Psychological Factors Influencing Cancer Post-traumatic Growth

NCT ID: NCT06278558

Last Updated: 2025-03-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

289 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-10

Study Completion Date

2027-11-10

Brief Summary

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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

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Conditions

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Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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).

Group Type EXPERIMENTAL

Interviews with a psychologist/psychiatrist

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ligue contre le cancer, France

OTHER

Sponsor Role collaborator

Centre Oscar Lambret

OTHER

Sponsor Role collaborator

Centre de Cancérologie Les Dentellières

UNKNOWN

Sponsor Role collaborator

Clinique Teissier

UNKNOWN

Sponsor Role collaborator

Hôpital Saint Vincent de Paul, Lille

UNKNOWN

Sponsor Role collaborator

Centre Hospitalier de Valenciennes

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Anne-Sophie Baudry

Role: PRINCIPAL_INVESTIGATOR

CH de Valenciennes

Locations

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Centre Hospitalier de Valenciennes

Valenciennes, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Anne-Sophie Baudry

Role: CONTACT

0327140523

Facility Contacts

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FODIL Hanane

Role: primary

0327140665

Other Identifiers

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2023-02-01

Identifier Type: -

Identifier Source: org_study_id

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