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Recruiting NCT06278558

Psychological Factors Influencing Cancer Post-traumatic Growth

No phase Interventional Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Interviews with a psychologist/psychiatrist.
Who it may be relevant to
Registry conditions: Cancer. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • Other 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 th

Primary outcome measures

  • Post-traumatic growth [Time frame: T1 : At the beginning of chemotherapy]
  • Post-traumatic growth [Time frame: T2 : Up to 3 weeks after the end of chemotherapy]
  • Post-traumatic growth [Time frame: T3 : 6 months after the end of chemotherapy protocol]
Secondary outcome measures (12)
  • Satisfaction of supportive care needs [Time frame: T1 : At the beginning of chemotherapy]
  • Satisfaction of supportive care needs [Time frame: T2 : Up to 3 weeks after the end of chemotherapy]
  • Satisfaction of supportive care needs [Time frame: T3 : 6 months after the end of chemotherapy protocol]
  • Emotional competence [Time frame: T1 : At the beginning of chemotherapy]
  • Emotional competence [Time frame: T2 : Up to 3 weeks after the end of chemotherapy]
  • Emotional competence [Time frame: T3 : 6 months after the end of chemotherapy protocol]
  • Anxiety and depression symptoms [Time frame: T1 : At the beginning of chemotherapy]
  • Anxiety and depression symptoms [Time frame: T2 : Up to 3 weeks after the end of chemotherapy]
  • Anxiety and depression symptoms [Time frame: T3 : 6 months after the end of chemotherapy protocol]
  • Psychological flexibility [Time frame: T1 : At the beginning of chemotherapy]
  • Psychological flexibility [Time frame: T2 : Up to 3 weeks after the end of chemotherapy]
  • Psychological flexibility [Time frame: T3 : 6 months after the end of chemotherapy protocol]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Supportive care

Study locations

France · 1 center
  • Centre Hospitalier de Valenciennes — Valenciennes

Identifiers

NCT: NCT06278558 · 2023-02-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