Palliative CareDTalkNCT01883375
Dignity Talk: Helping Palliative Care Patients and Families Have Important Conversations
A study testing Dignity Talk and The Dignity Talk Communication Topics in people with Palliative Care and Family, run by University of Manitoba at 13 sites in Canada.
Trial summary
Dying patients and their families face many challenges near the end-of-life. Not only do patients often experience physical distress, but they also have feelings of loss of dignity, isolation, and uncertainty. Family members also face many challenges. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Palliative Care, Family, End of Life Care
- What is being tested?
- Dignity Talk and The Dignity Talk Communication Topics
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 13 sitesCanada
- Study dates
- Mar 2013to 31 Oct 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- For Patient:
- Patients being cared for:
- in a palliative care unit or whose care is focused on palliation as determined by clinical staff
- or patients who have have a confirmed diagnosis of amyotropic lateral sclerosis, and have symptoms in a domain that interferes with their social or occupation functioning: a) mobility, b) dysphasia, c) dyspnea, or d) speech or patients who have are have been on dialysis > 3 months and are > 60 years of age - or residents of Personal Care Home all of whom are:
- 18 years of age or older
- able to provide informed oral and written consent
Show all 15Show fewer
- cognitive capacity (based on clinical consensus)
- For Family Member or Close Friend:
- Family member or close friend who the patient identifies they would be comfortable talking with using the Dignity Talk question framework
- Family member who is 18 years of age or older
- Family member who is able to provide oral and written consent
- Family member who has cognitive capacity to participate in meaningful conversation (based on research staff decision)
- For Healthcare Provider:
- Employed one of the participating sites
- in a discipline directly involved in clinical care (physician, nursing, social work, spiritual care, allied healthcare, etc.)
Who cannot join
- not meeting the above inclusion criteria
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
Canada13 sites
Dr. Bob Kemp Hospice
Hamilton, Ontario, L9B 1B1
Victoria Hospice
Victoria, British Columbia
St. Boniface Hospital
Winnipeg, Manitoba, R3E 0V9
Riverview Health Centre
Winnipeg, Manitoba, R3L 2P4
Concordia Hospital
Winnipeg, Manitoba
Deer Lodge Centre
Winnipeg, Manitoba
Grace Hospital
Winnipeg, Manitoba
Health Sciences Centre
Winnipeg, Manitoba
Manitoba Renal Program
Winnipeg, Manitoba
Seven Oaks Hospital
Winnipeg, Manitoba
Victoria Hospital
Winnipeg, Manitoba
Winnipeg Regional Health Authority
Winnipeg, Manitoba
WRHA Personal Care Homes
Winnipeg, Manitoba
About this study
Official title: Dignity Talk: a Novel Palliative Care Intervention for Patients and Their Families
Dying patients and their families face many challenges near the end-of-life. Not only do patients often experience physical distress, but they also have feelings of loss of dignity, isolation, and uncertainty. Family members also face many challenges. They bear witness to the suffering of loved ones, and they face uncertainty, loss, and at times a mounting sense of helplessness.
The purpose of this study is to introduce and evaluate a new intervention called Dignity Talk, meant to enhance end-of-life experience for both patients and their families. Dignity Talk is based on a set of questions by which terminally ill patients and their family members can engage in meaningful conversations with each other. It is intended to lessen feelings of loss and helplessness and enhance feelings of connectedness by facilitating conversations that tap into a sense of meaning and purpose, sharing of memories, wishes, hopes, and giving guidance to those who will soon be left behind.
Read more
In Phase 1, 20 patients and family members will help finalize the method and Dignity Talk question framework (is it easy to understand, do the investigators have the right questions, and is the wording sensitive). In Phase 2 of the study the investigators will ask 100 patient-family pairs for feedback about Dignity Talk: what influence it had on their palliative care experience, whether it works well, and whether this intervention should become a regular part of palliative care. The investigators will also ask for feedback from health-care providers in both phases. We are requesting approval for an amendment to the healthcare provider feedback focus group questions. Will add those documents when they are approved.
Four to six months after the death of their loved one, the investigators will contact the family member to ask their thoughts about Dignity Talk, how it shaped their experience of their grief and bereavement.
The investigators expect that the study will show that Dignity Talk can be an effective, highly accessible palliative care intervention, which will enhance the end-of-life experience for palliative patients and the families who support them.
Read the detailed description
See above summary
- Conditions
- Palliative Care, Family, End of Life Care
- Being tested
- Dignity Talk, The Dignity Talk Communication Topics
- Keywords
- Palliative Care, Family, adaptation, psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dignity TalkBehavioural
Patient and family member participants will be given the Dignity Talk framework questions and asked to use them in conversation with each other. Research nurse will return at day 4-6 to confirm both participants have covered all items they wish to discuss. 4-6 months after the death of patient, family members will be contacted in order to collect data pertaining to their bereavement experiences and distress. Will also be asked to complete evaluative feedback on Dignity Talk.
The Dignity Talk Communication TopicsBehavioural
There have not been any non-completers - this arm not being used currently
| Study group | Role | What they receive |
|---|---|---|
| Dignity Talk dyad completers | Experimental | Those dyads where both patient and family member co-participant complete the protocol using the Dignity Talk Communication Topics Receives: Behavioral: Dignity Talk |
| Dignity Talk non-completers | Experimental | Those dyads where patient and family member co-participant either do not complete the protocol or do not use the Dignity Talk Communication Topics (November 2016 - the investigators have not as yet enrolled any participants who have not completed the study without using the Dignity Talk Topics. However some participants have withdrawn from the study without completing. Receives: Behavioral: The Dignity Talk Communication Topics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Family communication connectedness Index
Measured: 31 months
Secondary outcomes (1)
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Measured: 31 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2013 (estimated)
- Study startMar 2013
- Primary completion30 Sep 2017
- Study completion31 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Palliative CareStudies of the same condition, open and under way.
