LeukemiaNCT01608152
Development of a Video Game for the Improvement of Outcomes in Stem Cell Transplant Survivors
An observational study of Leukemia and Lymphoma, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
This trial collects feedback from patients to develop a video game in improving the outcomes in stem cell transplant survivors. A video game may help to improve health behaviors for leukemia or lymphoma patients after stem cell transplant. Read more about this study
- Who is it for?
- Ages 15 to 39 years
- What is being tested?
- Focus Group, Internet-Based Intervention and Interview
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 144 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Feb 2013to 31 Dec 2026
- Phase
- Observational
- 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 15 to 39 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Patients with leukemia or lymphoma
Who may be able to join
- Phase I
- The target population for this study will consist of:
- Individuals ages 15-29
- Able to read and speak English
- Diagnosis of leukemia or lymphoma
- First time allogeneic SCT recipient
Show all 12Show fewer
- Phase II
- The target population for this study will consist of:
- Individuals ages 18-39 (in phase I, we recruited only individuals age 15-29. For phase II, we will recruit young adults, and will expand the eligible age range up to 39 years. This expansion in age eligibility to 39 years is consistent with the National Cancer Institute definition of adolescents and young adults with cancer, and is consistent with the age range of patients seen at MD Anderson in the Adolescent and Young Adult Center.
- Able to read and speak English
- Diagnosis of leukemia or lymphoma (including Myelodysplastic Syndrome - MDS) or lymphoma
- HSCT recipient
Who cannot join
- Phase I
- The target population will be excluded if:
- They do not speak English
- They have vision problems
- They have cognitive problems
- They have psychological difficulties
Show all 11Show fewer
- Phase II
- The target population will be excluded if:
- They do not speak English
- They have vision problems that would preclude them from viewing a computer screen.
- They have an intellectual deficiency that would prevent the potential participant from understanding information delivered on the computer platform or as defined by the DSM-V Diagnostic and Statistical Manual of Mental Disorders that would prevent them from understanding information delivered on the computer platform.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Using Game Mechanics to Improve Outcomes Among Stem Cell Transplant Survivors
This trial collects feedback from patients to develop a video game in improving the outcomes in stem cell transplant survivors. A video game may help to improve health behaviors for leukemia or lymphoma patients after stem cell transplant.
Read the detailed description
PRIMARY OBJECTIVES:
- Develop a prototype intervention electronic game that implements a baseline testable feature set, including features for social networking within a virtual game space, managing an intermittent mediated reward cycle, goal setting and tracking, and collaborative problem solving.
II. Evaluate the technical merit, feasibility, user perception and acceptance of the prototype system with adolescents and young adults (AYAs) allogeneic hematopoietic stem cell transplantation (HSCTs) patients in recovery.
III. Based on the results of the prototype evaluation, enhance and complete development of the Stempowerment on-line intervention.
IV. This is a single arm study with no comparison group; therefore, the purpose is to evaluate the impact of the Stempowerment intervention on
OUTLINE: Patients are assigned to 1 of 2 groups.
GROUP I: Patients attend a focus group for up to 1.5 hours and provide feedback on design elements, specific desirable features, and preferences for the initial prototype.
GROUP II: Patients have access to the game for 3 weeks and then provide feedback on problems or questions regarding the use of the prototype.
- Being tested
- Focus Group, Internet-Based Intervention, Interview
- Keywords
- Leukemia, Lymphoma, Game mechanics, Stem cell transplant survivors, Hematopoietic stem cell transplantation, HSCT, Internet-based, Interactive and personalized intervention, Questionnaires, Focus groups, Interviews
- Medical subject headings
- Leukemia, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Focus GroupBehavioural
Attend a focus group
Internet-Based InterventionOther
Have access to the game
InterviewBehavioural
1 week after the 3-week period ends, interview conducted over the phone or at a clinic visit.
