DignityNCT04738305
Feasibility of Dignity Therapy Intervention on Cancer Patients in Charge to an Hospital Palliative Care Unit.
A study testing Dignity Therapy in people with Dignity and Advanced Cancer, run by Azienda USL Reggio Emilia - IRCCS at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dignity, Advanced Cancer
- What is being tested?
- Dignity Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteItaly
- Study dates
- Jun 2016to Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- < 18 years old
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Dignity, Advanced Cancer
- Being tested
- Dignity Therapy
- Keywords
- Hospital palliative care unit
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Dignity Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Enrollment rate
The number of participants who sign the informed consent form divided by the number who are asked to participate in the study
Measured: 1 year
Retention rate
The number of participants who performed the post intervention assesment divided by the number of enrolled one.
Measured: 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.
Measured: 12-18 months
Secondary outcomes (2)
Patient dignity-related
Patient Dignity Inventory (Italian version). Scale range 25-125, higher value means higher dignity-related distress.
Measured: Baseline; day 62
Patient feedback
The acceptability of Dignity Therapy was assessed by the Italian version of "Dignity Therapy Patient Feedback Questionnaire" survey.
Measured: day 62
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2021
- Study startJun 2016
- Primary completionApr 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for DignityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda USL Reggio Emilia - IRCCS
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Francesca Nunziante, Principal investigator, Azienda USL Reggio Emilia - IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04738305
- Sponsor's protocol ID
- 2016/0007193
- Other IDs
- 2016
- Status last verified
- Jan 2021
- First submitted
- 26 Jan 2021
- Last updated
- 8 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 34399737
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Acceptability of a Dignity Therapy Intervention on Palliative Care Program's Cancer Patients Referring to a Medical Oncology Ward.
- ClinicalTrials.gov ID
- NCT04738305
- Acronym / sponsor ID
- 2016/0007193
- Conditions
- Dignity, Advanced Cancer
- Keywords
- Hospital palliative care unit
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Azienda USL Reggio Emilia - IRCCSOther government
- Study start
- Jun 2016 (actual)
- Primary completion
- Apr 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 4 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dignity Therapy Intervention | Other | Other: Dignity TherapyAll 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (1 listed)
- < 18 years old
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dignity TherapyThe 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. | Other | Dignity Therapy Intervention |
Primary outcome
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
Retention rate
Time frame: 1 year
The number of participants who performed the post intervention assesment divided by the number of enrolled one.
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.
2 secondary outcomes
Patient dignity-related
Time frame: Baseline; day 62
Patient feedback
Time frame: day 62
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2021.
- BackgroundChochinov HM. Terapia della dignità: parole per il tempo che rimane. Il pensiero scientifico, 2015.
- Derived from this study: PubMed 34399737Nunziante 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Francesca Nunziante principal investigator
Azienda USL Reggio Emilia - IRCCS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dignity Therapy in people with Dignity and Advanced Cancer, run by Azienda USL Reggio Emilia - IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Enrollment rate (time frame: 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04738305, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2021.