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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

29 participants

Primary outcome timeframe

6 months

Results posted on

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

Participant milestones
Measure
Psychological Support
Monthly psychological support
Overall Study
STARTED
29
Overall Study
COMPLETED
22
Overall Study
NOT COMPLETED
7

Reasons for withdrawal

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

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 months

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.

Outcome measures

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 months

Population: 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

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 events: 0 serious events
Other events: 0 other events
Deaths: 2 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

François Christy

Centre François Baclesse

Phone: 0231450002

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place