NCT01742143招募中不适用
A Randomized Controlled Trial of the Impact of ICCAN on Cancer Treatment Completion and Quality of Life
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 347
- 试验地点
- 21
- 主要终点
- Treatment completion/adherence
研究概览
简要总结
The purpose of this study is to see if the ICCAN program is working, and to compare the ICCAN program to the standard hospital services provided in New York City hospitals, like meeting with a Social Worker or a Patient Navigator (a person who provides personal hospital guidance).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 21 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant Inclusion Criteria:
- •Patient is eligible if he/she is
- •fluent in English, Spanish, or Mandarin
- •between the ages of 21-80 years old
- •cancer patients currently receiving chemotherapy (started within the past month) and/or radiation therapy (started within the past week), or
- •scheduled to begin chemotherapy and/or radiation therapy within the next 2 months (excluding surgery only patients)
- •planning on remaining in the area for at least 1 year
- •Clinician is eligible if he/she:
- •Has an MD or DO degree
- •Is the treating physician providing care to a patient enrolled to the study
- •ICCAN-IO Phase 1: Refinement, participant is eligible if he/she per EMR or self-report:
- •Is 18 - 85 years of age
- •Has unresectable locally advanced, locally recurrent unresectable, metastatic, or high risk/early stage TNBC or stage I-IV lung cancer
- •Eligible for FDA approved immunotherapy in the NYC metropolitan area (per self-report or per MSK patient EMR records).
- •Is treated in the NY metropolitan area
- •Self-identifies as Black or Hispanic, and/or is low-SES (low SES will be defined as household income < 200% of federal poverty level)
- •Has English or Spanish proficiency
- •Agrees to be audio-recorded
- •ICCAN-IO Phase 2: Pilot RCT, participant is eligible if he/she per EMR or self-report:
- •Is 18 - 85 years of age
- •Has stage II-III TNBC
- •Treated at MSK Manhattan or OneMSK regional sites
- •Self identifies as Black or Hispanic, and/or is low SES (low SES will be defined as household income < 200% of federal poverty level)
- •Has English or Spanish proficiency
- •Agrees to be audio-recorded
- •ICCAN-IO process evaluation study team participants only:
- •Staff member who serves as an Access Facilitator
- •Agrees to be audio-recorded
- •Over the age of 18 (per EMR)
- •Diagnosed with Glioblastoma (per EMR)
- •Has not yet started radiation and concurrent temozolomide treatment (per EMR)
- •Has a primary neuro-oncologist at MSK (per EMR)
- •Will be undergoing radiation at MSK (per EMR)
- •Treatment plan consists of a 6-week or 3-week (hypofractionated) course of radiation and chemotherapy (per EMR)
- •Participant or caregiver is fluent in English or Spanish
- •Planning on remaining in the tri-state area during the 6 weeks or 3 weeks of radiation and chemotherapy (per self-report)
- •Screens positive on SDOH screening tool, referred by the clinical team through traditional screening tools for SDOH assistance (per EMR or self-report), demonstrates financial need per MSK guidelines (up to 500% of the federal poverty limit), and/or requests help with SDOH resources or navigation
- •Participant
排除标准
- •Patient is ineligible if he/she is:
- •Diagnosed with Stage IV disease
- •Presence of untreated psychiatric disturbance (i.e. acute psychiatric symptoms which require individual treatment) and/or cognitive impairment disorder (e.g., delirium or dementia) verified by medical record sufficient to preclude completion of the assessment measures, interview or informed consent
- •Has another family member already enrolled in ICCAN (as determined by patient report)
- •ICCAN-IO Phase 1: Refinement, participant is ineligible if he/she per EMR or self-report:
- •Presence of untreated psychiatric disturbance (e.g., acute psychiatric symptoms which require individual treatment) and/or cognitive impairment disorder (e.g., delirium or dementia) sufficient to preclude completion of the assessment measures, interview or informed consent
- •Participants or family members who are participating in MSK IHCD studies related to social determinants of health
- •ICCAN-IO Phase 2: Pilot RCT, participant is ineligible if he/she per EMR or self-report:
- •Presence of untreated psychiatric disturbance (e.g, acute psychiatric symptoms which require individual treatment) and/or cognitive impairment disorder (e.g., delirium or dementia) sufficient to preclude completion of the assessment measures, interview or informed consent
- •Participants or family members who are participating in MSK IHCD studies related to social determinants of health at the PI's discretion
- •No recurrences - must be newly diagnosed glioblastoma (per EMR)
- •Patients undergoing different treatment regimens from the 15 fraction/3 week or 30 fraction/6 week course of radiation (i.e. patients undergoing 10 fractions of palliative radiation due to poor functional status) (per EMR)
- •Presence of untreated psychiatric disturbance (i.e. acute psychiatric symptoms that require individual treatment) (per EMR or self-report)
- •Severe cognitive impairment or fluent aphasia as not to understand the assessment measures, interview, or informed consent, without a health care proxy or caregiver that can assist as indicated by clinician or per judgement of study staff. Completion of assessments with the help of caregivers is acceptable. (per EMR or self-report)
- •Has another family member or household member already enrolled in ICCAN (per self-report)
- •Already participated in or already completed the ICCAN program (per self-report)
研究组 & 干预措施
Phase II, Arm 2: ICCAN-IO
Arm 2 will consist of everything in Arm 1
干预措施: The Integrated Cancer Care Access Network (ICCAN) (Behavioral)
Phase I: Refinement
10 Black, Hispanic, and/or low-SES patients with TNBC (5 Spanish-speaking), will be recruited from MSK
干预措施: The Integrated Cancer Care Access Network (ICCAN) (Behavioral)
Phase II, Arm 1: Usual and Customary Care (U&C)
Participants in this group will receive the same referrals on social and economic resources as ICCAN group.
干预措施: Usual and Customary Group (U&C) (Behavioral)
结局指标
主要结局
Treatment completion/adherence
时间窗: 1 year
The primary outcome, cancer treatment completion, will be determined by chart review at 3, 6, and 12 months after enrollment.
次要结局
- Quality of life(1 year)
研究者
研究点 (21)
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