Feasibility, Acceptability, and Preliminary Effects of a Physical Activity Intervention on Psychological Need Satisfaction, Exercise Motivation, Physical Activity Level, and Quality of Life: A Pilot Randomized Controlled Trial Among Young Adult Lymphoma Survivors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- Retention rate from baseline to end of intervention
研究概览
简要总结
Background: Lymphoma is one of the most diagnosed cancers in young adults aged 18 to 39. Lymphoma is highly treatable, and the survival rate is often high. Yet, cancer treatments can be toxic, and their side effects can negatively impact the quality of life among cancer survivors. The current research suggests that being active after treatment can improve cancer outcomes. For instance, reducing cancer-related fatigue, anxiety, depression, and improving sleep quality and survival. Physical activities can greatly improve the quality of life after cancer treatment.
Knowledge Gap: Young adults are unique from cancer patients of other age groups. Young adults need stage-of-life-specific, person-centred cancer and survivorship care. Despite knowing that exercise is beneficial in improving cancer outcomes, cancer survivors' engagement and adherence to exercise guidelines remain poor. It is crucial to develop an effective intervention that can motivate lymphoma patients to be active after treatment.
Purposes: Our study team developed a behavioural change intervention named LymFit. The LymFit intervention involves a personalized exercise program, bi-weekly kinesiology follow-ups, and the use of activity trackers. The aim of this study is to test if the design of the intervention is feasible and acceptable. The investigators also aim to test if the intervention is able to promote exercise motivation among young adult lymphoma survivors.
Implications: This 12-week pilot study examines the implementation strategies and clinical relevance of a behavioural change intervention targeting young adult lymphoma survivors. The study results have the potential to map out the optimal design of an effective physical activity intervention in improving cancer outcomes, and optimize post-cancer treatment care coordination among health professionals.
详细描述
Background: Lymphoma and its subtypes are among the most commonly diagnosed cancers in young adults aged 18 to 39. Most types of lymphoma are often treated with curative therapies. Unfortunately, treatment side effects, and unhealthy or sedentary lifestyles can substantially affect quality of life and long-term cancer prognosis outcomes among young adult cancer survivors.
A growing body of evidence reveals significant associations between physical activity and cancer-related outcomes. Evidence suggests that specific frequency, intensity, timing, and types of physical activity can have positive effects on cancer treatment processes and outcomes. Physical activity is also significantly associated with enhanced health-related quality of life among cancer survivors.
Despite sustained efforts in the development and implementation of exercise interventions geared towards specific cancer populations and age groups, evidence suggests that lymphoma survivors' exercise engagements remain suboptimal. This warrants the development of an intervention that is theoretically guided, and specific to cancer type and age, to enhance physical activity levels sufficient to improve cancer outcomes. Grounded in self-determination theory, the Lymfit intervention (an individualized exercise program with bi-weekly kinesiology assessments and an activity tracker device) supports the psychological need satisfaction of competence, relatedness, and autonomy in engaging physical activities.
Purpose: To evaluate the feasibility, acceptability, and preliminary effects of the Lymfit intervention on participants' motivation to engage in exercise among young adult lymphoma survivors.
Methods: This study is a two-armed feasibility pilot randomized controlled trial. A target sample size of 28 young adult lymphoma survivors (at the end of their treatment up to six months post-treatment) will be randomly allocated to receive either the 12-week Lymfit intervention (intervention group; n=14) or be on a wait-list (control group; n=14). Feasibility will be assessed by examining criteria related to recruitment, randomization, retention, questionnaire completion, and intervention fidelity. Acceptability will be assessed by examining participant satisfaction with the intervention and the perceived suitability of intervention delivery procedures. Preliminary effects will be assessed using self-report questionnaires at baseline and post-intervention with four study outcomes: psychological need satisfaction, exercise motivation, physical activity level, and quality of life.
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
- 否
入选标准
- •Newly diagnosed lymphoma patients who received an initial diagnosis at the age of 18 to 39
- •Receiving or have received chemotherapy with curative intent within the past six months
- •Own a smartphone that is able to download the Fitbit application
- •Have an internet connection at home that supports participation in coaching sessions via videoconferencing and the ability to complete the study questionnaires online
- •Proficient in either French or English
排除标准
- •Have any contra-indications to moderate to vigorous levels of exercise
结局指标
主要结局
Retention rate from baseline to end of intervention
时间窗: 3 months
Measured by calculating the percentage of participants completing the post-intervention survey (retained in the study).
Acceptability of the study procedures assessed using a set of self-report items
时间窗: 3 months
10 self-report items examining participant satisfaction with the intervention and perceived suitability of intervention delivery procedures. The items are assessed using a Likert scale ranging from "1. very dissatisfied" to "5. very satisfied".
次要结局
- Change from baseline Quality of life (QoL) assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS-Preference)(3 months)
- Change from baseline Exercise level assessed by the Godin-Shephard leisure-time physical activity questionnaire (LTPA-Q)(3 months)
- Change from baseline Psychological Need Satisfaction assessed by The Psychological Need Satisfaction in Exercise (PNSE) scale(3 months)
- Change from baseline Exercise motivation assessed by the Behavioral Regulation in Exercise Questionnaire (BREQ-3)(3 months)
研究者
Christine Maheu
Associate Professor
McGill University