Evaluating In Home Cancer Therapy Versus In Clinic Cancer Therapy in Black Men With Locally Advanced, Biochemically Recurrent and Metastatic Prostate Cancer

Официальное название

A Phase 2 Pragmatic Clinical Trial to Evaluate Administration of Cancer Therapy in the Patients' Homes Versus in Clinic in Black Men With Advanced or Metastatic Prostate Cancer

Обзор

This phase II trial evaluates the impact of cancer therapy in the patients' home compared to in the clinic on safety, side effects, patient preference, and satisfaction in Black men with prostate cancer that has spread to nearby tissue or lymph nodes (locally advanced), that has increasing prostate-specific antigen after treatment (biochemically recurrent) or that has spread from where it first started (primary site) to other places in the body (metastatic). Typically drug-related cancer care is conducted at a medical center which causes patients to have to spend considerable time away from family, friends, and familiar surroundings. This separation may add to the physical, emotional, social, and financial burden for patients and their families during this difficult time in their lives. Therapy administered to a patient in the patients' residence in the comfort of familiar surrounding using Cancer Connected Access and Remote Expertise (CARE) Beyond Walls (CCBW) may help reduce psychological and financial distress, increase access to care and improve treatment compliance. Giving cancer therapy in the home compared in the clinic may be safe, tolerable and improve patient satisfaction with overall cancer care in Black men with locally advanced, biochemically recurrent or metastatic prostate cancer.

Подробное описание

PRIMARY OBJECTIVES:

I. To establish patient-centeredness by comparing patient ratings of their overall cancer care experience in the clinic versus in the home.

II. To establish patient-centeredness by evaluating patient preferences regarding the location of cancer treatment delivery.

SAFETY OBJECTIVES:

I. To assess the safety of home administered intravenous (IV)/subcutaneous (SQ) drug treatment by a home health provider with remote patient monitoring and Command Center support as measured by the incidence of grade 3+ adverse events at least possibly related to cancer treatment delivery.

II. To describe the incidence of acute care visits, emergency room visits, and hospitalizations during the entire study treatment period and by location of cancer treatment delivery (i.e., during in-clinic cancer treatment versus at-home cancer treatment).

III. To describe the incidence of avoidable (in the opinion of the treating physician) acute care visits, emergency room visits, and hospitalizations during at-home cancer treatment.

SECONDARY OBJECTIVE:

I. To evaluate the impact of home cancer treatment delivery on patient-reported function and global health/quality of life, patient-reported symptoms, satisfaction, and clinical outcomes.

EXPLORATORY OBJECTIVES:

I. To summarize patient perceptions and reasons for patient preferences regarding the location of cancer treatment delivery.

II. To describe overall survival. III. To assess the cost outcomes related to patient treatment in the clinic or in the home.

OUTLINE:

Patients receive standard of care treatment in the clinic for 6-12 weeks then receive treatment in the home with CCBW for 12-24 weeks in the absence of disease progression or unacceptable toxicity. Patients receive any remaining treatment in the clinic.

Вмешательства

• Препарат Cancer Therapeutic Procedure
  Given standard of care cancer treatment in clinic
• Препарат Cancer Therapeutic Procedure
  Given standard of care cancer treatment in home
• Другое Health Care Delivery
  Receive in home cancer treatment with CCBW
• Другое Questionnaire Administration
  Ancillary studies

Первичные конечные точки

• Patient rating of overall cancer care experience - CAHPS [Срок оценки: Up to 48 weeks]
• Patient preferences regarding the location of cancer treatment delivery [Срок оценки: Up to 48 weeks]
• Incidence of grade 3+ adverse events (AEs) [Срок оценки: Up to 30 days after last dose of study treatment]
• Acute care visits, emergency room visits, and hospitalizations [Срок оценки: Up to 48 weeks]
• Avoidable acute care visits, emergency room visits and hospitalizations [Срок оценки: Up to 48 weeks]

Вторичные конечные точки (5)

