Cancer
Conditions
Keywords
Palliative Care, Supportive Care, Caregiver, Phase I
Brief summary
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.
Detailed description
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: 1. To compare adverse event profiles, duration on study, and quality of life between patients who receive structured palliative care and those receiving standard supportive care. 2. To compare caregiver burden and quality of life between the study arms.
Interventions
BEHAVIORALStructured palliative care
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.
BEHAVIORALStandard supportive care
Supportive care for the patient and caregiver will be provided by the treating oncologist.
Sponsors
Case Comprehensive Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Average total MSAS score | Up to 6 months | Assessment of patient burden |
| Adverse events | Up to 6 months | 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 |
| Duration on Study | Up to 6 months | 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 |
| Reason for study discontinuation (Patient reported outcome) | Up to 6 months | Measure of central tendency for why patients discontinued the phase I study. Patient reported outcomes for reason for study discontinuation will be qualitatively assessed |
| Average total FACT-G score | Up to 6 months | Measure patient quality of life |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean number of hours of palliative care services | Up to 6 months | Mean number of hours utilized by patients and caregivers who received structured palliative care. This analysis will be descriptive, reporting measures of central tendency |
| Type of palliative care services | Up to 6 months | 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Average days on study | Up to 6 months | — |
| Change in QOLLTI-F score | From baseline to last contact, up to 6 months | 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 |
| Change in CRA score | From baseline to last contact, up to 6 months | Change in caregiver burden when compared to baseline between those who received structured palliative care and those who received standard supportive care |
| Change in MSAS score | From baseline to last contact, up to 6 months | Change in quality of life when compared to baseline between patients who received structured palliative care and those who received standard supportive care |
| Change in FACT-G score | From baseline to last contact, 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 |
| Frequency of adverse events of patients receiving structured and usual supportive care | Up to 6 months | — |
Countries
United States
Outcome results
None listed