Clinical trial NCT01608152: Development of a Video Game for the Improvement of Outcomes in Stem Cell Transplant Survivors
Official title: Using Game Mechanics to Improve Outcomes Among Stem Cell Transplant Survivors
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Leukemia
Lymphoma
Keywords: Leukemia
Lymphoma
Game mechanics
Stem cell transplant survivors
Hematopoietic stem cell transplantation
HSCT
Internet-based
Interactive and personalized intervention
Questionnaires
Focus groups
Interviews
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2012-05-30
Enrollment: 40
Sex: ALL
Minimum age (years): 15
Maximum age (years): 39
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with leukemia or lymphoma

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Feasibility of electronic game intervention
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Susan K Peterson
role: PRINCIPAL_INVESTIGATOR
References: