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Recruiting Not applicable

Psychological Factors Influencing Cancer Post-traumatic Growth

NCT06278558 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2023-11-10
Last updated
2025-03-24

Condition(s) studied

Cancer

Investigational drug(s) / intervention(s)

Interviews with a psychologist/psychiatrist

Interviews with a psychologist/psychiatrist: All patients with a high score (≥11) on the HADS anxiety and/or depressive symptoms scale and who are not already receiving known psychological treatment or treatment mentioned in the file will be contacted by telephone by the investigator or a qualified person designated by him/her in order to conduct a telephone interview with the patient and refer him/her to a psychologist or psychiatrist if necessary. The number and percentage of consultations with a psychologist or psychiatrist following this telephone interview will be calculated in order to highlight the benefits of such a practice (HADS assessment + telephone interview with +/- referral) for earlier and easier referral. Depending on the number of patients contacted, consideration may be given to testing the effect of this approach on post-traumatic development.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Post-traumatic growth — T1 : At the beginning of chemotherapy
    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).
  • Post-traumatic growth — T2 : Up to 3 weeks after the end of chemotherapy
    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).
  • Post-traumatic growth — 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).

Trial sites (1)

FacilityCityRegionStatus
Centre Hospitalier de Valenciennes Valenciennes France Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06278558 on ClinicalTrials.gov ↗ ← All trials in France