Skip to main content
Clinical Trials/NCT06278558
NCT06278558
Recruiting
Not Applicable

Study of the Psychological Factors Influencing Post-traumatic Growth During Oncological Pathway

Centre Hospitalier de Valenciennes1 site in 1 country289 target enrollmentNovember 10, 2023
ConditionsCancer

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cancer
Sponsor
Centre Hospitalier de Valenciennes
Enrollment
289
Locations
1
Primary Endpoint
Post-traumatic growth
Status
Recruiting
Last Updated
last year

Overview

Brief Summary

The study focuses on post-traumatic growth (positive changes linked to appreciation of life, personal strengths, social relationships...) in the context of different types of cancer and with a longitudinal approach to the care pathway. The aim of the study is to better understand whether psychological variables (emotional competence, psychological flexibility, psychological distress) and patients' care satisfaction, assessed at the start of the cancer treatment pathway, can influence their post-traumatic growth at the end of the chemotherapy protocol and 6 months later.

Registry
clinicaltrials.gov
Start Date
November 10, 2023
End Date
November 10, 2027
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Patients over 18 years of age
  • Patients in the initial phase of curative treatment for a 1st solid cancer
  • At the start of neo-adjuvant or adjuvant chemotherapy (1st course or 2nd course)
  • At less than 6 months from the initial diagnosis
  • Patient having given written consent to participate in the study

Exclusion Criteria

  • Patients with a previous history of cancer
  • Patients with incurable cancer progression, recurrence or relapse
  • Metastatic, brain, hematological or skin cancer
  • Patients who have difficulty understanding written French
  • Patient psychologically or physically unable to answer questionnaires

Outcomes

Primary Outcomes

Post-traumatic growth

Time Frame: T3 : 6 months after the end of chemotherapy protocol

Post-traumatic growth will be assessed using a 21-item self-report questionnaire and a Likert scale ranging from 0 (Not at all) to 4 (Totally), the Posttraumatic growth inventory (PTGI), which has been revalidated in French (Dubuy et al., 2022) in 4 dimensions: new direction for life (6 items), personal abilities (6 items), spiritual change (2 items) and relationships with others (7 items).

Secondary Outcomes

  • Satisfaction of supportive care needs(T3 : 6 months after the end of chemotherapy protocol)
  • Anxiety and depression symptoms(T3 : 6 months after the end of chemotherapy protocol)
  • Psychological flexibility(T3 : 6 months after the end of chemotherapy protocol)
  • Emotional competence(T3 : 6 months after the end of chemotherapy protocol)

Study Sites (1)

Loading locations...

Similar Trials