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

Advanced Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04738305
• Other study ID #: 2016/0007193
• Status: Completed
• Phase: N/A
• Start date: June 2016
• Est. completion date: December 2017

Study information

• Verified date: January 2021
• Source: Azienda Unità Sanitaria Locale Reggio Emilia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Advanced Cancer
• Dignity

Intervention

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.

Locations

Country	Name	City	State
Italy	Azienda USL - IRCCS di Reggio Emilia	Reggio Emilia

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Unità Sanitaria Locale Reggio Emilia

Country where clinical trial is conducted

Italy, 

References & Publications (1)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Retention rate	The number of participants who performed the post intervention assesment divided by the number of enrolled one.	1 year
Primary	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	Patient dignity-related	Patient Dignity Inventory (Italian version). Scale range 25-125, higher value means higher dignity-related distress.	Baseline; day 62
Secondary	Patient feedback	The acceptability of Dignity Therapy was assessed by the Italian version of "Dignity Therapy Patient Feedback Questionnaire" survey.	day 62