Effectiveness and Implementation of a Brief Motivational Intervention to Increase Physical Activity for World Trade Center Health Program Cancer Survivors
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Change in Moderate to Vigorous Physical Activity
研究概览
简要总结
The goal of this study is to test a brief motivational intervention to increase physical activity in a group of cancer survivors who are participants in the World Trade Center Health Program.
详细描述
The World Trade Center Health Program (WTCHP) tracks the ongoing health and well-being of over 91,000 first responders and people who lived and worked near the World Trade Center. Research has established that WTCHP members are at higher risk for a constellation of health conditions, including cancer. Cancer survivors, the focus of this study, are at risk for physical and functional impairment. As WTCHP members with cancer age, developing pragmatic interventions to mitigate physical decline is an important next step in a coordinated program of care and research in this vulnerable population. Physical activity (PA) interventions are strong candidates for investigation, given that physical inactivity in WTCHP members has been correlated with respiratory illness, poor sleep, and PTSD. PA has many health benefits, yet interventions to support PA are not routinely incorporated into clinical practice. Evidence-based guidelines recommend PA counseling in clinical care and health professionals believe they should be doing this. However, a gap remains in implementing PA interventions at the point of care. This study will test an evidence-based motivational intervention to initiate and maintain PA among WTCHP particpatants with cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participation in the World Trade Center Health Program
- •History of cancer, completed treatment
- •Ability to be physically active (at minimum be able to walk slowly)
排除标准
- •Participants receiving active cancer treatment (excluding hormonal therapy);
- •Late-stage cancer (metastatic);
- •Inability to follow the scheduled visits;
- •Women who are pregnant
- •Patients who would not be safe exercising without medical supervision (ECOG score of 3, significant comorbidities, unable to even walk slowly)
- •Inability to speak and read English.
研究组 & 干预措施
Intervention
Motivational Intervention:
The intervention group will receive a 3-component motivational intervention based on the Theory of Planned Behavior in addition to an enhanced standard of care. The components of the intervention include motivational interviewing (MI); mobile health monitoring; and action planning.
At the initial visit, following baseline data collection, the clinician will use MI to build a positive attitude towards physical activity (PA). Next, they will discuss why and how to use Fitbit to monitor steps per day. The last component of the intervention includes action planning to design a PA program that fits their abilities and lifestyle. Following the in-person baseline visit, participants will be called approximately every 2 weeks during the 3-month intervention period. During these calls, the action plan will be reviewed and updated, and their step count reviewed.
干预措施: Brief Motivational Intervention (Behavioral)
Wait List Control
Wait List Control:
The control group will receive a Fitbit and advice to continue their normal physical activity. At the end of 3 months, the wait-list control group will be seen in the clinic for the motivational intervention which will be the same as the intervention group. They will return to the clinic at the end of the study (6 months) for final data collection. Participants in the wait list control group will use the Fitbit for the full 6 months of the study, during the 3 month waiting period and the 3 month intervention.
干预措施: Brief Motivational Intervention (Behavioral)
结局指标
主要结局
Change in Moderate to Vigorous Physical Activity
时间窗: Baseline to end of study (6 months)
The primary outcomes will be measured with Fitbit data. Fitbit software allows classification of each minute as being in sedentary, light, moderate, or vigorous activity, and provides metabolic equivalents (METs) for each minute. Positive changes in levels of physical activity will be determined by a 25% increase in MVPA from baseline to end of intervention. This estimation is based on a systematic review of motivational physical activity interventions in cancer survivors (Takemura, 2024). This change in outcome measure is well justified and sensitive to small changes in activity.
次要结局
- Quality of Life (SF-20)(Baseline to end of study (6 months))
- Sleep (PROMIS Sleep SF)(Baseline to end of study (6 months))
- Fatigue (PROMIS Fatigue SF)(Baseline to end of study (6 months))
- Physical Functioning (Short Physical Performance Battery)(Baseline to end of study (6 months))
- Quality of Life (SF-20)(Baseline to end of study (6 months))
- Sleep (PROMIS Sleep SF)(Baseline to end of study (6 months))
- Fatigue (PROMIS Fatigue SF)(Baseline to end of study (6 months))
- Physical Functioning (Short Physical Performance Battery)(Baseline to end of study (6 months))
- Post traumatic stress disorder (PCL-5)(Baseline to end of study (6 months))
研究者
Pamela Ginex
Assistant Professor
Stony Brook University