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Lafayette, Colorado
Recruiting
Mobile Health for Adherence in Breast Cancer Patients
PRIMARY OBJECTIVE: I. To compare CDK4/6 inhibitors (CDK4/6i) adherence at 12 months after completion of the baseline survey captured using electronic monitoring between the EUC (Arm A) and CONCURxP (Arm B) arms. SECONDARY OBJECTIVES: I. To compare CDK4/6i adherence at 12 months after completion of the baseline survey captured through self-report between the EUC (Arm A) and CONCURxP (Arm B) arms. II. To compare CDK4/6i persistence at 12 months after completion of the baseline survey captured using electronic monitoring between the EUC (Arm A) and CONCURxP (Arm B) arms. III. To compare symptom burden at 12 months between the EUC (Arm A) and CONCURxP (Arm B) arms. IV. To compare quality of life at 12 months between the EUC (Arm A) and CONCURxP (Arm B) arms. V. To compare patient-provider communication at 12 months between the EUC (Arm A) and CONCURxP (Arm B) arms. VI. To compare self-efficacy for managing symptoms at 12 months between the EUC (Arm A) and CONCURxP (Arm B) arms. VII. To compare financial worry at 12 months between the EUC (Arm A) and CONCURxP (Arm B) arms. EXPLORATORY OBJECTIVES: I. To assess longitudinal changes of patient-reported outcomes (self reported adherence, symptom burden, quality of life, and financial worry) from the EUC (Arm A) and CONCURxP (Arm B) arms. II. To compare healthcare utilization at 12 months between the EUC (Arm A) and CONCURxP (Arm B) arms. III. To compare progression-free survival at 12 months between the EUC (Arm A) and CONCURxP (Arm B) arms. IV. To compare overall survival at 12 months between the EUC (Arm A) and CONCURxP (Arm B) arms. V. To describe CONCURxP (Arm B) patients and their provider experience with various implementation outcomes. OUTLINE: Patients are randomized into 1 of 2 arms. Non-patient participants are assigned to arm C. ARM A: Patients use the WiseBag medication dispenser and receive access to educational materials every 4 weeks over 12 months. ARM B: Patients use the WiseBag medication dispenser and receive personalized text message reminders, medication tracking and healthcare provider follow ups as part of the CONCURxP platform over 12 months. Patients may complete an interview over 20-30 minutes within 6 months of study completion. ARM C: Participants complete an interview over 20-30 minutes 15-39 months post-first patient enrollment. After completion of study intervention, patients may be followed up to 6 months.
Phase
N/ASpan
184 weeksSponsor
ECOG-ACRIN Cancer Research GroupLafayette, Colorado
Recruiting
Healthy Volunteers
Pembrolizumab vs. Observation in People With Triple-negative Breast Cancer Who Had a Pathologic Complete Response After Chemotherapy Plus Pembrolizumab
PRIMARY OBJECTIVES: I. To evaluate whether observation results in a non-inferior recurrence-free survival (RFS) compared to adjuvant pembrolizumab in early-stage triple-negative breast cancer (TNBC) patients who achieve a pathologic complete response (pCR) after neoadjuvant chemotherapy with pembrolizumab. II. To compare quality of life (QOL) at approximately 27 weeks as assessed by the Functional Assessment of Cancer Therapy-Breast (FACT-B) Trial Outcome Index between patients randomized to adjuvant pembrolizumab versus observation. (Quality of Life) III. To assess the social value of de-escalation of adjuvant breast cancer immunotherapy at approximately 27 weeks and, by modeling, over a lifetime. (Value of Care) SECONDARY OBJECTIVES: I. To evaluate whether observation compared to adjuvant pembrolizumab impacts the following: Ia. RFS by stage at presentation and by receipt of prior anthracycline therapy; Ib. Adverse event rate: difference in Grade 3 or higher adverse event rates overall and Grade 3 or higher immune-related adverse events (irAEs) rates; Ic. Overall Survival (OS); Id. Locoregional recurrence (LRR both isolated LRR as first events and LRR events simultaneous with DM); Ie. RFS, LRR, OS, adverse events, and QOL by age (=< 45, 46-65, and > 65), race, and ethnicity; If. Adverse events related to receipt of radiotherapy. II. To assess the value of de-escalation of breast cancer immunotherapy from the payer perspective at approximately 27 weeks and, by modelling, over a lifetime. (Value of Care) III. To compare patient out-of-pocket costs at approximately 27 weeks between patients randomized to adjuvant pembrolizumab versus observation. (Value of Care) IV. To compare financial toxicity at approximately 27 weeks between patients randomized to adjuvant pembrolizumab versus observation. (Value of Care) V. To compare work/productivity