Evaluating the Impact of Proactive Palliative Care in Patients Initiating Phase I Targeted or Immune-Based Cancer Therapeutics: A Randomized Controlled Trial

Memorial Sloan Kettering Cancer Center1 site in 1 country83 target enrollmentSeptember 7, 2018

ConditionsMetastatic Solid Tumor Cancers Locally Advanced Solid Tumor Cancers

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Metastatic Solid Tumor Cancers
Sponsor: Memorial Sloan Kettering Cancer Center
Enrollment: 83
Locations: 1
Primary Endpoint: patients' expectations for therapeutic benefit
Status: Active, not recruiting
Last Updated: 6 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This study will test whether adding personalized supportive care to medical treatment on a clinical trial affects the study participants' ability and desire to discuss their symptoms, their concerns about the future, and their approach to coping with cancer. The effects of supportive care on participants' responses to questions about these topics will be compared with those of other study participants who are being treated for cancer in a clinical trial, but are not receiving personalized supportive care.

Registry

clinicaltrials.gov

Start Date

September 7, 2018

End Date

September 1, 2026

Last Updated

6 months ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Memorial Sloan Kettering Cancer Center

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Patients with disease progression on at least one standard chemotherapy regimen, and now eligible and consented to begin Phase I, Phase I/Ib, Phase I/II and non-randomized Phase II (including basket studies) investigational targeted and immune-based therapeutics in MSK medical oncology, EDD, or ITC clinics
•Able to speak, read, and understand English well enough to complete study assessments in the judgment of the consenting professional
•18 years of age and older
•Has a progressive or metastatic solid tumor cancer with MSK pathology confirmation at the primary or metastatic anatomic site

Exclusion Criteria

•Patients who already are receiving specialty supportive care (already referred for a supportive care consultation) prior to enrollment in a Phase I protocol.
•Patients will be excluded if the Phase I, Phase I/Ib, Phase I/II or Phase II trial involves known active drugs in combination with experimental drugs, in which the patient has not previously received the known active drug or active drugs of the same class. For example, a patient with metastatic pancreatic cancer who has not received gemcitabine/nab-paclitaxel, but enrolls on a study that tests an experimental drug in addition to gemcitabine/nab-paclitaxel, will be excluded.
•Significant psychiatric or cognitive disturbance in the primary clinician"s or investigator"s judgment, to preclude providing informed consent or participating in the interventions (i.e. acute psychiatric symptoms which require individual treatment)

Outcomes

Primary Outcomes

patients' expectations for therapeutic benefit

Time Frame: 3 months

using the CanCORS Expectations Survey, which will assess, on a 4-point Likert-type scale, patients' expectations for therapeutic benefit after talking with their doctors about their experimental drug