Personalised Exercise Rehabilitation for Cancer Survivorship
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Percentage of people who attended assessment who proceed to attend level 2 or level 3 referral service
研究概览
简要总结
There is strong evidence that exercise can help improve physical and mental wellbeing after treatment for cancer. However, at present, people with cancer in Ireland are not given the opportunity to have an individual assessment of their physical and psychological wellbeing as part of standard care and are not routinely prescribed exercise-based rehabilitation.
The researchers will run and evaluate a system to i. assess physical and psychological wellbeing of people who have completed cancer treatment, ii. apply a rehabilitation triage system, based on findings of the assessment, iii. refer participants to one of three rehabilitation pathways, as per outcome of the triage process.
Rehabilitation pathways are as follows:
- Participants who are currently active and have no cancer-specific impairments will receive advice from the physiotherapist on maintaining their current levels of activity.
- Participants who are not active and have no cancer-specific impairments will be referred to a suitable community-based exercise programme. This programme must contain both resistance and aerobic training and should have some level of supervision from a fitness professional.
- Participants who are not active and have ongoing cancer-specific impairments will be referred to an oncology specialist physiotherapist, funded through this work, at St James's Hospital for assessment and treatment.
All participants will be encouraged to visit www.cancerrehabilitation.ie for information through out the study. Participants will be reassessed 12 weeks after the initial assessment.
The implementation of this system will be evaluated using the RE-AIM framework.
详细描述
Background During and following treatment for cancer, people can experience negative side-effects of treatment, including loss of fitness, weakness, fatigue and psychological issues such as depression and anxiety. There is strong evidence that exercise can help improve these symptoms. The impact of the COVID-19 pandemic means that many people who had cancer treatment since March 2020 may need additional support to achieve optimum physical and psychological wellbeing. At present, people with cancer in Ireland are not given the opportunity to have an individual assessment of their physical and psychological wellbeing as part of standard care and are not routinely prescribed exercise-based rehabilitation.
Aim To run and evaluate an exercise-based rehabilitation triage and assessment clinic for people who had cancer treatment since the beginning of the COVID-19 pandemic.
Study Design:
Patients who were diagnosed with cancer in St James Hospital since March 2020 will be invited to participate in the study. Participants will attend an appointment with a physiotherapist, who will assess their physical and mental wellbeing. On the basis of the assessment findings, participants will be assigned to one of three categories, which will determine their ongoing rehabilitation plan. The three categories are as follows:
- Participants who are currently active and have no cancer-specific impairments will receive advice from the physiotherapist on maintaining their current levels of activity.
- Participants who are not active and have no cancer-specific impairments will be referred to a suitable community-based exercise programme. This programme must contain both resistance and aerobic training and should have some level of supervision from a fitness professional.
- Participants who are not active and have ongoing cancer-specific impairments will be referred to an oncology specialist physiotherapist, funded through this work, at St James's Hospital for assessment and treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
盲法说明
Implementation study designed to operate closely to clinical practice: no masking appropriate or required.
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 will be eligible to participate if they:
- •Were diagnosed with cancer at St James's Hospital since March 2020
- •Have completed adjuvant chemotherapy and/or radiotherapy
- •Are at least 6 weeks post-surgery
- •Do not show signs of recurrent or metastatic disease at the time of enrolment
- •Are over the age of 18 years
排除标准
- •Anyone who is unable to provide informed consent Any person with known or signs or symptoms suggestive of cardiovascular, metabolic or renal disease will require medical clearance from a physiotherapist or medical professional prior to participation, based on criteria outlined in the Safety Reference Guide to support the safe delivery of exercise services to people with cancer by Santa Mina et al. (2018). Preparticipation screening will be completed in accordance with the American College of Sports Medicine Preparticipation health screening recommendations.
结局指标
主要结局
Percentage of people who attended assessment who proceed to attend level 2 or level 3 referral service
时间窗: Data reported by 12 months
Attrition rate - referrals
RE-AIM Framework
时间窗: Data reported by 12 months
Evaluation of system Reach, Effectiveness, Adoption, Implementation, Maintenance
Percentage of people attending scheduled assessments at i. T0 and ii. T1
时间窗: Data reported by 12 months
Assessment completion rate
i. Time from assessment to referral being sent ii. Percentage of referral accepted at initial site iii. Time from referral sent to initial appointment
时间窗: Data reported by 12 months
Referral outcome - time frame and acceptance
Percentage of patients on Prehabilitation list which are eligible for the study
时间窗: Data reported by 12 months
Referral - Eligible referral rate from prehabilitation group
The percentage of referrals to the study from clinical team which are eligible for the study
时间窗: Data reported by 12 months
Referral - Eligible referral rate from clinical teams
Percentage of people enrolled in study who have received both recruitment letter and phone call
时间窗: Data reported by 12 months
Enrolment rate
i. Percentage of people triaged to each level (1, 2 or 3) ii. Percentage triaged to another level after initial triage and why
时间窗: Data reported by 12 months
Triage results
Number and nature of adverse events occurring in assessment process
时间窗: Data reported by 12 months
Adverse events
Percentage of people who attended T0 assessment that attend T1 assessment
时间窗: Data reported by 12 months
Attrition rate - assessments
Information related to feasibility gathered from semi-structured interviews with participants
时间窗: Data reported by 12 months
Qualitative feasibility
次要结局
- Sociodemographic details(T0 assessment; data reported by 12 months)
- International Physical Activity Questionnaire(T0 assessment, T1 (+12 weeks from T0 assessment); data reported by 12 months)
- Timed Up and Go(T0 assessment, T1 (+12 weeks from T0 assessment); data reported by 12 months)
- Hand grip strength(T0 assessment, T1 (+12 weeks from T0 assessment); data reported by 12 months)
- Six minute walk test(T0 assessment, T1 (+12 weeks from T0 assessment); data reported by 12 months)
- Height(T0 assessment, T1 (+12 weeks from T0 assessment); data reported by 12 months)
- EOCG-PS(T0 assessment, T1 (+12 weeks from T0 assessment); data reported by 12 months)
- Medical history(T0 assessment; data reported by 12 months)
- Health Behaviour and Stages of Change Questionnaire(T0 assessment, T1 (+12 weeks from T0 assessment); data reported by 12 months)
- Self-efficacy for exercise scale(T0 assessment, T1 (+12 weeks from T0 assessment); data reported by 12 months)
- Patient specific funcational scale(T0 assessment, T1 (+12 weeks from T0 assessment); data reported by 12 months)
- 30 second Sit-to-Stand(T0 assessment, T1 (+12 weeks from T0 assessment); data reported by 12 months)
- Weight(T0 assessment, T1 (+12 weeks from T0 assessment); data reported by 12 months)
- Waist Circumference(T0 assessment, T1 (+12 weeks from T0 assessment); data reported by 12 months)
- Mid-arm Circumference(T0 assessment, T1 (+12 weeks from T0 assessment); data reported by 12 months)
- Mini Nutritional Assessment(T0 assessment, T1 (+12 weeks from T0 assessment); data reported by 12 months)
- European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC- QLQ-C30)(T0 assessment, T1 (+12 weeks from T0 assessment); data reported by 12 months)
- Multidimensional Fatigue Inventory (MFI-20)(T0 assessment, T1 (+12 weeks from T0 assessment); data reported by 12 months)
- Hospital Anxiety and Depression Scale (HADS)(T0 assessment, T1 (+12 weeks from T0 assessment); data reported by 12 months)
研究者
Emer Guinan
Assistant Professor
University of Dublin, Trinity College