Feasibility of Dignity Therapy Intervention on Cancer Patients in Charge to an Hospital Palliative Care Unit.

Study Overview
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Brief Summary
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Aim of the study was to asses feasibility and acceptability of a nurse delivered Dignity Therapy (DT) intervention on advanced cancer patients referring to an Hospital palliative care unit. To achieve this aim a mixed-method approach using before and after evaluation and semi-structured interviews has been used.

Official Title
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Feasibility and Acceptability of a Dignity Therapy Intervention on Palliative Care Program's Cancer Patients Referring to a Medical Oncology Ward.

Conditions
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Dignity, Advanced Cancer

Intervention / Treatment
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* Other: Dignity Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: advanced cancer patients over 3 months life expectancy referring to hospital palliative care unit performance status (Eastern Cooperative Oncology Group - ECOG) between 0 and 2 awareness of being affected by an incurable cancer cognitive ability to read, understand and fill in a questionnaire in Italian willing and able to give written informed consent Exclusion Criteria: < 18 years old

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Dignity Therapy Intervention<br>All the patients that accepted to participate in the study were provided with Dignity Therapy Intervention. A short-term intervention aimed at reducing existential distress of patients facing with advanced illness. | Other: Dignity Therapy<br>* The Italian version Dignity Therapy intervention (Chochinov HM 2015) has been delivered. Intervention questions were not previously delivered to patients. DT interview was provided to patients by Specifically trained Nurses. Interviews were audio-recorded and transcribed then revised by the patients to develop the final Generativity Document. Generativity Document was delivered to patients that could share it with their loved ones.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Enrollment rate | The number of participants who sign the informed consent form divided by the number who are asked to participate in the study | 1 year | 
| Retention rate | The number of participants who performed the post intervention assesment divided by the number of enrolled one. | 1 year | 
| Professionals' experience in implementing DT | Semi-structured interviews administered to the three nurses that implemented the higher number of DT interventions. Interview were performed after the last patient completed the post intervention assessment. | 12-18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient dignity-related | Patient Dignity Inventory (Italian version). Scale range 25-125, higher value means higher dignity-related distress. | Baseline; day 62 | 
| Patient feedback | The acceptability of Dignity Therapy was assessed by the Italian version of Dignity Therapy Patient Feedback Questionnaire survey. | day 62 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hospital palliative care unit