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

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).

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.