impairment at approximately 27 weeks between patients randomized to adjuvant pembrolizumab versus observation. (Value of Care) EXPLORATORY OBJECTIVES: I. To describe trajectories of QOL over time among patients randomized to adjuvant pembrolizumab versus (vs.) observation. (Quality of Life) II. To compare various QOL domains after approximately 27 weeks as assessed by the 5 subscales of the FACT-B Index between patients randomized to adjuvant pembrolizumab versus observation. (Quality of Life) III. To compare self-reported symptomatic adverse events at approximately 27 weeks assessed by the patient reported outcome Common Terminology Criteria for Adverse Events (PRO-CTCAE) between patients randomized to adjuvant pembrolizumab versus observation. (Quality of Life) IV. To describe trajectories of financial toxicity and work/productivity impairment over time from baseline to approximately 27 weeks among patients randomized to adjuvant pembrolizumab versus observation. (Value of Care) V. To develop and assess a measure of value from the patient perspective at approximately 27 weeks. (Value of Care) OUTLINE: Patients are randomized to 1 of 2 arms after completing neoadjuvant chemotherapy in combination with pembrolizumab, followed by definitive breast surgery. ARM I (PEMBROLIZUMAB): Patients receive pembrolizumab intravenously (IV) on study. Patients also undergo tumor biopsy on study, and collection of blood on study and during follow-up. ARM II (OBSERVATION): Patients undergo observation on study. Patients also undergo tumor biopsy on study, and collection of blood on study and during follow-up.
Phase
3Span
520 weeksSponsor
Alliance for Clinical Trials in OncologyLafayette, Colorado
Recruiting
MFOLFIRINOX Versus MFOLFOX with or Without Nivolumab for the Treatment of Advanced, Unresectable, or Metastatic HER2 Negative Esophageal, Gastroesophageal Junction, and Gastric Adenocarcinoma
PRIMARY OBJECTIVE: I. To determine if overall survival (OS) is improved in patients who received mFOLFIRINOX +/- nivolumab in comparison to FOLFOX +/- nivolumab as first-line chemotherapy for metastatic gastroesophageal adenocarcinoma. SECONDARY OBJECTIVES: I. To compare other indices of efficacy, including progression-free survival, objective response rates and duration of response between both treatment arms. II. To evaluate safety and tolerability associated with treatment in each of the treatment arms. III. To evaluate the proportion of patients receiving second line of therapy in both arms. IV. To evaluate tolerability of the treatment in both arms using Patient Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE). EXPLORATORY OBJECTIVES: I. Exploratory correlative markers will also be measured and evaluated within and between arms to better assess mechanisms and prognostic impact of markers on impact. These will include baseline PD-L1 combined positive score (CPS) and cell free deoxyribonucleic acid (cfDNA) before and after treatment. II. To evaluate and assess the feasibility and compliance associated with not centrally collecting perceived attribution of protocol treatment to reported adverse events. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients receive fluorouracil intravenously (IV), leucovorin calcium IV, oxaliplatin IV, and irinotecan IV on study and nivolumab IV as clinically indicated. Patients undergo magnetic resonance imaging (MRI) and a computed tomography (CT) scan throughout the trial. Patients may also undergo blood sample collection on study. ARM II: Patients receive fluorouracil IV, leucovorin calcium IV, and oxaliplatin IV on study and nivolumab IV as clinically indicated. Patients undergo MRI and a CT scan throughout the trial. Patients may also undergo blood sample collection on study.
Phase
3Span
302 weeksSponsor
Alliance for Clinical Trials in OncologyLafayette, Colorado
Recruiting
Ramucirumab Plus Pembrolizumab vs Usual Care for Treatment of Stage IV or Recurrent Non-Small Cell Lung Cancer Following Immunotherapy, Pragmatica-Lung Study
PRIMARY OBJECTIVE: I. To compare overall survival (OS) in participants previously treated with platinum-based chemotherapy and immunotherapy for stage IV or recurrent non-small cell lung cancer (NSCLC) randomized to pembrolizumab and ramucirumab versus standard of care. SECONDARY OBJECTIVE: I. To summarize reports of serious and unexpected high-grade (>= grade 3) treatment-related adverse events determined by the treating physician within each treatment arm. OUTLINE: Patients are randomized to 1 of 2 arms. ARM A: Patients receive chemotherapy per standard of care on study. ARM B: Patients receive ramucirumab intravenously (IV) and pembrolizumab IV on study.
