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临床试验/NCT05376293
NCT05376293已完成不适用

Web-based Intervention for Increasing Physical Activity in Cancer Survivors

The Miriam Hospital2 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2022年8月23日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
46
试验地点
2
主要终点
Program Satisfaction Via Likert Scale

研究概览

简要总结

Rates of cancer survivorship are on the rise and cancer survivors face unique health challenges that are common across cancer types that last well beyond the cessation of cancer treatment (e.g., increased fatigue, anxiety/depression, fear of recurrence, risk of cardiovascular disease, and lower health-related quality of life). While physical activity (PA) has favorable effects on these health parameters and is highly recommended for cancer survivors, this population engages in lower-than-average levels of PA. Effective PA interventions with high translation potential are important for improving the health of this population. The Internet overcome barriers to traditional face-to-face treatment programs (e.g., high cost, participant burden, geographical constraints) and represents a disseminable intervention approach. While behaviorally-based Internet programs significantly increase PA in other health domains, the application of these programs to cancer survivors is relatively new. This study will randomize 50 cancer survivors to a 12-week Internet PA program or usual-care newsletter condition. Primary outcomes include intervention engagement and program satisfaction related to the Internet program and changes in PA by intervention arm at post-treatment (3 months). Secondary aims include comparison of intervention arms on changes in sleep, weight, fatigue, anxiety/depression, health-related quality of life, and fear of recurrence.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Confirmed cancer diagnosis and have either completed all cancer-directed treatment in the past 3-12 months or be on a maintenance/continuous treatment regimen for which they have been stable for at least 3 months
  • Inactive - defined as engaging in <60 min/week of moderate-intensity PA over the past 3 months
  • BMI between 18.5 and 45 kg/m2
  • English speaking
  • Daily Internet access

排除标准

  • Any medical condition for which physical activity is contraindicated
  • Unable to attend assessment visits in Providence RI

结局指标

主要结局

Program Satisfaction Via Likert Scale

时间窗: 3 months

Participants used a 1-7 Likert scale to answer 'how satisfied are you with the program received?" (higher score indicates greater satisfaction)

Change in Physical Activity

时间窗: baseline to 3 months

Change in minutes/week of moderate-to-vigorous intensity physical activity from baseline to 3 months as assessed by Actigraph accelerometers. Positive number indicates an increase in physical activity

Intervention Engagement - Planning of Physical Activity (Internet Program Only)

时间窗: weekly from weeks 2-12

Participants were asked to submit an exercise plan (i.e., when they intended to exercise that week) at the beginning of weeks 2-12. This is the percentage of weeks that an exercise plan was submitted on the study website by the participant.

Intervention Engagement - Self-monitoring of Physical Activity (Internet Program Only)

时间窗: weekly during weeks 1-12

Participants were asked to log their exercise minutes each week on the study website. This is the percentage of weeks that exercise minutes were reported on the study website by the participant over the 12-week period.

次要结局

  • Fatigue Measured Via the Brief Fatigue Inventory (BFI)(baseline to 3 months)
  • Health-related Quality of Life (General Health Subscale) Measured Via the SF-36(baseline to 3 months)
  • Psychological Distress Measured Via the 'Global Severity Index' Scale of the Brief Symptom Inventory-18 (BSI-18)(baseline to 3 months)
  • Fear of Recurrence Measured Via the Fear of Cancer Recurrence Inventory (FCRI)(baseline to 3 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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