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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.
Primary Objective(s): To assess symptoms, adverse events, duration on study, reason for study discontinuation, and quality of life among patients participating in phase I clinical trials who receive structured palliative care, and those who receive standard supportive care. Duration on study will serve as the primary objective for sample size determination.
Secondary Objective(s):
1. To describe the quantity (e.g. hours), type, and cost of palliative care personnel services used by patients and caregivers receiving structured palliative care.
Exploratory:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Supportive Care | Active Comparator |
| |
| Structured Supportive Care | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Structured palliative care | Behavioral | Supportive care for the patient and caregiver will be provided by the outpatient palliative care team which includes clinicians with specialized palliative care training, social workers, spiritual care specialists and mental health clinical nurse specialist. |
| Measure | Description | Time Frame |
|---|---|---|
| Average total MSAS score | Assessment of patient burden | Up to 6 months |
| Average total FACT-G score | Measure patient quality of life | Up to 6 months |
| Reason for study discontinuation (Patient reported outcome) | Measure of central tendency for why patients discontinued the phase I study. Patient reported outcomes for reason for study discontinuation will be qualitatively assessed | Up to 6 months |
| Duration on Study | Measure of central tendency of the duration patients were on the phase I study. Duration on study will serve as the primary objective for sample size determination | Up to 6 months |
| Adverse events | Measure of central tendency of adverse events. AE will be described and further categorized as modifiable (primary symptom experience) and non-modifiable (laboratory abnormalities). The influence of adverse events on study outcomes particularly duration on study and reason for study discontinuation will be assessed. An exploratory weighted adverse event score will be calculated using the equation: adverse event score = ∑ (NAE * GAE) where N denotes the adverse event number, G denotes grade, AE denotes adverse event. These scores will be compared between study arms | Up to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Mean number of hours of palliative care services | Mean number of hours utilized by patients and caregivers who received structured palliative care. This analysis will be descriptive, reporting measures of central tendency | Up to 6 months |
| Type of palliative care services |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of adverse events of patients receiving structured and usual supportive care | Up to 6 months | |
| Average days on study | Up to 6 months | |
| Change in FACT-G score |
Patient Inclusion Criteria:
Patient Exclusion Criteria:
Caregiver Inclusion Criteria:
Caregiver Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michelle Treasure, MD | Metrohealth Medical Center and Case Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Case Comprehensive Cancer Center | Cleveland | Ohio | 44106 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34033228 | Derived | Treasure 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. |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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|
| Standard supportive care | Behavioral | Supportive care for the patient and caregiver will be provided by the treating oncologist. |
|
Measure of central tendency for the type of palliative care services utilized by patients and caregivers who received structured palliative care. This analysis will be descriptive, reporting measures of central tendency |
| Up to 6 months |
Change in patient symptom burden when compared to baseline between patients who received structured palliative care and those who received standard supportive care |
| From baseline to last contact, up to 6 months |
| Change in MSAS score | Change in quality of life when compared to baseline between patients who received structured palliative care and those who received standard supportive care | From baseline to last contact, up to 6 months |
| Change in CRA score | Change in caregiver burden when compared to baseline between those who received structured palliative care and those who received standard supportive care | From baseline to last contact, up to 6 months |
| Change in QOLLTI-F score | Change in caregiver quality of life as assessed through change in QOLLTI-F score when compared to baseline between those who received structured palliative care and those who received standard supportive care | From baseline to last contact, up to 6 months |