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Psychological Factors Influencing Cancer Post-traumatic Growth

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06278558
Acronym
CEMA-P
Enrollment
289
Registered
2024-02-26
Start date
2023-11-10
Completion date
2027-11-10
Last updated
2025-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer

Keywords

Cancer, Post-traumatic growth, Emotional competence, Emotional distress

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.

Interventions

OTHERInterviews 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.

Sponsors

Ligue contre le cancer, France
CollaboratorOTHER
Centre Oscar Lambret
CollaboratorOTHER
Centre de Cancérologie Les Dentellières
CollaboratorUNKNOWN
Clinique Teissier
CollaboratorUNKNOWN
Hôpital Saint Vincent de Paul, Lille
CollaboratorUNKNOWN
Centre Hospitalier de Valenciennes
Lead SponsorNETWORK

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Post-traumatic growthT1 : At the beginning of chemotherapyPost-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

MeasureTime frameDescription
Anxiety and depression symptomsT1 : At the beginning of chemotherapyAnxiety 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 flexibilityT1 : At the beginning of chemotherapyPsychological 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).
Satisfaction of supportive care needsT1 : At the beginning of chemotherapyPatients' 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).
Emotional competenceT1 : At the beginning of chemotherapyEmotional 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).

Countries

France

Contacts

Primary ContactAnne-Sophie Baudry
baudry-as@ch-valenciennes.fr0327140523

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026