Psychological Factors Influencing Cancer Post-traumatic Growth

Not Applicable

Recruiting

• Conditions: Cancer

• Registration Number: NCT06278558
• Lead Sponsor: Centre Hospitalier de Valenciennes

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-11-10
• Study First Submitted: 2023-12-07
• Study First Submitted QC: 2024-02-22
• Study First Posted: 2024-02-26
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-19
• Last Update Posted: 2025-03-24
• Primary Completion: 2026-11-10
• Study Completion: 2027-11-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 289

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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).

Secondary Outcome Measures

Name	Time	Method
Satisfaction of supportive care needs	T3 : 6 months after the end of chemotherapy protocol	Patients' satisfaction of supportive care needs are assessed using the Supportive Care Needs Survey (SCNS), validated in French (Brédart et al., 2012), comprising 34 items and 5 dimensions (Physical and daily life, psychological and emotional, sexuality, information, care system).
Anxiety and depression symptoms	T3 : 6 months after the end of chemotherapy protocol	Anxiety and depressive symptoms were assessed using the Hospital Anxiety and Depression Scale (HADS), validated in French (Razavi et al., 1989), comprising 14 items and 2 dimensions (anxiety and depression).
Psychological flexibility	T3 : 6 months after the end of chemotherapy protocol	Psychological flexibility is assessed using the multidimensional psychological flexibility inventory (MPFI-24), validated in French (Grégoire et al., 2020), consisting of 24 items and 2 dimensions (flexibility and inflexibility).
Emotional competence	T3 : 6 months after the end of chemotherapy protocol	Emotional competence are assessed using the Profile of Emotional Competence (S-PEC), validated in French (Baudry et al., 2020), comprising 13 items and 2 dimensions (intrapersonal and interpersonal emotional skills).

Trial Locations

Locations (1)

Centre Hospitalier de Valenciennes; 🇫🇷 Valenciennes, France