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.

Structured palliative care

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

Standard supportive care

Michelle Treasure, MD

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:

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.

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

Change in patient symptom burden when compared to baseline between patients who received structured palliative care and those who received standard supportive care

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 caregiver burden when compared to baseline between those who received structured palliative care and those who received standard supportive care

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

Measure of central tendency for why patients discontinued the phase I study. Patient reported outcomes for reason for study discontinuation will be qualitatively assessed

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

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

Mean number of hours utilized by patients and caregivers who received structured palliative care. This analysis will be descriptive, reporting measures of central tendency

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

Case Comprehensive Cancer Center

Symptoms and General Pathology

All Conditions

Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Rare Diseases

Recurrence

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Carcinoma

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Endocrine System Diseases

Gonadal Disorders

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Ovarian Cancer

Ovarian Epithelial Cancer

Structured palliative care approach, defined as the gynecologic oncology team performing comprehensive symptom assessment with the Quality Data Collection Tool Palliative Care (QDACT-PC) and providing interventions based on National Comprehensive Cancer Network (NCCN) guidelines. Symptom scores above the acceptable threshold in the QDACT-PC tool that occur after two consecutive visits will automatically trigger palliative care consultation.

Structured Palliative Care

Usual care described as current practice by the gynecologic oncology team with referral to PC specialist at provider discretion or at the request of the patient or their families.

Usual Care

Paula S Lee, MD

The purpose of this study is to test the effect of the gynecologic oncologists with palliative care specialist collaboration (GO-PC) intervention on patient quality of life.

Eligible patients include women diagnosed with platinum-resistant ovarian cancer or recurrent ovarian cancer cancer. All patient participants will complete two quality of life (QOL) questionnaires and a cost-diary documenting their health care experience at time of consent and every 12 weeks thereafter. Consenting care givers will also be asked to complete two questionnaires to asses the impact of structured palliative care on them every 12 weeks.

Patients will be assigned to two arms randomly: 1) usual care or 2) structured palliative care. The primary endpoint is quality of life. A two-sided Chi-square test will be used to compare the proportion of patients who have improved quality of life after treatment between control arm and intervention arm. The average value of multiple scores after treatment will be used to compare with the baseline score before treatment for each question in the standard questionnaire.

H.O.P.E: Helping Ovarian Cancer Patients Cope

Pilot Study on H.O.P.E: Helping Ovarian Cancer Patients Cope During Disease Recurrence

A combined FACT-O and FACIT-PAL (version 4)16 will be administered at baseline and 12 week intervals on all subjects. The FACT Measurement System is a validated group of questions that measure health-related QOL in cancer patients. Both questionnaires have identical questions for physical well-being, functional well-being, emotional well-being, and social well-being. The additional subscales of the FACT-O and FACIT-PAL will be combined to provide a comprehensive quality of life assessment specific to ovarian cancer and palliative care.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Pilot Study of Structured Palliative Care for Patients Enrolled on Phase I Clinical Trials	NCT02543541	Cancer	Structured pall... Standard suppor...	18 Years -	Case Comprehensive Cancer Center
H.O.P.E: Helping Ovarian Cancer Patients Cope	NCT02090582	Platinum-resist... Recurrent Ovari... Palliative Care	Structured Pall... Usual Care	18 Years -	Duke University

Spots Global Cancer Trial Database for structured palliative care