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L'essai clinique NCT07290543 pour Néoplasme du système hématopoïétique et lymphatique, Néoplasme Solide Malin est en recrutement. Consultez la vue en carte du Radar des Essais Cliniques et les outils de découverte par IA pour tous les détails, ou posez vos questions ici.
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Web-Based Toolkit to Improve Cancer-Related Emotional Distress and Anxiety in Rural Older Cancer Survivors 578 Télésanté

En recrutement
Les détails de l'essai clinique sont principalement disponibles en anglais. Cependant, l'IA Trial Radar peut vous aider ! Cliquez simplement sur 'Expliquer l'étude' pour voir et discuter des informations sur l'étude dans la langue sélectionnée.
L'essai clinique NCT07290543 est une étude interventionnel pour Néoplasme du système hématopoïétique et lymphatique, Néoplasme Solide Malin. Son statut actuel est : en recrutement. L'étude a débuté le 26 août 2025 et vise à recruter 578 participants. Dirigée par l'Université Northwestern, l'étude devrait être terminée d'ici le 26 août 2032. Les données du site ClinicalTrials.gov ont été mises à jour pour la dernière fois le 18 décembre 2025.
Résumé succinct
This clinical trial tests how well a web based toolkit works to improve cancer related emotional distress and anxiety in rural older cancer survivors. Rural older adults with cancer-related distress are particularly vulnerable to poorer mental health and cancer-related outcomes including increased difficulties identifying symptoms of anxiety, a reduced likelihood of knowing when to access mental health services, and ...Afficher plus
Description détaillée
PRIMARY OBJECTIVES:

I. Co-design Objective (Aim 1): Finalize the CONNECT digital tool design through qualitative co-design evaluations with stakeholders to prepare the intervention for efficacy testing.

II. Efficacy Objective (Aim 2): Evaluate the efficacy of the CONNECT digital tool in reducing cancer-related distress among rural cancer survivors and caregivers, as measured by the validated 23-item Cancer and Trea...

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Titre officiel

Designing for Sustainability: Co-Designing and Testing the Efficacy of a Web-Based Toolkit to Improve Cancer-Related Emotional Distress and Anxiety for Rural Older Cancer Survivors

Pathologies
Néoplasme du système hématopoïétique et lymphatiqueNéoplasme Solide Malin
Autres identifiants de l'étude
Numéro NCT
NCT07290543
Date de début (réel)
2025-08-26
Dernière mise à jour publiée
2025-12-18
Date de fin (estimée)
2032-08-26
Inscription (estimée)
578
Type d'étude
Interventionnel
PHASE
N/A
Statut
En recrutement
Objectif principal
Soins de soutien
Méthode d'allocation
Randomisé
Modèle d'intervention
Séquentiel
Masquage
Simple aveugle
Bras / Interventions
Groupe de participants/BrasIntervention/Traitement
ExpérimentalArm I (Advisory board)
Advisory board members complete small group workshops, interviews and surveys on study.
Entretien
Complete interview
Entretien
Complete small group workshop
Administration de sondage
Ancillary study
ExpérimentalArm II (CONNECT platform)
Patients and their caregivers receive access to the CONNECT platform, which includes educational materials on distress management, guides to telehealth and personalized recommendations for resources. Patients and their caregivers complete a guided tutorial of the platform with a research assistant at the start of the intervention period, receive biweekly phone calls with the research assistant, for 20 minutes startin...Afficher plus
Intervention éducative
Receive educational materials on distress management and guides to telehealth
Intervention basée sur Internet
Receive access to CONNECT platform
Entretien
Complete interview
Navigation du patient
Receive personalized recommendations for resources
Administration de sondage
Ancillary study
Intervention par téléphone
Complete calls with research assistant
intervention de navigation basée sur des messages texte
Receive text message reminders
Comparateur actifArm III (Educational brochure)
Patients are mailed an educational brochure about distress management on study.
Intervention éducative
Receive written educational brochure about distress management
Entretien
Complete interview
Administration de sondage
Ancillary study
Critère principal d'évaluation
Critères d'évaluationDescription de la mesurePériode
Cancer Related Distress (validated 23-item scale)
Cancer-related distress will be measured using the Cancer and Treatment Distress Scale (23 items; item scores 0-3; higher scores indicate greater distress). The CTXD assesses distress over the past week and includes six subscales: (1) uncertainty, (2) family strain, (3) health burden, (4) finances, (5) identity/appearance, and (6) medical demands. The primary outcome is the mean cumulative score across all items and subscales. A mean score above 0.85 indicates elevated distress in long-term survivors. The CTXD has demonstrated high validity and reliability across time, from pre-treatment to 18 years post-treatment, with Cronbach's alphas ranging from 0.77 to 0.90. The subscales align with the psychosocial domain identified in the NCCN Guidelines for Distress Management.
Up to 1 year
Critère secondaire d'évaluation
Critères d'évaluationDescription de la mesurePériode
Self-reported Healthcare Resource Usage
Self-reported healthcare service usage will be measured as a count outcome at 4, 8, and 12 months post-randomization. At each follow-up, participants will report the number of times they accessed healthcare services, including primary care, oncology consultations, mental health counseling, urgent care, and survivorship care visits, since their last assessment. Data will be collected using a structured checklist within the participant survey. Evaluable participants are those who complete the survey. Both service-specific and total counts will be summarized, and a cumulative total across all intervals (0-12 months) will serve as the overall indicator of healthcare resource utilization.
Up to 12 months
Self-reported Shared Device Use
Assessed as a binary outcome at each follow-up time point (4, 8, and 12 months post-randomization). Participants will report whether they shared a digital device (e.g., smartphone, tablet, or computer) with a caregiver, family member, or friend to access health-related information or services since their last assessment. The structured survey item captures both access and behavioral engagement with health technologies through shared devices.
Up to 12 months
Telehealth Utilization (self-reported use of portal, completed visits, and visit modality)
Telehealth utilization will be self-reported by rural cancer survivors (ROCS) and caregivers at baseline and follow-up assessments at 4, 8, and 12 months post-randomization. Participants will indicate whether they have used any telehealth services in the last 4 months, and if so, specify the type (e.g., oncology follow-up, primary care, mental health), frequency, and modality (e.g., video, phone). Utilization will be operationalized as a binary indicator at each time point (1 = used, 0 = did not use, NA = missing). We will also summarize cumulative utilization across all time points to derive an overall indicator of self-reported telehealth utilization during the 12-month study period.
Up to 12 months
Cancer Survivors' Unmet Needs (validated 35-item scale)
Cancer Survivors' Unmet Needs will be assessed using a validated 35-item questionnaire evaluating emotional, informational, physical, and practical support needs. A total unmet needs score and domain-specific scores will be calculated per the scoring manual, with higher scores indicating greater levels of unmet need. The outcome will be analyzed as a continuous variable at 4, 8, and 12 months post-randomization. Primary analyses will compare total unmet needs between the CONNECT and control groups at 12 months, with longitudinal models assessing changes across all time points.
Up to 12 months
Caregiver Strain Index (validated 13-item scale)
Caregiver strain will be measured using the Caregiver Strain Index (CSI), a validated 13-item scale assessing the level of strain experienced by caregivers after hospital discharge of an elderly family member. Each item is scored as 0 (no) or 1 (yes), with total scores ranging from 0 to 13, where higher scores indicate greater caregiver strain. The CSI will be administered at baseline and follow-up assessments (4, 8, and 12 months post-randomization). The outcome will be analyzed as a continuous variable, with the primary comparison of mean CSI scores between the CONNECT and control arms at 12 months to evaluate the cumulative effect of the intervention.
Up to 12 months
Assistant à la participation
Critères d'éligibilité

