Study Results
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View full resultsBasic Information
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COMPLETED
NA
579 participants
INTERVENTIONAL
2017-07-26
2022-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
FACTORIAL
SUPPORTIVE_CARE
NONE
Study Groups
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usual outpatient palliative care
During the usual care steps, patients will receive usual outpatient palliative care
Usual care
Palliative care nurses usually see patients each clinic visit to assess vital signs, function, symptoms, and to provide patient and family education. They document findings and interventions in the electronic health record (EHR). Whereas usual care for palliative care chaplaincy in the outpatient setting varies by site, chaplaincy care for usual care patients in this study will follow the usual practice for inpatient palliative care chaplaincy, which is to visit all new referrals to the clinic and assess their spiritual and religious needs. This assessment is then memorialized in a spiritual treatment plan documented in the EHR.
Dignity Therapy - Nurse Led
During the experimental steps as part of routine palliative care service delivery, patients receive nurse-led DT.
Dignity Therapy - Nurse Led
The nurse-led intervention involves three sessions, each of which follows a set process. The standardize approach to the delivery of the intervention facilitates a personal process of reflection and recognition that allows the patient to make meaning of their experience.
Dignity Therapy - Chaplain Led
During the experimental steps as part of routine palliative care service delivery, patients will receive chaplain-led DT.
Dignity Therapy - Chaplain Led
The chaplain-led DT intervention involves three sessions, each of which follows a set process. The standardize approach to the delivery of the intervention facilitates a personal process of reflection and recognition that allows the patient to make meaning of their experience.
Interventions
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Dignity Therapy - Nurse Led
The nurse-led intervention involves three sessions, each of which follows a set process. The standardize approach to the delivery of the intervention facilitates a personal process of reflection and recognition that allows the patient to make meaning of their experience.
Usual care
Palliative care nurses usually see patients each clinic visit to assess vital signs, function, symptoms, and to provide patient and family education. They document findings and interventions in the electronic health record (EHR). Whereas usual care for palliative care chaplaincy in the outpatient setting varies by site, chaplaincy care for usual care patients in this study will follow the usual practice for inpatient palliative care chaplaincy, which is to visit all new referrals to the clinic and assess their spiritual and religious needs. This assessment is then memorialized in a spiritual treatment plan documented in the EHR.
Dignity Therapy - Chaplain Led
The chaplain-led DT intervention involves three sessions, each of which follows a set process. The standardize approach to the delivery of the intervention facilitates a personal process of reflection and recognition that allows the patient to make meaning of their experience.
Eligibility Criteria
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Inclusion Criteria
2. receiving outpatient palliative care
3. age 55 years or older
4. able to speak and read English
5. physically able to complete the study (Palliative Performance Scale \[PPS\]\>50, suggesting a mean in life expectancy of 53 days at the time of enrollment since each patient is expected to participate in the study for 28-42 days maximum \[4-6 weeks\]).
Exclusion Criteria
2. cognitively unable to complete study measures (Mini Mental Status Exam \[MMSE\] does not correctly spell the word world backwards)
3. history of psychosis (medical record review)
4. Patient Dignity Inventory score that indicates their distress level falls outside the remaining quota for a given step (quota is 50% of sample/site/step with low distress ≤ 2 problems rated \>2 \& 50% with high distress ≥ 3 problems rated \>2)
5. Spiritual distress score that indicates their distress level falls outside the remaining quota for a given step (quota is 50% of sample/site/step with low distress ≤ 2 problems rated \>2 \& 50% with high distress ≥ 3 problems rated \>2)
6. are participating in another psychosocial intervention study that is focused on concepts similar to the proposed study.
55 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Northwestern University
OTHER
Rush University
OTHER
Emory University
OTHER
M.D. Anderson Cancer Center
OTHER
University of California, San Francisco
OTHER
Healthcare Chaplaincy
OTHER
University of Florida
OTHER
Responsible Party
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Principal Investigators
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Diana J Wilkie, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Florida
Tammi Quest, MD
Role: STUDY_DIRECTOR
Emory University
George Fitchett, PhD
Role: PRINCIPAL_INVESTIGATOR
Rush University
Michael Rabow, MD
Role: STUDY_DIRECTOR
University of California, San Francisco
Linda Emanuel, MD/PhD
Role: PRINCIPAL_INVESTIGATOR
Northwestern University
Marvin Delgado, MD
Role: STUDY_DIRECTOR
MD Anderson
Locations
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University of Florida
Gainesville, Florida, United States
Countries
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References
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Scarton LJ, Boyken L, Lucero RJ, Fitchett G, Handzo G, Emanuel L, Wilkie DJ. Effects of Dignity Therapy on Family Members: A Systematic Review. J Hosp Palliat Nurs. 2018 Dec;20(6):542-547. doi: 10.1097/NJH.0000000000000469.
Scarton L, Oh S, Sylvera A, Lamonge R, Yao Y, Chochinov H, Fitchett G, Handzo G, Emanuel L, Wilkie D. Dignity Impact as a Primary Outcome Measure for Dignity Therapy. Am J Hosp Palliat Care. 2018 Nov;35(11):1417-1420. doi: 10.1177/1049909118777987. Epub 2018 May 24.
Kittelson S, Scarton L, Barker P, Hauser J, O'Mahony S, Rabow M, Delgado Guay M, Quest TE, Emanuel L, Fitchett G, Handzo G, Yao Y, Chochinov HM, Wilkie D. Dignity Therapy Led by Nurses or Chaplains for Elderly Cancer Palliative Care Outpatients: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2019 Apr 17;8(4):e12213. doi: 10.2196/12213.
