Increasing Adoption of a Telehealth-Delivered Collaborative Care Program for Patients With Lung Cancer: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Reach - Completion of the intake assessment amongst referred patients.
研究概览
简要总结
The goal of this trial is to compare the impact of two outreach strategies (high touch vs. standard outreach) on a collaborative care program delivered via telehealth to patients with lung cancer.
详细描述
The goal of this project is to pilot test the effectiveness of using a more-intensive (high touch) outreach strategy to increase the reach of an adapted, standard of care CoCM for patients with lung cancer who are experiencing depression and/or anxiety. The investigators will specifically test the effect of two outreach strategies (high touch vs. standard outreach) on reach of the CoCM program (primary outcome) and on several secondary implementation and effectiveness outcomes. Given the demonstrated efficacy of the CoCM in patients with cancer, the main target of this research study is the impact of the outreach strategies and delivery of the CoCM via telehealth.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Double (Participant, Outcomes Assessor)
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
- •Are aged 18 years or older.
- •Are currently being seen by Penn Medicine Thoracic Oncology for lung cancer treatment or survivorship care.
- •Are referred to collaborative care by a Penn Medicine Thoracic Oncology clinician for treatment of depression, anxiety, or other psycho-therapy services.
排除标准
- •Are already receiving psycho-therapy treatment services outside of Penn Medicine's collaborative care program, Penn Integrated Care (PIC).
- •Have a significant and/or untreated medical and/or psychiatric co-morbidity (e.g., other cancers, schizophrenia, acute suicidal and/or homicidal ideation) that make them ineligible for the Penn CoCM program.
研究组 & 干预措施
High Touch Outreach
Patients in the high touch outreach arm will receive a gain-framed message via text (preferred modality), MyPennMedicine message, email, and/or postal mail that links to the digital screener; an informational flyer about collaborative care sent via postal mail, the MyPennMedicine portal, email, and/or text; and a direct request from their oncology provider to collaborative care for those patients who have not responded to outreach efforts by their next oncology visit post-referral.
干预措施: High Touch Outreach (Behavioral)
Standard Outreach
Patients in the standard outreach arm will receive a standard message sent via text (preferred modality), MyPennMedicine message, email, and/or postal mail that links to the digital screener; this message is one that is similar to that already used in Penn Integrated Care's practice.
结局指标
主要结局
Reach - Completion of the intake assessment amongst referred patients.
时间窗: Measured per patient up to 30 days after randomization.
The number of referred patients that complete the intake assessment divided by the total number of referred patients.
Reach - Completion of the intake assessment amongst referred patients.
时间窗: Measured per patient up to 30 days after randomization.
The number of referred patients that complete the intake assessment divided by the total number of referred patients.
次要结局
- Treatment Initiation - Completion of one or more oncology-based collaborative care appointments amongst patients deemed to be appropriate for oncology-based collaborative care at intake.(Measured per patient up to 60 days after randomization.)
- Treatment Retention - Completion of oncology-based collaborative care appointments amongst patients deemed to be appropriate for oncology-based collaborative care at intake.(Measured per patient at end of collaborative care treatment (assessed up to 6 months).)
- Clinical Effectiveness (PHQ-9) - Change in symptom measure using the Patient Health Questionnaire-9 (PHQ-9) validated instrument.(Measured per patient at first collaborative care appointment (baseline) and at end of collaborative care treatment (up to 6 months).)
- Clinical Effectiveness (GAD-7) - Change in symptom measure using the Generalized Anxiety Disorder-7 item (GAD-7) validated instrument.(Measured per patient at first collaborative care appointment (baseline) and at end of collaborative care treatment (up to 6 months).)
- Clinical Effectiveness (PROMIS Fatigue) - Change in symptom measure using the Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue - Short Form 7a validated instrument.(Measured per patient at first collaborative care appointment (baseline) and at end of collaborative care treatment (up to 6 months).)
- Treatment Initiation - Completion of one or more oncology-based collaborative care appointments amongst patients deemed to be appropriate for oncology-based collaborative care at intake.(Measured per patient up to 60 days after randomization.)
- Treatment Retention - Completion of oncology-based collaborative care appointments amongst patients deemed to be appropriate for oncology-based collaborative care at intake.(Measured per patient at end of collaborative care treatment (assessed up to 6 months).)
- Clinical Effectiveness (PHQ-9) - Change in symptom measure using the Patient Health Questionnaire-9 (PHQ-9) validated instrument.(Measured per patient at first collaborative care appointment (baseline) and at end of collaborative care treatment (up to 6 months).)
- Clinical Effectiveness (GAD-7) - Change in symptom measure using the Generalized Anxiety Disorder-7 item (GAD-7) validated instrument.(Measured per patient at first collaborative care appointment (baseline) and at end of collaborative care treatment (up to 6 months).)
- Clinical Effectiveness (PROMIS Fatigue) - Change in symptom measure using the Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue - Short Form 7a validated instrument.(Measured per patient at first collaborative care appointment (baseline) and at end of collaborative care treatment (up to 6 months).)
研究者
Alexandria Muench
Staff Psychologist
Abramson Cancer Center at Penn Medicine