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Completed

NCT Number: NCT03209440

Palliative Care for Elderly Outpatients

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.

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Key information

Conditions

Cancer Terminal

Age range

55 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Florida

Gainesville, Florida, 32611, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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]).

Exclusion criteria

  • 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.

Treatment and study plan

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.

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.

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.

Primary outcomes

  1. Dignity Impact Scale

    Time frame: 5 weeks

    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.

Secondary outcomes

  1. Preparation

    Time frame: 5 weeks

    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.

  2. Completion

    Time frame: 5 weeks

    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.

  3. Peaceful Awareness

    Time frame: 5 weeks

    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.

  4. Treatment Preference

    Time frame: 5 weeks

    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.

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Collaborators

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

Registry information

Important dates

Study start
2017
Primary completion
2022
Study completion
2022
First posted
Jul 6, 2017
Registry last updated
Apr 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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