Psychological Factors Influencing Cancer Post-traumatic Growth (CEMA-P)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Cancer
• Intervention / Treatment: Other: Interviews with a psychologist/psychiatrist

• Study Type: Interventional
• Enrollment (Estimated): 289
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Anne-Sophie Baudry; Phone Number: 0327140523; Email: baudry-as@ch-valenciennes.fr

Study Locations

• France
  • Valenciennes, France, 59300
    • Recruiting
    • Centre Hospitalier de Valenciennes
    • Contact: FODIL Hanane; Phone Number: 0327140665; Email: fodil-h@ch-valenciennes.fr
    • Principal Investigator: Anne Sophie Baudry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Interviews with a psychologist/psychiatrist; Implementation of an interview with a psychologist or psychiatrist following a telephone conversation with patients with no psychological follow-up and a high HADS score (≥11), at all stages of the study (start of chemotherapy T1, end of chemotherapy T2, 6 months after the end of chemotherapy).

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Centre Hospitalier de Valenciennes
• Collaborators: Centre Oscar Lambret; Ligue contre le cancer, France; Centre de Cancérologie Les Dentellières; Clinique Teissier
• Investigators: Principal Investigator: Anne-Sophie Baudry, CH de Valenciennes

Study record dates

Study Major Dates

• Study Start (Actual): November 10, 2023
• Primary Completion (Estimated): November 10, 2026
• Study Completion (Estimated): November 10, 2027

Study Registration Dates

• First Submitted: December 7, 2023
• First Submitted That Met QC Criteria: February 22, 2024
• First Posted (Estimated): February 26, 2024

Study Record Updates

• Last Update Posted (Estimated): February 26, 2024
• Last Update Submitted That Met QC Criteria: February 22, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Cancer; Emotional distress; Post-traumatic growth; Emotional competence
• Other Study ID Numbers: 2023-02-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No