Coordinator

Institut de Cancérologie de l'Ouest

Phone: 02 41 35 27 00

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place