CancerPhase 2DignityDKNCT01507571
Implementation and Evaluation of Dignity Therapy in Denmark
A Phase 2 study testing Dignity Therapy in people with Cancer, run by Bispebjerg Hospital at 2 sites in Denmark.
Trial summary
The purpose of the study is to investigate whether Danish patients with incurable cancer have a need of, interest in and benefit from Dignity Therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- Dignity Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 2 sitesDenmark
- Study dates
- Sep 2005to Sep 2007
- Phase
- Phase 2
- 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
- diagnosis of incurable cancer,
- 18 years or older,
- informed of diagnosis and the incurable prognosis.
Who cannot join
- dementia and other cognitive impairment,
- physical limitations,
- sufficient to preclude participation.
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Department of Palliative Medicine
Copenhagen, 2400
Sankt Lukas Hospice
Hellerup, 2900
About this study
The purpose of the study is to investigate whether Danish patients with incurable cancer have a need of, interest in and benefit from Dignity Therapy.
Read the detailed description
Research in palliative care has primarily focused on physical and psychological symptoms. Research in other psychosocial and existential problems has been sparse. Loss of dignity as a consequence of serious illness may be an important cause of suffering. The research team of the Canadian psychiatrist and professor, Harvey Chochinov has investigated the concept of dignity and developed the psychosocial intervention 'Dignity Therapy' (DT). The preliminary research results were promising.
Research questions: Do Danish cancer patients have a need of, interest in, and benefit from DT? Methods: DT consists of an interview revolving around the patient's life, values, and accomplishments and is also an opportunity to leave messages and words of hope and compassion for friends and family. The interview is audio taped, transcribed, and edited together with the patient, and made into a tangible document, which the patient can give to his/her relatives. The project consists of three parts: (1) a cross-sectional investigation of the prevalence of loss of dignity and related symptoms/problems among at least 200 incurable cancer patients. (2) A feasibility study, testing the intervention in terms of relevance and the need of any modifications in relation to Danish patients. (3) An evaluation study testing the effect of and satisfaction with DT.
At least 80 patients are planned for the feasibility and evaluation studies. Questionnaires are used for detection of loss of dignity and as measures of effect. These will be administered before the intervention and, along with a semi-structured evaluation questionnaire, right after the intervention, when the document is received and again approximately two weeks later.
The duration of the intervention (DT) varies markedly between patients. In some cases the process (interview, transcription, editing of document, and the final meeting where the document is given back to the patient) is completed urgently in a few days, whereas in other cases, the patient prefers a slower pace, and may want to sub-divide the interview into two or more parts. Also, when presented with the document, some patients want to have something changed or they want add material. This variation is seen as intentional, as it illustrates that the process is tailored to the patient's wishes.
As stated, the effect of the DT intervention is evaluated at completion of the intervention, i.e. when the final document is given back to the patient, and about two weeks later. Due to process described above, the time from the first measurement (before intervention) to the second measurement (which takes places at completion of the intervention) therefore varies considerably (median 36 days after baseline, range 7-121 days).
Perspective: If Danish patients have a need of, an interest in and benefit from DT, it can be offered to Danish patients admitted to palliative care.
- Conditions
- Cancer
- Being tested
- Dignity Therapy
- Keywords
- Incurable cancer, Palliative care, Dignity Therapy, Loss of dignity, Patient Dignity Intventory, Eortc QLQ-C15-PAL, Structured Interview for Symptoms and Concerns, Hospital Anxiety and Depression Scale
- Medical subject headings
- Neoplasms, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dignity TherapyOther
Also called Psychotherapeutic intervention, Psychosocial intervention, End of life care
Dignity Therapy is a brief psychotherapeutic intervention consisting of:
- a tape-recorded session with the patient using the DT question protocol
- Transcription of the interview, which is then edited
- A session where the edited transcript is returned to the patient who can give it to family members or friends.
If needed, one or more sessions are added. Dt allows the patient to give voice to the matters of importance concerning himself and his loved ones. Its purpose is to enhance sense of meaning, purpose and worth. It also gives the opportunity to leave something behind to be remembered by.
| Study group | Role | What they receive |
|---|---|---|
| Dignity Therapy | Experimental | Not described Receives: Other: Dignity Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sense of dignity
Measured with the Structured Interview for Symptoms and Concerns (SISC)
Measured: Pre-post intervention (when the document was recieved by the patient), and again two weeks later.
