N/A
N=142
Palliative Care for Elderly Outpatients
Cancer Terminal
Bottom Line
View on ClinicalTrials.gov: NCT03209440 ↗Enrolled (actual)
142
Serious AEs
0.0%
Results posted
Apr 2024
Primary outcome: Primary: Dignity Impact Scale — 26.3; 26.2; 26.2 score on a scale — p=0.02
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Dignity Therapy - Nurse Led (Behavioral); Usual care (Behavioral); Dignity Therapy - Chaplain Led (Behavioral)
- Age
- Adult, Older Adult · 55+ yrs
- Sex
- All
- Sponsor
- University of Florida
- Primary completion
- Aug 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Dignity Impact Scale |
26.3; 26.2; 26.2 | 0.02 sig |
| SECONDARY Preparation |
15.6; 14.7; 14.9 | 0.21 |
| SECONDARY Completion |
27.0; 27.2; 28.2 | 0.21 |
| SECONDARY Peaceful Awareness |
61; 31; 44; 201; 98; 144 | 0.11 |
| SECONDARY Treatment Preference |
24; 15; 11; 91; 44; 45 | 0.05 |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT03209440). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.