Managing Symptoms and Psychological Distress During Oral Anti-Cancer Treatment
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- NRG Oncology
- 入组人数
- 600
- 试验地点
- 35
- 主要终点
- Symptom severity/toxicity index
研究概览
简要总结
In this clinical trial, symptom monitoring (interactive voice response [IVR] is compared to automated telephone symptom management [ATSM] and telephone interpersonal counseling [TIPC]) for reducing symptom burden and psychological distress (depressive and anxiety symptoms) among people receiving oral anti-cancer treatment. Symptoms are the number one driver of treatment interruptions and unscheduled health services use. To reduce the risk of these events, symptom monitoring and management are necessary. However, these services are not implemented routinely, especially in the community oncology settings. Further, depressive and anxiety symptoms are a key barrier to enacting symptom self-management strategies. IVR is a form of symptom monitoring where patients, when called, enter their symptom ratings over the phone. Their symptom summary is sent to their provider, and patients may be advised to reach out to their oncology provider, based on their symptoms. The ATSM intervention combines IVR assessments with a Symptom Management and Survivorship educational handbook with self-management strategies. Patients receiving ATSM enter their symptom ratings over the phone and have their symptoms reported to their provider, but patients are also directed to the handbook for strategies to manage elevated symptoms. Patients receiving ATSM who report being anxious, discouraged, or sad will also receive TIPC, which targets psychological distress and its connection to social support and interpersonal communication. Information gathered from this study may help researchers learn more about the best ways to manage patient symptoms and improve patient outcomes.
详细描述
PRIMARY OBJECTIVE:
I. Test the effectiveness of Automated Telephone System Management (ATSM) + Telephone Interpersonal Counseling (TIPC) versus active control on patient-level outcome of the summary toxicity index of 24 Patient Reported Outcomes Common Terminology Criteria for Adverse Events (PRO-CTCAE) symptoms that include depressive, anxiety, and other symptoms commonly experienced during oral anti-cancer treatment over weeks 1-12 (immediate effect) and 13-17 (sustained effect).
SECONDARY OBJECTIVE:
I. Test the effectiveness of ATSM+TIPC versus active control on patient-level outcome of unscheduled health services over weeks 1-12 and 13-17.
EXPLORATORY OBJECTIVES:
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
- Single (Outcomes Assessor)
盲法说明
Interviewers will be blinded to the study arm; IVR is automated.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •PRACTICES: All institutions participating in the practice are National Cancer Institute Community Oncology Research Program (NCORP) affiliates or sub-affiliates.
- •PRACTICES: Administer oral therapy to at least 40 patients per year that meet protocol eligibility criteria.
- •PRACTICES: Completion and submission of the NRG-CC012CD Letter of Intent (LOI) (posted on the Cancer Trials Support Unit [CTSU] website).
- •PRACTICES: Having a social worker licensed in behavioral counseling or other person eligible for behavioral licensing in the practice's state or territory (if licensure is required by state or territory) who can be trained to deliver TIPC or willingness of practice to work with TIPC intervener contracted by the study team. Note: If the practice's social worker or other behavioral health professional is trained to deliver TIPC, they will be compensated for their time training and delivering the TIPC intervention.
- •PRACTICE PERSONNEL: Age ≥ 18 years.
- •PRACTICE PERSONNEL: Planned to be involved in usual care for at least one enrolled patient during patient's participation in the study.
- •PRACTICE PERSONNEL: For a social worker or other behavioral health professional who will deliver TIPC intervention, licensure, or eligibility for licensure in behavioral counseling if required by the state or territory.
- •PRACTICE PERSONNEL: The practice personnel must provide study-specific informed consent prior to study entry.
- •RETAIN PRACTICE PARTICIPATION: In order to maintain participation in the study, practices must enroll at least 8 patients in the first 6 months (based upon the practice's monthly tracking reports) the practice is open to patient accrual to ensure that the practice can meet the accrual goals. If a practice does not meet this criterion they will be replaced.
- •RETAIN PRACTICE PARTICIPATION: Complete monthly forms on actions taken on IVR symptom reports. If fewer than 2 forms are completed in the first 6 months of practice's participation, practice will be replaced.
- •RETAIN PRACTICE PARTICIPATION: Participate in monthly study calls for the duration of practice's participation in the study.
- •PATIENTS: Starting a new course of an oral anti-cancer agent (the list of agents is posted to the CTSU website) other than sex hormone inhibitors, within 4 weeks after registration or have started an oral anti-cancer agent in the past 8 weeks.
- •PATIENTS: All concomitant medications and supportive care treatments are acceptable.
- •PATIENTS: Age ≥ 18 years.
- •PATIENTS: Able to speak and understand English or Spanish.
- •PATIENTS: Access to a telephone and ability to answer questions via telephone in English or Spanish.
- •PATIENTS: The patient must provide study-specific informed consent prior to study entry and authorization permitting release of personal health information.
排除标准
- •PRACTICES: Active telephone symptom management program at the practice that is beyond symptom and oral agent adherence monitoring.
