Patient Ambassador Support in Newly Diagnosed Patients With Acute Leukemia During Treatment: a Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 61
- 试验地点
- 6
- 主要终点
- Recruitment rate
研究概览
简要总结
Background: Acute leukemia is a life threatening hematological malignancy which can result in substantial symptom burden including impaired psychological wellbeing. Peer-to-peer support has positive and beneficial effects on patients with cancer. Yet there is lack of knowledge and evidence of the feasibility and the effect of peer-to-peer support on patient with acute leukemia
Aims: The study aim to examine the feasibility and safety of Patient Ambassador Support in newly diagnosed patients with acute leukemia during treatment, and to examine the benefit on symptoms and psychological wellbeing in both patients and ambassadors.
Design and methods: This study is a one arm feasibility intervention trial with patients n=40; patient ambassadors (PA) n=30. Patients will be consecutively recruited at the Departments of Hematology, Rigshospitalet, Herlev and Gentofte Hospital and Sjællands Universitetshospital, Roskilde, and paired with a PA who will follow and assist the patient over the course of two series of chemotherapy for a 12 week period, with one follow-up contact at 3 month. Data is collected at baseline (within 2 weeks of diagnosis), post intervention (12 weeks) and follow-up 6 months.
Implication: This study has the potential to be a new model for care incorporated in the oncology/hematology clinical care setting, creating an active partnership between patients and former patients; and in collaboration with the health care professionals which may strengthen the existing care and support system.
详细描述
Study Part 2 Aim To investigate the feasibility and safety of Patient Ambassador Support (PAS) and whether there is benefit on psychological wellbeing and symptoms among newly diagnosed patients with acute leukemia and among former patients with acute leukemia (patient ambassadors).
Design and Methods A one arm feasibility intervention trial with patients (n=40) and patient ambassadors (PA) (n=30).
Recruitment Patients will be recruited at three Danish hematology departments: Rigshospitalet (RH), Herlev og Gentofte Hospital (HGH and Sjællands Universitetshospital, Roskilde (SUR), from January 2018 to June 2019. Eligible patients receive oral and written project information from KHN within two weeks from diagnosis. KHN provides a summary of the study and gives the opportunity to raise questions or concerns related to the study.
PA´s will be recruited voluntarily from the patient association LyLe and from the outpatient hematology departments of RH, HGH and SUR by KHN, and screened by interview to assess their appropriateness for the intervention. Screening interviews include questions about a survivor´s motivation for volunteering, availability, ability to respect confidentiality, and ability to acknowledge the vulnerability that may occur when they revisiting experience of others with acute leukemia. The PA is obligated to sign a confidentiality commitment, and knows and accepts the terms and requirements included in the intervention. Furthermore, the PA provides information regarding age, gender, diagnose, treatment, interests, work, education, social conditions in order to match with patients. The PA must provide transportation themselves but will receive a monetary incentive for their participation. During the intervention we will adjust the PA recruitment process in order to fill specific needs in the program such as age groups or diagnosis. This will ensure that we do not have a larger ambassador pool than we effectively utilize.
Patients and ambassadors who have consented and agreed to participate in the study will complete the baseline testing (patient reported outcome questionnaires) before the beginning of intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 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
- 是
入选标准
- •Eligible patients are > 18 years and newly diagnosed with acute leukemia < 2 weeks of diagnosis who are planned to receive intensive treatment during a course of minimum two series of chemotherapy, and ambassadors (PA) > 18 years who have completed treatment for their acute leukemia > 6 month (in complete remission) and provides consent to participate in the ambassador training program, and applicable to all participants (patients and PA) written informed consent is provided.
排除标准
- •Patients and ambassadors are excluded if they do not understand, read and speak Danish, if they have unstable medical disease or cognitive / psychiatric disorders.
结局指标
主要结局
Recruitment rate
时间窗: Up to 2 years
Number of participants included from eligible patients
Emotional reactions (content of contacts with project team members)
时间窗: Up to 24 weeks
Measured by registration quality of contact made by participants to primary investigator / project psychologist / project nurse
Emotional reactions (Total numbers of contacts with project team members)
时间窗: Up to 24 weeks
Measured by registration on numbers of contact made by participants to primary investigator / project psychologist / project nurse
Adherence to intervention
时间窗: Up to 24 weeks
number of weeks completed out of planned weeks of intervention
次要结局
- Anxiety and Depression(Change measures (baseline, 12 weeks, and 24 weeks))
- Quality Of Life(Change measures (baseline, 12 weeks, and 24 weeks))
- Infections (days)(Up to 24 weeks)
- Symptom burden(Change measures (baseline, 12 weeks, and 24 weeks))
- Self-efficacy(Change measures (baseline, 12 weeks, and 24 weeks))
- Hospital admissions (total number of admissions)(Up to 24 weeks)
- Hospital admissions (causes)(Up to 24 weeks)
- Hospital admissions (days)(Up to 24 weeks)
- Proportion of participants with overall survival up to 24 weeks(Up to 24 weeks)
- Patient Activation Measure(Change measures (baseline, 12 weeks, and 24 weeks))
- Quality of Life(Change measures (baseline, 12 weeks, and 24 weeks))
- Physical activity level(Change measures (baseline, 12 weeks, and 24 weeks))
- Length of contacts between patient and ambassador(Up to 12 weeks)
- Infections (type)(Up to 24 weeks)
- Number of contacts between patient and ambassador(Up to 12 weeks)
- Thematic content of the contacts between patient and ambassador(Up to 12 weeks)
研究者
Kristina Holmegaard Nørskov
Principal Investigator
Rigshospitalet, Denmark