Psychological Factors Influencing Cancer Post-traumatic Growth

Cancer Clinical Trial

— CEMA-P  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06278558
• Other study ID #: 2023-02-01
• Status: Recruiting
• Phase: N/A
• Start date: November 10, 2023
• Est. completion date: November 10, 2027

Study information

• Verified date: February 2024
• Source: Centre Hospitalier de Valenciennes
• Contact: Anne-Sophie Baudry
• Phone: 0327140523
• Email: baudry-as[@]ch-valenciennes.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 289
• Est. completion date: November 10, 2027
• Est. primary completion date: November 10, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 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

Related Conditions & MeSH terms

• Cancer

Intervention

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 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.

Locations

Country	Name	City	State
France	Centre Hospitalier de Valenciennes	Valenciennes

Sponsors (5)

Lead Sponsor	Collaborator
Centre Hospitalier de Valenciennes	Centre de Cancérologie Les Dentellières, Centre Oscar Lambret, Clinique Teissier, Ligue contre le cancer, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post-traumatic growth	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).	T1 : At the beginning of chemotherapy
Primary	Post-traumatic growth	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).	T2 : Up to 3 weeks after the end of chemotherapy
Primary	Post-traumatic growth	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).	T3 : 6 months after the end of chemotherapy protocol
Secondary	Satisfaction of supportive care needs	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).	T1 : At the beginning of chemotherapy
Secondary	Satisfaction of supportive care needs	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).	T2 : Up to 3 weeks after the end of chemotherapy
Secondary	Satisfaction of supportive care needs	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).	T3 : 6 months after the end of chemotherapy protocol
Secondary	Emotional competence	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).	T1 : At the beginning of chemotherapy
Secondary	Emotional competence	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).	T2 : Up to 3 weeks after the end of chemotherapy
Secondary	Emotional competence	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).	T3 : 6 months after the end of chemotherapy protocol
Secondary	Anxiety and depression symptoms	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).	T1 : At the beginning of chemotherapy
Secondary	Anxiety and depression symptoms	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).	T2 : Up to 3 weeks after the end of chemotherapy
Secondary	Anxiety and depression symptoms	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).	T3 : 6 months after the end of chemotherapy protocol
Secondary	Psychological flexibility	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).	T1 : At the beginning of chemotherapy
Secondary	Psychological flexibility	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).	T2 : Up to 3 weeks after the end of chemotherapy
Secondary	Psychological flexibility	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).	T3 : 6 months after the end of chemotherapy protocol