Psychological Factors Influencing Cancer Post-traumatic Growth
ConditionCancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre Hospitalier de Valenciennes
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Interviews with a psychologist/psychiatrist
Other interventionAll 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.
Treatment groups
289 Participants
are divided into 1 treatment groupGroup A: Interviews with a psychologist/psychiatristExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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).
Time frame
T1 : At the beginning of chemotherapy2
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).
Time frame
T2 : Up to 3 weeks after the end of chemotherapy3
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).
Time frame
T3 : 6 months after the end of chemotherapy protocolSecondary outcomes
1
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).
Time frame
T1 : At the beginning of chemotherapy2
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).
Time frame
T2 : Up to 3 weeks after the end of chemotherapy3
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).
Time frame
T3 : 6 months after the end of chemotherapy protocol4
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).
Time frame
T1 : At the beginning of chemotherapySponsors and contacts
Click on the lead sponsor to view all of their trials.
Centre Hospitalier de Valenciennes
Lead sponsor
Ligue contre le cancer, France
Collaborator
Centre Oscar Lambret
Collaborator
Centre de Cancérologie Les Dentellières
Collaborator
Clinique Teissier
Collaborator
Hôpital Saint Vincent de Paul, Lille
Collaborator
Source ClinicalTrials.gov