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

Sponsor

Azienda Unità Sanitaria Locale Reggio Emilia (Other)

Overall Status

Completed

CT.gov ID

NCT04738305

Collaborator

(none)

Enrollment

Location

Arm

Actual Duration (Months)

2.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Dignity Advanced Cancer	Other: Dignity Therapy	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

50 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Jun 1, 2016

Actual Primary Completion Date :

Apr 1, 2017

Actual Study Completion Date :

Dec 1, 2017

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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
Retention rate [1 year]
The number of participants who performed the post intervention assesment divided by the number of enrolled one.
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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Azienda USL - IRCCS di Reggio Emilia	Reggio Emilia		Italy	42123

Sponsors and Collaborators

Azienda Unità Sanitaria Locale Reggio Emilia

Investigators

Principal Investigator: Francesca Nunziante, Azienda USL-IRCCS di Reggio Emilia

Study Documents (Full-Text)

None provided.

More Information

Publications

Chochinov HM. Terapia della dignità: parole per il tempo che rimane. Il pensiero scientifico, 2015.

Responsible Party:

Azienda Unità Sanitaria Locale Reggio Emilia

ClinicalTrials.gov Identifier:

NCT04738305

Other Study ID Numbers:

2016/0007193

First Posted:

Feb 4, 2021

Last Update Posted:

Feb 8, 2021

Last Verified:

Jan 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Azienda Unità Sanitaria Locale Reggio Emilia

Hospital palliative care unit

Study Results

No Results Posted as of Feb 8, 2021