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临床试验/NCT05257785
NCT05257785招募中不适用

Lymfit to Improve the Fitness and Quality of Life in Lymphoma Survivors: A Randomized Controlled Trial

McGill University2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2022年1月15日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
50
试验地点
2
主要终点
Change of the exercise guideline as determined by comparing the active minutes captured in the Fitbit

研究概览

简要总结

This randomized control trial seeks to determine whether a tailored and supervised exercise program adopting mobile-health technology will be able to improve fitness and quality of life among lymphoma survivors.

详细描述

Lymphoma is the most common cancer diagnosed in young adults. While curing 80% of patients, lymphoma treatment has a significant impact on young adults' health and psycho-social wellbeing by increasing fatigue and anxiety, risk of cardiovascular disease and other chronic disorders, all of which compromise one's quality of life. Regular exercise has the potential to reduce the side effects associated with cancer treatments. Thus, the most recent guidelines suggest that cancer patients should engage in adapted exercise programs during and after their treatment.

However, these guidelines are not systematically recommended by doctors and are often not followed by patients. Fatigue and lack of motivation are the main barriers to exercise among cancer survivors. Our study aims to identify young adults lymphoma patients and encourage them to adhere to the exercise guidelines with the help of an exercise physiologist and a fitness tracker. The investigators will evaluate the efficacy of these strategies in motivating exercise among young adults lymphoma survivors. Our proposed study carries significant implications for the prevention of complications of treatment for young adults lymphoma survivors.

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
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 39 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • newly diagnosed lymphoma patients who received an initial diagnosis at the age of age 18-39,
  • approved by their hematologist as having no contra-indications to vigorous exercise,
  • receiving or has received chemotherapy with curative intent within the past 6 months,
  • own a cellular phone that is able to download the Fitbit app and to complete the study questionnaires online in either French or English, and
  • has an Internet connection at home that supports participation in coaching sessions via videoconferencing (zoom).

排除标准

  • The patient has contra-indications to vigorous exercise,
  • the patient doesn't want to wear a fitness tracker due to various concerns (as no Fitbit data could be collected).

结局指标

主要结局

Change of the exercise guideline as determined by comparing the active minutes captured in the Fitbit

时间窗: 3 months

The investigators will determine the percentage of lymphoma patients who adhere to the recommended exercise guidelines for cancer patients at baseline and after the intervention, i.e. compare the minutes of Moderate to vigorous physical activity per week captured in the Fitbit among participants in the intervention arm and waitlist control arm at baseline and 3 months.

次要结局

  • Change from baseline Work Ability assessed by the Work Ability Index (WAI)(12 months)
  • Change from baseline Fear of Cancer Recurrence assessed by the Cancer Worry Scale (CWS)(12 months)
  • Change from baseline multi-dimensional Quality of life (QoL) assessed by the Patient-Reported Outcomes Measurement Information System-29(12 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Christine Maheu

Associate Professor

McGill University

研究点 (2)

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