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Keep Social Randomized Controlled Trial for Young Adults With Cancer

21 août 2026 mis à jour par: UNC Lineberger Comprehensive Cancer Center
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).

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Estimé)

395

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Lieux d'étude

  • États-Unis
    • North Carolina
      • Chapel Hill, North Carolina, États-Unis, 27599
        • University of North Carolina at Chapel Hill
        • Contact:
        • Chercheur principal:
          • Allison Lazard, PhD

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte

Accepte les volontaires sains

Non

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Autre
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Seul

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Social connectedness intervention
See intervention description.
Comportemental: Social 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.
Aucune 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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Social well-being
Délai: 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.
Up to 7 weeks
Emotional well-being
Délai: 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.
Up to 7 weeks

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Resilience
Délai: 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.
Up to 7 weeks
Loneliness
Délai: 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.
Up to 7 weeks
Perceived stress
Délai: 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.
Up to 7 weeks
Anxiety
Délai: 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.
Up to 7 weeks
Depression
Délai: 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.
Up to 7 weeks
Behavioral adherence
Délai: 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.
Up to 7 weeks
Positivity resonance
Délai: 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.
Up to 7 weeks

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

UNC Lineberger Comprehensive Cancer Center

Collaborateurs

National Cancer Institute (NCI)

Les enquêteurs

  • Chercheur principal: Allison Lazard, PhD, UNC Lineberger Comprehensive Cancer Center

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Liens utiles

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

14 septembre 2026

Achèvement primaire (Estimé)

1 mars 2027

Achèvement de l'étude (Estimé)

1 mars 2027

Dates d'inscription aux études

Première soumission

21 août 2026

Première soumission répondant aux critères de contrôle qualité

21 août 2026

Première publication (Réel)

26 août 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

26 août 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

21 août 2026

Dernière vérification

1 août 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 26-0723-RCT
  • R01CA276176 (Subvention/contrat des NIH des États-Unis)

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

OUI

Description du régime IPD

Researchers may request de-identified data 1 year after publication.

Type d'informations de prise en charge du partage d'IPD

  • PROTOCOLE D'ÉTUDE
  • SÈVE

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

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