Piloting Single Session Consultation for Cancer (SSC-C) to Alleviate Distress Among Breast Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 26
- 试验地点
- 14
- 主要终点
- Acceptability (SSC-C participants)
研究概览
简要总结
The purpose of this study is to see if a Single Counseling Session for Cancer can help reduce psychosocial distress and improve quality of life in people with breast cancer who are waiting to receive ongoing counseling services (outpatient psychotherapy services). The Single Counseling Session for Cancer-which I will refer to as the "study counseling" during this call-is a one-session, 60-minute counseling program designed to reduce anxiety and depression symptoms in people with cancer who are waiting to receive outpatient psychotherapy services. The researchers will look at whether the study counseling is effective in participants and practical (feasible) for them to complete.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patient must have pathologically confirmed breast cancer (per EMR).
- •Patient with localized or advanced cancer (per EMR).
- •Patient is on a waitlist of at least 2 weeks or more for MSK Counseling Center intake and will not complete a New Visit with a clinical psychologist prior to intervention (these patients will be replaced) (per EMR, patient's care team, or self-report)
- •Has not had and is not scheduled to have an appointment with an MSK psychiatrist or MSK Counseling Center advanced practice provider (per EMR, patient's care team, or self-report)
- •Female (per EMR)
- •Age ≥ 18 (per EMR)
- •English fluency - Per self-report: How well do you speak English?
- •Agrees to be audio-recorded (per self-report) NOTE: Participants who report Very well are considered fluent.
- •Lives in New York, New Jersey, Connecticut, or Florida (per self-report).
- •Has no significant psychiatric disturbance sufficient to preclude completion of the assessment measures, interview, or informed consent (i.e., acute psychiatric symptoms which require urgent or extended individual treatment) (per EMR, patient's care team, or study team).
- •Has no presence of cognitive impairment disorder (i.e., delirium, dementia, or traumatic brain injury) sufficient to preclude meaningful informed consent and/or data collection (per EMR, patient's care team, study team, or per self-report of BOMC cognitive test).
- •Has no current active or passive suicidal ideation ((per EMR, patient's care team, study team, per item 9 of the PHQ-9, or the CSSRS).
排除标准
- 未提供
研究组 & 干预措施
SSC-C - Single Session Consultation for Cancer
will receive the study counseling
干预措施: Single Counseling Session (Behavioral)
PPSB - Psychosocial Patient Support Booklet
will receive an American Cancer Society booklet for review (and no counseling)
干预措施: American Cancer Society booklet (Other)
结局指标
主要结局
Acceptability (SSC-C participants)
时间窗: up to 3 months
Participants will complete a satisfaction survey after completing the SSC-C intervention. A 5-item, investigator- initiated, face-valid satisfaction survey will assess the degree with which participant found SSC-C helpful in developing an action plan to address their concerns, their perceived utility of the action plan, the degree with which they believe they will use the action plan, their motivation to do so, and the extent to which they will recommend SSC-C to other patients.
Acceptability (PPSB participants)
时间窗: up to 3 months
Participants will complete a satisfaction survey after receiving PPSB intervention materials. A 6-item, investigator- initiated, face-valid satisfaction survey will assess the degree with which participants found PPSB intervention helpful in developing an action plan to address their concerns, their perceived utility of the booklet, the degree with which they believe they will use the booklet, their motivation to do so, and the extent to which they will recommend the booklet materials to other patients.
Acceptability (SSC-C participants)
时间窗: up to 3 months
Participants will complete a satisfaction survey after completing the SSC-C intervention. A 5-item, investigator- initiated, face-valid satisfaction survey will assess the degree with which participant found SSC-C helpful in developing an action plan to address their concerns, their perceived utility of the action plan, the degree with which they believe they will use the action plan, their motivation to do so, and the extent to which they will recommend SSC-C to other patients.
Acceptability (PPSB participants)
时间窗: up to 3 months
Participants will complete a satisfaction survey after receiving PPSB intervention materials. A 6-item, investigator- initiated, face-valid satisfaction survey will assess the degree with which participants found PPSB intervention helpful in developing an action plan to address their concerns, their perceived utility of the booklet, the degree with which they believe they will use the booklet, their motivation to do so, and the extent to which they will recommend the booklet materials to other patients.
次要结局
- Psychosocial distress(up to 3 months)
- Psychosocial distress(up to 3 months)