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OpenTrials
Completed

NCT Number: NCT04738305

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

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.

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Key information

Conditions

Dignity Advanced Cancer

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Azienda USL - IRCCS di Reggio Emilia

Reggio Emilia, 42123, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dignity Therapy

Other

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.

Primary outcomes

  1. Enrollment rate

    Time frame: 1 year

    The number of participants who sign the informed consent form divided by the number who are asked to participate in the study

  2. Retention rate

    Time frame: 1 year

    The number of participants who performed the post intervention assesment divided by the number of enrolled one.

  3. Professionals' experience in implementing DT

    Time frame: 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 outcomes

  1. Patient dignity-related

    Time frame: Baseline; day 62

    Patient Dignity Inventory (Italian version). Scale range 25-125, higher value means higher dignity-related distress.

  2. Patient feedback

    Time frame: day 62

    The acceptability of Dignity Therapy was assessed by the Italian version of "Dignity Therapy Patient Feedback Questionnaire" survey.

Sponsors and collaborators

Lead sponsor

Azienda USL Reggio Emilia - IRCCS

Other Gov

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Feb 4, 2021
Registry last updated
Feb 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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