O'Mahony S, Kittelson S, Barker PC, Delgado Guay MO, Yao Y, Handzo GF, Chochinov HM, Fitchett G, Emanuel LL, Wilkie DJ. Association of Race with End-of-Life Treatment Preferences in Older Adults with Cancer Receiving Outpatient Palliative Care. J Palliat Med. 2021 Aug;24(8):1174-1182. doi: 10.1089/jpm.2020.0542. Epub 2021 Mar 23.
Samuels V, Schoppee TM, Greenlee A, Gordon D, Jean S, Smith V, Reed T, Kittelson S, Quest T, O'Mahony S, Hauser J, Guay MOD, Rabow MW, Emanuel L, Fitchett G, Handzo G, Chochinov HM, Yao Y, Wilkie DJ. Interim Analysis of Attrition Rates in Palliative Care Study on Dignity Therapy. Am J Hosp Palliat Care. 2021 Dec;38(12):1503-1508. doi: 10.1177/1049909121994309. Epub 2021 Feb 9.
Bluck S, Mroz EL, Wilkie DJ, Emanuel L, Handzo G, Fitchett G, Chochinov HM, Bylund CL. Quality of Life for Older Cancer Patients: Relation of Psychospiritual Distress to Meaning-Making During Dignity Therapy. Am J Hosp Palliat Care. 2022 Jan;39(1):54-61. doi: 10.1177/10499091211011712. Epub 2021 Apr 29.
Schoppee TM, Scarton L, Bluck S, Yao Y, Keenan G, Handzo G, Chochinov HM, Fitchett G, Emanuel LL, Wilkie DJ. Description of a training protocol to improve research reproducibility for dignity therapy: an interview-based intervention. Palliat Support Care. 2022 Apr;20(2):178-188. doi: 10.1017/S1478951521000614.
Damen A, Exline J, Pargament K, Yao Y, Chochinov H, Emanuel L, Handzo G, Wilkie DJ, Fitchett G. Prevalence, Predictors and Correlates of Religious and Spiritual Struggles in Palliative Cancer Patients. J Pain Symptom Manage. 2021 Sep;62(3):e139-e147. doi: 10.1016/j.jpainsymman.2021.04.024. Epub 2021 May 10.
Bylund CL, Taylor G, Mroz E, Wilkie DJ, Yao Y, Emanuel L, Fitchett G, Handzo G, Chochinov HM, Bluck S. Empathic communication in dignity therapy: Feasibility of measurement and descriptive findings. Palliat Support Care. 2022 Jun;20(3):321-327. doi: 10.1017/S1478951521001188.
Rantanen P, Chochinov HM, Emanuel LL, Handzo G, Wilkie DJ, Yao Y, Fitchett G. Existential Quality of Life and Associated Factors in Cancer Patients Receiving Palliative Care. J Pain Symptom Manage. 2022 Jan;63(1):61-70. doi: 10.1016/j.jpainsymman.2021.07.016. Epub 2021 Jul 29.
Schoppee TM, Scarton L, Bluck S, Yao Y, Keenan G, Samuels V, Fitchett G, Handzo G, Chochinov HM, Emanuel LL, Wilkie DJ. Dignity therapy intervention fidelity: a cross-sectional descriptive study with older adult outpatients with cancer. BMC Palliat Care. 2022 Jan 11;21(1):8. doi: 10.1186/s12904-021-00888-y.
Handzo GF, Chochinov HM, Emanuel L, Fitchett G, Hauser J, Kittelson S, Schoppee TM, Yao Y, Solomon S, Wilkie DJ. Letter to the Editor: Feasibility of Dignity Therapy to Reduce Death Anxiety. J Palliat Med. 2022 Oct;25(10):1458-1459. doi: 10.1089/jpm.2022.0263. No abstract available.
Emanuel LL, Solomon S, Chochinov HM, Delgado Guay MO, Handzo G, Hauser J, Kittelson S, O'Mahony S, Quest TE, Rabow MW, Schoppee TM, Wilkie DJ, Yao Y, Fitchett G. Death Anxiety and Correlates in Cancer Patients Receiving Palliative Care. J Palliat Med. 2023 Feb;26(2):235-243. doi: 10.1089/jpm.2022.0052. Epub 2022 Sep 2.
Al Yacoub R, Rangel AP, Shum-Jimenez A, Greenlee A, Yao Y, Schoppee TM, Fitchett G, Handzo G, Chochinov HM, Emanuel LL, Kittelson S, Wilkie DJ. Cost considerations for implementing dignity therapy in palliative care: Insights and implications. Palliat Support Care. 2023 Aug 11:1-5. doi: 10.1017/S1478951523001177. Online ahead of print.
Wilkie DJ, Fitchett G, Yao Y, Schoppee T, Delgado Guay MO, Hauser J, Kittelson S, O'Mahony S, Rabow M, Quest T, Solomon S, Handzo G, Chochinov HM, Emanuel LL. Engaging Mortality: Effective Implementation of Dignity Therapy. J Palliat Med. 2024 Feb;27(2):176-184. doi: 10.1089/jpm.2023.0336. Epub 2023 Sep 7.
Koch MK, Bluck S, Maggiore S, Chochinov HM, Cogdill-Richardson K, Bylund CL. Facing off-time mortality: Leaving a legacy. Psychol Aging. 2024 Jun;39(4):400-412. doi: 10.1037/pag0000815. Epub 2024 Apr 11.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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OCR17893
Identifier Type: OTHER
Identifier Source: secondary_id
PRO00002457
Identifier Type: OTHER
Identifier Source: secondary_id
IRB201601190-N
Identifier Type: -
Identifier Source: org_study_id
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