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

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

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.

Study Overview

• Status: Completed
• Conditions: Advanced Cancer; Dignity
• Intervention / Treatment: Other: Dignity Therapy

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Reggio Emilia, Italy, 42123
    • Azienda USL - IRCCS di Reggio Emilia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: Dignity Therapy Intervention; 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; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Azienda Unita Sanitaria Locale Reggio Emilia
• Investigators: Principal Investigator: Francesca Nunziante, Azienda USL-IRCCS di Reggio Emilia

Publications and helpful links

General Publications

• Chochinov HM. Terapia della dignità: parole per il tempo che rimane. Il pensiero scientifico, 2015.
• Nunziante F, Tanzi S, Alquati S, Autelitano C, Bedeschi E, Bertocchi E, Dragani M, Simonazzi D, Turola E, Braglia L, Masini L, Di Leo S. Providing dignity therapy to patients with advanced cancer: a feasibility study within the setting of a hospital palliative care unit. BMC Palliat Care. 2021 Aug 16;20(1):129. doi: 10.1186/s12904-021-00821-3.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2016
• Primary Completion (Actual): April 1, 2017
• Study Completion (Actual): December 1, 2017

Study Registration Dates

• First Submitted: January 26, 2021
• First Submitted That Met QC Criteria: January 31, 2021
• First Posted (Actual): February 4, 2021

Study Record Updates

• Last Update Posted (Actual): February 8, 2021
• Last Update Submitted That Met QC Criteria: February 4, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: Hospital palliative care unit
• Other Study ID Numbers: 2016/0007193

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No