- More trials run by University of ManitobaThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01883375
- Sponsor's protocol ID
- H2013:024
- Acronym
- DTalk
- Status last verified
- Nov 2016
- First submitted
- 11 Feb 2013
- Last updated
- 14 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Guo Q, Chochinov HM, McClement S, Thompson G, Hack T. Development and evaluation of the Dignity Talk question framework for palliative patients and their families: A mixed-methods study. Palliat Med. 2018 Jan;32(1):195-205. doi: 10.1177/0269216317734696. Epub 2017 Nov 13.
PubMed 29130367
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dignity Talk: a Novel Palliative Care Intervention for Patients and Their Families
- ClinicalTrials.gov ID
- NCT01883375
- Acronym / sponsor ID
- DTalk / H2013:024
- Conditions
- Palliative Care, Family, End of Life Care
- Keywords
- Palliative Care, Family, adaptation, psychological
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- Mar 2013
- Primary completion
- 30 Sep 2017 (actual)
- Study completion
- 31 Oct 2017 (actual)
- First posted
- 21 Jun 2013 (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.
Dying patients and their families face many challenges near the end-of-life. Not only do patients often experience physical distress, but they also have feelings of loss of dignity, isolation, and uncertainty. Family members also face many challenges. They bear witness to the suffering of loved ones, and they face uncertainty, loss, and at times a mounting sense of helplessness.
The purpose of this study is to introduce and evaluate a new intervention called Dignity Talk, meant to enhance end-of-life experience for both patients and their families. Dignity Talk is based on a set of questions by which terminally ill patients and their family members can engage in meaningful conversations with each other. It is intended to lessen feelings of loss and helplessness and enhance feelings of connectedness by facilitating conversations that tap into a sense of meaning and purpose, sharing of memories, wishes, hopes, and giving guidance to those who will soon be left behind.
In Phase 1, 20 patients and family members will help finalize the method and Dignity Talk question framework (is it easy to understand, do the investigators have the right questions, and is the wording sensitive). In Phase 2 of the study the investigators will ask 100 patient-family pairs for feedback about Dignity Talk: what influence it had on their palliative care experience, whether it works well, and whether this intervention should become a regular part of palliative care. The investigators will also ask for feedback from health-care providers in both phases. We are requesting approval for an amendment to the healthcare provider feedback focus group questions. Will add those documents when they are approved.
Four to six months after the death of their loved one, the investigators will contact the family member to ask their thoughts about Dignity Talk, how it shaped their experience of their grief and bereavement.
The investigators expect that the study will show that Dignity Talk can be an effective, highly accessible palliative care intervention, which will enhance the end-of-life experience for palliative patients and the families who support them.
Detailed description
See above summary
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dignity Talk dyad completers | Experimental | Behavioral: Dignity TalkThose dyads where both patient and family member co-participant complete the protocol using the Dignity Talk Communication Topics |
| Dignity Talk non-completers | Experimental | Behavioral: The Dignity Talk Communication TopicsThose dyads where patient and family member co-participant either do not complete the protocol or do not use the Dignity Talk Communication Topics (November 2016 - the investigators have not as yet enrolled any participants who have not completed the study without using the Dignity Talk Topics. However some participants have withdrawn from the study without completing. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- in a palliative care unit or whose care is focused on palliation as determined by clinical staff
- or patients who have have a confirmed diagnosis of amyotropic lateral sclerosis, and have symptoms in a domain that interferes with their social or occupation functioning: a) mobility, b) dysphasia, c) dyspnea, or d) speech or patients who have are have been on dialysis > 3 months and are > 60 years of age - or residents of Personal Care Home all of whom are:
- 18 years of age or older
- able to provide informed oral and written consent
- cognitive capacity (based on clinical consensus)
Key exclusion criteria (1 listed)
- not meeting the above inclusion criteria
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 TalkPatient and family member participants will be given the Dignity Talk framework questions and asked to use them in conversation with each other. Research nurse will return at day 4-6 to confirm both participants have covered all items they wish to discuss. 4-6 months after the death of patient, family members will be contacted in order to collect data pertaining to their bereavement experiences and distress. Will also be asked to complete evaluative feedback on Dignity Talk. | Behavioural | Dignity Talk dyad completers |
| The Dignity Talk Communication TopicsThere have not been any non-completers - this arm not being used currently | Behavioural | Dignity Talk non-completers |
Primary outcome
Family communication connectedness Index
Time frame: 31 months
1 secondary outcome
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time frame: 31 months
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 14 Dec 2017.
- Derived from this study: PubMed 29130367Guo Q, Chochinov HM, McClement S, Thompson G, Hack T. Development and evaluation of the Dignity Talk question framework for palliative patients and their families: A mixed-methods study. Palliat Med. 2018 Jan;32(1):195-205. doi: 10.1177/0269216317734696. Epub 2017 Nov 13.
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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.
The record lists no contact. Use the official record to reach the sponsor.
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dignity Talk and The Dignity Talk Communication Topics in people with Palliative Care and Family, run by University of Manitoba at 13 sites in Canada.
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 15 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 14 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Canada. 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?
Family communication connectedness Index (time frame: 31 months). 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 NCT01883375, which also lists 1 linked publication.
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 14 Dec 2017; AzTrials last refreshed its copy on 7 Nov 2026.