Phase
3Span
262 weeksSponsor
SWOG Cancer Research NetworkLafayette, Colorado
Recruiting
Comparing High-Dose Cisplatin Every Three Weeks to Low-Dose Cisplatin Weekly When Combined With Radiation for Patients With Advanced Head and Neck Cancer
PRIMARY OBJECTIVES: I. To determine whether radiation with low-dose cisplatin weekly is superior in terms of acute toxicity, as measured by the T-scores (TAME method), to radiation with high-dose cisplatin every 3 weeks for patients with locoregionally advanced squamous cell carcinoma of the head and neck (SCCHN). (Phase II) II. To determine whether radiation with low-dose cisplatin weekly is non-inferior to radiation with high-dose cisplatin every 3 weeks in terms of overall survival (OS) for patients with locoregionally advanced SCCHN. (Phase III) III. To determine whether radiation with low-dose cisplatin weekly is superior in terms of acute toxicity, as measured by the T-scores (TAME method), to radiation with high-dose cisplatin every 3 weeks for patients with locoregionally advanced SCCHN. (Phase III) SECONDARY OBJECTIVES: I. To assess and compare progression-free survival (PFS) between arms. II. To assess and compare locoregional failure and distant metastasis between arms . III. To assess acute and late toxicity (Common Terminology Criteria for Adverse Events [CTCAE] version 5.0). IV. To assess patient-reported outcomes quality of life (PRO/QOL), as measured by the Functional Assessment of Cancer Therapy-Head and Neck (FACT-H&N) (primary PRO), between arms. V. To assess hearing loss, as measured by audiograms and the modified TUNE grading scale between arms. VI. To assess hearing loss, as measured by speech audiometry Consonant-Nucleus-Consonant word scores and tympanometry (subject to the modified TUNE grading scale testing results; otherwise, it will be an exploratory objective). VII. To assess hearing-related QOL as measured by the Hearing Handicap Inventory-Screening (HHIA-S) (secondary PRO), between arms. EXPLORATORY OBJECTIVE: I. To collect blood and tissue specimens for future translational science studies. For instance, to examine how germline and somatic genetic variants, such as TP53, CDKN2A, PIK3CA, PTEN, NFE2L2, and KEAP1, may influence cisplatin-related efficacy and toxicity, and to assess the effect of regular nonsteroidal anti-inflammatory drugs (NSAIDs) use and genomic activation of PIK3CA (mutation or amplification) or loss of PTEN, the negative regulator of PI3K, on disease-free survival or overall survival. OUTLINE: Patients are assigned to 1 of 2 groups. GROUP I (NON-OROPHARYNGEAL CANCER [OPC]/p16-NEGATIVE OPC): Patients are randomized to 1 of 2 arms. ARM I: Patients undergo radiation therapy over 5 fractions a week for a total of 33-35 fractions in the absence of disease progression or unacceptable toxicity. Patients also receive high-dose cisplatin intravenously (IV) once every 3 weeks (Q3W) (on days 1, 22, and 43) during radiation therapy in the absence of disease progression or unacceptable toxicity. ARM II: Patients undergo radiation therapy over 5 fractions a week for a total of 33-35 fractions in the absence of disease progression or unacceptable toxicity. Patients also receive low-dose cisplatin IV once a week (QW) during radiation therapy in the absence of disease progression or unacceptable toxicity. GROUP II (p16-POSITIVE OPC/CANCER OF UNKNOWN PRIMARY [CUP]): Patients are randomized to 1 of 2 arms. ARM III: Patients undergo radiation therapy over 5 fractions a week for a total of 33-35 fractions in the absence of disease progression or unacceptable toxicity. Patients also receive high-dose cisplatin IV Q3W (on days 1, 22, and 43) during radiation therapy in the absence of disease progression or unacceptable toxicity. ARM IV: Patients undergo radiation therapy over 5 fractions a week for a total of 33-35 fractions in the absence of disease progression or unacceptable toxicity. Patients also receive low-dose cisplatin IV QW during radiation therapy in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 1 month, every 3 months during year 1-2, every 6 months during year 3-5, then annually thereafter.
