CancerNCT07788339
Keep Social Randomized Controlled Trial for Young Adults With Cancer
A study testing Social connectedness intervention in people with Cancer, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 22 to 39 years
- Conditions the study is for
- Cancer
- What is being tested?
- Social connectedness intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 395 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Sep 2026to Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 39 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Are ages 22-39
- Received a cancer diagnosis between ages 15-39
- Use social media
- Reside in the United States
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
Mirian Avendano-Galdamez, BA, 984-974-0000, Mirian_Avendano_Galdamez@med.unc.edu
Allison Lazard, PhD
About this study
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.
- Conditions
- Cancer
- Being tested
- Social connectedness intervention
- Keywords
- Social connectedness, Psychosocial health, Communication, Social media
- Medical subject headings
- Neoplasms, Communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Social connectedness interventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Social connectedness intervention | Experimental | See intervention description. Receives: Behavioral: Social connectedness intervention |
| Control | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 7 weeks
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.
Measured: Up to 7 weeks
Secondary outcomes (7)
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.
Measured: Up to 7 weeks
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.
Measured: Up to 7 weeks
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.
Measured: Up to 7 weeks
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.
Measured: Up to 7 weeks
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.
Measured: Up to 7 weeks
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.
Measured: Up to 7 weeks
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.
Measured: Up to 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2026
- Study start15 Sep 2026
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by UNC Lineberger Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel, two-arm randomized controlled trial (RCT) with 1:1 allocation in a superiority framework
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 395 participants (estimated)
Sponsor and investigators
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Allison Lazard, PhD, Principal investigator, UNC Lineberger Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07788339
- Sponsor's protocol ID
- 26-0723-RCT
- Other IDs
- R01CA276176
- Status last verified
- Oct 2026
- First submitted
- 21 Aug 2026
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Researchers may request de-identified data 1 year after publication.
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Keep Social Randomized Controlled Trial for Young Adults With Cancer
- ClinicalTrials.gov ID
- NCT07788339
- Acronym / sponsor ID
- 26-0723-RCT
- Conditions
- Cancer
- Keywords
- Social connectedness, Psychosocial health, Communication, Social media
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 395 participants (estimated)
- Lead sponsor
- UNC Lineberger Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 15 Sep 2026 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 26 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Parallel, two-arm randomized controlled trial (RCT) with 1:1 allocation in a superiority framework
| Arm | Type | Receives |
|---|---|---|
| Social connectedness intervention | Experimental | Behavioral: Social connectedness interventionSee intervention description. |
| Control | No intervention | –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. |
Who may qualify
- Ages
- 22 to 39 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Are ages 22-39
- Received a cancer diagnosis between ages 15-39
- Use social media
- Reside in the United States
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Social connectedness interventionParticipants 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. | Behavioural | Social connectedness intervention |
Primary outcome
Social well-being
Time frame: 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 scores representing better social well-being.
Emotional well-being
Time frame: 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 scores representing better emotional well-being.
7 secondary outcomes
Resilience
Time frame: Up to 7 weeks
Loneliness
Time frame: Up to 7 weeks
Perceived stress
Time frame: Up to 7 weeks
Anxiety
Time frame: Up to 7 weeks
Depression
Time frame: Up to 7 weeks
Behavioral adherence
Time frame: Up to 7 weeks
Positivity resonance
Time frame: Up to 7 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
- University of North Carolina Lineberger Comprehensive Cancer Center Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Researchers may request de-identified data 1 year after publication.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Allison Lazard, PhD principal investigator
UNC Lineberger Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Social connectedness intervention in people with Cancer, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mirian Avendano-Galdamez, BA (984-974-0000, Mirian_Avendano_Galdamez@med.unc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Social well-being (time frame: Up to 7 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2026.