Keep Social Randomized Controlled Trial for Young Adults With Cancer
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 395
- 试验地点
- 1
- 主要终点
- Social well-being
研究概览
简要总结
The main purpose of this Keep Social randomized controlled trial is to examine the effectiveness of our social connectedness intervention to improve social and emotional well-being among young adults with cancer. The investigators will conduct a randomized controlled trial with a sample of up to 395 US young adults (ages 22-39) who previous had a cancer diagnosis as an adolescent or young adult (diagnosed at age 15-39).
详细描述
This trial aims to examine the effectiveness of our social connectedness intervention to improve social and emotional well-being among young adults with cancer. The investigators will enroll up to 395 young adults ages 22-39 who had received a cancer diagnosis as an adolescent or young adult (diagnosed at age 15-39). Participants will complete our 7-week protocol, which includes a 4-week intervention phase. During weeks 1 and 2, we will gather information about daily life as usual (e.g., social interactions). At the beginning of week 3, participants will be randomized to trial arm (experimental or control) and introduced to a beta version of a simulated social media site. Participants who do not take the week 3 survey will not be randomized and will be dropped from the study. During weeks 3-6, participants will interact with a simulated social media platform, branded as Invibe. Participants will have passive exposure to intervention or control stimuli in the social media feeds. Participants also had forced exposure to stimuli posts (intervention messages vs. control messages) in the online survey after interacting with Invibe. During week 7, participants will complete the final weekly survey.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
盲法说明
Participants will be masked to trial arm assignment, trial design (e.g., 2-arm), and study hypotheses.
入排标准
- 年龄范围
- 22 Years 至 39 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Are ages 22-39
- •Received a cancer diagnosis between ages 15-39
- •Use social media
- •Reside in the United States
排除标准
- •Report high psychosocial health (≥4.5 mean of two mental health quality of life items)
- •Report being unable to take the study surveys because their schedule will not allow, they are not interested in taking the study surveys, or do not intend to complete the study surveys
研究组 & 干预措施
Social connectedness intervention
See intervention description.
干预措施: Social connectedness intervention (Behavioral)
Control
To rule out placebo and nonspecific effects, the Keep Social RCT engenders positive expectations in all participants by promoting the use of Invibe to build and maintain social ties, a framing that mirrors information-as-usual for well-being through social media connections. Those in the placebo control condition receive no further social connectedness education (view no psychoeducational video, no if/then plan) and encounter all background content on Invibe (all intervention messages excluded) with control posts that feature unrelated content.
结局指标
主要结局
Social well-being
时间窗: Up to 7 weeks
Measured with 8 items from the General Belongingness Scale. Participants will complete a 4-item acceptance/inclusion subscale and 4-item rejection/exclusion subscale weekly, up to 5 times, during the intervention phase of the RCT (weeks 3-7). Rejection/exclusion items will be reverse coded. We will average responses to the 8 items each week. Social well-being scores will range from 1-5, with higher score are representing better social well-being.
Emotional well-being
时间窗: Up to 7 weeks
Measured with the 9-item Positive Affect and Well-Being assessment from the Neuro-QOL Item Bank v1.0. Emotional wellbeing will be measured weekly, up to 5 times, during the intervention phase of the RCT (weeks 3-7). We will average responses to the 9 items each week. Emotional well-being scores will range from 1-5, with higher score are representing better emotional well-being.
次要结局
- Resilience(Up to 7 weeks)
- Loneliness(Up to 7 weeks)
- Perceived stress(Up to 7 weeks)
- Anxiety(Up to 7 weeks)
- Depression(Up to 7 weeks)
- Behavioral adherence(Up to 7 weeks)
- Positivity resonance(Up to 7 weeks)