Âges éligibles
Adulte, Adulte âgé
Âge minimum
18 Years
Sexes éligibles
Tous
Accepte les volontaires en bonne santé
Oui

  • AIM 1: Invited by a member of the study team

  • AIM 1: In the following or related field:

    • Healthcare professionals (physicians, nurses, pharmacists, etc.)
    • Patient advocates and representatives
    • Researchers in healthcare or technology fields
    • Healthcare administrators and managers

  • AIM 1: Must be over 18 years old

  • AIM 1: English-speaking

  • AIM 1: Willing and able to provide informed consent

  • AIM 2 (RURAL OLDER CANCER SURVIVORS): A rural resident based on the Health Resources & Services Administration (HRSA) rural analyzer

  • AIM 2 (RURAL OLDER CANCER SURVIVORS): Self-report of diagnosis with any cancer

  • AIM 2 (RURAL OLDER CANCER SURVIVORS): Self-report posttreatment (i.e., completion of curative intent therapy including surgery, chemotherapy, molecularly targeted, and endocrine therapy)

  • AIM 2 (RURAL OLDER CANCER SURVIVORS): Have access to a computer, a smartphone, or a tablet computer

  • AIM 2 (RURAL OLDER CANCER SURVIVORS): Aged > 65 years old

  • AIM 2 (RURAL OLDER CANCER SURVIVORS): Assessed as having Cancer and Treatment Distress scale (CTXD) scores > 0.85 at screening

  • AIM 2 (RURAL OLDER CANCER SURVIVORS): Have a caregiver willing to participate

  • AIM 2 (RURAL OLDER CANCER SURVIVORS): Non-institutionalized

  • AIM 2 (RURAL OLDER CANCER SURVIVORS): English proficient

  • AIM 2 (RURAL OLDER CANCER SURVIVORS): Willing and able to provide informed consent

  • AIM 2 (CAREGIVER): An identified informal caregiver of an eligible ROCS (caregivers include, but are not limited to, a child, partner, or friend; caregivers can reside in a rural or urban area and may or may not live with the ROCS

  • AIM 2 (CAREGIVER): Have internet access

  • AIM 2 (CAREGIVER): ≥ 18 years old

  • AIM 2 (CAREGIVER): Non-institutionalized

  • AIM 2 (CAREGIVER): English proficient

  • AIM 2 (CAREGIVER): Willing and able to provide informed consent

  • AIM 3 (FINAL WORKSHOP): Includes providers, medical and practice managers, patient care coordinators, and medical health technologists

  • AIM 2 (RURAL OLDER CANCER SURVIVORS): Experience a cancer recurrence or a new cancer diagnosis during their participation in the trial because of the body of literature that reports increased distress associated with cancer recurrence
  • AIM 2 (RURAL OLDER CANCER SURVIVORS AND CAREGIVER): Are inpatients
  • AIM 2 (RURAL OLDER CANCER SURVIVORS AND CAREGIVER): Cognitive impairment precludes the ability to provide written consent
Northwestern University logoUniversité Northwestern
Contact central de l'étude
Contact: Study Coordinator, 312-503-1986, [email protected]
1 Centres de l'étude dans 1 pays

Illinois

Northwestern University, Chicago, Illinois, 60611, United States
Marquita W. Lewis, Contact, 312-503-1986, [email protected]
Marquita W. Lewis, PhD, Investigateur principal
En recrutement