| Study group | Role | What they receive |
|---|---|---|
| Group I (focus group) | Patients attend a focus group for up to 1.5 hours and provide feedback on design elements, specific desirable features, and preferences for the initial prototype. Receives: Behavioral: Focus Group | |
| Group II (access to the game) | Patients have access to the game for 3 weeks and then provide feedback on problems or questions regarding the use of the prototype. Receives: Other: Internet-Based Intervention; Behavioral: Interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of electronic game intervention
Primary feasibility benchmark based on responses to questions regarding users' perceptions of the technology. If 75% of respondents have a mean score reflecting positive responses (e.g., strongly agree or agree) to each of the 7 constructs related to users' perceptions, as described above, then feasibility benchmark met. Responses to open-ended questions analyzed qualitatively using Atlas.ti software. Responses to individual questions evaluated to look for common themes, and findings used to inform future development of the prototype.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2012 (estimated)
- Study start20 Feb 2013
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LeukemiaStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Susan K Peterson, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01608152
- Sponsor's protocol ID
- 2012-0362
- Other IDs
- NCI-2020-00573, 2012-0362, R41CA168107
- Status last verified
- Jul 2026
- First submitted
- 25 May 2012
- Last updated
- 15 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Game Mechanics to Improve Outcomes Among Stem Cell Transplant Survivors
- ClinicalTrials.gov ID
- NCT01608152
- Acronym / sponsor ID
- 2012-0362
- Keywords
- Leukemia, Lymphoma, Game mechanics, Stem cell transplant survivors, Hematopoietic stem cell transplantation, HSCT, Internet-based, Interactive and personalized intervention
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 144 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 20 Feb 2013 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 30 May 2012 (estimated)
- 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 trial collects feedback from patients to develop a video game in improving the outcomes in stem cell transplant survivors. A video game may help to improve health behaviors for leukemia or lymphoma patients after stem cell transplant.
Detailed description
PRIMARY OBJECTIVES:
- Develop a prototype intervention electronic game that implements a baseline testable feature set, including features for social networking within a virtual game space, managing an intermittent mediated reward cycle, goal setting and tracking, and collaborative problem solving.
II. Evaluate the technical merit, feasibility, user perception and acceptance of the prototype system with adolescents and young adults (AYAs) allogeneic hematopoietic stem cell transplantation (HSCTs) patients in recovery.
III. Based on the results of the prototype evaluation, enhance and complete development of the Stempowerment on-line intervention.
IV. This is a single arm study with no comparison group; therefore, the purpose is to evaluate the impact of the Stempowerment intervention on
OUTLINE: Patients are assigned to 1 of 2 groups.
GROUP I: Patients attend a focus group for up to 1.5 hours and provide feedback on design elements, specific desirable features, and preferences for the initial prototype.
GROUP II: Patients have access to the game for 3 weeks and then provide feedback on problems or questions regarding the use of the prototype.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I (focus group) | – | Behavioral: Focus GroupPatients attend a focus group for up to 1.5 hours and provide feedback on design elements, specific desirable features, and preferences for the initial prototype. |
| Group II (access to the game) | – | Other: Internet-Based Intervention, Behavioral: InterviewPatients have access to the game for 3 weeks and then provide feedback on problems or questions regarding the use of the prototype. |
Who may qualify
- Ages
- 15 to 39 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patients with leukemia or lymphoma
Key inclusion criteria (12 listed)
- Phase I
- Individuals ages 15-29
- Able to read and speak English
- Diagnosis of leukemia or lymphoma
- First time allogeneic SCT recipient
Key exclusion criteria (11 listed)
- Phase I
- They do not speak English
- They have vision problems
- They have cognitive problems
- They have psychological difficulties
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 |
|---|---|---|
| Focus GroupAttend a focus group | Behavioural | Group I (focus group) |
| Internet-Based InterventionHave access to the game | Other | Group II (access to the game) |
| Interview1 week after the 3-week period ends, interview conducted over the phone or at a clinic visit. | Behavioural | Group II (access to the game) |
Primary outcome
Feasibility of electronic game intervention
Time frame: 4 weeks
Primary feasibility benchmark based on responses to questions regarding users' perceptions of the technology. If 75% of respondents have a mean score reflecting positive responses (e.g., strongly agree or agree) to each of the 7 constructs related to users' perceptions, as described above, then feasibility benchmark met. Responses to open-ended questions analyzed qualitatively using Atlas.ti software. Responses to individual questions evaluated to look for common themes, and findings used to inform future development of the prototype.
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 15 Jul 2026.
- MD Anderson Cancer CenterLink provided by the sponsor.
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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. This study is not recruiting at the moment.
Susan K Peterson principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Leukemia and Lymphoma, run by M.D. Anderson Cancer Center at 1 site 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 12 inclusion and 11 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: under way, not looking for participants, as of the sponsor's last update on 15 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of electronic game intervention (time frame: 4 weeks). 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 15 Jul 2026.