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Dignity Talk: Helping Palliative Care Patients and Families Have Important Conversations (DTalk)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01883375
Recruitment Status : Completed
First Posted : June 21, 2013
Last Update Posted : December 14, 2017
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
University of Manitoba

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Palliative Care Family End of Life Care Behavioral: Dignity Talk Behavioral: The Dignity Talk Communication Topics Not Applicable

Detailed Description:
See above summary

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Dignity Talk: a Novel Palliative Care Intervention for Patients and Their Families
Study Start Date : March 2013
Actual Primary Completion Date : September 30, 2017
Actual Study Completion Date : October 31, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Palliative Care

Arm Intervention/treatment
Experimental: Dignity Talk dyad completers
Those dyads where both patient and family member co-participant complete the protocol using the Dignity Talk Communication Topics
Behavioral: Dignity Talk
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.

Experimental: Dignity Talk non-completers
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.
Behavioral: The Dignity Talk Communication Topics
There have not been any non-completers - this arm not being used currently

Primary Outcome Measures :
  1. Family communication connectedness Index [ Time Frame: 31 months ]

Secondary Outcome Measures :
  1. Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 31 months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

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
  • 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.)

Exclusion Criteria:

  • not meeting the above inclusion criteria

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01883375

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Canada, British Columbia
Victoria Hospice
Victoria, British Columbia, Canada
Canada, Manitoba
St. Boniface Hospital
Winnipeg, Manitoba, Canada, R3E 0V9
Riverview Health Centre
Winnipeg, Manitoba, Canada, R3L 2P4
Concordia Hospital
Winnipeg, Manitoba, Canada
Deer Lodge Centre
Winnipeg, Manitoba, Canada
Grace Hospital
Winnipeg, Manitoba, Canada
Health Sciences Centre
Winnipeg, Manitoba, Canada
Manitoba Renal Program
Winnipeg, Manitoba, Canada
Seven Oaks Hospital
Winnipeg, Manitoba, Canada
Victoria Hospital
Winnipeg, Manitoba, Canada
Winnipeg Regional Health Authority
Winnipeg, Manitoba, Canada
WRHA Personal Care Homes
Winnipeg, Manitoba, Canada
Canada, Ontario
Dr. Bob Kemp Hospice
Hamilton, Ontario, Canada, L9B 1B1
Sponsors and Collaborators
University of Manitoba
Canadian Institutes of Health Research (CIHR)
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: University of Manitoba Identifier: NCT01883375    
Other Study ID Numbers: H2013:024
First Posted: June 21, 2013    Key Record Dates
Last Update Posted: December 14, 2017
Last Verified: November 2016
Keywords provided by University of Manitoba:
Palliative Care
adaptation, psychological
Additional relevant MeSH terms:
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Pathologic Processes