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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorDana-Farber Cancer Institute

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Healing Gardens content development/refinement activities

    Behavioral

    Participant feedback activities used to optimize the Healing Gardens serious game and related patient-facing content.

  • Healing Gardens serious game

    Behavioral

    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.

Treatment groups

46 Participants
are divided into 2 treatment groups
Group A: Content Development and RefinementActive comparator 1 intervention
Group B: Pre-pilot User Acceptability TestingExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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)

Time frame
At completion of the participant's game testing period (up to 12 weeks)
2

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.

Time frame
At completion of the participant's game testing period (up to 12 weeks)
3

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).

Time frame
At completion of the participant's game testing period (up to 12 weeks)
4

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.

Time frame
During the 12-month enrollment period beginning in Year 2 of the study.

Secondary outcomes

Other outcomes

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: