Mobile Health Application for Family Caregivers in Home Palliative Care
NCT07654998
Behavior, Behavioral Symptoms
Simav, Kütahya, Turkey (Türkiye)
View Trial DetailsNCT Number: NCT06944262
The impact of cancer on the lives of patients and their caregivers is undeniable. In addition to the potentially traumatic aspects (i.e., creating a very violent emotional shock) linked to the announcement of the disease and the various stages of the care pathway (effects of treatment, announcement of a cancer recurrence), even before the onset of the disease, patients and their caregivers may have been directly or indirectly confronted with traumatogenic events (e.g., childhood abuse, sudden death). They may therefore be more likely to develop a stress-related mental disorder in their lifetime. The question of the accumulation of traumatic events, the identification of groups of people at risk of developing symptoms of distress, and the management of these symptoms is therefore crucial. In addition, the mutual influence within the patient-caregiver dyad in terms of emotional adjustment, and its evolution throughout the cancer care pathway, are key elements to be considered in these issues.
The CandyStress project is based on a partnership with patients, their caregivers and carers to identify the needs of patient-caregiver dyads at risk of cancer-related post-traumatic stress disorder (Ca-PTS). Longitudinal screening for Ca-PTS in the year following cancer diagnosis will be carried out to identify the characteristics of at-risk dyads who could benefit from long-term support. The aim of this project is to identify the potential need for targeted support and the desired format of this support. This is a preliminary step in identifying needs and the context conducive to the implementation of personalized support, but in no way an evaluation of the effectiveness of an intervention.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Centre Oscar Lambret, Lille, Nord, France
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Part 1. Diagnosis of Ca-PTS
Patient inclusion criteria:
Inclusion criteria
for caregivers:
Part 2. Gathering expectations for personalized support and its components.
In addition, 3 types of focus groups will be set up remote :
Focus groups with patients from local associations, as well as patient partners of the Oscar Lambret Center and patients from Part 1 if they are interested.
Inclusion criteria
for patient focus groups:
Focus group with caregivers from local associations as well as "partner caregivers" from the Oscar Lambret Center and caregivers from part 1 if they are interested.
Inclusion criteria
for "caregiver" focus groups:
Focus groups with hospital medical and paramedical staff as well as non-hospital caregivers involved in the medical in the medical and psychological follow-up of patients.
Inclusion criteria
for caregiver focus groups:
Exclusion criteria
Part 1. Diagnosis of Ca-PTS
Non inclusion criteria for patients :
Non-inclusion criteria for caregivers:
Part 2. Collection of expectations for personalized support and its components.
Non-inclusion criteria for patients and caregivers who participated in the screening part of the Ca-PTS :
Non-inclusion criteria for focus groups (patients, caregivers): none
Time frame: measured in the month following the announcement of the cancer treatment, then 6 months and 12 months later - in patients and their caregiver
total score (0-80) reflects the severity of Post Traumatic Stress Disorder (PTSD) symptoms. A score threshold > 32 has been validated as reflecting probable PTSD
Time frame: from baseline (in the month following the announcement of the cancer treatment) to 6 months and 12 months later
answer to the item "How do you feel physically impaired at the moment?" (likert scale from 0: "not at all" to 10: "absolutely")
Time frame: from baseline (in the month following the announcement of the cancer treatment) to 6 months and 12 months later
answer to the item:: "To what extent do you think your loved one feels physically diminished at the moment? " (likert scale from 0: "not at all" to 10: "absolutely")
Time frame: from baseline (in the month following the announcement of the cancer treatment) to 6 months and 12 months later
answer to the item "To what extent do you feel psychologically distressed at the moment? " ((likert scale from 0: "not at all" to 10: "absolutely")
Time frame: from baseline (in the month following the announcement of the cancer treatment) to 6 months and 12 months later
answer to the item: "To what extent do you think your loved one feels psychologically distressed at the moment? " (likert scale from 0: "not at all" to 10: "absolutely")
Time frame: from baseline (in the month following the announcement of the cancer treatment) to 6 months and 12 months later
answer to the item "to what extent are you currently experiencing physical pain?" (likert scale from 0: "not at all" to 10: "absolutely")
Time frame: from baseline (in the month following the announcement of the cancer treatment) to 6 months and 12 months later
self reported Life Event Checklist for DSM-5 (LEC-5). The total score is 0 to 48. The higher the score, the more the participant reports traumatic events.
Time frame: from baseline (in the month following the announcement of the cancer treatment) to 6 months and 12 months later
PTSD checklist for DSM 5 (PCL-5). The total score (0-80) reflects the severity of the PSTD symptoms, and a cut off of 32 a possible PTSD.
Time frame: : from baseline (in the month following the announcement of the cancer treatment) to 6 months and 12 months later
Generalized Anxiety Disorder (GAD7). The overall score ranges from 0 to 21. Scores of 5, 10 and 15 represent thresholds for mild, moderate and severe anxiety respectively
Time frame: from baseline (in the month following the announcement of the cancer treatment) to 6 months and 12 months later
Patient Health Questionnaire (PHQ9). The total score ranges from 0 to 27, with a score of 10 or more indicating moderate depression.
Time frame: from baseline (in the month following the announcement of the cancer treatment) to 6 months and 12 months later
Social Support Questionnaire SSQ6. Higher SSQ6 scores reflect greater satisfaction with the level of social support.
Time frame: from baseline (in the month following the announcement of the cancer treatment) to 6 months and 12 months later
Difficulties in Emotion Regulation Scale Short Form (DERS SF). The higher the score, the greater the difficulty of emotional regulation.
Time frame: from baseline (in the month following the announcement of the cancer treatment) to 6 months and 12 months later
Resilience Resources Scale (RSS). The total score ranges from 12 to 60. Higher scores reflect greater resilience
Time frame: baseline
Participants will be asked whether they personally feel the need for psychological support to manage their symptoms, and whether they would be willing to engage in such support. If so, they will be asked to specify when they think this support should be offered, and in what form These answers will be collected using open-ended questions.
Time frame: at inclusion (i.e in the month following the announcement of the cancer treatment) - for patients and caregivers
age, gender, marital status, socio-professional category, level of education
Lille University
Other
Évaluation de la détresse Post-traumatique Relative au Cancer Dans l'année Suivant le Diagnostic Chez Les Patients et Les Aidants et Identification de Leurs Attentes Envers un Accompagnement personnalisé
Acronym: CANDYSTRESS
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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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