A Multicomponent Support Program to Enhance Quality of Life in Chinese Cancer Patients and Survivors (MSP-CCS): Pilot Optimization Trial and Implementation Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 64
- 试验地点
- 7
- 主要终点
- Proportion of eligible participants who enroll in the trial.
研究概览
简要总结
The purpose of this study is to evaluate different combinations of cancer education sessions, counseling sessions, and peer support meetings developed for Chinese cancer patients and survivors. The researchers will look at whether the combinations are practical and effective, and how they impact participants' quality of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 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
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with cancer (any type/stage) (per EMR for MSK patients or self-report for external participants) within the last 5 years
- •Age ≥ 18 years (per EMR for MSK patients or self-report for external participants)
- •Self-Report Criteria:
- •Of Chinese descent
- •Speaks Mandarin "well" or "very well"
- •Moderately low HRQOL (<70 FACT-G score)4, 48
- •Resides in New York or New Jersey
- •Agrees to participate via telehealth (video or phone)
- •Agrees to be audio-recorded
排除标准
- •Self-Report Criteria:
- •Per PI determination, requires a higher level of care for current passive or active suicidal ideation than current protocol is able to provide. If a participant receives a score of > 0 on item 9 of the PHQ-9,5 they will be referred to study PI for further evaluation using the Columbia-Suicide Severity Rating Scale. They will be excluded from participation in this study if there is presence of suicidal risk, determined by affirmative response(s) on the Columbia-Suicide Severity Rating Scale (C-SSRS)
- •Too ill to participate determined by the question: "Do you feel too ill to participate because of communication problems, uncontrollable pain, or other symptoms that prevent you from participating?"
- •Cognitive impairment (Montreal Cognitive Assessment 5 Minute - telephone version with a score < 12)
- •Per consenting professional determination, unable to understand the informed consent procedure
- •Participation in study #14-076: Adaptation of Individual Meaning-Centered Psychotherapy for Chinese immigrant cancer patients)
- •Currently receiving/have received psychotherapy/counseling/peer support within the last 6 months (patients being treated solely with psychotropic medications will not be excluded if they are not receiving psychotherapy/counseling/peer support)
研究组 & 干预措施
4 - Cancer Education + Enhanced Standard Care
All participants will also receive cancer information materials and resources. Cancer education sessions, will have 3 weekly sessions.
干预措施: Enhanced Standard Care (Other)
1 - Cancer Education + Meaning-Centered Counseling + Peer Support + Enhanced Standard Care
All participants will also receive cancer information materials and resources. Cancer education sessions, will have 3 weekly sessions.Counseling sessions, will have 3 weekly sessions. Peer support meetings, will have 3 monthly meetings.
干预措施: Cancer Education (Other)
1 - Cancer Education + Meaning-Centered Counseling + Peer Support + Enhanced Standard Care
All participants will also receive cancer information materials and resources. Cancer education sessions, will have 3 weekly sessions.Counseling sessions, will have 3 weekly sessions. Peer support meetings, will have 3 monthly meetings.
干预措施: Meaning-Centered Counseling (Other)
1 - Cancer Education + Meaning-Centered Counseling + Peer Support + Enhanced Standard Care
All participants will also receive cancer information materials and resources. Cancer education sessions, will have 3 weekly sessions.Counseling sessions, will have 3 weekly sessions. Peer support meetings, will have 3 monthly meetings.
干预措施: Peer Support (Other)
2 - Cancer Education + Meaning-Centered Counseling + Enhanced Standard Care
All participants will also receive cancer information materials and resources. Cancer education sessions, will have 3 weekly sessions.Counseling sessions, will have 3 weekly sessions.
干预措施: Enhanced Standard Care (Other)
5 - Meaning-Centered Counseling + Peer Support + Enhanced Standard Care
All participants will also receive cancer information materials and resources.Counseling sessions, will have 3 weekly sessions. Peer support meetings, will have 3 monthly meetings
干预措施: Meaning-Centered Counseling (Other)
5 - Meaning-Centered Counseling + Peer Support + Enhanced Standard Care
All participants will also receive cancer information materials and resources.Counseling sessions, will have 3 weekly sessions. Peer support meetings, will have 3 monthly meetings
干预措施: Enhanced Standard Care (Other)
5 - Meaning-Centered Counseling + Peer Support + Enhanced Standard Care
All participants will also receive cancer information materials and resources.Counseling sessions, will have 3 weekly sessions. Peer support meetings, will have 3 monthly meetings
干预措施: Peer Support (Other)
1 - Cancer Education + Meaning-Centered Counseling + Peer Support + Enhanced Standard Care
All participants will also receive cancer information materials and resources. Cancer education sessions, will have 3 weekly sessions.Counseling sessions, will have 3 weekly sessions. Peer support meetings, will have 3 monthly meetings.
干预措施: Enhanced Standard Care (Other)
2 - Cancer Education + Meaning-Centered Counseling + Enhanced Standard Care
All participants will also receive cancer information materials and resources. Cancer education sessions, will have 3 weekly sessions.Counseling sessions, will have 3 weekly sessions.
干预措施: Cancer Education (Other)
2 - Cancer Education + Meaning-Centered Counseling + Enhanced Standard Care
All participants will also receive cancer information materials and resources. Cancer education sessions, will have 3 weekly sessions.Counseling sessions, will have 3 weekly sessions.
干预措施: Meaning-Centered Counseling (Other)
3 - Cancer Education + Peer Support + Enhanced Standard Care
All participants will also receive cancer information materials and resources. Cancer education sessions, will have 3 weekly sessions. Peer support meetings, will have 3 monthly meetings.
干预措施: Cancer Education (Other)
3 - Cancer Education + Peer Support + Enhanced Standard Care
All participants will also receive cancer information materials and resources. Cancer education sessions, will have 3 weekly sessions. Peer support meetings, will have 3 monthly meetings.
干预措施: Peer Support (Other)
3 - Cancer Education + Peer Support + Enhanced Standard Care
All participants will also receive cancer information materials and resources. Cancer education sessions, will have 3 weekly sessions. Peer support meetings, will have 3 monthly meetings.
干预措施: Enhanced Standard Care (Other)
4 - Cancer Education + Enhanced Standard Care
All participants will also receive cancer information materials and resources. Cancer education sessions, will have 3 weekly sessions.
干预措施: Cancer Education (Other)
6 - Meaning-Centered Counseling- + Enhanced Standard Care
All participants will also receive cancer information materials and resources. Counseling sessions, will have 3 weekly sessions.
干预措施: Meaning-Centered Counseling (Other)
6 - Meaning-Centered Counseling- + Enhanced Standard Care
All participants will also receive cancer information materials and resources. Counseling sessions, will have 3 weekly sessions.
干预措施: Enhanced Standard Care (Other)
7 - Peer Support + Enhanced Standard Care
All participants will also receive cancer information materials and resources. Peer support meetings, will have 3 monthly meetings
干预措施: Peer Support (Other)
7 - Peer Support + Enhanced Standard Care
All participants will also receive cancer information materials and resources. Peer support meetings, will have 3 monthly meetings
干预措施: Enhanced Standard Care (Other)
8 - Enhanced Standard Care
All participants will also receive cancer information materials and resources.
干预措施: Enhanced Standard Care (Other)
结局指标
主要结局
Proportion of eligible participants who enroll in the trial.
时间窗: 2 years
Proportion of participants who complete treatment
时间窗: 24 weeks
Pproportion of assessments that are completed, with completion defined as submitting the 24-week assessment with a minimum of the FACT-G completed.
次要结局
未报告次要终点