Ignite Creation Date:
2024-10-25 @ 7:58 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06549075
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-08
Brief Title:
Therapeutic Support to Strengthen Dignity Mental Well-being and Quality of Life in Acute Palliative Care Patients
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Efficacy of a Personalized Modular Intervention to Promote Dignity Meaningfulness and Mindfulness by a Palliative Care Consultation-Liaison Service in Swiss Acute Hospital Care A Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical trial is to test the benefit of a newly designed personalized therapeutic intervention compared to the standard specialized palliative care service at the swiss acute palliative hospital careThe main questions it aims to answer are
Does an additional therapeutic support that fits the individual needs of a palliative care patient increases dignity and mental well-being as measures by a questionnaire Patient Dignity Inventory to a larger extent than standard palliative care alone Is the additional therapeutic support perceived as helpful Researchers will compare the additional therapeutic support with standard palliative care to standard palliative care alone
Participants will
Receive additional therapeutic support in two structured sessions a 60 minutes andor standard palliative care Fill out questionnaires before and after therapeutic interventions and standard palliative care Provide a semi-structured interview following the therapeutic support
Does an additional therapeutic support that fits the individual needs of a palliative care patient increases dignity and mental well-being as measures by a questionnaire Patient Dignity Inventory to a larger extent than standard palliative care alone Is the additional therapeutic support perceived as helpful Researchers will compare the additional therapeutic support with standard palliative care to standard palliative care alone
Participants will
Receive additional therapeutic support in two structured sessions a 60 minutes andor standard palliative care Fill out questionnaires before and after therapeutic interventions and standard palliative care Provide a semi-structured interview following the therapeutic support
Detailed Description:
Patient with a life-limiting serious illness commonly experience substantial emotional and spiritual distress death anxieties depressive symptoms and loss of dignity and purpose in life Fostering dignity and meaning and relieving psychological distress have been identified as a core objective for end-of-life care However individuals needs for dignity and psychological support at the end of life may vary Therefore a personalized approach is needed On the basis of theoretical frameworks and existing dignityfostering and meaning based interventions and a workshop with international experts in the field of palliative care we have developed a personalized modular intervention consisting of three modules including CALM Therapy Dignity Therapy and a mindfulness-based intervention
The overall purpose of this study is to test the efficacy of the designed personalized modular intervention compared to the specialized palliative care service at the swiss acute palliative hospital care
Patients are randomized to either receiving standard specialized palliative consultation SSPC and the modular intervention or standard palliative consultation services alone Within the intervention group participants can choose one of the three modules based on personal preference and the recommendation of the palliative care team based on assessment All three interventions consist of two structured sessions
The control group will receive SSPC alone According to needs standard specialized palliative care will include support of symptom control shared decision making advance care planning network planning and support of relatives
SSPC is performed by specialized inter-professional palliative care service including doctors and advanced nurse practitioners certified by national standards for specialist palliative care Other professions are involved depending on needs Patients are seen as required at least twice a week
Patients will be asked to fill in a set of questionnaires at baseline T0 after the completion of the intervention T1 and at 1-month follow-up T2 A brief semi-structured qualitative interview will be conducted with the patients following completion of the intervention to assess perceived benefits and challenges of the intervention
The primary objective is to evaluate if mental well-being tend to improve over the pre- versus post study design as measured by the Patient Dignity Inventory and if this effect is significantly larger in the modular intervention group as compared to the standard specialized palliative consultation SSPC group
The overall purpose of this study is to test the efficacy of the designed personalized modular intervention compared to the specialized palliative care service at the swiss acute palliative hospital care
Patients are randomized to either receiving standard specialized palliative consultation SSPC and the modular intervention or standard palliative consultation services alone Within the intervention group participants can choose one of the three modules based on personal preference and the recommendation of the palliative care team based on assessment All three interventions consist of two structured sessions
The control group will receive SSPC alone According to needs standard specialized palliative care will include support of symptom control shared decision making advance care planning network planning and support of relatives
SSPC is performed by specialized inter-professional palliative care service including doctors and advanced nurse practitioners certified by national standards for specialist palliative care Other professions are involved depending on needs Patients are seen as required at least twice a week
Patients will be asked to fill in a set of questionnaires at baseline T0 after the completion of the intervention T1 and at 1-month follow-up T2 A brief semi-structured qualitative interview will be conducted with the patients following completion of the intervention to assess perceived benefits and challenges of the intervention
The primary objective is to evaluate if mental well-being tend to improve over the pre- versus post study design as measured by the Patient Dignity Inventory and if this effect is significantly larger in the modular intervention group as compared to the standard specialized palliative consultation SSPC group
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None