Phase
2/3Span
746 weeksSponsor
NRG OncologyLafayette, Colorado
Recruiting
Financial Navigation Program to Improve Understanding and Management of Financial Aspects of Cancer Care for Patients and Their Spouses
PRIMARY OBJECTIVE: I. To determine whether a proactive financial navigation program for patients planning to receive anti-cancer treatment decreases the risk of material household financial hardship over 12 months among patients with newly diagnosed or recurrent metastatic solid tumor, or a newly diagnosed hematologic malignancy. SECONDARY OBJECTIVES: I. To examine whether proactive financial navigation improves patient quality of life. II. To examine whether proactive financial navigation decreases financial worry among patients relative to usual care and explore the extent to which financial worry correlates with financial hardship. III. To explore whether the proactive financial navigation intervention leads to decreased cost-related medication non-adherence and fewer patient emergency department (ED) visits and unplanned hospital admissions. ADDITIONAL OBJECTIVES: I. To explore the impact of proactive financial navigation on spouse/partner caregiver financial hardship, quality of life, and caregiver burden and evaluate the concordance between patient and caregiver credit data. II. To explore the utilization of financial navigation services by younger, financially fragile, and lower income patients and households and evaluate the moderator effect of age, financial fragility, and income on the impact of the proactive financial navigation intervention. OUTLINE: Patients are randomized to 1 of 2 groups. GROUP I: Patients receive financial literacy training consisting of watching online educational videos over 2-8 minutes. Patients also complete questionnaires over 30-60 minutes about education, employment, finances (assets, debt), insurance, and quality of life (financial worry) and have credit reports assessed at baseline and 3, 6, and 12 months. GROUP II: Patients receive financial literacy training consisting of watching online educational videos over 2-8 minutes. Patients also meet with Consumer Education and Training Services (CENTS) counselor and Patient Advocate Foundation (PAF) case manager over approximately 1 hour every month for 6 months (with each group). Patients also complete questionnaires over 30-60 minutes about education, employment, finances (assets, debt), insurance, and quality of life (financial worry) and have credit reports assessed at baseline and 3, 6, and 12 months. Spouse/partner caregiver participation is optional. If a spouse/partner caregiver is participating in the trial along with the patient. If participating, the spouse/partner caregiver receives the same intervention as the patient and will complete questionnaires and have credit reports assessed at baseline and 3, 6, and 12 months. SAMPLE SIZE: Study participants include both patients and optional spouse/partner caregivers. Study enrollment targets are based entirely on patients, but the anticipated number of participants includes both groups. We expect to enroll 326 patients and approximately 196 spouse/partner caregivers for a total of 522 anticipated participants, but the study will be closed to accrual when the patient accrual target of 326 is reached, regardless of the number of participating spouse/partner caregivers.
Phase
N/ASpan
260 weeksSponsor
SWOG Cancer Research NetworkLafayette, Colorado
Recruiting
Healthy Volunteers
S1501 Carvedilol in Preventing Cardiac Toxicity in Patients With Metastatic HER-2-Positive Breast Cancer
PRIMARY OBJECTIVES: I. To assess whether prophylactic beta blocker therapy with carvedilol compared with no intervention reduces the risk of subsequent cardiac dysfunction in patients with metastatic breast cancer receiving trastuzumab?based HER-2 targeted therapy. SECONDARY OBJECTIVES: I. To assess whether prophylactic beta blocker therapy with carvedilol compared with no intervention reduces the risk of predefined subsequent cardiac events in patients with metastatic breast cancer receiving trastuzumab?based HER-2 targeted therapy. II. To evaluate if prophylactic carvedilol compared with no intervention results in a longer time to first interruption of trastuzumab?based HER-2 targeted therapy due to either cardiac dysfunction or events. III. To assess whether prophylactic beta blocker therapy with carvedilol compared with no intervention reduces the risk of subsequent cardiac dysfunction OR events in this population. IV. To establish and prospectively collect a predefined panel of baseline core cardiovascular measures and develop a predictive model of cardiac dysfunction. V. To evaluate the rate of cardiac dysfunction in an observational arm consisting of individuals otherwise eligible for the study except for use of beta blockers, angiotensin receptor blocker (ARB), or angiotensin converting enzyme (ACE) inhibitors for other medical reasons. TERTIARY OBJECTIVES: I. To evaluate the isoleucine (lle) 655 valine (Val) and and alanine (Ala)ll70 proline (Pro) single nucleotide polymorphisms (SNPs) of the HER-2 gene as a predictive biomarker of study-defined cardiac dysfunction. II. To evaluate plasma neuregulin-1 at baseline and over study time as a predictive biomarker of study-defined cardiac dysfunction. III. To evaluate the feasibility of performing serial left ventricular strain in a National Clinical Trials Network (NCTN) group setting, with the goal of 75% of patients contributing both a baseline and at least one follow-up strain measurement. IV. To bank blood for future translational medicine studies such as brain natriuretic peptide (BNP), additional SNPs, and high sensitivity troponin. OUTLINE: Patients are randomized to 1 of 2 arms. Patients taking beta blocker, ARB, or ACE inhibitor at registration are assigned to Arm III. ARM I: Patients not taking beta blocker, ARB, or ACE inhibitor at registration receive carvedilol orally (PO) twice daily (BID). Courses repeat every 12 weeks for 108 weeks in the absence of disease progression or unacceptable toxicity. ARM II: Patients not taking beta blocker, ARB, or ACE inhibitor at registration receive no study intervention for up to 108 weeks. ARM III: Patients undergo observation for up to 108 weeks. After completion of study, patients are followed up for up to 108 weeks.
