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Palliative Care for Elderly Outpatients

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ClinicalTrials.gov Identifier: NCT03209440
Recruitment Status : Recruiting
First Posted : July 6, 2017
Last Update Posted : July 28, 2021
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Northwestern University
Rush University
Emory University
M.D. Anderson Cancer Center
University of California, San Francisco
Healthcare Chaplaincy
Information provided by (Responsible Party):
University of Florida

Tracking Information
First Submitted Date  ICMJE June 26, 2017
First Posted Date  ICMJE July 6, 2017
Last Update Posted Date July 28, 2021
Actual Study Start Date  ICMJE July 26, 2017
Estimated Primary Completion Date August 31, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 5, 2017)
  • Compare usual care and usual care with nurse-led groups [ Time Frame: 5 weeks ]
    patient outcome (dignity impact). 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 Cronbach's α from a preliminary study was .85. Scores ranged from 7-35 in the DT group and 5-29 in the usual care group and showed sensitivity to DT effects at posttest with an effect size of 0.7; it was not measured at pretest, but we will do to increase power and potential for inferences.
  • Compare usual care and usual care with chaplain-led DT groups [ Time Frame: 5 weeks ]
    patient outcome (dignity impact). 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 Cronbach's α from a preliminary study was .85. Scores ranged from 7-35 in the DT group and 5-29 in the usual care group and showed sensitivity to DT effects at posttest with an effect size of 0.7; it was not measured at pretest, but we will do to increase power and potential for inferences. We have two outcomes because we are testing two interventions and will use appropriate statistical approach to avoid multiplicity.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 5, 2017)
  • Usual care compared with usual care with nurse-led groups - QUAL-E [ Time Frame: 5 weeks ]
    QUAL-E, its 4-item Preparation subscale rated on a 5 point scale
  • Usual care compared with usual care with chaplain-led DT groups - QUAL-E [ Time Frame: 5 weeks ]
    QUAL-E, its 4-item Preparation subscale rated on a 5 point scale
  • Usual care compared with usual care with nurse-led groups - Peace [ Time Frame: 5 weeks ]
    The PEACE questionnaire is a valid and reliable measure of Peaceful Acceptance and Struggle with Illness. Scores are associated with some choices for end of life care among patients with advanced cancer.
  • Usual care compared with usual care with chaplain-led DT groups - Peace [ Time Frame: 5 weeks ]
    The PEACE questionnaire is a valid and reliable measure of Peaceful Acceptance and Struggle with Illness. Scores are associated with some choices for end of life care among patients with advanced cancer.
  • Usual care compared with usual care with nurse-led groups - H-CAP-S [ Time Frame: 5 weeks ]
    Hypothetical Advanced Care Planning Scenario (H-CAP-S)
  • Usual care compared with usual care with chaplain-led DT groups - H-CAP-S [ Time Frame: 5 weeks ]
    Hypothetical Advanced Care Planning Scenario (H-CAP-S)
  • Usual care compared with usual care with nurse-led groups - Patient satisfaction [ Time Frame: 5 weeks ]
    Patient satisfaction. 7-item measure of Patient Satisfaction with Nurse or Chaplain Care
  • Usual care compared with usual care with chaplain-led DT groups - Patient satisfaction [ Time Frame: 5 weeks ]
    Patient satisfaction. 7-item measure of Patient Satisfaction with Nurse or Chaplain Care
  • Usual care compared with usual care with nurse-led groups -spiritual needs [ Time Frame: 5 weeks ]
    Unmet spiritual needs. 14-item Religious/Spiritual Struggle.
  • Usual care compared with usual care with chaplain-led DT groups -spiritual needs [ Time Frame: 5 weeks ]
    Unmet spiritual needs. 14-item Religious/Spiritual Struggle.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Palliative Care for Elderly Outpatients
Official Title  ICMJE Palliative Care for Elderly Outpatients
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.
Detailed 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Intervention Model Description:
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).
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Cancer Terminal
Intervention  ICMJE
  • 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.
  • Behavioral: 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.
  • Behavioral: 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.
Study Arms  ICMJE
  • Active Comparator: usual outpatient palliative care
    During the usual care steps, patients will receive usual outpatient palliative care
    Intervention: Behavioral: Usual care
  • Experimental: Dignity Therapy - Nurse Led
    During the experimental steps as part of routine palliative care service delivery, patients receive nurse-led DT.
    Intervention: Behavioral: Dignity Therapy - Nurse Led
  • Experimental: Dignity Therapy - Chaplain Led
    During the experimental steps as part of routine palliative care service delivery, patients will receive chaplain-led DT.
    Intervention: Behavioral: Dignity Therapy - Chaplain Led
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 27, 2018)
120
Original Estimated Enrollment  ICMJE
 (submitted: July 5, 2017)
700
Estimated Study Completion Date  ICMJE August 31, 2022
Estimated Primary Completion Date August 31, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 55 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Diana J Wilkie, PhD 352-273-6401 diwilkie@ufl.edu
Contact: Yingwei Yao, PhD (352) 273-6524 y.yao@ufl.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03209440
Other Study ID Numbers  ICMJE IRB201601190-N
1R01CA200867-01A1 ( U.S. NIH Grant/Contract )
OCR17893 ( Other Identifier: UF OnCore )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University of Florida
Study Sponsor  ICMJE University of Florida
Collaborators  ICMJE
  • National Cancer Institute (NCI)
  • Northwestern University
  • Rush University
  • Emory University
  • M.D. Anderson Cancer Center
  • University of California, San Francisco
  • Healthcare Chaplaincy
Investigators  ICMJE
Principal Investigator: Diana J Wilkie, PhD University of Florida
Study Director: Tammi Quest, MD Emory University
Principal Investigator: George Fitchett, PhD Rush University
Study Director: Michael Rabow, MD University of California, San Francisco
Principal Investigator: Linda Emanuel, MD/PhD Northwestern University
Study Director: Marvin Delgado, MD MD Anderson
PRS Account University of Florida
Verification Date July 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP