A Multi-Centre, Randomized Controlled Trial of Self-Management and Activation to Reduce Treatment-Related Toxicities in Patients Receiving Adjuvant or First-Line Metastatic Oral or Systematic Therapy for Colorectal, Lymphoma or Lung Cancer (SMARTCare)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 62
- 试验地点
- 6
- 主要终点
- Reasons for premature discontinuation or withdrawal
研究概览
简要总结
The investigators will undertake a multi-centre, randomized controlled trial to implement and evaluate a proactive model of care (SMARTCare) during active cancer treatment that incorporates self-management support (SMS). Patients allocated to the control arm will receive care from ambulatory clinic nurses trained in SMS. Patients allocated to the intervention arm will will receive care from ambulatory clinic nurses trained in SMS, in addition to being given access to a web-based, self-management education program and nurse-led health coaching during the first four months following the first systemic therapy administration.
详细描述
Self-management describes patient's behaviours and skills to manage the physical and psychosocial impact of their illness. Empirical evidence shows that patient activation in self-management results in improved disease control and quality of life (QOL), and lower emergency department visits and hospitalizations (ED+H) and costs in other chronic conditions. Previous research conducted by the investigators of this study has shown that the quality of SMS in ambulatory care was poor and patients felt unprepared to manage treatment-related toxicities. Building on previous work, this study will evaluate a multi-faceted proactive model of care that includes: (1) training in self-management support (SMS) strategies for ambulatory nursing staff; (2) a web-based self-management education program for patients; and (3) provision of proactive, nurse-led health coaching during the first four months following the first systemic therapy administration. Using a computer-generated permuted blocks randomization scheme (permuted blocks of random size) stratified by cancer type and centre, 160 evaluable patients will be enrolled across the three participating regional cancer centres. 80 patients will be randomized to the intervention arm and 80 to the control arm. The primary objective of this study is to compare the feasibility and acceptability of the SMARTCare intervention to the active comparator (control arm). The secondary objectives are to: (1) assess the effect of the intervention on symptom control, health-related quality of life, psychological distress, patient activation and self-efficacy; (2) evaluate the effect of the intervention on service outcomes: ED+H and resource utilization; and (3) evaluate implementation outcomes: fidelity, adherence and adoption. In addition, patients randomized to the intervention arm will be asked to participate in a sub-study interview at the end of the study to gain further knowledge about the SMARTCare intervention components from the patient's perspective.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •Diagnosis of lymphoma (Hodgkin's or non-Hodgkin's), colorectal, or lung cancer.
- •Initiating adjuvant or first-line metastatic treatment with oral or systemic therapy within the accrual period at a participating centre. Patients receiving treatment with immunotherapy are eligible to participate.
- •Eastern Cooperative Oncology Group (ECOG) </=
- •Ability to understand and provide written informed consent.
- •Access to an electronic device and internet connection to allow the participant to access the web-based I-Can-Manage Cancer education modules.
- •Language and literacy skills consistent with completing validated questionnaires, and willingness to complete questionnaires as required.
排除标准
- •Currently participating in a clinical trial involving receipt of an investigational agent.
结局指标
主要结局
Reasons for premature discontinuation or withdrawal
时间窗: Assessed at baseline to 6 months post first dose +/- 2 weeks
Reasons for premature discontinuation or withdrawal will be captured in MedidataRAVE and evaluated as one aspect of feasibility.
Usage of I-Can-Manage (intervention arm only)
时间窗: Assessed at baseline to 6 months post first dose +/- 2 weeks
Automated back-end analytics will be utilized to track patterns of usage of the I-Can-Manage Cancer Education Modules.
Retention rate
时间窗: Assessed at baseline to 6 months post first dose +/- 2 weeks
Retention rate will be calculated as the proportion of patients who did not prematurely discontinue or withdraw among those that consented to participate, and evaluated as one aspect of feasibility.
Reasons for non-participation
时间窗: Assessed at baseline to 6 months post first dose +/- 2 weeks
Participating cancer centres will maintain Screening and Enrollment logs for the duration of the study. Reasons for non-participation will be documented on the logs and evaluated as one aspect of feasibility.
Recruitment rate
时间窗: Assessed at baseline to 6 months post first dose +/- 2 weeks
Participating cancer centres will maintain Screening and Enrollment logs for the duration of the study. The logs will be used to calculate recruitment rates. The recruitment rate will be calculated as the proportion of patients that have agreed to participate among those approached and evaluated as one aspect of feasibility.
Compare the acceptability of the SMARTCare intervention to the active comparator by administering an Intervention Acceptability Questionnaire and conduct a thematic analysis of qualitative data from end of study interviews.
时间窗: Assessed at 4-6 months post first dose +/- 2 weeks
Acceptability of the intervention to patients will be evaluated using the Intervention Acceptability Questionnaire that has been developed for the study. The 3-section questionnaire (I-Can-Manage Cancer Modules; Health Coaching Calls; Overall Acceptability) asks patients to rate agreement statements from "Disagree Strongly" to "Agree Strongly". Individual scores for each statement in each section will be recorded. Audio recorded end of study qualitative interviews (approximately 30 minutes) will be conducted by a member of the study steering committee. The interviewer will follow a SMARTCare Patient Interview Guide. The guide consists of open-ended questions focusing on: (1) access, use, content and utility of the I-Can-Manage Cancer Modules; (2) logistics/timing/dose, content and utility of Health Coaching; and (3) General Comments. Interview transcripts will be analyzed in NVIVO to identify common themes.
次要结局
- System Outcomes - Impact of the intervention on incidence of emergency department visits and hospitalizations (ED+H) from administrative data.(Assessed at baseline to 6 months post first dose +/- 2 weeks)
- Patient Outcomes - EQ-5D-5L to evaluate the impact of the intervention on health-related quality of life(Assessed at baseline and 2, 4 and 6 months post first dose +/- 2 weeks)
- Patient Outcomes - Hospital Anxiety and Depression Scale (HADS) to assess psychological distress(Assessed at baseline and 2, 4 and 6 months post first dose +/- 2 weeks)
- System Outcomes - Impact of the intervention on resource utilization (acute care visits and use of supportive care) from administrative data.(Assessed at baseline to 6 months post first dose +/- 2 weeks)
- Implementation Outcomes - Patient adherence to the intervention(Assessed at baseline to 6 months post first dose +/- 2 weeks)
- Implementation Outcomes - Provider adoption of the intervention(Assessed at baseline to 6 months post first dose +/- 2 weeks)
- Patient Outcomes - Memorial Symptom Assessment Scale - Short Form (MSAS-SF) to evaluate the impact of the intervention on symptom control(Assessed at 2, 4 and 6 months post first dose +/- 2 weeks)
- Patient Outcomes - Patient Activation Measure (PAM) to evaluate the impact of the intervention on patient activation(Assessed at baseline and 2, 4 and 6 months post first dose +/- 2 weeks)
- Patient Outcomes - Patient Reported Outcomes Measurement Information System (PROMIS) short form to evaluate the impact of the intervention on self-efficacy(Assessed at baseline and 2, 4 and 6 months post first dose +/- 2 weeks)
- Implementation Outcomes - Fidelity of the intervention(Assessed at baseline to 6 months post first dose +/- 2 weeks)