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

September 14, 2026 updated by: 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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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).

Study Type

Interventional

Enrollment (Estimated)

46

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
Behavioral: Healing Gardens content development/refinement activities
Participant feedback activities used to optimize the Healing Gardens serious game and related patient-facing content.
Experimental: 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.
Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Score of Acceptability E-Scale
Time Frame: 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)
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dana-Farber Cancer Institute

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Desiree Azizoddin, PsyD, Dana-Farber Cancer Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 13, 2027

Primary Completion (Estimated)

June 1, 2030

Study Completion (Estimated)

June 1, 2030

Study Registration Dates

First Submitted

September 14, 2026

First Submitted That Met QC Criteria

September 14, 2026

First Posted (Actual)

September 17, 2026

Study Record Updates

Last Update Posted (Actual)

September 17, 2026

Last Update Submitted That Met QC Criteria

September 14, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 26-075
  • R34CA308746 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

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

IPD Sharing Access Criteria

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

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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