Trial Outcomes & Findings for Psychological Care of Oncology Patients With Post-traumatic Stress in the Context of a COVID-19 (NCT NCT04747249)
NCT ID: NCT04747249
Last Updated: 2026-07-31
Results Overview
Improvement in post-traumatic stress symptoms observed during or at the end of the intervention, defined as a decrease below the threshold of 24 on the Impact of Event Scale-Revised (IES-R) compared with baseline. The Impact of Event Scale-Revised (IES-R) is a 22-item self-report questionnaire assessing post-traumatic stress symptoms across intrusion, avoidance, and hyperarousal domains, with total scores ranging from 0 to 88 and higher scores indicating higher symptom severity.
COMPLETED
NA
29 participants
6 months
2026-07-31
Participant Flow
Patients aged ≥18 years, treated or followed for a solid tumor at Centre François Baclesse, and presenting moderate to high post-traumatic stress symptoms (score ≥24 on the Impact of Event Scale-Revised (IES-R)) related to the COVID-19 epidemic.
Participant milestones
| Measure |
Psychological Support
Monthly psychological support
|
|---|---|
|
Overall Study
STARTED
|
29
|
|
Overall Study
COMPLETED
|
22
|
|
Overall Study
NOT COMPLETED
|
7
|
Reasons for withdrawal
| Measure |
Psychological Support
Monthly psychological support
|
|---|---|
|
Overall Study
Death
|
2
|
|
Overall Study
Patient's decision
|
5
|
Baseline Characteristics
All patients included were described at baseline.
Baseline characteristics by cohort
| Measure |
Psychological Support
n=29 Participants
Monthly psychological support
|
|---|---|
|
Age, Continuous
|
62 Years
n=29 Participants • All patients included were described at baseline.
|
|
Sex: Female, Male
Female
|
26 Participants
n=29 Participants • All patients included were described at baseline.
|
|
Sex: Female, Male
Male
|
3 Participants
n=29 Participants • All patients included were described at baseline.
|
PRIMARY outcome
Timeframe: 6 monthsImprovement in post-traumatic stress symptoms observed during or at the end of the intervention, defined as a decrease below the threshold of 24 on the Impact of Event Scale-Revised (IES-R) compared with baseline. The Impact of Event Scale-Revised (IES-R) is a 22-item self-report questionnaire assessing post-traumatic stress symptoms across intrusion, avoidance, and hyperarousal domains, with total scores ranging from 0 to 88 and higher scores indicating higher symptom severity.
Outcome measures
| Measure |
Psychological Support
n=22 Participants
Monthly psychological support
|
|---|---|
|
Proportion of Patients With Improvement in Post-traumatic Stress Symptoms
|
12 Participants
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Among the included patients, 7 patients end the study prematurely (2 deaths and 5 patient decision).
Done with Connor-Davidson Resiliency Scale. The Connor-Davidson Resilience Scale (CD-RISC) is a self-report questionnaire (commonly 25 items) assessing resilience, with total scores ranging from 0 to 100 and higher scores indicating greater resilience.
Outcome measures
| Measure |
Psychological Support
n=22 Participants
Monthly psychological support
|
|---|---|
|
Resilience Scores
|
62 Score range 0 to 100
Interval 18.0 to 93.0
|
Adverse Events
Psychological Support
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place