Cancer
Conditions
Keywords
Social connectedness, Psychosocial health, Communication, Social media
Brief summary
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).
Detailed description
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.
Interventions
BEHAVIORALSocial connectedness intervention
Participants view a brief psychoeducational video about the value of connecting in-person with others and receive guided instructions for creating if-then behavioral plans for increasing moments of high-quality social connection. Over the next four weeks, they view messages to encourage in-person connections with strangers and acquaintances on our simulated social media platform called Invibe. During the 4-week intervention phase with Invibe (weeks 3-6), participants will view the Invibe simulated social media feed in each survey. Participant exposure to each intervention message will be both passive, via that day's feed, and forced, via inclusion on the following pages of that survey. Participants will see 12 intervention messages during this 4-week phase, each shown within the first five posts of the Invibe feed.
Sponsors
UNC Lineberger Comprehensive Cancer Center
National Cancer Institute (NCI)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)
Masking description
Participants will be masked to trial arm assignment, trial design (e.g., 2-arm), and study hypotheses.
Intervention model description
Parallel, two-arm randomized controlled trial (RCT) with 1:1 allocation in a superiority framework
Eligibility
Sex/Gender
ALL
Age
22 Years to 39 Years
Healthy volunteers
No
Inclusion criteria
* Are ages 22-39 * Received a cancer diagnosis between ages 15-39 * Use social media * Reside in the United States
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Social well-being | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Resilience | Up to 7 weeks | Measured with the 11-item ego-resiliency short form (ER-11) focused on the time-varying subscales (active engagement with the world, integrated performance under stress, repertoire of problem-solving strategies) from the 14-item ego-resiliency scale (ER-89). Resilience will be measured weekly, up to 5 times, during the intervention phase of the RCT (weeks 3-7). We will average responses to the 11 items each week. Resilience scores will range from 1-4, with higher score are representing more resilience. |
| Loneliness | Up to 7 weeks | Measured with 4 items from the Loneliness (Ages 18+) - Fixed Form in the National Institute of Health (NIH) Toolbox® Item Bank v3.0 for adult social relationship scales. Loneliness will be measured weekly, up to 5 times, during the intervention phase of the RCT (weeks 3-7). We will average responses to the 4 items each week. Loneliness scores will range from 1-5, with higher score are representing more loneliness. |
| Perceived stress | Up to 7 weeks | Measured with 3 selected items that focus on feeling stressed, inability to cope, and feeling that difficulties are piling high from the 14-item perceived stress scale (PSS). Perceived stress will be measured weekly, up to 5 times, during the intervention phase of the RCT (weeks 3-7). We will average responses to the 3 items each week. Perceived stress scores will range from 1-5, with higher score are representing more stress. |
| Anxiety | Up to 7 weeks | Measured with 4 items from the PROMIS-29 Profile v2.0. Anxiety will be measured weekly, up to 5 times, during the intervention phase of the RCT (weeks 3-7). We will average responses to the 3 items each week. Anxiety scores will range from 1-5, with higher score are representing more anxiety. |
| Depression | Up to 7 weeks | Measured with 4 items from the PROMIS-29 Profile v2.0. Depression will be measured weekly, up to 5 times, during the intervention phase of the RCT (weeks 3-7). We will average responses to the 3 items each week. Depression scores will range from 1-5, with higher score are representing more depression. |
| Behavioral adherence | Up to 7 weeks | Measured with 3 items about participants' 1) social opportunity, 2) openness to and 3) initiation of in-person connections. Behavioral adherence will be measured in up to 13 times in each weekly survey and day report (weeks 1-7), including up to 4 assessments during the intro/baseline period and up to 9 assessments for the intervention period. We will analyze each type of behavioral adherence separately. Behavioral adherence (social opportunity) scores will be binary, with 1 representing social opportunity and 0 representing no opportunity. Behavioral adherence (openness, initiation) scores will range from 1-5, with higher score are representing more behavioral adherence. |
| Positivity resonance | Up to 7 weeks | Measured with 2 adapted items for stranger interactions and 2 adapted items for acquaintance interactions from the Perceived Positivity Resonance Scale. Positivity resonance will be measured up to 13 times in each weekly survey and day report (weeks 1-7), including up to 4 assessments during the intro/baseline period and up to 9 assessments for the intervention period. We will average the responses to the 2 items for each type of interaction (stranger, acquaintance) from each weekly survey and day report. Positivity resonance scores will range from 1-10, with higher score are representing more positivity resonance. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORAllison Lazard, PhD
UNC Lineberger Comprehensive Cancer Center
Outcome results
None listed