A Pilot Study of Structured Palliative Care for Patients Enrolled on Phase I Clinical Trials

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

132 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-25

Study Completion Date

2019-01-10

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Palliative Care Intervention in Improving Symptom Control and Quality of Life in Patients With Stage II-IV Non-small Cell Lung Cancer and Their Family Caregivers

NCT02243748

Caregiver Psychological Impact of Cancer and Its Treatment Recurrent Non-small Cell Lung Cancer +5 more

COMPLETED NA

Comparing Optimized Models of Primary And Specialist Services for Palliative Care: Pilot Feasibility Trial

NCT06629142

Seriously Ill Hospitalized Patients

COMPLETED NA

Family Caregiver Palliative Care Intervention in Supporting Caregivers of Patients With Stage II-IV Gastrointestinal, Gynecologic, Urologic and Lung Cancers

NCT01846520

Healthy Subject Localized Transitional Cell Cancer of the Renal Pelvis and Ureter Metastatic Transitional Cell Cancer of the Renal Pelvis and Ureter +81 more

COMPLETED NA

Building Family Caregiver Skills Using a Simulation-Based Intervention for Care of Cancer Patients

NCT04055948

Cancer

COMPLETED NA

Palliative Care Intervention in Patients With Solid Tumors Participating in Phase I Clinical Trials

NCT01612598

Unspecified Adult Solid Tumor, Protocol Specific

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Standard Supportive Care

Group Type ACTIVE_COMPARATOR

Standard supportive care

Intervention Type BEHAVIORAL

Supportive care for the patient and caregiver will be provided by the treating oncologist.

Structured Supportive Care

Group Type EXPERIMENTAL

Structured palliative care

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Structured 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.

Intervention Type BEHAVIORAL

Standard supportive care

Supportive care for the patient and caregiver will be provided by the treating oncologist.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

* 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.