Secondary outcomes (43)
Hopelessness
Measured with the Structured Interview for Symptoms and Concerns (SISC)
Measured: Pre-post intervention (when the document was recieved by the patient), and again two weeks later.
Anxiety
Measured on the Hospital anxiety and depression scale
Measured: Pre-post intervention (when the document was received by the patient), and again two weeks later.
Depression
Measured on the Hospital Anxiety and Depression scale
Measured: Pre-post intervention (when the document was received by the patient), and again two weeks later.
Not able to perform tasks of daily living
Measured on the Patient Dignity Inventory
Measured: Pre-post intervention (when the document was received by the patient), and again two weeks later.
Suffering
Measured with the Structured Interview for Symptoms and Concerns
Measured: Pre-post intervention (when the document was received by the patient), and again two weeks later.
performance status
Measured on the Palliative Performance Scale v2
Measured: Pre-post intervention (when the document was received by the patient), and again two weeks later.
Communication
Measured on the Structured Interview for Symptoms and Concerns
Measured: Pre-post intervention (when the document was received by the patient), and again two weeks later.
Social Contact
Measured on the Structured Interview for Symptoms and Concerns
Measured: Pre-post intervention (when the document was received by the patient), and again two weeks later.
Depression
Measured with the Structured Interview for Symptoms and Concerns
Measured: Pre-post intervention (when the document was received by the patient), and again two weeks later.
Not able to attend to bodily functions
Item from the Patient Dignity Inventory
Measured: Pre-post intervention (when the document was received by the patient), and again two weeks later.
Physically distressing symptoms
Item from the Patient Dignity Inventory
Measured: Pre-post intervention (when the document was received by the patient), and again two weeks later.
Feeling how I look has changed
Item from the Patient Dignity Inventory
Measured: Pre-post intervention (when the document was received by the patient), and again two weeks later.
Feeling depressed
Item from the Patient Dignity Inventory
Measured: Pre-post intervention (when the document was received by the patient), and again two weeks later.
Feeling anxious
Item from the Patient Dignity Inventory
Measured: Pre-post intervention (when the document was received by the patient), and again two weeks later.
Feeling uncertain
Item from the Patient Dignity Inventory
Measured: Pre-post intervention (when the document was received by the patient), and again two weeks later.
Worried about future
Item from the Patient Dignity Inventory
Measured: Pre-post intervention (when the document was received by the patient), and again two weeks later.
Not able to think clearly
Item from the Patient Dignity Inventory
Measured: Pre-post intervention (when the document was received by the patient), and again two weeks later.
Not able to continue usual routines
Item from the Patient Dignity Inventory
Measured: Pre-post intervention (when the document was received by the patient), and again two weeks later.
Feeling no longer who I was
Item from the Patient Dignity Inventory
Measured: Pre-post intervention (when the document was received by the patient), and again two weeks later.
Not feeling worthwhile or valued
Item from the Patient Dignity Inventory
Measured: Pre-post intervention (when the document was received by the patient), and again two weeks later.
Not able to carry out important roles
Item from the Patient Dignity Inventory
Measured: Pre-post intervention (when the document was received by the patient), and again two weeks later.
Feeling life no longer has meaning or purpose
Item from the Patient Dignity Inventory
Measured: Pre-post intervention (when the document was received by the patient), and again two weeks later.
Feeling of not having made a meaningful contribution
Item from the Patient Dignity Inventory
Measured: Pre-post intervention (when the document was received by the patient), and again two weeks later.
Feeling of unfinished business
Item from the Patient Dignity Inventory
Measured: Pre-post intervention (when the document was received by the patient), and again two weeks later.
Concerns regarding spiritual life
Item from the Patient Dignity Inventory
Measured: Pre-post intervention (when the document was received by the patient), and again two weeks later.
Feeling like a burden to others
Item from the Patient Dignity Inventory
Measured: Pre-post intervention (when the document was received by the patient), and again two weeks later.
Feeling of not having control
Item from the Patient Dignity Inventory
Measured: Pre-post intervention (when the document was received by the patient), and again two weeks later.
Feeling of reduced privacy
Item from the Patient Dignity Inventory
Measured: Pre-post intervention (when the document was received by the patient), and again two weeks later.
Not feeling supported by friends or family
Item from the Patient Dignity Inventory
Measured: Pre-post intervention (when the document was received by the patient), and again two weeks later.
