Palliative Care for Elderly Outpatients

Cancer Terminal Clinical Trial

Official title:

Palliative Care for Elderly Outpatients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03209440
• Other study ID #: IRB201601190-N
• Secondary ID: 5R01CA200867-05O
• Status: Completed
• Phase: N/A
• Start date: July 26, 2017
• Est. completion date: August 31, 2022

Study information

• Verified date: March 2024
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

The study team propose a 3 arm pre/posttest, RCT with a 4-step (approximately 12 months per step), stepped-wedge design to compare effects of usual outpatient palliative care (usual care) and usual care along with either nurse-led or chaplain-led DT on patient outcomes, cancer prognosis awareness. The study team will assign 6 outpatient palliative care sites to usual care during the first-step, and randomly assign two sites per step to begin and continue DT led by either a nurse or a chaplain during each of the next 3 steps. During the usual care steps, 280 patients will complete pretest measures and satisfaction with palliative spiritual care services, receive usual palliative care, and complete posttest measures. During the experimental steps as part of routine palliative care service delivery, 280 patients will complete pretest measures, receive nurse-led or chaplain-led DT, and complete posttest measures. Using mixed level analysis with site, provider (nurse, chaplain) and time (step) included in the model, the study team will compare the usual care and each of the DT groups for effects on dignity impact, existential tasks, and cancer prognosis awareness and explore the moderating effects of physical symptoms and spiritual distress. The study team will also determine the effect of usual care and DT on the patient's satisfaction with palliative spiritual care services and the report of the patient's unmet spiritual needs.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 579
• Est. completion date: August 31, 2022
• Est. primary completion date: August 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years and older

Eligibility

Inclusion Criteria:

1. cancer diagnosis (receiving cancer therapy or cancer control care)

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:

1. legally blind

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.

Related Conditions & MeSH terms

• Cancer Terminal

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	University of Florida	Gainesville	Florida

Sponsors (8)

Lead Sponsor	Collaborator
University of Florida	Emory University, Healthcare Chaplaincy, M.D. Anderson Cancer Center, National Cancer Institute (NCI), Northwestern University, Rush University, University of California, San Francisco

Country where clinical trial is conducted

United States, 

References & Publications (15)

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 Sup — View Citation

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. — View Citation

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: 10.10 — View Citation

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: — View Citation

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. 202 — View Citation

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. — View Citation

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. — View Citation

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 — View Citation

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. — View Citation

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 — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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):1 — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Preparation	Preparation for death subscale taken from the QUAL-E, a measure designed to evaluate quality of life and to assess the effectiveness of interventions targeted to improve the quality of life at the end of life. Scores range from 4 to 20 with higher scores representing better outcomes.	5 weeks
Secondary	Completion	Life completion subscale taken from the QUAL-E, a measure designed to evaluate quality of life and to assess the effectiveness of interventions targeted to improve the quality of life at the end of life. Scores range from 7 to 35 with higher scores representing better outcomes.	5 weeks
Secondary	Peaceful Awareness	We measured peaceful awareness with the 2 items: terminal illness awareness and peaceful awareness questionnaire. The first focused on terminal illness acknowledgement (TIA) in which patients rated their current health status as 1) relatively healthy, 2) seriously but not terminally ill, or 3) seriously and terminally ill. The second item focused on the frequency of feeling deep inner peace or harmony, which was rated on a 6-point Likert scale ranging from 1) never or almost never to 6) many times a day. Scores of at least 3 on each of the two items defined positive peaceful awareness, a dichotomous measure.	5 weeks
Secondary	Treatment Preference	We measured treatment preferences with a single item from the standardized and validated Hypothetical Advanced Care Planning Scenario (H-CAP-S) that assesses treatment preferences.	5 weeks