Survivorship Intervention for Patients Living With Advanced and Metastatic Cancers: a Randomized Controlled Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 68
- 试验地点
- 10
- 主要终点
- Adherence rate to intervention
研究概览
简要总结
To conduct a feasibility trial to examine the feasibility and acceptability of conducting a randomized controlled trial that evaluates the effect of the survivorship care intervention on patient-reported outcomes, defined as symptom distress and health-related quality of life.
详细描述
The primary aim of this study is to examine the feasibility and acceptability of conducting a randomized controlled trial (RCT) that evaluates a community-based survivorship care intervention to reduce symptom distress and improve health-related quality of life and self-management efficacy among patients with advanced or metastatic cancer. No hypothesis was proposed for this feasibility trial as the current Consolidation Standards of Reporting Trials (CONSORT) guidelines for reporting feasibility trials do not recommend hypothesis testing of clinical outcomes. The rationale is that pilot trials are often underpowered to detect differences, and this should be the aim of the main trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
The investigator and outcomes assessor are masked in terms of not knowing to which condition the participants will be randomized until after the completion of the baseline assessment. The outcomes assessor will break the envelope for the next eligible participant indicating if that participant is to be allocated to the intervention or the control arm.
The participants are masked in terms of not knowing that the intervention are hypothesized to yield larger effects than the others (i.e. controls).
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
- •Patients diagnosed with advanced or metastatic cancer
- •are at least 18 years of age
- •physically able to attend the supportive clinic.
排除标准
- •Participants will be excluded from the study if they are non-Cantonese-, non-Mandarin-, or non-English-speakers.
研究组 & 干预措施
Supportive clinic
Patients randomized to the intervention arm will attend a 120-minute survivorship clinic in which each participant will be assessed by members of a multidisciplinary team comprising an oncology nurse practitioner, a dietitian, a cancer exercise specialist, and a counsellor.
干预措施: Supportive clinic (Behavioral)
Control: Self-management
Patients randomized to the control group will be given a set of pamphlets explaining symptoms and describing skill-based self-management for symptom management and lifestyle recommendations.
干预措施: Control: Self-management (Behavioral)
结局指标
主要结局
Adherence rate to intervention
时间窗: immediate post-intervention
number of participants who complete the intervention/number of being allocated to attend the intervention x 100
Rate of missing data
时间窗: baseline, 6-months and 9- months post-baseline
number of participants with completed datasets for outcome measures/number of participant enrolled x 100
Rate of subject recruitment
时间窗: baseline
number of participants consent and being randomized/number of eligible patients x 100
Rate of subject retention
时间窗: baseline, 6-months and 9- months post-baseline
number of participants who complete follow-up assessments at 6 and 9 months post-baseline/number of participants enrolled x 100
Change of symptom distress
时间窗: baseline, 6-months and 9- months post-baseline
The 10-items Edmonton Symptom Checklist (ESAS) will be used to assess symptom distress. The ESAS assesses 10 symptoms commonly observed in cancer patients: pain, tiredness, nausea, depression, anxiety, drowsiness, appetite, well-being, shortness of breath, and sleep. A numerical rating scale 0 (no symptom at all) to 10 (the worst possible symptom) is used to measure distress associated with each symptom. ESAS has been widely adopted worldwide for standardized symptom screening in routine cancer care including palliative care, The total scores ranges from 0 to 100, with a higher score indicating greater total symptom distress. The minimal clinically important difference for improvement of the ESAS total symptom scores is 5.7 .
change of health-related quality of life
时间窗: baseline, 6-months and 9- months post-baseline
The Standard Chinese version of the European Organization Research Treatment Cancer (EORTC) general quality of life questionnaire (QLQ-C30) will assess health-related quality of life. The EORTC QLQ-C30 includes 30 items that measure five function scales (physical, role, emotional, cognitive, and social), three symptom scales (fatigue, pain, and nausea/vomiting), a global health QoL subscale, five single symptom items (dyspnea, appetite loss, sleep disturbance, constipation, and diarrhea) and financial difficulty. All of the scales range in score from 0 to 100.The 10-point EORTC-QLQ-C30 scores changes are considered to be clinically important.
次要结局
- Change of self-efficacy(baseline, 6-months and 9- months post-baseline)
- Change of supportive care needs(baseline, 6-months and 9- months post-baseline)