Healing Gardens: Leveraging Serious Games to Deliver Accessible Pain-CBT and Pharmacologic Support for Patients With Advanced Cancer Managing Pain
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 46
- 试验地点
- 2
- 主要终点
- Mean Score of Acceptability E-Scale
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Healing Gardens content development/refinement activities (Behavioral)
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.
干预措施: Healing Gardens serious game (Behavioral)
结局指标
主要结局
Mean Score of Acceptability E-Scale
时间窗: 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)
Mean Score of System Usability Survey (SUS)
时间窗: 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.
Module Completion Rate
时间窗: 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).
Recruitment Success Rate
时间窗: 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.
Retention Rate
时间窗: 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.
次要结局
未报告次要终点
研究者
Desiree R. Azizoddin PsyD
Principal Investigator
Dana-Farber Cancer Institute