About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
Healing Gardens content development/refinement activities
BehavioralParticipant feedback activities used to optimize the Healing Gardens serious game and related patient-facing content.
Healing Gardens serious game
BehavioralA 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.
Treatment groups
Trial outcomes
Primary outcomes
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)
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.
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).
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.
Sponsors and contacts
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Dana-Farber Cancer Institute
Lead sponsor
National Cancer Institute (NCI)
Collaborator
This trial is not recruiting at the moment. You can still explore other options: