Testing the Feasibility and Efficacy of Two Different Intensities of an Intervention to Enhance REsilience and to Reduce SupportIve Care Needs in Cancer Patients: A Phase II TriaL
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 86
- 主要终点
- Connor Davidson Resilience Scale Score Change
研究概览
简要总结
The aim of this phase II study is to test by feasibility and efficacy of two interprofessional supportive care interventions with different intensities to facilitate resilience in patients and thereby to reduce their unmet supportive care needs.
详细描述
Intervention A (tested in arm A) includes screening of resilience and supportive care needs as well as direct feed-back of the screening results on a monitoring sheet to nurses and oncologists in charge of the patient. Nurses and oncologists follow three training sessions to be trained in a) resilience facilitation, b) interventions to adress supportive care needs, c) use of the monitoring sheet.
Intervention B (tested in arm B) includes same intervention as arm A supplemented by 5 structured nurse led consultations, two face to face (F2F), three by phone (PC) provided by clinical nurse specialists and based on a consultation manual.
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
- None
入排标准
- 接受健康志愿者
- 否
入选标准
- •age 18 years and older
- •attending the clinic for the first chemotherapy administration
- •newly diagnosed (between 4-15 weeks after diagnosis) with a new carcinoma / lymphoma
- •sufficiently literate in French or German to complete questionnaires.
排除标准
- •recurrent disease
- •being treated in in-patient or palliative care units
- •diagnosed with all other cancers
- •in need of complex chemotherapy
- •being judged by the oncologist as not being emotionally or physically capable to participate in the trial will be excluded.
研究组 & 干预措施
Arm A: Low Intensity
RESIL Intervention provided by nurses and oncologists of the outpatient oncology unit.
干预措施: RESIL Intervention (Behavioral)
Arm B: High Intensity
RESIL Intervention provided by nurses and oncologists of the outpatient oncology unit plus 5 nurse-led consultations (3 face-to-face and 2 telephone consultations)
干预措施: RESIL Intervention (Behavioral)
结局指标
主要结局
Connor Davidson Resilience Scale Score Change
时间窗: week 1 (first intervention application) and week 16
Number of patients expressing a CD-RISK score change of ≥ 5 in arms A and B
次要结局
- Supportive Care Needs Survey 9 item version score changes(week 1 (first intervention application) and week 16)
研究者
Manuela Eicher
Professeure Associée
University of Lausanne