Not feeling supported by health care providers
Item from the Patient Dignity Inventory
Measured: Pre-post intervention (when the document was received by the patient), and again two weeks later.
Not feeling able to mentally fight illness
Item from the Patient Dignity Inventory
Measured: Pre-post intervention (when the document was received by the patient), and again two weeks later.
Not being able to accept things as they are
Item from the Patient Dignity Inventory
Measured: Pre-post intervention (when the document was received by the patient), and again two weeks later.
Not being treated with respect
Item from the Patient Dignity Inventory
Measured: Pre-post intervention (when the document was received by the patient), and again two weeks later.
Physical function
Measured on the EORTC QLQ-C15-PAL
Measured: Pre-post intervention (when the document was received by the patient), and again two weeks later.
Emotional function
Measured on the EORTC QLQ-C15-PAL
Measured: Pre-post intervention (when the document was received by the patient), and again two weeks later.
Overall quality of life
Measured on the EORTC QLQ-C15-PAL
Measured: Pre-post intervention (when the document was received by the patient), and again two weeks later.
Fatigue
Measured on the EORTC QLQ-C15-PAL
Measured: Pre-post intervention (when the document was received by the patient), and again two weeks later.
Nausea / Vomiting
Measured on the EORTC QLQ-C15-PAL
Measured: Pre-post intervention (when the document was received by the patient), and again two weeks later.
Pain
Measured on the EORTC QLQ-C15-PAL
Measured: Pre-post intervention (when the document was received by the patient), and again two weeks later.
Dyspnoea
Measured on the EORTC QLQ-C15-PAL
Measured: Pre-post intervention (when the document was received by the patient), and again two weeks later.
Insomnia
Measured on the EORTC QLQ-C15-PAL
Measured: Pre-post intervention (when the document was received by the patient), and again two weeks later.
Appetite loss
Measured on the EORTC QLQ-C15-PAL
Measured: Pre-post intervention (when the document was received by the patient), and again two weeks later.
Constipation
Measured on the EORTC QLQ-C15-PAL
Measured: Pre-post intervention (when the document was received by the patient), and again two weeks later.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2012 (estimated)
- Study startSep 2005
- Primary completionSep 2007
- Study completionSep 2007
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 CancerStudies 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 2
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bispebjerg Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mogens Groenvold, Bispebjerg Hospital
- Investigators
- Mogens Groenvold, MD PhD DSci, Principal investigator, Bispebjerg Hospital/ Department of Public Health, Faculty of Health Sciences, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01507571
- Sponsor's protocol ID
- DignityTherapyDK 01
- Other IDs
- PP04011
- Acronym
- DignityDK
- Status last verified
- Jan 2012
- First submitted
- 11 Nov 2011
- Last updated
- 11 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Houmann LJ, Rydahl-Hansen S, Chochinov HM, Kristjanson LJ, Groenvold M. Testing the feasibility of the Dignity Therapy interview: adaptation for the Danish culture. BMC Palliat Care. 2010 Sep 22;9:21. doi: 10.1186/1472-684X-9-21.
PubMed 20860786Houmann LJ, Chochinov HM, Kristjanson LJ, Petersen MA, Groenvold M. A prospective evaluation of Dignity Therapy in advanced cancer patients admitted to palliative care. Palliat Med. 2014 May;28(5):448-58. doi: 10.1177/0269216313514883. Epub 2013 Dec 5.
PubMed 24311296
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation and Evaluation of Dignity Therapy in Denmark
- ClinicalTrials.gov ID
- NCT01507571
- Acronym / sponsor ID
- DignityDK / DignityTherapyDK 01
- Conditions
- Cancer
- Keywords
- Incurable cancer, Palliative care, Dignity Therapy, Loss of dignity, Patient Dignity Intventory, Eortc QLQ-C15-PAL, Structured Interview for Symptoms and Concerns, Hospital Anxiety and Depression Scale
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Bispebjerg HospitalUniversity, hospital or other
- Study start
- Sep 2005
- Primary completion
- Sep 2007 (actual)
- Study completion
- Sep 2007 (actual)
- First posted
- 11 Jan 2012 (estimated)
- 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.
The purpose of the study is to investigate whether Danish patients with incurable cancer have a need of, interest in and benefit from Dignity Therapy.
