NCT04738305

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2016

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

January 26, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 4, 2021

Completed
Last Updated

February 8, 2021

Status Verified

January 1, 2021

Enrollment Period

10 months

First QC Date

January 26, 2021

Last Update Submit

February 4, 2021

Conditions

DignityAdvanced Cancer

Keywords

Hospital palliative care unit

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (2)

  • Patient dignity-related

    Baseline; day 62

  • Patient feedback

    day 62

Study Arms (1)

Dignity Therapy Intervention

OTHER

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

Interventions

Dignity TherapyOTHER

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.

Dignity Therapy Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • \< 18 years old

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Azienda USL - IRCCS di Reggio Emilia

Reggio Emilia, 42123, Italy

Location

Related Publications (2)

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

    BACKGROUND

  • 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.

    PMID: 34399737DERIVED

MeSH Terms

Interventions

Dignity Therapy

Intervention Hierarchy (Ancestors)

PsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Francesca Nunziante

    Azienda USL - IRCCS di Reggio Emilia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 26, 2021

First Posted

February 4, 2021

Study Start

June 1, 2016

Primary Completion

April 1, 2017

Study Completion

December 1, 2017

Last Updated

February 8, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)