Keep Social Randomized Controlled Trial for Young Adults With Cancer

NCT07788339 | Not Yet Recruiting DMC

• 2 other identifiers: 26-0723-RCTR01CA276176
• Study Type: interventional
• Target: 395
• Locations: 1 country
• Sites: 1

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).

Conditions

Cancer

Keywords

Social connectedness; Psychosocial health; Communication; Social media

Outcome Measures

Primary Outcomes (2)

• 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 score are representing better social well-being.

  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 score are representing better emotional well-being.

  Up to 7 weeks

Secondary Outcomes (7)

• 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

Study Arms (2)

Social connectedness intervention

EXPERIMENTAL

See intervention description.

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.

Interventions

Social connectedness intervention BEHAVIORAL

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.

Social connectedness intervention

Eligibility Criteria

• Age: 22 Years - 39 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• UNC Lineberger Comprehensive Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Related Links

• University of North Carolina Lineberger Comprehensive Cancer Center Clinical Trials

MeSH Terms

Conditions

Neoplasms; Communication

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Allison Lazard, PhD

  UNC Lineberger Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mirian Avendano-Galdamez, BA

CONTACT

984-974-0000; Mirian_Avendano_Galdamez@med.unc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will be masked to trial arm assignment, trial design (e.g., 2-arm), and study hypotheses.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Parallel, two-arm randomized controlled trial (RCT) with 1:1 allocation in a superiority framework

Study Record Dates

• First Submitted: August 21, 2026
• First Posted: August 26, 2026
• Study Start (Estimated): September 14, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: August 26, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP

Locations

US (1)