Cancer Behavioural Nutrition and Exercise Feasibility Trial - Phase II Randomised Controlled Trial Among Older Adults With Lung Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 4
- 主要终点
- Recruitment Rate
研究概览
简要总结
People with cancer affecting the lungs tend to be older and frailer compared to people with other cancers. As a result, they may have poorer quality of life and are less able to tolerate treatments for their cancer, such as chemotherapy. Research to date show that nutrition and physical activity support helps people with cancer, but not many older people are included in these studies.
The investigators want to develop and test a nutrition and activity programme for older people with lung cancer that can be tailored to each patient to help them have the best possible quality of life from the moment they start a new line of cancer treatment.
The research team has conducted the development work to find which nutrition and activity programmes are best for this patient group and how best to deliver the programme by looking at prior studies and talking to patients and carers as well as health care providers.
The next step is to test the developed programme in a small pilot study, to i) see if it is possible and acceptable (to patients, families, and staff) to deliver and ii) see if it helps patients have and cope with anti-cancer treatments and improve patient quality of life.
详细描述
BACKGROUND
Lung cancer is the third most commonly diagnosed cancer in the UK and most common in Yorkshire. It is also the most common cause of cancer death in UK. People with lung cancer are often older with co-morbidities and frailty resulting in a poor prognosis - especially if they are unfit for treatment. Approximately half of new cancer cases in UK are people aged 65 and over. Frailty, with sarcopenia (age-related decline in skeletal muscle), cachexia (disease-related body wasting) and nutritional deficiencies, may limit chemotherapy options, reduce treatment effectiveness, result in dose reductions and poor treatment completion rates.
Physical activity (PA) interventions benefit people living with or beyond cancer by improving physical function and quality of life (QoL) during and after cancer treatment. Reduced physical function is associated with higher mortality in older adults with cancer.PA improves treatment completion, treatment recovery, survival rates and reduces healthcare use. Emerging work indicates that activity improves immune function in older adults with cancer; important as better immune function has been linked to improved treatment outcomes. A recent meta-analysis shows reduced risk of cancer-specific and all-cause mortality for those more active among people with lung cancer.
Weight loss and poor nutrition may prevent patients from completing cancer treatments and increase the risk and severity of treatment toxicity. In those receiving chemotherapy, better nutritional status is associated with improved survival and, in lung cancer patients undergoing chemotherapy, better QoL. Cancer treatments can cause many side-effects that impact eating, including; fatigue, nausea, vomiting, dry mouth/oral candidiasis, disordered taste, ill-fitting dentures, diarrhoea, constipation, oesophagitis, early satiety and poor appetite; all difficult for patients to self-manage. Nutritional interventions, including dietary counselling and nutrition advice, improve patient wellbeing and rate of treatment completion. Despite the urgent need for improvements in survival outcomes for older people with lung cancer, a significant evidence gap remains regarding nutrition.
This team's systematic review highlighted the lack of PA and nutrition programme research for older adults living with and beyond cancer. Studies including older adults often focus on prostate cancer, generally a group with a better prognosis. Therefore, many older adults with other cancers, such as lung cancer (only one study in our review), are not represented. Qualitative interviews with patients, carers, and clinicians in Hull (with experience of lung cancer) confirmed poor access to, but support for and interest in, wellbeing interventions but only if tailored to their needs - including management of activity-related breathlessness.
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
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age ≥65 years,
- •diagnosed with stage III or IV lung cancer or mesothelioma,
- •starting a new line of systemic anti-cancer treatment,
- •willing and able to complete study measures and be randomised
- •able to provide informed written or verbal witnessed consent
排除标准
- •Patients receiving radical chemoradiation therapy (potentially curative and require parental feeding)
- •Have had more than one dose of new treatment.
- •Unstable acute condition (e.g., acute infection, severe uncontrolled symptoms) or
- •Underlying chronic condition (e.g., severe arthritis or dementia) that would impact study compliance.
- •Unable to provide written or verbal consent.
- •Insufficient English for consent and study procedures and appropriate interpretation unavailable
结局指标
主要结局
Recruitment Rate
时间窗: 24 weeks
The Recruitment Rate will be assessed by the number of eligible patients approached vs the number of eligible patients consent for the study, providing a number of non-participations. This will be gathered as an aspect of feasibility.
Retention Rate
时间窗: 24 weeks
Retention rate will be examined via the number of those who consent to the study compared to the number of those who complete the study.
Secondary outcome data completion rate
时间窗: 24 weeks
Assessed by the total number of missing data from the total list of secondary outcomes
Incidence of adverse effects and injuries related to the intervention
时间窗: Week 1 to week 12
Assessed by the number and rate of participant recorded adverse effects and injuries related to the intervention
Incidence of adverse events not related to the intervention
时间窗: Week 1 to week 52
The number of adverse events exhibited by the participants will be recorded with an associated grade (where relevant). A example list of adverse events are given below: * Constipation * Nausea * Vomiting * Diarrhoea * Skin Rash
Rate of Intervention Completion
时间窗: 12 weeks
The percentage of exercises prescribed to the participants compared to the number of those completed.
次要结局
- Free-living daily activity(Baseline, 24 weeks)
- Australian Karnofsky Performance Scale (AKPS)(baseline, 12 and 24 weeks)
- Short Physical Performance Battery (SPBB)(baseline, 12 and 24 weeks)
- Bioelectrical impedance(baseline, 12 and 24 weeks)
- Community Healthy Activities Model Program for Seniors (CHAMPS)(baseline and after 6, 12, and 24 weeks)
- Days alive and out of hospital(baseline, and after 6, 12, and 24 weeks)
- Treatment completion rate(baseline, and after 6, 12, and 24 weeks)
- Height(baseline, 12 and 24 weeks)
- Rockwood Frailty Index, a 7-point Clinical Frailty Scale(baseline, 12 and 24 weeks)
- Grip strength(baseline, 12 and 24 weeks)
- Weight (kg)(baseline, 12 and 24 weeks)
- Patient-Generated Subjective Global Assessment (PG-SGA)(baseline and after 6, 12, and 24 weeks)
- Integrated Patient Outcome Scale (IPOS)(baseline and after 6, 12, and 24 weeks)
- Client Service Receipt Inventory(baseline and after 6, 12, and 24 weeks)
- Infection rate(baseline, and after 6, 12, and 24 weeks)
- EuroQol-5 Dimensions-5 Levels(baseline and after 6, 12, and 24 weeks)
- EuroQol-Visual Analogue Scale(baseline and after 6, 12, and 24 weeks)
- Treatment toxicity(baseline, and after 6, 12, and 24 weeks)