StepByStep: A Randomized Trial of a Mobile Health and Social Media Physical Activity Intervention Among Adolescent and Young Adult Childhood Cancer Survivors
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 387
- 试验地点
- 197
- 主要终点
- Minutes of moderate-to-vigorous physical activity (MVPA) per day
研究概览
简要总结
This phase III trial compares a multi-component mobile health and social media physical activity intervention versus wearing a physical activity tracker alone among adolescent and young adult childhood cancer survivors. Regular physical activity helps maintain healthy weight, energy levels, and health. Adolescents and young adults who complete treatment for cancer are often less active. They may gain weight and have more health problems compared to people the same age who have not had treatment for cancer. Comparing the 2 programs will help researchers learn how to increase physical activity levels over time and also how changes in physical activity levels affect health and quality of life over time.
详细描述
PRIMARY OBJECTIVE:
I. To evaluate the effects of a multi-component physical activity intervention including a Fitbit, individualized goal setting, and a social media peer support group compared to the control condition (Fitbit only) on physical activity among adolescent and young adult survivors of childhood cancer (AYA survivors) who do not meet physical activity guidelines.
SECONDARY OBJECTIVES:
I. To evaluate the effects of a multi-component physical activity intervention including a Fitbit, individualized goal setting, and a social media peer support group compared to the control condition (Fitbit only) on biomarkers predictive of cardiometabolic health among adolescent and young adult survivors of childhood cancer (AYA survivors) who do not meet physical activity guidelines.
II. To evaluate the effects of a multi-component physical activity intervention including a Fitbit, individualized goal setting, and a social media peer support group compared to the control condition (Fitbit only) on health-related quality of life among adolescent and young adult survivors of childhood cancer (AYA survivors) who do not meet physical activity guidelines.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 15 Years 至 20 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •First diagnosis of malignant neoplasm (International Classification of Diseases for Oncology [ICD-O] behavior code of "3") in first and continuous remission at the time of enrollment
- •Curative cancer treatment must have included chemotherapy (including cellular therapy) and/or radiation (including radioactive iodine)
- •Note: Childrens Oncology Group (COG) therapeutic trial participation is not required
- •All cancer treatment must have been completed within 3-36 calendar months prior to enrollment
- •Patients must have a life expectancy of > 1 year
- •Self-report of < 420 minutes of moderate-to-vigorous physical activity per week as assessed via the study-specific Physical Activity Worksheet
- •Note: See COG Study Web Page for the Godin-Shephard Leisure Time Physical Activity Questionnaire or link to online calculator
- •Ambulatory and no known medical contraindications to increasing physical activity
- •Note: Patients with amputation, rotationplasty, or other prothesis are not automatically excluded as long as they are ambulatory and have no known medical contraindications to increasing physical activity and all other eligibility criteria are satisfied
- •No known significant physical or cognitive impairment that would prevent use of the electronic devices used for the protocol intervention (e.g. Fitbit, smartphone, tablet, or computer)
- •Able to read and write English
- •Note: For patients < 18 years, consenting parent/legal guardian does not have to be able to read and write English
- •All patients and/or their parents or legal guardians must sign a written informed consent
- •Note: Informed consent may be obtained electronically/online if allowed by local site policy and Institutional Review Board (IRB)/Research Ethics Board (REB) of record
- •All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met
排除标准
- •Post-menarchal female patients who are pregnant or planning to become pregnant in the next year are excluded
- •Note: Pregnancy status can be established by clinical history with patient. Post-menarchal female patients are eligible as long as they agree to use an effective contraceptive method (including abstinence) during study participation
- •Patients with previous hematopoietic stem cell transplant (HSCT) are excluded
- •Note: Patients with previous autologous HSCT, chimeric antigen receptor T-cell (CAR T-cell) therapy, and other cellular cancer therapies can participate as long as all other eligibility criteria are satisfied
研究组 & 干预措施
Intervention group (educational materials, goal set, Fitbit)
See outline
干预措施: Health Promotion and Education (Other)
Control Group (educational materials, Fitbit)
Participants receive educational materials about physical activity and wear a Fitbit daily for 48 weeks.
干预措施: FitBit (Device)
Control Group (educational materials, Fitbit)
Participants receive educational materials about physical activity and wear a Fitbit daily for 48 weeks.
干预措施: Educational Intervention (Other)
Intervention group (educational materials, goal set, Fitbit)
See outline
干预措施: Educational Intervention (Other)
Intervention group (educational materials, goal set, Fitbit)
See outline
干预措施: FitBit (Device)
Intervention group (educational materials, goal set, Fitbit)
See outline
干预措施: Goal Setting (Other)
Intervention group (educational materials, goal set, Fitbit)
See outline
干预措施: Media Intervention (Other)
Intervention group (educational materials, goal set, Fitbit)
See outline
干预措施: Telephone-Based Intervention (Behavioral)
结局指标
主要结局
Minutes of moderate-to-vigorous physical activity (MVPA) per day
时间窗: 12 months
Moderate-to-vigorous physical activity (MVPA) will be measured with a research-grade accelerometer which records minutes of MVPA over a 7 day period. This is used to calculate MVPA minutes at baseline and 12 months post-baseline. Total minutes above the moderate-intensity threshold will be divided by the number of valid days to obtain minutes of MVPA per day. Will report the mean difference in average daily minutes of MVPA from baseline to 12 months, by arm, with corresponding 95% confidence intervals.
次要结局
- Total cholesterol(12 months)
- Hemoglobin A1c (HbA1c)(12 months)
- Insulin (HOMA-IR)(12 months)
- High sensitivity C-reactive protein (CRP)(12 months)
- High density lipoprotein (HDL)(12 months)
- Low density lipoprotein (LDL)(12 months)
- Triglycerides(12 months)
- Cardiopulmonary fitness(12 months)
- Resting heart rate(12 months)
- Health-related quality of life (HRQOL) Global Functioning(12 months)
- Health-related quality of life (HRQOL) Physical Functioning(12 months)
- Health-related quality of life (HRQOL) Social Functioning(12 months)
- Health-related quality of life (HRQOL) Fatigue(12 months)