ClinicalTrials.gg
Not yet recruitingNCT07825051Updated Sep 17, 2026

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

An interventional study of Healing Gardens content development/refinement activities and Healing Gardens serious game in Advanced Cancer, Cancer Pain and Chronic Pain, sponsored by Dana-Farber Cancer Institute. Not yet recruiting at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-17.

Sponsored by Dana-Farber Cancer Institute · Not applicable, Interventional, and Supportive care

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Phase
Not applicable
Study type
Interventional
Enrollment
46
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 75 studies in Cancer Pain with a site in United States — 14 open to participants now, 20 under way, none of them phase 3. Cancer Pain · United States.

Planned enrollment
28th of 68
46 · median 36
Started
2027
the only one that year
No phase
35 of 75
9 open now
Primary completion
2030-06
later than 19 of 19 live
Registered
74th of 75
by date
Lead sponsor
2 of 75
Dana-Farber Cancer Institute

Among the 75 studies in Cancer Pain with a site in United States, this one is the 28th largest by planned enrollment of the 68 interventional ones that give a count, is the only one that started in 2027, is one of 35 with no phase, reaches primary completion later than 19 of the 19 other live ones, and was the 74th registered.

Cancer Pain

310 studies on the registry are indexed under Cancer Pain; 73 are open to participants now.

Browse Cancer Pain studies →

Open to participants now

14 of the 75 studies in Cancer Pain with a site in United States are open now. Recruiting first, the newest first:

8 more — sign in →

All 14 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 43 Cancer Pain studies recruiting now, 31 (72%) set no upper age limit and 4 (9%) stop at 75 or younger; 4 take children under 18; none take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

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02

Study 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 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).

03

Conditions studied

  • Advanced Cancer
  • Cancer Pain
  • Chronic Pain

Keywords

  • advanced cancer
  • cancer pain
  • chronic pain in patients with cancer
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age ≥ 18 years
  • Patient is diagnosed with a locally advanced or solid tumor , 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

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.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
46 participants (estimated)

Study arms

  • Active comparator
    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.

    Behavioral: Healing Gardens content development/refinement activities

  • Experimental
    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.

    Behavioral: Healing Gardens serious game

Interventions

  • BehavioralHealing Gardens content development/refinement activities

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

  • BehavioralHealing Gardens serious game

    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.

06

What researchers measure

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.

  5. Retention Rate

    Retention rate is defined as the proportion of participants who complete the follow-up assessments and provide study data.

    Time frame: At completion of the participant's game testing period (up to 12 weeks after enrollment, with enrollment beginning in Year 2).

07

Study locations

2 sites
08

References and documents

Individual participant data

Plan to share: 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.

Supporting information: Study protocol, Statistical analysis plan

Time frame: Data can be shared no earlier than 1 year following the date of publication

Access criteria: Contact the Belfer office for Dana -Farber Innovations (BODFI) at innovations@dfci.harvard.edu

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Feb 2027; primary completion for Jun 2030, 39 months later.

Of 72 non-industry interventional studies with no phase under Cancer Pain, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 40. This study's planned 39 months is above that.

Counting every sponsor, half of 75 studies reached it within 18 months; a quarter within 10 and three quarters within 40.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 14, 2026
First posted
Sep 17, 2026
StartEst.
Feb 13, 2027
Primary completionEst.
Jun 1, 2030
CompletionEst.
Jun 1, 2030
Last update
Sep 17, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 17, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07825051
Responsible party
Desiree R. Azizoddin PsyD (Principal Investigator, Dana-Farber Cancer Institute) — Principal investigator
First posted
Sep 17, 2026
Start date
Feb 13, 2027 (estimated)
Primary completion
Jun 1, 2030 (estimated)
Completion
Jun 1, 2030 (estimated)
Last update
Sep 17, 2026

Study contacts

Desiree R Azizoddin, PsyD
Contact
Desiree_azizoddin@DFCI.Harvard.edu
626-826-7984
Desiree Azizoddin, PsyD
Contact
Desiree_azizoddin@DFCI.Harvard.edu
626-826-7984
Desiree Azizoddin, PsyD
principal investigator · Dana-Farber Cancer Institute

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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