Detailed description
Research in palliative care has primarily focused on physical and psychological symptoms. Research in other psychosocial and existential problems has been sparse. Loss of dignity as a consequence of serious illness may be an important cause of suffering. The research team of the Canadian psychiatrist and professor, Harvey Chochinov has investigated the concept of dignity and developed the psychosocial intervention 'Dignity Therapy' (DT). The preliminary research results were promising.
Research questions: Do Danish cancer patients have a need of, interest in, and benefit from DT? Methods: DT consists of an interview revolving around the patient's life, values, and accomplishments and is also an opportunity to leave messages and words of hope and compassion for friends and family. The interview is audio taped, transcribed, and edited together with the patient, and made into a tangible document, which the patient can give to his/her relatives. The project consists of three parts: (1) a cross-sectional investigation of the prevalence of loss of dignity and related symptoms/problems among at least 200 incurable cancer patients. (2) A feasibility study, testing the intervention in terms of relevance and the need of any modifications in relation to Danish patients. (3) An evaluation study testing the effect of and satisfaction with DT.
At least 80 patients are planned for the feasibility and evaluation studies. Questionnaires are used for detection of loss of dignity and as measures of effect. These will be administered before the intervention and, along with a semi-structured evaluation questionnaire, right after the intervention, when the document is received and again approximately two weeks later.
The duration of the intervention (DT) varies markedly between patients. In some cases the process (interview, transcription, editing of document, and the final meeting where the document is given back to the patient) is completed urgently in a few days, whereas in other cases, the patient prefers a slower pace, and may want to sub-divide the interview into two or more parts. Also, when presented with the document, some patients want to have something changed or they want add material. This variation is seen as intentional, as it illustrates that the process is tailored to the patient's wishes.
As stated, the effect of the DT intervention is evaluated at completion of the intervention, i.e. when the final document is given back to the patient, and about two weeks later. Due to process described above, the time from the first measurement (before intervention) to the second measurement (which takes places at completion of the intervention) therefore varies considerably (median 36 days after baseline, range 7-121 days).
Perspective: If Danish patients have a need of, an interest in and benefit from DT, it can be offered to Danish patients admitted to palliative care.
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 | Experimental | Other: Dignity Therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- diagnosis of incurable cancer,
- 18 years or older,
- informed of diagnosis and the incurable prognosis.
Key exclusion criteria (3 listed)
- dementia and other cognitive impairment,
- physical limitations,
- sufficient to preclude participation.
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 TherapyAlso: Psychotherapeutic intervention, Psychosocial intervention, End of life careDignity Therapy is a brief psychotherapeutic intervention consisting of: 1. a tape-recorded session with the patient using the DT question protocol 2. Transcription of the interview, which is then edited 3. A session where the edited transcript is returned to the patient who can give it to family members or friends. If needed, one or more sessions are added. Dt allows the patient to give voice to the matters of importance concerning himself and his loved ones. Its purpose is to enhance sense of meaning, purpose and worth. It also gives the opportunity to leave something behind to be remembered by. | Other | Dignity Therapy |
Primary outcome
Sense of dignity
Time frame: Pre-post intervention (when the document was recieved by the patient), and again two weeks later.
Measured with the Structured Interview for Symptoms and Concerns (SISC)
43 secondary outcomes
Hopelessness
Time frame: Pre-post intervention (when the document was recieved by the patient), and again two weeks later.
Anxiety
Time frame: Pre-post intervention (when the document was received by the patient), and again two weeks later.
Depression
Time frame: Pre-post intervention (when the document was received by the patient), and again two weeks later.
Not able to perform tasks of daily living
Time frame: Pre-post intervention (when the document was received by the patient), and again two weeks later.
Suffering
Time frame: Pre-post intervention (when the document was received by the patient), and again two weeks later.
performance status
Time frame: Pre-post intervention (when the document was received by the patient), and again two weeks later.
Communication
Time frame: Pre-post intervention (when the document was received by the patient), and again two weeks later.
Social Contact
Time frame: Pre-post intervention (when the document was received by the patient), and again two weeks later.
Depression
Time frame: Pre-post intervention (when the document was received by the patient), and again two weeks later.
Not able to attend to bodily functions
Time frame: Pre-post intervention (when the document was received by the patient), and again two weeks later.
Physically distressing symptoms
Time frame: Pre-post intervention (when the document was received by the patient), and again two weeks later.
Feeling how I look has changed
Time frame: Pre-post intervention (when the document was received by the patient), and again two weeks later.
