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Healing Gardens: Leveraging Serious Games to Deliver Accessible Pain-CBT and Pharmacologic Support for Patients With Advanced Cancer Managing Pain

14 settembre 2026 aggiornato da: Desiree R. Azizoddin PsyD, Dana-Farber Cancer Institute
This study is being done to determine the feasibility and acceptability of Healing Gardens, a standalone mobile health serious game designed to deliver pain-CBT and cancer pain education to help patients with advanced cancer manage chronic pain.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

This is a single-site, interventional feasibility/pilot study evaluating Healing Gardens, a technology-based serious game intervention designed to deliver pain-CBT and cancer pain education for patients with advanced cancer and chronic pain. The study is intended to refine the intervention and establish its initial feasibility, acceptability, and usability through Cohort A content refinement/user acceptability testing and Cohort B pre-pilot testing.

Study procedures include screening and recruitment from DFCI outpatient oncology and palliative care clinics and DFCI satellite clinics at South Shore Health; baseline assessments; medical record abstraction; qualitative interviews and optional focus group/community advisory board activities for Cohort A; usability and acceptability surveys for both cohorts; and, for Cohort B, at-home use of the Healing Gardens game for up to 12 weeks with study contacts to address technical issues and complete end-of-study assessments. Study procedures may be conducted in person, by phone, or through secure HIPAA-compliant video platforms.

It is expected that up to 46 participants will take part in this study, including up to 25 participants in Cohort A and up to 21 participants in Cohort B.

Participation length varies by cohort. Cohort A participants will complete a 30-60 minute interview/user acceptability testing session and may optionally participate in community advisory board meetings up to twice monthly during Year 1. Cohort B participants will test the game at home for up to 12 weeks and complete baseline and end-of-study assessments and a 30-60 minute semi-structured interview. Overall subject accrual and participation are expected to occur over approximately 29 months. There is no long-term follow-up for this study.

This is a DF/HCC PI-sponsored study with funding/support listed from Dana-Farber/Harvard Cancer Center and the National Cancer Institute/NIH/DHHS (R34CA308746, pending).

Tipo di studio

Interventistico

Iscrizione (Stimato)

46

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Backup dei contatti dello studio

Luoghi di studio

  • Stati Uniti
    • Massachusetts
      • Boston, Massachusetts, Stati Uniti, 02215
      • Weymouth, Massachusetts, Stati Uniti, 02190

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

Inclusion Criteria:

  • Age ≥ 18 years
  • Patient is diagnosed with a locally advanced or metastatic solid tumor malignancy, either undergoing active treatment or receiving treatment for an advanced cancer or are receiving supportive/palliative care at DFCI
  • Chronic pain related to cancer or treatment (> pain score of 4 on a 0-10 scale on average over the past two weeks, Numeric Rating Scale)
  • Own/use a compatible device (e.g., smartphone, laptop)

Exclusion Criteria:

  • Patients in survivorship: patients who have completed their treatment regimens, are not actively receiving curative or palliative treatment for an advanced cancer, or have a cancer that is in remission
  • Cognitive impairment that would interfere with study participation, as judged by the treating clinician (e.g. delirium, dementia)
  • Inability to speak English (the intervention has not yet been translated to other languages)
  • Enrolled in hospice
  • Currently hospitalized
  • Pain primarily related to a recent surgery (within the last 2 weeks)
  • Conditions that hinder device use (e.g., vision impairment)
  • We will exclude adults who are unable to consent, individuals who are not yet adults (infants, children, teenagers), pregnant women, and prisoners.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Terapia di supporto
  • Assegnazione: Non randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: Content Development and Refinement
Participants complete a baseline assessment, a semi-structured interview for content development and refinement and/or optional focus groups, and usability/acceptability surveys.
Comportamentale: Healing Gardens content development/refinement activities
Participant feedback activities used to optimize the Healing Gardens serious game and related patient-facing content.
Sperimentale: Pre-pilot User Acceptability Testing
Participants complete a baseline assessment, at-home testing of the Healing Gardens game for up to 12 weeks, a semi-structured debriefing interview, and end-of-intervention surveys.
Comportamentale: Healing Gardens serious game
A story-led mHealth serious game delivering pain-CBT and cancer pain education, including pain psychoeducation, pain coping skills, cognitive restructuring, and safe/effective opioid use content.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Mean Score of Acceptability E-Scale
Lasso di tempo: At completion of the participant's game testing period (up to 12 weeks)
Acceptability E-scale is a 6-item self-reported measure of participant acceptability of the intervention. Each item is rated on a 5-point Likert scale, yielding a total score ranging from 6 to 30, with higher scores indicating greater acceptability of the intervention. The intervention will be considered acceptable if the mean score exceeds 24 out of 30. (Tariman et al., Appl Nurs Res 2011)
At completion of the participant's game testing period (up to 12 weeks)
Mean Score of System Usability Survey (SUS)
Lasso di tempo: At completion of the participant's game testing period (up to 12 weeks)
SUS is a 10-item questionnaire used to assess the usability of the intervention. SUS is scored on a scale 0-100 with higher scores representing better acceptability. A score of 75 or higher is deemed acceptable.
At completion of the participant's game testing period (up to 12 weeks)
Module Completion Rate
Lasso di tempo: At completion of the participant's game testing period (up to 12 weeks)
Module completion rate is defined as the proportion of participants who complete at least 75% of intervention modules (4 of 5 modules).
At completion of the participant's game testing period (up to 12 weeks)
Recruitment Success Rate
Lasso di tempo: During the 12-month enrollment period beginning in Year 2 of the study.
Recruitment success rate is defined as the proportion of months during the enrollment period in which at least 8 participants provided informed consent.
During the 12-month enrollment period beginning in Year 2 of the study.
Retention Rate
Lasso di tempo: At completion of the participant's game testing period (up to 12 weeks after enrollment, with enrollment beginning in Year 2).
Retention rate is defined as the proportion of participants who complete the follow-up assessments and provide study data.
At completion of the participant's game testing period (up to 12 weeks after enrollment, with enrollment beginning in Year 2).

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Dana-Farber Cancer Institute

Collaboratori

National Cancer Institute (NCI)

Investigatori

  • Investigatore principale: Desiree Azizoddin, PsyD, Dana-Farber Cancer Institute

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

13 febbraio 2027

Completamento primario (Stimato)

1 giugno 2030

Completamento dello studio (Stimato)

1 giugno 2030

Date di iscrizione allo studio

Primo inviato

14 settembre 2026

Primo inviato che soddisfa i criteri di controllo qualità

14 settembre 2026

Primo Inserito (Effettivo)

17 settembre 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

17 settembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

14 settembre 2026

Ultimo verificato

1 settembre 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 26-075
  • R34CA308746 (Sovvenzione/contratto NIH degli Stati Uniti)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano IPD

The Harvard Cancer Consortium encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.

Periodo di condivisione IPD

Data can be shared no earlier than 1 year following the date of publication

Criteri di accesso alla condivisione IPD

Contact the Belfer office for Dana -Farber Innovations (BODFI) at innovations@dfci.harvard.edu

Tipo di informazioni di supporto alla condivisione IPD

  • STUDIO_PROTOCOLLO
  • LINFA

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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