Prostate Cancer Survivorship 360°
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 203
- 试验地点
- 6
- 主要终点
- Changes in the Patient Activation measure questionnaire
研究概览
简要总结
Prostate Cancer Survivorship 360º is a collaboration-based initiative involving prostate cancer (PC) and survivorship researchers/clinicians from three Canadian prostate centers with the goal of identifying and tracking unmet supportive care needs of patients with localized PC and responding to these needs through survivorship care. The current randomized control trail (RCT) will focus on the development and evaluation of a facilitated electronic Prostate Cancer Survivorship Care Plan (PC-SCP). The aims of this project are: 1) to develop an appropriate and tailored SCP and transition care delivery process; and 2) to conduct an RCT to evaluate whether a personalized PC SCP intervention is more effective than usual care (UC) on patient activation (primary outcome) and access to services, self-Management support, satisfaction with information, HRQoL and cancer worry (secondary outcomes). Data from a multi-site prospective database- Prostate Cancer Survivorship Information System (PC360-IS) will be used to electronically populate the survivorship care plans. Overall, this proposal represents initial steps in uniting the country in sharing programmatic resources, data, expertise, and enthusiasm to transform survivorship care for men with PC and their families.
详细描述
A Phase III RCT will evaluate the superiority of a Survivorship Care Plan (SCP) intervention (SCP-Int) compared with usual care (UC) after primary curative prostate cancer (PC) treatment. Each of the three sites has designated clinical study leads (AM, LG, and ST), high referral volumes and study leads' patients will be entered into the PC360-IS database which will be interfaced to the PC-SCP system to consolidate patient details and generate personalized SCPs. Research ethics approval will be obtained at each site. The trial will be registered with clinicaltrials.gov and reported using the CONSORT recommendations for trials.
The study population inclusion criteria are as follows: Histologically confirmed localized (T1-T3N0M0) PC; age at diagnosis >18 years; treated with curative intent; treatment received >1 month and <6 months; disease-free as defined by absence of somatic disease activity parameters as per oncologist/urologist; consented to participate in the PC360-IS database. Exclusion Criteria: Patients who do not receive treatment and are followed by active surveillance; inability to complete study questionnaires.
Eligible patients will be randomly assigned to either the intervention arm or the control arm. A biostatistician will randomly assign participants to ensure that both the study RA and the participants are unaware of the treatment (SCP-int)/control groups (UC). Consenting patients will be registered into the study and randomized to receive either the SCP-Int or UC. Patients in the SCP-Int arm will be scheduled for the SCP-Int appointment on the same day as the patient's first (or second) follow-up appointment.
Eligible patients will be sent a study information letter which will be signed by the patient's urologist/ oncologist one month after the end of primary treatment. The RA will then contact patients to further explain the study. If agreeable, the patients will be sent consent forms, two stamped envelopes, and a baseline questionnaire to complete prior to the scheduled follow-up appointment. The patients will be asked to mail back the signed consent form and the completed questionnaire in each the envelopes provided.
Participants will have as much time as needed to decide if the participants would like to participate in the study prior to signing the consent form. The Research Analyst will obtain consent.
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
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed localized (T1-T3N0M0) PC
- •age at diagnosis >18 years
- •treated with curative intent
- •treatment received >1 month and <6 months
- •disease-free as defined by absence of somatic disease activity parameters as per oncologist/urologist
- •consented to participate in the PC360-IS database.
排除标准
- •Patients who do not receive treatment and are followed by active surveillance
- •inability to complete study questionnaires.
结局指标
主要结局
Changes in the Patient Activation measure questionnaire
时间窗: Change from baseline (prior to intervention), 6 months post intervention, 12 months post intervention.
次要结局
- Changes in the Assessment of Survivors Concerns measure(baseline (prior to intervention), 6 months post intervention, 12 months post intervention.)
- Changes in the Expanded Prostate Cancer Index Composite(Change from baseline (prior to intervention), 6 months post intervention, 12 months post intervention.)
- Changes in the Health and Social Services Utilization Inventory(change from baseline (prior to intervention), 6 months post intervention, 12 months post intervention.)
- Changes in the Quality of Life INFO25 module(Change from baseline (prior to intervention), 6 months post intervention, 12 months post intervention.)
- Changes in the Health Education Impact Questionnaire(Change from baseline (prior to intervention), 6 months post intervention, 12 months post intervention.)