Using MOST to EMPOWER: Optimizing an Emotion Regulation Intervention to Enhance Well-being Among Adolescents and Young Adult Cancer Survivors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 352
- 试验地点
- 6
- 主要终点
- Patient-Reported Outcomes Measurement Information System (PROMIS) Positive Affect Computer Adaptive Test (CAT) Questionnaire
研究概览
简要总结
This purpose of this study is to test a digital health intervention that may promote well-being among young adult cancer survivors. Investigators hope to learn more about wellness and health-related quality of life among young adult cancer survivors by promoting well-being and teaching skills for healthy coping and mood management.
详细描述
The EMPOWER Intervention is composed of five components:
- Noting daily positive event, capitalizing on and savoring positive events, and gratitude.
- Mindfulness
- Positive Reappraisal
- Focusing on personal strengths, setting and working toward attainable goals
- Small Acts of Kindness
For subjects who do not receive EMPOWER components or only receive some of the EMPOWER components, they will be given inert content. The inert content will cover Cognitive changes during Cancer, Diet, Weight Management, Financial Literacy and Sun Protection. The trial is a composed of a full factorial design with 32 (2X2X2X2X2) experimental conditions. Adolescents and Young Adults will receive 0, 1,2,3,4 or 5 Empower components.
Primary Objective
• Identify which of five components in the EMPOWER web based curriculum, contribute meaningfully to positive affect among post-treatment adolescent and young adult cancer survivors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 39 Years(Child, Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able to read and understand English
- •Past history of a cancer diagnosis (excluding basal cell skin carcinoma)
- •15 to 39 years of age at diagnosis of first cancer and currently between the ages of 15 to 39
- •Within 0-5 year's post-active treatment for initial diagnosis or recurrence (Note: Maintenance therapy for hematologic or hormonal therapy for breast cancers are not considered "active treatments" for purposes of this study).
- •Internet access through a home computer, tablet or smartphone.
排除标准
- •Ever been hospitalized for a psychiatric illness
- •Currently receiving palliative or hospice care
研究组 & 干预措施
Arm 6 No PE, No M, Yes PR, No PS, Yes AK
干预措施: EMPOWER (Behavioral)
Arm 7 No PE, No M, Yes PR, Yes PS, No AK
干预措施: EMPOWER (Behavioral)
Arm 8 No PE, No M, Yes PR, Yes PS, Yes AK
干预措施: EMPOWER (Behavioral)
Arm 9 No PE, Yes M, No PR, No PS, No AK
干预措施: EMPOWER (Behavioral)
Arm 10 No PE, Yes M, No PR, No PS, Yes AK
干预措施: EMPOWER (Behavioral)
Arm 11 No PE, Yes M, No PR, Yes PS, No AK
干预措施: EMPOWER (Behavioral)
Arm 12 No PE, Yes M, No PR, Yes PS, Yes AK
干预措施: EMPOWER (Behavioral)
Arm 13 No PE, Yes M, Yes PR, No PS, No AK
干预措施: EMPOWER (Behavioral)
Arm 14 No PE, Yes M, Yes PR, No PS, Yes AK
干预措施: EMPOWER (Behavioral)
Arm 15 No PE, Yes M, Yes PR, Yes PS, No AK
干预措施: EMPOWER (Behavioral)
Arm 16 No PE, Yes M, Yes PR, Yes PS, Yes AK
干预措施: EMPOWER (Behavioral)
Arm 17 Yes PE, No M, No PR, No PS, No AK
干预措施: EMPOWER (Behavioral)
Arm 18 Yes PE, No M, No PR, No PS, Yes AK
干预措施: EMPOWER (Behavioral)
Arm 19 Yes PE, No M, No PR, No PS, Yes AK
干预措施: EMPOWER (Behavioral)
Arm 20 Yes PE, No M, No PR, Yes PS, Yes AK
干预措施: EMPOWER (Behavioral)
Arm 21 Yes PE, No M, Yes PR, No PS, No AK
干预措施: EMPOWER (Behavioral)
Arm 22 Yes PE, No M, Yes PR, No PS, Yes AK
干预措施: EMPOWER (Behavioral)
Arm 23 Yes PE, No M, Yes PR, Yes PS, No AK
干预措施: EMPOWER (Behavioral)
Arm 24 Yes PE, No M, Yes PR, Yes PS, Yes AK
干预措施: EMPOWER (Behavioral)
Arm 25 Yes PE, Yes M, No PR, No PS, No AK
干预措施: EMPOWER (Behavioral)
Arm 26 Yes PE, Yes M, No PR, No PS, Yes AK
干预措施: EMPOWER (Behavioral)
Arm 27 Yes PE, Yes M, No PR, Yes PS, No AK
干预措施: EMPOWER (Behavioral)
Arm 28 Yes PE, Yes M, No PR, Yes PS, Yes AK
干预措施: EMPOWER (Behavioral)
Arm 29 Yes PE, Yes M, Yes PR, No PS, No AK
干预措施: EMPOWER (Behavioral)
Arm 30 Yes PE, Yes M, Yes PR, No PS, Yes AK
干预措施: EMPOWER (Behavioral)
Arm 31 Yes PE, Yes M, Yes PR, Yes PS, No AK
干预措施: EMPOWER (Behavioral)
Arm 32 Yes PE, Yes M, Yes PR, Yes PS, Yes AK
干预措施: EMPOWER (Behavioral)
Arm 4 No PE, No M, No PR, Yes PS, Yes AK
干预措施: EMPOWER (Behavioral)
Arm 5 No PE, No M, Yes PR, No PS, No AK
干预措施: EMPOWER (Behavioral)
Arm 1 No PE, No M, No PR, No PS, No AK
干预措施: EMPOWER (Behavioral)
Arm 2 No PE, No M, No PR, No PS, Yes AK
干预措施: EMPOWER (Behavioral)
Arm 3 No PE, No M, No PR, Yes PS, No AK
干预措施: EMPOWER (Behavioral)
结局指标
主要结局
Patient-Reported Outcomes Measurement Information System (PROMIS) Positive Affect Computer Adaptive Test (CAT) Questionnaire
