Training in Evidence-based Treatments in Psycho-Oncology
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 115
- 试验地点
- 1
- 主要终点
- Evidence-Based Treatment Acceptability
研究概览
简要总结
The goal of this research study is to train psychotherapists to administer individualized evidence-based psychotherapies in a cancer care setting to patients and caregivers with elevated levels of distress.
The intervention will mirror clinical care in psycho-oncology in which the therapist, collaboratively with their supervisor, will choose specific components of the following evidence-based treatments to administer based on the clinical presentation of the patient or caregiver and referring problem.
- Cognitive Behavioral Therapy (CBT)
- Acceptance Commitment Therapy (ACT)
- Mindfulness-Based Cognitive Therapy (MBCT)
- Mindfulness-Based Stress Reduction (MBSR)
- Meaning-Centered Psychotherapy (MCP)
- Cognitive Behavioral Therapy for Insomnia (CBT-I)
- CBT for other cancer-related physical symptoms like pain, fatigue, and nausea.
Participation in this research study is expected to last about 26 weeks.
It is expected that about 75 patients, 25 caregivers, and 15 therapists will take part in this research study.
详细描述
This is a single-arm, behavioral intervention study to train psychotherapists to administer individualized evidence-based psychotherapies in a cancer care setting to patients and caregivers with elevated levels of distress related to their illness, treatment and/or caregiving responsibilities. For participants with cancer and their caregivers, common treatment goals include improving health behaviors, reducing psychological symptoms that may exacerbate medical disability, and/or improving functional status.
Research procedures include screening for eligibility, completion of surveys and questionnaires, and virtual or in-person therapy sessions.
The intervention will mirror clinical care in psycho-oncology in which the therapist, collaboratively with their supervisor, will choose specific components of the following evidence-based treatments to administer based on the clinical presentation of the patient or caregiver and referring problem.
- Cognitive Behavioral Therapy (CBT)
- Acceptance Commitment Therapy (ACT)
- Mindfulness-Based Cognitive Therapy (MBCT)
- Mindfulness-Based Stress Reduction (MBSR)
- Meaning-Centered Psychotherapy (MCP)
- Cognitive Behavioral Therapy for Insomnia (CBT-I)
- CBT for other cancer-related physical symptoms like pain, fatigue, and nausea.
Participation in this research study is expected to last about 26 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
盲法说明
There will be two groups in this study- one is patient and caregiver participants (n=100) and the other is therapist participants (n=15). Therapist participants will deliver evidence-based therapy treatments to patients participants. Outcomes in each group will not be compared to each other.
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
- •Patient Inclusion Criteria:
- •Adults > 18 years of age.
- •Currently receiving oncology treatment/care at the MGH Cancer Center, including active treatment and/or surveillance.
- •Reports elevated levels of distress on the National Comprehensive Cancer Network (NCCN) Distress Thermometer >
- •Reports distress or presenting problem is related to patients' illness and/or treatment (e.g., cancer treatment).
- •Has a clinical presentation that matches an evidence-based treatment (e.g., CBT-I for insomnia/sleep disturbance) for cancer-related distress per therapist and supervising therapist discretion.
- •Located in the state of Massachusetts for the duration of sessions.
- •Caregiver Inclusion criteria:
- •Adults > 18 years of age
- •Currently caring for someone receiving oncology treatment/care at the MGH Cancer Center, including active treatment and/or surveillance
- •Reports elevated levels of distress on the National Comprehensive Cancer Network (NCCN) Distress Thermometer > 3
- •Reports distress or presenting problem is related to caregiving
- •Has a clinical presentation that matches an evidence-based treatment (e.g., CBT-I for insomnia/sleep disturbance) for caregiving-related distress per therapist and supervising therapist discretion
- •Located in the state of Massachusetts for the duration of sessions
排除标准
- •Has uncontrolled psychosis, active suicidal ideation, or psychiatric hospitalization within the past year (assessed through EHR review and screening session using the QuickSCID-5), indicating the need for tailored treatment referral to specialty mental healthcare outside of psycho-oncology or to a higher level of care such as an intensive outpatient program (IOP).
- •Has a cognitive impairment that prohibits participation in the study (assessed through EHR review and screening session).
- •Currently participating in group or individual evidence-based psychotherapy treatment or other psychosocial intervention trial.
- •Has an alcohol or substance dependence (other than nicotine dependence) in the past 8 weeks (assessed through EHR review and screening session using the QuickSCID-5), indicating the need for tailored treatment referral to specialty mental healthcare outside of psycho-oncology or to a higher level of care such as an intensive outpatient program (IOP).
- •Therapist Inclusion criteria:
- •Current appointment as a clinical psychology fellow or psychiatry resident at the Massachusetts General Hospital or equivalent designation.
- •Therapist Exclusion criteria:
- •Obtained licensure as a clinical psychologist in any state.
研究组 & 干预措施
Individualized Evidence-Based Therapy in Cancer (Patients and Caregivers)
This arm will enroll patient and caregiver participants receiving evidence-based therapy as part of the protocol.
Participants will complete:
- 6-16 sessions of therapy 1x/week. Sessions are virtual or in-person at the Massachusetts General Hospital Cancer Center.
- Surveys and questionnaires pre- and post-treatment.
At the discretion of the therapist and the supervising therapist, the participant may receive up to 4 booster sessions after completion of the specific treatment protocol.
干预措施: Individualized Evidence-Based Therapy in Cancer (Patients and Caregivers) (Behavioral)
Training in Individualized Evidence-Based Therapy in Cancer (Therapists)
This arm will enroll therapist participants as part of the protocol. Therapists participants will enroll in the study and receive training in delivering evidence-based therapy to patients in the cancer center. Therapists will complete pre and post-measures of therapist self-efficacy and competence, as well as a semi-structured exit interview.
干预措施: Training in Individualized Evidence-Based Therapy in Cancer (Therapists) (Behavioral)
结局指标
主要结局
Evidence-Based Treatment Acceptability
时间窗: up to 26 weeks
Patients and caregivers will report acceptability of evidence-based treatment delivered by therapists receiving training in psycho-oncology on the Client Satisfaction Questionnaire (acceptability criteria: \>75% of patients score ≥ the CSQ's midpoint \[3\]). Defined by the Client Satisfaction Questionnaire (CSQ), a 3-item, validated measure to assess satisfaction with services provided to the participant. Each item is answered on a scale of 1-4 with a total score range of 3-12. Acceptability criteria is \> 75% of participants with a score ≥ the CSQ's midpoint.
次要结局
- Coping Self-Efficacy(up to 26 weeks)
- Patient Quality of Life (FACT-G)(up to 26 weeks)
- Caregiver Quality of Life (CarGOQoL)(up to 26 weeks)
研究者
Jamie Jacobs
Principal Investigator
Massachusetts General Hospital