- •PATIENTS: Only receiving treatment with sex hormone inhibitors.
- •PATIENTS: Enrollment in the intervention arm of another symptom management trial at intake into the trial. Participation in lifestyle trials with primary outcomes other than symptoms is acceptable.
- •PATIENTS: Currently receiving regular behavioral counseling for psychological symptoms. Regular behavioral counseling is defined as at least two counseling sessions with a behavioral health care provider scheduled within the past two months. Patients who completed behavioral counseling within 2 months prior to registration are eligible. Behavioral counseling for issues other than psychological symptoms (e.g., as part of weight loss or smoking cessation program) is not an exclusion criterion.
- •PATIENTS: Pregnancy at intake into the trial.
研究组 & 干预措施
Arm II (ATSM, TIPC)
Patients receive the Symptom Management and Survivorship handbook and receive IVR symptom monitoring calls for 12 weeks, with summary symptom reports sent to their provider. Call duration is approximately 20 minutes. Patients who report anxious, discouraged, or sad mood items on their monitoring calls for two consecutive weeks between weeks 1 and 4 also receive TIPC calls for up to 8 weeks. TIPC call duration is approximately 30 minutes.
干预措施: Counseling (Other)
Arm I (IVR monitoring)
Patients receive IVR symptom monitoring calls once a week for 12 weeks, and a summary symptom report is sent to their provider. Call duration is approximately 15 minutes.
干预措施: Interview (Other)
Arm I (IVR monitoring)
Patients receive IVR symptom monitoring calls once a week for 12 weeks, and a summary symptom report is sent to their provider. Call duration is approximately 15 minutes.
干预措施: Monitoring (Other)
Arm I (IVR monitoring)
Patients receive IVR symptom monitoring calls once a week for 12 weeks, and a summary symptom report is sent to their provider. Call duration is approximately 15 minutes.
干预措施: Questionnaire Administration (Other)
Arm II (ATSM, TIPC)
Patients receive the Symptom Management and Survivorship handbook and receive IVR symptom monitoring calls for 12 weeks, with summary symptom reports sent to their provider. Call duration is approximately 20 minutes. Patients who report anxious, discouraged, or sad mood items on their monitoring calls for two consecutive weeks between weeks 1 and 4 also receive TIPC calls for up to 8 weeks. TIPC call duration is approximately 30 minutes.
干预措施: Health Education (Behavioral)
Arm II (ATSM, TIPC)
Patients receive the Symptom Management and Survivorship handbook and receive IVR symptom monitoring calls for 12 weeks, with summary symptom reports sent to their provider. Call duration is approximately 20 minutes. Patients who report anxious, discouraged, or sad mood items on their monitoring calls for two consecutive weeks between weeks 1 and 4 also receive TIPC calls for up to 8 weeks. TIPC call duration is approximately 30 minutes.
干预措施: Interview (Other)
Arm II (ATSM, TIPC)
Patients receive the Symptom Management and Survivorship handbook and receive IVR symptom monitoring calls for 12 weeks, with summary symptom reports sent to their provider. Call duration is approximately 20 minutes. Patients who report anxious, discouraged, or sad mood items on their monitoring calls for two consecutive weeks between weeks 1 and 4 also receive TIPC calls for up to 8 weeks. TIPC call duration is approximately 30 minutes.
干预措施: Questionnaire Administration (Other)
Arm II (ATSM, TIPC)
Patients receive the Symptom Management and Survivorship handbook and receive IVR symptom monitoring calls for 12 weeks, with summary symptom reports sent to their provider. Call duration is approximately 20 minutes. Patients who report anxious, discouraged, or sad mood items on their monitoring calls for two consecutive weeks between weeks 1 and 4 also receive TIPC calls for up to 8 weeks. TIPC call duration is approximately 30 minutes.
干预措施: Monitoring (Other)
Arm I (IVR monitoring)
Patients receive IVR symptom monitoring calls once a week for 12 weeks, and a summary symptom report is sent to their provider. Call duration is approximately 15 minutes.
干预措施: Medical Chart Review (Other)
Arm II (ATSM, TIPC)
Patients receive the Symptom Management and Survivorship handbook and receive IVR symptom monitoring calls for 12 weeks, with summary symptom reports sent to their provider. Call duration is approximately 20 minutes. Patients who report anxious, discouraged, or sad mood items on their monitoring calls for two consecutive weeks between weeks 1 and 4 also receive TIPC calls for up to 8 weeks. TIPC call duration is approximately 30 minutes.
干预措施: Medical Chart Review (Other)
结局指标
主要结局
Symptom severity/toxicity index
时间窗: Up to 12 weeks from the start of therapy (trial interventions)
Toxicity index across 24 symptoms will be measured using Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events. Linear mixed effects or generalized linear mixed effects models will be used.
次要结局
- Unscheduled health services(Up to 17 weeks from the start of therapy (trial interventions))
- Unscheduled health services(Up to 17 weeks from the start of therapy (trial interventions))