Clinical trial · Interventional
Palliative Care for Elderly Outpatients
NCT03209440CI-TRIAL-00075743completedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer Terminal | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Dignity Therapy - Chaplain Led | Behavioral | — | UNRESOLVED |
| Dignity Therapy - Nurse Led | Behavioral | — | UNRESOLVED |
| Usual care | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- ACTIVE_COMPARATOR
- label
- usual outpatient palliative care
- description
- During the usual care steps, patients will receive usual outpatient palliative care
- interventionNames
- Behavioral: Usual care
- type
- EXPERIMENTAL
- label
- Dignity Therapy - Nurse Led
- description
- During the experimental steps as part of routine palliative care service delivery, patients receive nurse-led DT.
- interventionNames
- Behavioral: Dignity Therapy - Nurse Led
- type
- EXPERIMENTAL
- label
- Dignity Therapy - Chaplain Led
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 55 Years
Show eligibility criteria text
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.
References
Publications (16)
- BACKGROUNDScarton 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. PMID 30379798
- BACKGROUNDScarton 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. PMID 29793345
- BACKGROUNDKittelson 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. PMID 30994466
- RESULTO'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 Med. 2021 Aug;24(8):1174-1182. doi: 10.1089/jpm.2020.0542. Epub 2021 Mar 23. PMID 33760658
- RESULTSamuels 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 Study on Dignity Therapy. Am J Hosp Palliat Care. 2021 Dec;38(12):1503-1508. doi: 10.1177/1049909121994309. Epub 2021 Feb 9. PMID 33557587
- RESULTBluck 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. doi: 10.1177/10499091211011712. Epub 2021 Apr 29.