A Comparison of Exercise Training With Relaxation Intervention in Lymphoma Patients Post-chemotherapy.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 2
- 主要终点
- Change in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC-QLQ-C30)
研究概览
简要总结
This study will aim to compare the effects of an Exercise programme and a Relaxation Intervention in lymphoma patients in remission post-chemotherapy on quality of life, cardiovascular fitness, exercise tolerance, muscle strength, psychological status, social well-being and biological markers.
Subjects will be recruited from a specialist lymphoma clinic in South West London and randomly allocated to an exercise or a relaxation home programme. The study aims to determine the more effective intervention of the two in relation to the outcome measures.
The investigators anticipate that the interventions will result in less adverse events and improved quality of life and physical fitness, and subjects will require less medication, less counseling and cancer nurse specialist care, leading to leading to a reduction in hospital and surgery attendances.
详细描述
Significant improvements have been made in the survival rates in cancer patients. Due to factors such as screening and earlier detection of cancer and advances in treatment, cancer today is a curable disease for many. However, cancer survivors are at a significantly increased risk of morbidity and adverse effects due to treatment exposures. Commonly reported consequences of cancer treatment include fatigue, pain, depression, anxiety, reduced performance status and decreased quality of life Hence cancer today is considered more as a chronic illness, and there is increasing research being carried out on cancer survivorship and recommendations for survivorship care pathways to include interventions to enhance both physical and psychosocial functioning in cancer survivors.
Previous studies have demonstrated that both exercise and interventions such as relaxation have a positive effect on both physical and psychosocial complaints of cancer survivors. These interventions are carried out in different ways, have different requirements and perceptions of the two can also be very different. No trial to date has been carried out comparing the effects of these interventions on the quality of life in cancer survivors. Furthermore, majority of the above research has been carried out on the most prevalent cancers including breast cancer, prostate cancer and colorectal cancer, and several authors have called for future research to focus on other understudied survivor groups, including haematologic cancer sites. This study aims to compare the effect of exercise and relaxation interventions on quality of life in lymphoma survivors.
The aim of the present study is to compare the effects of an Exercise Intervention Program with a Relaxation Intervention in a sample of lymphoma patients in remission post-chemotherapy.
Eligible subjects will be randomised to one of two arms - either an exercise or a relaxation arm. Both arms comprise of a home programme of their intervention (either exercise or relaxation) for half an hour, carried out three times a week. Subjects are assessed using the primary and secondary outcome measures at baseline, midway (6 weeks) and at the end of the intervention (12 weeks). It is hypothesised that a 12 week training programme of both exercise and relaxation would improve the quality of life of lymphoma survivors, however the exercise programme would result in a significantly greater improvement than relaxation. The null hypothesis would state that there would be no significant difference between exercise or relaxation groups following a 12 week training programme in lymphoma survivors.
The aims of the study are as follows:
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
- 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 with histologically confirmed lymphoma in remission post-chemotherapy
- •Age 18 years or older
- •Ability to give informed consent
- •Good Performance status (ECOG 0-2)
- •Clinically able to carry out exercise training programme on a regular basis
排除标准
- •Patients with progressive disease
- •Poor performance status (ECOG status 3 or more)
- •Abnormal resting ECG unexplained by further cardiological investigations
- •Difficulty breathing at rest
- •Persistent cough, fever or illness
- •Cognitive impairment sufficient to limit ability to perform quality of life questionnaires or understand instructions
研究组 & 干预措施
Exercise Intervention
Subjects allocated to the Exercise arm will aim to undertake a personal prescribed home exercise programme for half an hour three times a week.
Exercises will be progressed at 6 weeks as subjects progress. All exercise sessions will be documented in the logbooks provided.
Outcome measures will be assessed at baseline, mid-way (6 weeks) and at the end of intervention (12 weeks).
干预措施: Exercise (Behavioral)
Relaxation Intervention
Subjects allocated to the Relaxation arm will aim to undertake a guided relaxation programme on a CD for half an hour three times a week.
All relaxation sessions will be documented in the logbooks provided. Outcome measures will be assessed at baseline, mid-way (6 weeks) and at the end of intervention (12 weeks).
干预措施: Relaxation (Behavioral)
结局指标
主要结局
Change in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC-QLQ-C30)
时间窗: Baseline, 6 weeks and 12 weeks
The EORTC-QLQ-C30 is a self-administered questionnaire which assesses aspects of function, symptoms, and global health and QOL in samples of cancer patients. It has been demonstrated to be a valid and reliable tool in the literature, takes approximately eleven minutes to complete and most subjects require no assistance.
次要结局
- Change in Grip Strength(Baseline, 6 weeks and 12 weeks)
- Change in Spirometry values(Baseline, 6 weeks and 12 weeks)
- Change in FACT-Lym Questionnaire(Baseline, 6 weeks and 12 weeks)
- Change in Hospital Anxiety and Depression Scale(Baseline, 6 weeks and 12 weeks)
- Change in Six Minute Walk Test distance and Heart Rate(Baseline, 6 weeks and 12 weeks)
