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NCT Number: NCT06278558

Psychological Factors Influencing Cancer Post-traumatic Growth

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.

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Key information

Conditions

Cancer Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier de Valenciennes

Valenciennes, 59300, France

Location status: Recruiting

Location contact

Anne Sophie Baudry

PRINCIPAL_INVESTIGATOR

FODIL Hanane

CONTACT

[email protected]

0327140665

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Interviews with a psychologist/psychiatrist

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.

Primary outcomes

  1. Post-traumatic growth

    Time frame: T1 : At the beginning of chemotherapy

    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).

  2. Post-traumatic growth

    Time frame: T2 : Up to 3 weeks after the end of chemotherapy

    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).

  3. Post-traumatic growth

    Time frame: T3 : 6 months after the end of chemotherapy protocol

    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).

Secondary outcomes

  1. Satisfaction of supportive care needs

    Time frame: T1 : At the beginning of chemotherapy

    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).

  2. Satisfaction of supportive care needs

    Time frame: T2 : Up to 3 weeks after the end of chemotherapy

    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).

  3. Satisfaction of supportive care needs

    Time frame: T3 : 6 months after the end of chemotherapy protocol

    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).

  4. Emotional competence

    Time frame: T1 : At the beginning of chemotherapy

    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).

  5. Emotional competence

    Time frame: T2 : Up to 3 weeks after the end of chemotherapy

    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).

  6. Emotional competence

    Time frame: T3 : 6 months after the end of chemotherapy protocol

    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).

  7. Anxiety and depression symptoms

    Time frame: T1 : At the beginning of chemotherapy

    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).

  8. Anxiety and depression symptoms

    Time frame: T2 : Up to 3 weeks after the end of chemotherapy

    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).

  9. Anxiety and depression symptoms

    Time frame: T3 : 6 months after the end of chemotherapy protocol

    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).

  10. Psychological flexibility

    Time frame: T1 : At the beginning of chemotherapy

    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).

  11. Psychological flexibility

    Time frame: T2 : Up to 3 weeks after the end of chemotherapy

    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).

  12. Psychological flexibility

    Time frame: T3 : 6 months after the end of chemotherapy protocol

    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).

Study contacts

Contact information is provided by the study sponsor or research team.

Anne-Sophie Baudry

CONTACT

[email protected]

0327140523

Sponsors and collaborators

Lead sponsor

Centre Hospitalier de Valenciennes

Network

Collaborators

  • Centre Oscar Lambret
  • Centre de Cancérologie Les Dentellières
  • Clinique Teissier
  • Hôpital Saint Vincent de Paul, Lille
  • Ligue contre le cancer, France

Registry information

Official study title

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

Acronym: CEMA-P

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Feb 26, 2024
Registry last updated
Mar 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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