Advanced CancerNCT07825051
Healing Gardens: Leveraging Serious Games to Deliver Accessible Pain-CBT and Pharmacologic Support for Patients With Advanced Cancer Managing Pain
A study testing Healing Gardens content development/refinement activities and Healing Gardens serious game in people with Advanced Cancer and Cancer Pain, run by Dana-Farber Cancer Institute at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Cancer, Cancer Pain, Chronic Pain
- What is being tested?
- Healing Gardens content development/refinement activities and Healing Gardens serious game
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 2 sitesUnited States
- Study dates
- 13 Feb 2027to 1 Jun 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
Desiree R Azizoddin, PsyD, 626-826-7984, Desiree_azizoddin@DFCI.Harvard.edu
Dana-Farber Cancer Institute at South Shore
Weymouth, Massachusetts, 02190
Meredith Faggen, MD, 781-624-4800, Meredith_Faggen@dfci.harvard.edu
About this study
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.
Read the detailed description
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).
- Conditions
- Advanced Cancer, Cancer Pain, Chronic Pain
- Being tested
- Healing Gardens content development/refinement activities, Healing Gardens serious game
- Keywords
- advanced cancer, cancer pain, chronic pain in patients with cancer
- Medical subject headings
- Cancer Pain, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Healing Gardens content development/refinement activitiesBehavioural
Participant feedback activities used to optimize the Healing Gardens serious game and related patient-facing content.
Healing Gardens serious gameBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Content Development and Refinement | Active comparator | Participants complete a baseline assessment, a semi-structured interview for content development and refinement and/or optional focus groups, and usability/acceptability surveys. Receives: Behavioral: Healing Gardens content development/refinement activities |
| Pre-pilot User Acceptability Testing | Experimental | 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. Receives: Behavioral: Healing Gardens serious game |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: At completion of the participant's game testing period (up to 12 weeks)
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.
Measured: At completion of the participant's game testing period (up to 12 weeks)
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).
Measured: At completion of the participant's game testing period (up to 12 weeks)
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.
Measured: During the 12-month enrollment period beginning in Year 2 of the study.
Retention Rate
Retention rate is defined as the proportion of participants who complete the follow-up assessments and provide study data.
Measured: At completion of the participant's game testing period (up to 12 weeks after enrollment, with enrollment beginning in Year 2).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2026
- Study start13 Feb 2027 (estimated)
- Primary completion1 Jun 2030 (estimated)
- Study completion1 Jun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced CancerStudies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Desiree R. Azizoddin PsyD, Dana-Farber Cancer Institute
- Investigators
- Desiree Azizoddin, PsyD, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07825051
- Sponsor's protocol ID
- 26-075
- Other IDs
- R34CA308746
- Status last verified
- Sep 2026
- First submitted
- 14 Sep 2026
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The Harvard Cancer Consortium encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Healing Gardens: Leveraging Serious Games to Deliver Accessible Pain-CBT and Pharmacologic Support for Patients With Advanced Cancer Managing Pain
- ClinicalTrials.gov ID
- NCT07825051
- Acronym / sponsor ID
- 26-075
- Conditions
- Advanced Cancer, Cancer Pain, Chronic Pain
- Keywords
- advanced cancer, cancer pain, chronic pain in patients with cancer
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 13 Feb 2027 (estimated)
- Primary completion
- 1 Jun 2030 (estimated)
- Study completion
- 1 Jun 2030 (estimated)
- First posted
- 17 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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).
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Content Development and Refinement | Active comparator | Behavioral: Healing Gardens content development/refinement activitiesParticipants complete a baseline assessment, a semi-structured interview for content development and refinement and/or optional focus groups, and usability/acceptability surveys. |
| Pre-pilot User Acceptability Testing | Experimental | Behavioral: Healing Gardens serious gameParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Healing Gardens content development/refinement activitiesParticipant feedback activities used to optimize the Healing Gardens serious game and related patient-facing content. | Behavioural | Content Development and Refinement |
| Healing Gardens serious gameA 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. | Behavioural | Pre-pilot User Acceptability Testing |
Primary outcome
Mean Score of Acceptability E-Scale
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
- Individual participant dataSharing planned: Yes. The Harvard Cancer Consortium encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Desiree Azizoddin, PsyD principal investigator
Dana-Farber Cancer Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Healing Gardens content development/refinement activities and Healing Gardens serious game in people with Advanced Cancer and Cancer Pain, run by Dana-Farber Cancer Institute at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Desiree R Azizoddin, PsyD (626-826-7984, Desiree_azizoddin@DFCI.Harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Score of Acceptability E-Scale (time frame: At completion of the participant's game testing period (up to 12 weeks)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026.