Healing Gardens: Leveraging Serious Games to Deliver Accessible Pain-CBT and Pharmacologic Support for Patients With Advanced Cancer Managing Pain
Studie Overzicht
Toestand
Gedetailleerde beschrijving
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).
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: Desiree Azizoddin, PsyD
- Telefoonnummer: 626-826-7984
- E-mail: Desiree_azizoddin@DFCI.Harvard.edu
Studie Contact Back-up
- Naam: Desiree R Azizoddin, PsyD
- Telefoonnummer: 626-826-7984
- E-mail: Desiree_azizoddin@DFCI.Harvard.edu
Studie Locaties
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Massachusetts
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Boston, Massachusetts, Verenigde Staten, 02215
- Dana-Farber Cancer Institute
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Contact:
- Desiree R Azizoddin, PsyD
- Telefoonnummer: 626-826-7984
- E-mail: Desiree_azizoddin@DFCI.Harvard.edu
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Weymouth, Massachusetts, Verenigde Staten, 02190
- Dana-Farber Cancer Institute at South Shore
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Contact:
- Meredith Faggen, MD
- Telefoonnummer: 781-624-4800
- E-mail: Meredith_Faggen@dfci.harvard.edu
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Beschrijving
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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ondersteunende zorg
- Toewijzing: Niet-gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Actieve vergelijker: 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.
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Participant feedback activities used to optimize the Healing Gardens serious game and related patient-facing content.
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Experimenteel: 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.
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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.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Mean Score of Acceptability E-Scale
Tijdsspanne: At completion of the participant's game testing period (up to 12 weeks)
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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)
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At completion of the participant's game testing period (up to 12 weeks)
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Mean Score of System Usability Survey (SUS)
Tijdsspanne: At completion of the participant's game testing period (up to 12 weeks)
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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.
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At completion of the participant's game testing period (up to 12 weeks)
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Module Completion Rate
Tijdsspanne: At completion of the participant's game testing period (up to 12 weeks)
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Module completion rate is defined as the proportion of participants who complete at least 75% of intervention modules (4 of 5 modules).
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At completion of the participant's game testing period (up to 12 weeks)
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Recruitment Success Rate
Tijdsspanne: During the 12-month enrollment period beginning in Year 2 of the study.
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Recruitment success rate is defined as the proportion of months during the enrollment period in which at least 8 participants provided informed consent.
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During the 12-month enrollment period beginning in Year 2 of the study.
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Retention Rate
Tijdsspanne: At completion of the participant's game testing period (up to 12 weeks after enrollment, with enrollment beginning in Year 2).
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Retention rate is defined as the proportion of participants who complete the follow-up assessments and provide study data.
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At completion of the participant's game testing period (up to 12 weeks after enrollment, with enrollment beginning in Year 2).
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Medewerkers en onderzoekers
Sponsor
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Desiree Azizoddin, PsyD, Dana-Farber Cancer Institute
Studie record data
Bestudeer belangrijke data
Studie start (Geschat)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 26-075
- R34CA308746 (Subsidie/contract van de Amerikaanse NIH)
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Beschrijving IPD-plan
IPD-tijdsbestek voor delen
IPD-toegangscriteria voor delen
IPD delen Ondersteunend informatietype
- LEERPROTOCOOL
- SAP
Informatie over medicijnen en apparaten, studiedocumenten
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