Phase
3Span
635 weeksSponsor
SWOG Cancer Research NetworkLafayette, Colorado
Recruiting
Comparing Brief Behavioral Therapy (BBT-CI) and Healthy Eating Education Learning (HEAL) for Cancer-Related Sleep Problems While Receiving Chemotherapy
PRIMARY OBJECTIVE: I. Determine the efficacy of BBT-CI compared to HEAL for treating insomnia as measured by the Insomnia Severity Index (ISI) at post-intervention. SECONDARY OBJECTIVE: I. Determine the efficacy of BBT-CI compared to HEAL for improving sleep efficiency as measured via actigraphy at post-intervention. MECHANISTIC OBJECTIVES: I. Examine the efficacy of BBT-CI compared to HEAL for regulating circadian rhythms as measured via actigraphy (i.e., Mesor, Acrophase, Amplitude, I<O dichotomy index). EXPLORATORY OBJECTIVES: I. Examine potential moderators of BBT-CI effects on insomnia (ISI). II. Examine potential mediators of BBT-CI effects on insomnia (ISI). III. Determine the efficacy of BBT-CI compared to HEAL for treating insomnia as measured by the Insomnia Severity Index at the 6-month follow-up. IV. Determine the efficacy of BBT-CI compared to HEAL for improving sleep efficiency as measured via actigraphy at the 6-month follow-up. OUTLINE: Patients are randomized to 1 of 2 groups. GROUP I (BBT-CI): Patients complete face to face/video sessions with a trained staff member. Patients also complete phone sessions. GROUP II (HEAL): Patients complete face to face/video sessions with a trained staff member. Patients also complete phone sessions. After completion of study, patients are followed for up to 6 months.
Phase
3Span
314 weeksSponsor
University of Rochester NCORP Research BaseLafayette, Colorado
Recruiting
Letrozole With or Without Paclitaxel and Carboplatin in Treating Patients With Stage II-IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
PRIMARY OBJECTIVE: I. To examine if letrozole monotherapy/maintenance (L/L) is non-inferior to intravenous (IV) paclitaxel/carboplatin and maintenance letrozole (CT/L) with respect to progression-free survival (PFS) in women with stage II-IV primary low-grade serous carcinoma of the ovary or peritoneum after primary surgical cytoreduction. SECONDARY OBJECTIVES: I. To compare the nature, frequency and maximum degree of toxicity as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0 for each treatment arm. II. To compare the relative frequency of objective tumor response in those with measurable disease after cytoreductive surgery for each treatment arm. III. To compare overall survival for each treatment arm. IV. To compare the CT/L and L/L arms with respect to patients' adherence to letrozole therapy as measured by pill counts. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients receive paclitaxel IV over 3 hours and carboplatin IV on day 1. Cycles repeat every 21 days for up to 6 cycles. Patients then receive letrozole orally (PO) once daily (QD) in the absence of disease progression or unacceptable toxicity. Patients undergo blood collection and tumor biopsy during screening as well as medical imaging throughout the study. ARM II: Patients receive letrozole PO QD. Cycles repeat every 21 days for up to 6 cycles. Patients then receive letrozole orally PO QD in the absence of disease progression or unacceptable toxicity as maintenance therapy. Patients undergo blood collection and tumor biopsy during screening as well as medical imaging throughout the study. After completion of study treatment/intervention, patients/participants are followed up every 3 months for 1 year, then every 6 months for 3 years, then annually thereafter.
Phase
3Span
437 weeksSponsor
NRG OncologyLafayette, Colorado
Recruiting