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

Not Applicable

Completed

• Conditions: Dignity; Advanced Cancer
• Interventions: Other: Dignity Therapy

• Registration Number: NCT04738305
• Lead Sponsor: Azienda Unità Sanitaria Locale Reggio Emilia

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-06
• Primary Completion: 2017-04
• Study Completion: 2017-12
• Status Verified: 2021-01
• Study First Submitted: 2021-01-26
• Study First Submitted QC: 2021-01-31
• Study First Posted: 2021-02-04
• Last Update Submitted: 2021-02-04
• Last Update Posted: 2021-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Dignity Therapy Intervention	Dignity Therapy	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.

Primary Outcome Measures

Name	Time	Method
Retention rate	1 year	The number of participants who performed the post intervention assesment divided by the number of enrolled one.
Enrollment rate	1 year	The number of participants who sign the informed consent form divided by the number who are asked to participate in the study
Professionals' experience in implementing DT	12-18 months	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Azienda USL - IRCCS di Reggio Emilia; 🇮🇹 Reggio Emilia, Italy