时间窗: Baseline up to 4 months after intervention
Participants will complete a self-reported questionnaire on psychological well being for feelings that reflect a level of pleasurable engagement with the environment, such as happiness, joy, excitement, enthusiasm, and contentment over the past seven days. A mixed model adjusted for baseline to model the value of the outcome (positive affect) at each time point following the intervention. Raw scores will be converted to T-scores with a mean of 50 and a standard deviation of 10. There is no fixed minimum or maximum score. Average score (50): Represents the national average for the general population. Higher scores (\>50): Indicate higher positive affect than the general population. For example, a T-score of 60 is one standard deviation better than the national average. Lower scores (\<50): Indicate lower positive affect than the general population. A T-score of 40 is one standard deviation worse than the national average.
T0 and T6 Positive Affect T-Scores--Patient-Reported Outcomes Measurement Information System (PROMIS) Positive Affect Computer Adaptive Test (CAT) Questionnaire
时间窗: At baseline (T0) and at intervention completion 10 weeks after baseline (T6)
Participants completed a self-reported questionnaire on psychological well being for feelings that reflect a level of pleasurable engagement with the environment, such as happiness, joy, excitement, enthusiasm, and contentment over the past seven days. We used a mixed model to estimate the mean within-group value of the outcome (positive affect T-score) at each time point following the intervention. Average score (50): Represents the national average for the general population. 50 indicates the population mean with a standard deviation of 10 Higher scores (\>50): Indicate higher positive affect than the general population. For example, a T-score of 60 is one standard deviation better than the national average. Lower scores (\<50): Indicate lower positive affect than the general population. A T-score of 40 is one standard deviation worse than the national average.
Patient-Reported Outcomes Measurement Information System (PROMIS) Positive Affect Computer Adaptive Test (CAT) Questionnaire
时间窗: Baseline up to 4 months after intervention
Participants will complete a self-reported questionnaire on psychological well being for feelings that reflect a level of pleasurable engagement with the environment, such as happiness, joy, excitement, enthusiasm, and contentment over the past seven days. A mixed model adjusted for baseline to model the value of the outcome (positive affect) at each time point following the intervention. Raw scores will be converted to T-scores with a mean of 50 and a standard deviation of 10. There is no fixed minimum or maximum score. Average score (50): Represents the national average for the general population. Higher scores (\>50): Indicate higher positive affect than the general population. For example, a T-score of 60 is one standard deviation better than the national average. Lower scores (\<50): Indicate lower positive affect than the general population. A T-score of 40 is one standard deviation worse than the national average.
次要结局
- Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety Questionnaire(Baseline up to 4 months after intervention)
- Patient-Reported Outcomes Measurement Information System (PROMIS) Depression Questionnaire(Baseline up to 4 months after intervention)
- Patient-Reported Outcomes Measurement Information System (PROMIS) Life Satisfaction Questionnaire(Baseline up to 4 months after intervention)
- T0 and T6 Anxiety T-Scores--Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety Computer Adaptive Test (CAT) Questionnaire(At baseline (T0) and at intervention completion 10 weeks after baseline (T6))
- T0 and T6 Depression T-Scores--Patient-Reported Outcomes Measurement Information System (PROMIS) Depression Questionnaire(At baseline (T0) and at intervention completion 10 weeks after baseline (T6))
- T0 and T6 Life Satisfaction T-Scores--Patient-Reported Outcomes Measurement Information System (PROMIS) Life Satisfaction Questionnaire(At baseline (T0) and at intervention completion 10 weeks after baseline (T6))
- Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety Questionnaire(Baseline up to 4 months after intervention)
- Patient-Reported Outcomes Measurement Information System (PROMIS) Depression Questionnaire(Baseline up to 4 months after intervention)
- Patient-Reported Outcomes Measurement Information System (PROMIS) Life Satisfaction Questionnaire(Baseline up to 4 months after intervention)
