Palliative Care for Elderly Outpatients

NCT03209440 | Completed Results

• 4 other identifiers: IRB201601190-N5R01CA200867-05OCR17893PRO00002457
• Study Type: interventional
• Target: 579
• Locations: 1 country
• Sites: 1

Brief Summary

Our long-term goal is to improve spiritual care outcomes for elderly patients with cancer. The study team will use a spiritual intervention, Dignity Therapy (DT), to help these patients maintain pride, find spiritual comfort, enhance continuity of self, and ultimately make meaning of their life threatening illness.

Conditions

Cancer Terminal

Outcome Measures

Primary Outcomes (1)

• Dignity Impact Scale

  Our primary outcome measure is a 7-item Dignity Impact Scale. The items are scored on a 5-point scale from 'strongly disagree' (1) to 'strongly agree' (5). The scores can range from 7 to 35 with higher scores representing better outcome.

  5 weeks

Secondary Outcomes (4)

• Preparation

  5 weeks

• Completion

  5 weeks

• Peaceful Awareness

  5 weeks

• Treatment Preference

  5 weeks

Study Arms (3)

usual outpatient palliative care

ACTIVE COMPARATOR

During the usual care steps, patients will receive usual outpatient palliative care

Behavioral: Usual care

Dignity Therapy - Nurse Led

EXPERIMENTAL

During the experimental steps as part of routine palliative care service delivery, patients receive nurse-led DT.

Behavioral: Dignity Therapy - Nurse Led

Dignity Therapy - Chaplain Led

EXPERIMENTAL

During the experimental steps as part of routine palliative care service delivery, patients will receive chaplain-led DT.

Behavioral: Dignity Therapy - Chaplain Led

Interventions

Dignity Therapy - Nurse Led BEHAVIORAL

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 - Nurse Led

Usual care BEHAVIORAL

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.

usual outpatient palliative care

Dignity Therapy - Chaplain Led BEHAVIORAL

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.

Dignity Therapy - Chaplain Led

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• cancer diagnosis (receiving cancer therapy or cancer control care)
• receiving outpatient palliative care
• age 55 years or older
• able to speak and read English
• 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 \[4-6 weeks\]).

You may not qualify if:

• legally blind
• cognitively unable to complete study measures (Mini Mental Status Exam \[MMSE\] does not correctly spell the word world backwards)
• history of psychosis (medical record review)
• 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)
• 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)
• are participating in another psychosocial intervention study that is focused on concepts similar to the proposed study.

Sponsors & Collaborators

• University of Florida: lead
• National Cancer Institute (NCI): collaborator
• Northwestern University: collaborator
• Rush University: collaborator
• Emory University: collaborator
• M.D. Anderson Cancer Center: collaborator
• University of California, San Francisco: collaborator
• Healthcare Chaplaincy: collaborator

Study Sites (1)

University of Florida

Gainesville, Florida, 32611, United States

Location

Related Publications (16)

• 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.

  PMID: 30379798 BACKGROUND

• 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.

  PMID: 29793345 BACKGROUND

• 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.

  PMID: 30994466 BACKGROUND

• 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.

  PMID: 33760658 RESULT

• 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.

  PMID: 33557587 RESULT

• 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.

  PMID: 33926243 RESULT

• 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.

  PMID: 34036932 RESULT

• 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.

  PMID: 33984462 RESULT

• 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.

  PMID: 35713352 RESULT

• 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.

  PMID: 34332045 RESULT

• 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.

  PMID: 35016670 RESULT

• 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.

  PMID: 36190483 RESULT

• 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.

  PMID: 36067074 RESULT

• 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.

  PMID: 37565429 RESULT

• 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.

  PMID: 37676977 RESULT

• 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.

  PMID: 38602809 DERIVED

Limitations and Caveats

Our loss to follow up was 22%, which was within our projected 20% to 30% attrition rate, but still may have unknown effects on validity of study findings. Our sample was intentionally focused on older adults with cancer. The recruited sample overrepresented the population with at least some college education and did not adequately represent the male or racial and ethnic minority populations. Future research is needed to determine the generalizability of DT.

Results Point of Contact

• Title: Dr. Diana Wilkie
• Organization: University of Florida

diwilkie@ufl.edu

352-273-6401

Study Officials

• Diana J Wilkie, PhD

  University of Florida

  PRINCIPAL INVESTIGATOR

• Tammi Quest, MD

  Emory University

  STUDY DIRECTOR

• George Fitchett, PhD

  Rush University

  PRINCIPAL INVESTIGATOR

• Michael Rabow, MD

  University of California, San Francisco

  STUDY DIRECTOR

• Linda Emanuel, MD/PhD

  Northwestern University

  PRINCIPAL INVESTIGATOR

• Marvin Delgado, MD

  MD Anderson

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: a 6-site, pre/posttest, randomized, controlled 4-step, stepped-wedge design to compare the effects of usual outpatient palliative care (arm 1) and usual outpatient palliative care along with nurse-led (arm 2) or chaplain-led (arm 3) DT on patient outcomes and palliative care processes. The study team will assign the 6 sites to usual care during the first-step period (approximately 12 months), and randomly assign 2 sites per step to begin and continue DT during each of the next 3 steps (12 months each).

Study Record Dates

• First Submitted: June 26, 2017
• First Posted: July 6, 2017
• Study Start: July 26, 2017
• Primary Completion: August 31, 2022
• Study Completion: August 31, 2022
• Last Updated: April 4, 2024
• Results First Posted: April 4, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)