Healing Gardens: Leveraging Serious Games to Deliver Accessible Pain-CBT and Pharmacologic Support for Patients With Advanced Cancer Managing Pain
2 other identifiers
interventional
46
1 country
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2027
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 14, 2026
CompletedFirst Posted
Study publicly available on registry
September 17, 2026
CompletedStudy Start
First participant enrolled
February 13, 2027
ExpectedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2030
Study Completion
Last participant's last visit for all outcomes
June 1, 2030
September 17, 2026
September 1, 2026
3.3 years
September 14, 2026
September 14, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
Mean Score of Acceptability E-Scale
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)
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
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
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
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).
Study Arms (2)
Content Development and Refinement
ACTIVE COMPARATORParticipants complete a baseline assessment, a semi-structured interview for content development and refinement and/or optional focus groups, and usability/acceptability surveys.
Pre-pilot User Acceptability Testing
EXPERIMENTALParticipants 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.
Interventions
Participant feedback activities used to optimize the Healing Gardens serious game and related patient-facing content.
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.
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Dana-Farber Cancer Institutelead
- National Cancer Institute (NCI)collaborator
Study Sites (2)
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215, United States
Dana-Farber Cancer Institute at South Shore
Weymouth, Massachusetts, 02190, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Desiree Azizoddin, PsyD
Dana-Farber Cancer Institute
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
September 14, 2026
First Posted
September 17, 2026
Study Start (Estimated)
February 13, 2027
Primary Completion (Estimated)
June 1, 2030
Study Completion (Estimated)
June 1, 2030
Last Updated
September 17, 2026
Record last verified: 2026-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- Data can be shared no earlier than 1 year following the date of publication
- Access Criteria
- Contact the Belfer office for Dana -Farber Innovations (BODFI) at innovations@dfci.harvard.edu
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.