Clinical trial · Interventional
A Pilot Study of Structured Palliative Care for Patients Enrolled on Phase I Clinical Trials
- 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)
The goal of this research study is to find out if providing patients who are enrolled in phase 1 clinical trials with structured supportive care will enable them to continue in the Phase 1 trial longer and improve their quality of life by reducing or treating side effects and by providing emotional and social support to the patient and family. The structured supportive or palliative care intervention will be provided by a team of trained specialists which include doctors, nurses, social workers and spiritual care providers. The supportive care team will provide treatment to address symptoms, such as pain or anxiety, caused by the cancer itself or from the treatment. The team can make referrals to other specialists. Such as psychologists or nutritionist, if needed, and can help arrange for services to address home care needs.
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 | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Standard supportive care | Behavioral | — | UNRESOLVED |
| Structured palliative care | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Standard Supportive Care
- interventionNames
- Behavioral: Standard supportive care
- type
- EXPERIMENTAL
- label
- Structured Supportive Care
- interventionNames
- Behavioral: Structured palliative care
Primary outcomes (5)
- measure
- Average total MSAS score
- timeFrame
- Up to 6 months
- description
- Assessment of patient burden
- measure
- Average total FACT-G score
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Patient Inclusion Criteria: * Patients must be enrolled in a Phase 1 clinical trial and be within 2 weeks of starting the experimental therapy or intervention. * Patients are eligible to enroll on this study with or without the enrollment of their caregiver. Patient Exclusion Criteria: * Patients diagnosed with a hematologic malignancy. Caregiver Inclusion Criteria: * Any caregiver is considered eligible for this study; The caregiver is the person identified by the patient as the one who provides the most regular physical and/or emotional support. * Caregivers must be willing to complete surveys at baseline and on monthly basis. Caregiver Exclusion Criteria: * Caregivers who are solely professional, paid caregivers
References
Publications (1)
- DERIVEDTreasure M, Daly B, Cao S, Fu P, Hong A, Weinstein E, Surdam J, Meropol NJ, Dowlati A. A randomized controlled trial of structured palliative care versus standard supportive care for patients enrolled in phase 1 clinical trials. Cancer Med. 2021 Jul;10(13):4312-4321. doi: 10.1002/cam4.3971. Epub 2021 May 25. PMID 34033228