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临床试验/NCT06037954
NCT06037954招募中不适用

Mental Health Care Initiation Intervention for Older Adults With Cancer

Memorial Sloan Kettering Cancer Center1 个研究点 分布在 1 个国家目标入组 130 人开始时间: 2023年9月7日最近更新:
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
130
试验地点
1
主要终点
Refusal rates

研究概览

简要总结

The purpose of this study is to look at mental health services for adults with depressed mood who were diagnosed with cancer at the age of 65 or older. This study will compare the usual approach for connecting older adults with depressed mood to mental health services with the Open Door for Cancer (OD-C) approach. We will find out if the OD-C approach is practical and useful for cancer patients who participate in the intervention and for providers who see or treat cancer patients.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • Per medical record and/or self-report, diagnosed with breast, colorectal, lung, or prostate cancer at age 65 years or older
  • Per medical record and/or self-report, undergoing active cancer treatment (e.g., radiation, chemotherapy, immunotherapy, surgery) or within six months of completing treatment
  • Score of ≥5 on the Patient Health Questionnaire-9 (PHQ-9)
  • Per self-report, fluent in English** ** Language verification: Prior to enrollment, patients will be asked the following two questions by a Clinical Research Coordinator (CRC) to verify English fluency necessary for participation in the study:
  • How well do you speak English? (must respond "very well" or "well" when given the choices of Very well, Well, Not well, Not at all, Don't know, or Refused)
  • What is your preferred language for healthcare? (must respond English)
  • Per self-report, works in oncology, nursing, social work, psychology, or psychiatry
  • Per self-report, currently works in oncology at least 50% of the time
  • Per self-report, provided cancer care for at least three years at time of consent
  • Per self-report, fluent in English

排除标准

  • Severely cognitively impaired as demonstrated by Blessed Orientation Memory Concentration scores of ≥ 11
  • Per research staff judgment and/or self-report, too ill or weak to complete study procedures
  • Per medical record and/or self-report, receiving hospice care at the time of enrollment
  • Per medical record and/or self-report, currently enrolled in mental health treatment

研究组 & 干预措施

Open Door for Cancer (OD-C)

Experimental

OD-C includes five components delivered in three 30-minute telephone or videoconference visits over six weeks and one booster telephone call. All sessions are audio-recorded.

干预措施: 30-minute telephone or videoconference sessions (Other)

Usual Care

Active Comparator

Participants assigned to Usual Care (n=50) will receive standard care. MSK's current usual care for distress screening is that all patients are screened for distress when they initiate care at MSK. Additional distress screening is conducted based on the determination of the oncology team. In addition, patients are referred to social work, psychology, and/or psychiatry based on the judgment of the oncology team.

干预措施: Questionnaires (Other)

Usual Care

Active Comparator

Participants assigned to Usual Care (n=50) will receive standard care. MSK's current usual care for distress screening is that all patients are screened for distress when they initiate care at MSK. Additional distress screening is conducted based on the determination of the oncology team. In addition, patients are referred to social work, psychology, and/or psychiatry based on the judgment of the oncology team.

干预措施: Interviews (Other)

结局指标

主要结局

Refusal rates

时间窗: 2 years

≥75% of eligible patients enroll in the study

Attrition rates

时间窗: 2 years

≥80% of patients who enroll complete all study procedures

次要结局

  • Treatment satisfaction(2 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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