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Trial record 3 of 4 for:    8857241 [PUBMED-IDS]

Palliative Care for Elderly Outpatients

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ClinicalTrials.gov Identifier: NCT03209440
Recruitment Status : Recruiting
First Posted : July 6, 2017
Last Update Posted : June 14, 2019
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

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.

Condition or disease Intervention/treatment Phase
Cancer Terminal Behavioral: Dignity Therapy - Nurse Led Behavioral: Usual care Behavioral: Dignity Therapy - Chaplain Led Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
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
Official Title: Palliative Care for Elderly Outpatients
Actual Study Start Date : July 26, 2017
Estimated Primary Completion Date : August 2021
Estimated Study Completion Date : September 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Palliative Care

Arm Intervention/treatment
Active Comparator: usual outpatient palliative care
During the usual care steps, patients will receive usual outpatient palliative care
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.

Experimental: Dignity Therapy - Nurse Led
During the experimental steps as part of routine palliative care service delivery, patients receive nurse-led DT.
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.

Experimental: Dignity Therapy - Chaplain Led
During the experimental steps as part of routine palliative care service delivery, patients will receive chaplain-led DT.
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.




Primary Outcome Measures :
  1. 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.

  2. 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.



Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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.

  4. 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.

  5. 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)

  6. 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)

  7. 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

  8. 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

  9. Usual care compared with usual care with nurse-led groups -spiritual needs [ Time Frame: 5 weeks ]
    Unmet spiritual needs. 14-item Religious/Spiritual Struggle.

  10. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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] <24)
  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03209440


Contacts
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Contact: Diana J Wilkie, PhD 352-273-6401 diwilkie@ufl.edu
Contact: Yingwei Yao, PhD (352) 273-6524 y.yao@ufl.edu

Locations
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United States, Florida
University of Florida Recruiting
Gainesville, Florida, United States, 32611
Sponsors and Collaborators
University of Florida
National Cancer Institute (NCI)
Northwestern University
Rush University
Emory University
M.D. Anderson Cancer Center
University of California, San Francisco
Healthcare Chaplaincy
Investigators
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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

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT03209440     History of Changes
Other Study ID Numbers: IRB201601190-N
1R01CA200867-01A1 ( U.S. NIH Grant/Contract )
OCR17893 ( Other Identifier: UF OnCore )
First Posted: July 6, 2017    Key Record Dates
Last Update Posted: June 14, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No