Healing Gardens: Leveraging Serious Games to Deliver Accessible Pain-CBT and Pharmacologic Support for Patients With Advanced Cancer Managing Pain
Обзор исследования
Статус
Подробное описание
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).
Тип исследования
Регистрация (Оцененный)
Фаза
- Непригодный
Контакты и местонахождение
Контакты исследования
- Имя: Desiree Azizoddin, PsyD
- Номер телефона: 626-826-7984
- Электронная почта: Desiree_azizoddin@DFCI.Harvard.edu
Учебное резервное копирование контактов
- Имя: Desiree R Azizoddin, PsyD
- Номер телефона: 626-826-7984
- Электронная почта: Desiree_azizoddin@DFCI.Harvard.edu
Места учебы
-
-
Massachusetts
-
Boston, Massachusetts, Соединенные Штаты, 02215
- Dana-Farber Cancer Institute
-
Контакт:
- Desiree R Azizoddin, PsyD
- Номер телефона: 626-826-7984
- Электронная почта: Desiree_azizoddin@DFCI.Harvard.edu
-
Weymouth, Massachusetts, Соединенные Штаты, 02190
- Dana-Farber Cancer Institute at South Shore
-
Контакт:
- Meredith Faggen, MD
- Номер телефона: 781-624-4800
- Электронная почта: Meredith_Faggen@dfci.harvard.edu
-
-
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Описание
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.
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Поддерживающая терапия
- Распределение: Нерандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Активный компаратор: 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.
|
Participant feedback activities used to optimize the Healing Gardens serious game and related patient-facing content.
|
|
Экспериментальный: 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.
|
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.
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Mean Score of Acceptability E-Scale
Временное ограничение: 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)
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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).
|
Соавторы и исследователи
Спонсор
Соавторы
Следователи
- Главный следователь: Desiree Azizoddin, PsyD, Dana-Farber Cancer Institute
Даты записи исследования
Изучение основных дат
Начало исследования (Оцененный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- 26-075
- R34CA308746 (Грант/контракт NIH США)
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
Описание плана IPD
Сроки обмена IPD
Критерии совместного доступа к IPD
Совместное использование IPD Поддерживающий тип информации
- STUDY_PROTOCOL
- САП
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .