ClinicalTrials.gg
RecruitingNCT07788339Updated Oct 30, 2026

Keep Social Randomized Controlled Trial for Young Adults With Cancer

An interventional study of Social connectedness intervention in Cancer, sponsored by UNC Lineberger Comprehensive Cancer Center. Recruiting at 1 site in United States. Open to participants aged 22 Years to 39 Years. Per ClinicalTrials.gov, last updated 2026-10-30.

Sponsored by UNC Lineberger Comprehensive Cancer Center · Not applicable, Interventional, and Other

From the registry’s dates

  • Started Sep 2026; still recruiting 1 month later.
Updated Oct 30, 2026Now RecruitingNow Active, not recruiting+4 moreGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
395
Allocation
Randomized
Ages
22 Years to 39 Years
Sex
All
01

Study 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).

Read the 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.

02

Conditions studied

  • Cancer

Keywords

  • Social connectedness
  • Psychosocial health
  • Communication
  • Social media
03

In context

Neoplasms

10,818 studies on the registry are indexed under Neoplasms; 2,324 are open to participants now.

This study's planned enrollment of 395 is above the median of 60 across 7,703 interventional studies indexed under Neoplasms.

Browse Neoplasms studies →

Lead sponsor

UNC Lineberger Comprehensive Cancer Center is the lead sponsor of 429 studies on the registry; 97 are open to participants now.

Of its 33 completed or terminated interventional studies of FDA-regulated products, 26 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
22 Years to 39 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Are ages 22-39
  • Received a cancer diagnosis between ages 15-39
  • Use social media
  • Reside in the United States

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
395 participants (estimated)

Study arms

  • Experimental
    Social connectedness intervention

    See intervention description.

    Behavioral: Social connectedness intervention

  • No intervention
    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.

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.

06

What researchers measure

Primary outcomes

  1. Social well-being

    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 scores representing better social well-being.

    Time frame: Up to 7 weeks

  2. Emotional well-being

    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 scores representing better emotional well-being.

    Time frame: Up to 7 weeks

Secondary outcomes

  1. Resilience

    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 scores representing more resilience.

    Time frame: Up to 7 weeks

  2. Loneliness

    Measured with 5 items from the Loneliness (Ages 18+) - Fixed Form in the National Institutes 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 5 items each week. Loneliness scores will range from 1-5, with higher scores representing more loneliness.

    Time frame: Up to 7 weeks

  3. Perceived stress

    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 scores representing more stress.

    Time frame: Up to 7 weeks

  4. Anxiety

    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 4 items each week. Anxiety scores will range from 1-5, with higher scores representing more anxiety.

    Time frame: Up to 7 weeks

  5. Depression

    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 4 items each week. Depression scores will range from 1-5, with higher scores representing more depression.

    Time frame: Up to 7 weeks

  6. Behavioral adherence

    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 scores representing more behavioral adherence.

    Time frame: Up to 7 weeks

  7. Positivity resonance

    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 0-10, with higher scores representing more positivity resonance.

    Time frame: Up to 7 weeks

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: Yes — Researchers may request de-identified data 1 year after publication.

Supporting information: Study protocol, Statistical analysis plan

09

Updates

3 registry updates since Sep 25, 2026
Status
Not yet recruiting→Active, not recruiting→Recruiting
changed Oct 5, 2026 · changed Oct 30, 2026
Sites
University of North Carolina at Chapel Hill is now Recruiting
Oct 30, 2026
Start date
Oct 15, 2026→Sep 15, 2026 (actual)
Oct 5, 2026
Primary outcomes
2 description edited
What changed in the outcomes
  • DescriptionEmotional well-being: how it is measured was reworded
  • DescriptionSocial well-being: how it is measured was reworded
Oct 27, 2026
Secondary outcomes
7 description edited
What changed in the outcomes
  • DescriptionAnxiety: how it is measured was reworded
  • DescriptionBehavioral adherence: how it is measured was reworded
  • DescriptionDepression: how it is measured was reworded
  • DescriptionLoneliness: how it is measured was reworded
  • DescriptionPerceived stress: how it is measured was reworded
  • DescriptionPositivity resonance: how it is measured was reworded
  • DescriptionResilience: how it is measured was reworded
Oct 27, 2026
Contact
Study contact now listed: added M•••@med.unc.edu · •••0000. See the current contact
Oct 30, 2026
Site contacts
Changed at 1 site. See the sites
Show the site
  • University of North Carolina at Chapel Hill · Chapel Hill, United StatesContact added M•••@med.unc.edu · •••0000Contact added (no phone or email listed)
Oct 30, 2026
Show all 3 updates
  1. Oct 30, 2026
    Active, not recruiting→Recruiting
    University of North Carolina at Chapel Hill is now Recruiting
    Contact Study contact now listed: added M•••@med.unc.edu · •••0000. See the current contact
    Site contacts Changed at 1 site. See the sites
    Show the site
    • University of North Carolina at Chapel Hill · Chapel Hill, United StatesContact added M•••@med.unc.edu · •••0000Contact added (no phone or email listed)
  2. Oct 27, 2026
    Primary outcomes 2 description edited
    What changed in the outcomes
    • DescriptionEmotional well-being: how it is measured was reworded
    • DescriptionSocial well-being: how it is measured was reworded
    Secondary outcomes 7 description edited
    What changed in the outcomes
    • DescriptionAnxiety: how it is measured was reworded
    • DescriptionBehavioral adherence: how it is measured was reworded
    • DescriptionDepression: how it is measured was reworded
    • DescriptionLoneliness: how it is measured was reworded
    • DescriptionPerceived stress: how it is measured was reworded
    • DescriptionPositivity resonance: how it is measured was reworded
    • DescriptionResilience: how it is measured was reworded
  3. Oct 5, 2026
    Not yet recruiting→Active, not recruiting
    Start date Oct 15, 2026→Sep 15, 2026 (now actual)
    + 2 other changes: verification date and contact details

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07788339
Responsible party
Sponsor
First posted
Aug 26, 2026
Start date
Sep 15, 2026
Primary completion
Mar 2027 (estimated)
Completion
Mar 2027 (estimated)
Last update
Oct 30, 2026

Study contacts

Mirian Avendano-Galdamez, BA
Contact
Mirian_Avendano_Galdamez@med.unc.edu
984-974-0000
Allison Lazard, PhD
principal investigator · UNC Lineberger Comprehensive Cancer Center

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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