Feasibility and Acceptability of the Care and Connect Program for Patients With Lung Cancer
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Feasibility Assessed by Recruitment Rates
研究概览
简要总结
Background: In Canada, lung cancer accounts for approximately 25% of cancer deaths each year. There are also known sociodemographic and racial inequities in the diagnosis and treatment of lung cancer. Studies have consistently found that patients with cancer have a high number of unmet needs, including psychological, physical, and informational. Navigation programs represent a potentially promising, equitable, and cost-effective approach to address the unmet needs of patients with lung cancer, but there is limited evidence about their effectiveness in patients with lung cancer. The investigators developed and have implemented a volunteer lay navigator program, Care and Connect (C&C), which aims to proactively reduce distress in patients, provide information and support, and increase access to treatment and supportive care resources. The proposed pilot randomized controlled trial (RCT) project plans to 1) assess the feasibility and acceptability of referral to C&C and, 2) examine the preliminary effectiveness of C&C.
Methods: The current study is a 2-arm, parallel group, mixed methods, pilot RCT with a 1:1 allocation ratio and 3 timepoints: baseline (T0), 3 months (T1), 6 months (T2). It is designed to test the trial feasibility and acceptability of the C&C intervention in patients with lung cancer. In total, 50 participants will be randomized to receive the C&C intervention or usual care only (25 per arm). At each timepoint, data will be collected on participants' access to psychosocial (PSO) services, psychological wellbeing, and satisfaction with care through participant medical record and a survey. To gain additional insights regarding the acceptability, feasibility, and impact of C&C, a subset of 15 participants from the intervention group will be contacted for qualitative exit interviews.
Expected outcomes: There is limited evidence about the effects of lay navigation programs on access to PSO services among patients with lung cancer. This work addresses this knowledge gap by evaluating the feasibility, acceptability, and preliminary impact of C&C on patients with lung cancer. The findings of the proposed work will expand the body of evidence supporting lay navigation to the lung cancer population, contributing to the evidence base for patient-centred care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Investigator, 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
- •Patient with diagnosis of non-small cell lung cancer (NSCLC) or small cell lung cancer (SCLC) of any stage
- •Have completed their first medical appointment at the Medical Oncology Lung Cancer Clinic at Princess Margaret Cancer Centre (PM), University Health Network
- •Cognitive capacity to consent and complete questionnaires
排除标准
- •Behavioural safety alert on medical record that would make their participation in Care & Connect inappropriate
- •Enrolment in another navigation study within University Health Network
- •Patients who come to PM for a clinical trial visit
- •Inability to communicate and read in English
研究组 & 干预措施
Intervention Group
Participants in the intervention group receive Care & Connect (C&C), a 6-month lay navigation program, in addition to usual care. Trained lay navigators provide psychosocial and informational support and assist with health system navigation, including directing patients to appropriate resources, facilitating referrals to psychosocial services as appropriate, and connecting participants with relevant hospital and community resources.
干预措施: Care & Connect (Behavioral)
Usual Care
Participants in the control group receive usual care, including routine treatment and follow up in outpatient oncology clinics. Usual care includes distress screening (whereby patients are invited to complete the Edmonton Symptom Assessment System-Revised as part of clinic visits), with results reviewed by clinic staff and communicated to oncologists for further assessment and referral to specialized services as needed. Participants may also be referred to specialized services based on clinical judgement or patient request and have access to standard informational and educational resources available through the hospital.
结局指标
主要结局
Feasibility Assessed by Recruitment Rates
时间窗: From study start date to the end of treatment at 6 months
≥50% recruitment rate (#patients consented/ #patients eligible and approached)
Feasibility Assessed by Questionnaire Completion
时间窗: From study start date to the end of treatment at 6 months
≥80% baseline questionnaire completion rate (#patients who complete baseline questionnaire/ #patients consented)
Feasibility Assessed by Protocol Adherence
时间窗: From study start date to the end of treatment at 6 months
≥65% of patients completing at least 1 session with a lay navigator
Acceptability
时间窗: This measure will be administered at 3 months and 6 months
Intervention acceptability will be assessed using the Patient Satisfaction with Navigator-Interpersonal Relationship scale (PSN-I), a 9-item self-report measure of patients' satisfaction with the relationship with their navigator. Higher PSN-I scores indicate greater patient satisfaction. Acceptability is defined as ≥70% of participants scoring ≥30 on the PSN-I.
次要结局
- Referral of Care to Psychosocial Oncology Services(From study start date to the end of treatment at 6 months)
- Referral of Care to Palliative Services(From study start date to the end of treatment at 6 months)
- Depressive symptoms using the PHQ-9(This measure will be administered at baseline, 3 months and 6 months)
- Generalized anxiety symptoms using the GAD-7(This measure will be administered at baseline, 3 months and 6 months)
- Distress about death and dying symptoms using the DADDS(This measure will be administered at baseline, 3 months and 6 months)
- Patient satisfaction with cancer care using the PSCC(This measure will be administered at baseline, 3 months and 6 months)
- Patient satisfaction with cancer care using the CEQ-INS(This measure will be administered at baseline, 3 months and 6 months)
研究者
Gilla Shapiro
Clinician Scientist
University Health Network, Toronto