Feeling depressed
Time frame: Pre-post intervention (when the document was received by the patient), and again two weeks later.
Feeling anxious
Time frame: Pre-post intervention (when the document was received by the patient), and again two weeks later.
Feeling uncertain
Time frame: Pre-post intervention (when the document was received by the patient), and again two weeks later.
Worried about future
Time frame: Pre-post intervention (when the document was received by the patient), and again two weeks later.
Not able to think clearly
Time frame: Pre-post intervention (when the document was received by the patient), and again two weeks later.
Not able to continue usual routines
Time frame: Pre-post intervention (when the document was received by the patient), and again two weeks later.
Feeling no longer who I was
Time frame: Pre-post intervention (when the document was received by the patient), and again two weeks later.
Not feeling worthwhile or valued
Time frame: Pre-post intervention (when the document was received by the patient), and again two weeks later.
Not able to carry out important roles
Time frame: Pre-post intervention (when the document was received by the patient), and again two weeks later.
Feeling life no longer has meaning or purpose
Time frame: Pre-post intervention (when the document was received by the patient), and again two weeks later.
Feeling of not having made a meaningful contribution
Time frame: Pre-post intervention (when the document was received by the patient), and again two weeks later.
Feeling of unfinished business
Time frame: Pre-post intervention (when the document was received by the patient), and again two weeks later.
Concerns regarding spiritual life
Time frame: Pre-post intervention (when the document was received by the patient), and again two weeks later.
Feeling like a burden to others
Time frame: Pre-post intervention (when the document was received by the patient), and again two weeks later.
Feeling of not having control
Time frame: Pre-post intervention (when the document was received by the patient), and again two weeks later.
Feeling of reduced privacy
Time frame: Pre-post intervention (when the document was received by the patient), and again two weeks later.
Not feeling supported by friends or family
Time frame: Pre-post intervention (when the document was received by the patient), and again two weeks later.
Not feeling supported by health care providers
Time frame: Pre-post intervention (when the document was received by the patient), and again two weeks later.
Not feeling able to mentally fight illness
Time frame: Pre-post intervention (when the document was received by the patient), and again two weeks later.
Not being able to accept things as they are
Time frame: Pre-post intervention (when the document was received by the patient), and again two weeks later.
Not being treated with respect
Time frame: Pre-post intervention (when the document was received by the patient), and again two weeks later.
Physical function
Time frame: Pre-post intervention (when the document was received by the patient), and again two weeks later.
Emotional function
Time frame: Pre-post intervention (when the document was received by the patient), and again two weeks later.
Overall quality of life
Time frame: Pre-post intervention (when the document was received by the patient), and again two weeks later.
Fatigue
Time frame: Pre-post intervention (when the document was received by the patient), and again two weeks later.
Nausea / Vomiting
Time frame: Pre-post intervention (when the document was received by the patient), and again two weeks later.
Pain
Time frame: Pre-post intervention (when the document was received by the patient), and again two weeks later.
Dyspnoea
Time frame: Pre-post intervention (when the document was received by the patient), and again two weeks later.
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 11 Jan 2012.
- Results publication: PubMed 20860786Houmann LJ, Rydahl-Hansen S, Chochinov HM, Kristjanson LJ, Groenvold M. Testing the feasibility of the Dignity Therapy interview: adaptation for the Danish culture. BMC Palliat Care. 2010 Sep 22;9:21. doi: 10.1186/1472-684X-9-21.
- Derived from this study: PubMed 24311296Houmann LJ, Chochinov HM, Kristjanson LJ, Petersen MA, Groenvold M. A prospective evaluation of Dignity Therapy in advanced cancer patients admitted to palliative care. Palliat Med. 2014 May;28(5):448-58. doi: 10.1177/0269216313514883. Epub 2013 Dec 5.
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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.
Mogens Groenvold, MD PhD DSci principal investigator
Bispebjerg Hospital/ Department of Public Health, Faculty of Health Sciences, University of Copenhagen
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dignity Therapy in people with Cancer, run by Bispebjerg Hospital at 2 sites in Denmark.
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 3 inclusion and 3 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 11 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Sense of dignity (time frame: Pre-post intervention (when the document was recieved by the patient), and again two weeks later.). 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 NCT01507571, 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 11 Jan 2012; AzTrials last refreshed its copy on 30 Oct 2026.