• Patient-reported function and global health status/quality of life [Срок оценки: Up to 48 weeks]
• Patient-reported symptoms as measured by Patient Reported Outcomes (PRO)-CTCAE [Срок оценки: Up to 48 weeks]
• Patient-reported symptoms as measured by Functional Assessment of Cancer Therapy General Population 5 (FACT GP5) [Срок оценки: Up to 48 weeks.]
• Patient Satisfaction and Feedback Questionnaire [Срок оценки: Up to 48 weeks]
• Patient satisfaction - Was It Worth It Questionnaire [Срок оценки: Up to 48 weeks]

Критерии участия

Критерии включения

• Age ≥ 18 years
• Participant must be receiving a standard-of-care treatment regimen listed in this protocol that is being used in accordance with standard medical practice. Specifically, it must be either a) FDA-approved for the participant's disease indication, or b) recommended in nationally recognized professional guidelines (e.g., NCCN, ASCO, ASH, etc.) as standard of care for the disease indication. Off-label use is permitted only if supported by such guidelines
• Black or African American male patients with locally advanced, high risk, biochemical recurrent, or metastatic prostate cancer who are currently receiving or planning to start treatment with one or more of the eligible regimens. Patients may be on any combination of these regimens, provided that at least one is administered by a home health nurse \[co-administration with second generation antiandrogens, poly adenosine diphosphate-ribose polymerase (PARP) inhibitors, oral gonadotrophin releasing hormone (GnRh) antagonists, estrogens, or older antiandrogens are allowed but combinations of oral regimens only are not permitted\]

• Androgen deprivation therapy (ADT):

• Leuprolide intramuscular (IM) or subcutaneous (SQ), 4 or 12 weeks cycle length
• Degarelix SQ, 4 weeks cycle length
• Chemotherapy: Cabazitaxel IV, 3 weeks cycle length
• Immunotherapy: Pembrolizumab IV, 3 weeks cycle length
• Bone modifying agent + any of the prostate cancer treatments:

• Zoledronic acid IV, 4 or 12 weeks cycle length
• Denosumab SQ, 4 or 12 weeks cycle length
• Patients who are anticipated to continue the treatment regimen they are currently prescribed for at least 18 weeks following registration (if on chemotherapy or immunotherapy) or 24 weeks following registration (for all other treatment regimens)
• Residing within the area serviced by supplier
• Provide written informed consent
• Willing and able to comply with the study protocol in the investigator's judgement
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, or 2 for patients on any qualifying treatment (tx) regimen; ECOG PS 0, 1, 2, or 3 for patients on ADT with or without second generation antiandrogen
• Ability to complete questionnaire(s) by themselves or with assistance
• Willingness to follow birth control requirements for males of reproductive potential

Критерии исключения

• Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm
• Current inpatient hospitalization (excluding admission to the Advanced Care at Home program)
• Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
• Uncontrolled intercurrent illness including, but not limited to:

• Ongoing or active infection
• Symptomatic congestive heart failure
• Unstable angina pectoris
• Cardiac arrhythmia
• Myocardial infarction ≤ 6 months
• Wound healing disorder
• Or psychiatric illness/social situations that would limit compliance with study requirements
• Patients with any severe infection within 4 weeks prior to registration including, but not limited to, hospitalization for complications of infections should not be enrolled in the trial (in the current situation, this also applies to patients with suspected or confirmed COVID-19 infection)
• Anticipation of the need for major surgery during the course of study treatment

• Note: Concomitant radiation therapy during the study period is allowed
• Not cleared for treatment in home via social stability screening
• Patients who received at home treatment through involvement in another CCBW trial

• Note: Patients who enrolled in another CCBW trial but had to be withdrawn prior to initiating treatment in the home would still be eligible

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Mayo Clinic in Florida — Jacksonville

Идентификаторы

NCT: NCT07073794 · MC240507 · NCI-2025-04662 · 24-010825 · MC240507 · W81XWH-24-1-1106

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