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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by University of Manitoba
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
University of Manitoba
ClinicalTrials.gov Identifier:
NCT01883375
First received: February 11, 2013
Last updated: June 26, 2014
Last verified: June 2014
  Purpose

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. 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 Intervention
Palliative Care
Family
End of Life Care
Behavioral: Dignity Talk
Behavioral: The Dignity Talk Communication Topics

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Dignity Talk: a Novel Palliative Care Intervention for Patients and Their Families

Resource links provided by NLM:


Further study details as provided by University of Manitoba:

Primary Outcome Measures:
  • Family communication connectedness Index [ Time Frame: 31 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 31 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 100
Study Start Date: March 2013
Estimated Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 twice (at 2-4 days and 4-6 days) to address participant issues/concerns. If at the end of 10 days, one or more Dignity Talk items have been discussed and participants confirm they have covered all items wish to discuss, patient and family member will be seen to be "completers". 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
Behavioral: The Dignity Talk Communication Topics
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 twice (at 2-4 days and 4-6 days) to address participant issues/concerns. If at the end of 10 days, participants have not completed Dignity Talk, patient and family member will be seen to be "non-completers". 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.

Detailed Description:

See above summary

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

For Patient:

  • Patient being cared for on in-patient palliative care unit whose life expectancy is 6 months or less
  • 18 years of age or older
  • able to provide informed oral and written consent
  • cognitive capacity (based on clinical consensus)

For Family Member:

  • Family member who the patient identifies they would be comfortable talking with about 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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01883375

Contacts
Contact: Katherine A Cullihall, RN BN 204-787-4924 katherine.cullihall@cancercare.mb.ca

Locations
Canada, Manitoba
St. Boniface Hospital Recruiting
Winnipeg, Manitoba, Canada, R3E 0V9
Contact: Lorie Forbes, MN    (204) 258-1044    lforbes@sbgh.mb.ca   
Principal Investigator: Harvey M Chochinov, MD PhD         
Riverview Health Centre Recruiting
Winnipeg, Manitoba, Canada, R3L 2P4
Contact: John B Bond, PhD    (204) 478-6215    jbond@rhc.mb.ca   
Principal Investigator: Harvey M Chochinov, MD PhD         
Sponsors and Collaborators
University of Manitoba
Canadian Institutes of Health Research (CIHR)
  More Information

No publications provided

Responsible Party: University of Manitoba
ClinicalTrials.gov Identifier: NCT01883375     History of Changes
Other Study ID Numbers: H2013:024
Study First Received: February 11, 2013
Last Updated: June 26, 2014
Health Authority: Canada: Ethics Review Committee

Keywords provided by University of Manitoba:
Palliative Care
Family
adaptation, psychological

ClinicalTrials.gov processed this record on October 01, 2014