Clinical trial · Observational
Symptom Management, Quality of Life and Satisfaction With Care for Advanced Stage Cancers - Control Arm
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Difficulty in recruitment and change in study site protocols.
Summary
Brief summary (as posted)
Symptom Management, Quality of Life and Satisfaction with Care for Advanced Stage Cancers is the first part of a two part study (The Lancaster Cancer Care Model (LCCM) - Non-Concurrent Control Study). The primary aim of the study is to compare the proportion of advanced cancer patients who have a hospitalization or emergency department visit in the last 6 months of life before and after implementation of a new care model that provides more comprehensive symptom management and supportive care, including earlier referral to palliative care. The secondary comparative aim is to assess measures of quality of life and satisfaction in both groups. This current study is to collect data on the control group only. After system redesign, we will open an intervention arm study to collect data after implementation of the new care model (about 18-24 months from start of control phase).
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Standard of care | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Non-concurrent control group
- description
- A group of advanced cancer patients who received care at our Center before implementation of the LCCM model. They will receive current standard of care. This current study is to collect data on the control group only. After system redesign, we will open an intervention arm study to collect data after implementation of the new care model (about 18-24 months from start of control phase).
- interventionNames
- Other: Standard of care
Primary outcomes (1)
- measure
- Frequency of patients' ED visits and hospitalizations
- timeFrame
- Collected at baseline and every 2 months from enrollment until death from any cause or assessed up to 18 months
- description
- All cause: ED admission treat and release, ED admission to inpatient visit and direct inpatient admission
Secondary outcomes (5)
- measure
- Patient quality of life
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Newly diagnosed with a solid tumor-type cancer that is considered either advanced and unresectable or metastatic Exclusion Criteria: * Non-English speaking * Age \< 18
References
Publications (59)
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- BACKGROUNDBaile WF, Lenzi R, Parker PA, Buckman R, Cohen L. Oncologists' attitudes toward and practices in giving bad news: an exploratory study. J Clin Oncol. 2002 Apr 15;20(8):2189-96. doi: 10.1200/JCO.2002.08.004. PMID 11956281
- BACKGROUNDBakitas M, Lyons KD, Hegel MT, Balan S, Brokaw FC, Seville J, Hull JG, Li Z, Tosteson TD, Byock IR, Ahles TA. Effects of a palliative care intervention on clinical outcomes in patients with advanced cancer: the Project ENABLE II randomized controlled trial. JAMA. 2009 Aug 19;302(7):741-9. doi: 10.1001/jama.2009.1198. PMID 19690306
- BACKGROUNDBarnato AE, Llewellyn-Thomas HA, Peters EM, Siminoff L, Collins ED, Barry MJ. Communication and decision making in cancer care: setting research priorities for decision support/patients' decision aids. Med Decis Making. 2007 Sep-Oct;27(5):626-34. doi: 10.1177/0272989X07306788. Epub 2007 Sep 14. PMID 17873249
- BACKGROUNDBrumley RD, Enguidanos S, Cherin DA. Effectiveness of a home-based palliative care program for end-of-life. J Palliat Med. 2003 Oct;6(5):715-24. doi: 10.1089/109662103322515220. PMID 14622451
- BACKGROUNDBrumley R, Enguidanos S, Jamison P, Seitz R, Morgenstern N, Saito S, McIlwane J, Hillary K, Gonzalez J. Increased satisfaction with care and lower costs: results of a randomized trial of in-home palliative care. J Am Geriatr Soc. 2007 Jul;55(7):993-1000. doi: 10.1111/j.1532-5415.2007.01234.x.