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

M.D. Anderson Cancer Center

Status: Enrolling

Conditions: Lymphoma; Leukemia

Treatments: Other: Internet-Based Intervention; Behavioral: Focus Group; Behavioral: Interview

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT01608152

NCI-2020-00573 (Registry Identifier)

R41CA168107 (U.S. NIH Grant/Contract)

2012-0362 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 15 to 39 years old

Volunteers: No Healthy Volunteers

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.

Trial design

40 participants in 2 patient groups

Group I (focus group)

Description:

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.

Treatment:

Behavioral: Focus Group

Group II (access to the game)

Description:

Patients have access to the game for 3 weeks and then provide feedback on problems or questions regarding the use of the prototype.

Treatment:

Behavioral: Interview

Other: Internet-Based Intervention