NCT06278558

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
289

participants targeted

Target at P75+ for not_applicable cancer

Timeline
19mo left

Started Nov 2023

Longer than P75 for not_applicable cancer

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress62%
Nov 2023Nov 2027

Study Start

First participant enrolled

November 10, 2023

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

December 7, 2023

Completed
3 months until next milestone

First Posted

Study publicly available on registry

February 26, 2024

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 10, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

November 10, 2027

Last Updated

March 24, 2025

Status Verified

March 1, 2025

Enrollment Period

3 years

First QC Date

December 7, 2023

Last Update Submit

March 19, 2025

Conditions

Cancer

Keywords

CancerPost-traumatic growthEmotional competenceEmotional distress

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (12)

  • Satisfaction of supportive care needs

    T1 : At the beginning of chemotherapy

  • Satisfaction of supportive care needs

    T2 : Up to 3 weeks after the end of chemotherapy

  • Satisfaction of supportive care needs

    T3 : 6 months after the end of chemotherapy protocol

  • Emotional competence

    T1 : At the beginning of chemotherapy

  • Emotional competence

    T2 : Up to 3 weeks after the end of chemotherapy

  • +7 more secondary outcomes

Study Arms (1)

Interviews with a psychologist/psychiatrist

EXPERIMENTAL

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

Interventions

Interviews with a psychologist/psychiatristOTHER

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.

Interviews with a psychologist/psychiatrist

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier de Valenciennes

Valenciennes, 59300, France

RECRUITING

MeSH Terms

Conditions

Neoplasms

Interventions

Interviews as TopicPsychiatrists

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public HealthPhysiciansHealth PersonnelHealth Care Facilities Workforce and Services

Study Officials

  • Anne-Sophie Baudry

    CH de Valenciennes

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Anne-Sophie Baudry

CONTACT

0327140523baudry-as@ch-valenciennes.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 7, 2023

First Posted

February 26, 2024

Study Start

November 10, 2023

Primary Completion (Estimated)

November 10, 2026

Study Completion (Estimated)

November 10, 2027

Last Updated

March 24, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)