Clinical trial NCT06278558: Psychological Factors Influencing Cancer Post-traumatic Growth
Official title: Study of the Psychological Factors Influencing Post-traumatic Growth During Oncological Pathway
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cancer
Keywords: Cancer
Post-traumatic growth
Emotional competence
Emotional distress
Lead sponsor: Centre Hospitalier de Valenciennes
Sponsor class: NETWORK
Collaborators: name: Ligue contre le cancer, France
name: Centre Oscar Lambret
name: Centre de Cancérologie Les Dentellières
name: Clinique Teissier
name: Hôpital Saint Vincent de Paul, Lille
First posted: 2024-02-26
Enrollment: 289
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.


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

Primary outcomes:
measure: Post-traumatic growth
timeFrame: T1 : At the beginning of chemotherapy
measure: Post-traumatic growth
timeFrame: T2 : Up to 3 weeks after the end of chemotherapy
measure: Post-traumatic growth
timeFrame: T3 : 6 months after the end of chemotherapy protocol
Secondary outcomes:
measure: Satisfaction of supportive care needs
timeFrame: T1 : At the beginning of chemotherapy
measure: Satisfaction of supportive care needs
timeFrame: T2 : Up to 3 weeks after the end of chemotherapy
measure: Satisfaction of supportive care needs
timeFrame: T3 : 6 months after the end of chemotherapy protocol
measure: Emotional competence
timeFrame: T1 : At the beginning of chemotherapy
measure: Emotional competence
timeFrame: T2 : Up to 3 weeks after the end of chemotherapy
measure: Emotional competence
timeFrame: T3 : 6 months after the end of chemotherapy protocol
measure: Anxiety and depression symptoms
timeFrame: T1 : At the beginning of chemotherapy
measure: Anxiety and depression symptoms
timeFrame: T2 : Up to 3 weeks after the end of chemotherapy
measure: Anxiety and depression symptoms
timeFrame: T3 : 6 months after the end of chemotherapy protocol
measure: Psychological flexibility
timeFrame: T1 : At the beginning of chemotherapy
measure: Psychological flexibility
timeFrame: T2 : Up to 3 weeks after the end of chemotherapy
measure: Psychological flexibility
timeFrame: T3 : 6 months after the end of chemotherapy protocol
Other outcomes:
Locations:
city: Valenciennes
country: France
facility: Centre Hospitalier de Valenciennes
Study officials:
affiliation: CH de Valenciennes
name: Anne-Sophie Baudry
role: PRINCIPAL_INVESTIGATOR
References: