Development of a Video Game for the Improvement of Outcomes in Stem Cell Transplant Survivors

April 19, 2024 updated by: M.D. Anderson Cancer Center

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

PRIMARY OBJECTIVES:

I. 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 Type

Observational

Enrollment (Estimated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • M D Anderson Cancer Center
        • Contact:
          • Susan K. Peterson
          • Phone Number: 713-792-8267
        • Principal Investigator:
          • Susan K. Peterson

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 39 years (Child, Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with leukemia or lymphoma

Description

Inclusion Criteria:

Phase I

The target population for this study will consist of:

  1. Individuals ages 15-29
  2. Able to read and speak English
  3. Diagnosis of leukemia or lymphoma
  4. First time allogeneic SCT recipient

Phase II

The target population for this study will consist of:

  1. 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.
  2. Able to read and speak English
  3. Diagnosis of leukemia or lymphoma (including Myelodysplastic Syndrome - MDS) or lymphoma
  4. HSCT recipient

Exclusion Criteria:

Phase I

The target population will be excluded if:

  1. They do not speak English
  2. They have vision problems
  3. They have cognitive problems
  4. They have psychological difficulties

Phase II

The target population will be excluded if:

  1. They do not speak English
  2. They have vision problems that would preclude them from viewing a computer screen.
  3. 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Behavioral: Focus Group
Attend a 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.
Other: Internet-Based Intervention
Have access to the game
Behavioral: Interview
1 week after the 3-week period ends, interview conducted over the phone or at a clinic visit.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

M.D. Anderson Cancer Center

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Susan K Peterson, M.D. Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 20, 2013

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

May 25, 2012

First Submitted That Met QC Criteria

May 29, 2012

First Posted (Estimated)

May 30, 2012

Study Record Updates

Last Update Posted (Actual)

April 22, 2024

Last Update Submitted That Met QC Criteria

April 19, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012-0362 (Other Identifier: M D Anderson Cancer Center)
  • NCI-2020-00573 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
  • R41CA168107 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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