Using Game Mechanics to Improve Outcomes Among Stem Cell Transplant Survivors

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by M.D. Anderson Cancer Center
Sponsor:
Collaborator:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01608152
First received: May 25, 2012
Last updated: February 21, 2014
Last verified: February 2014
  Purpose

Objectives:

Aim 1. 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.

Aim 2. 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.


Condition Intervention
Leukemia
Lymphoma
Behavioral: Needs Analysis
Behavioral: Video game
Behavioral: Interview

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Using Game Mechanics to Improve Outcomes Among Stem Cell Transplant Survivors

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Feasibility of Electronic Game Intervention [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 30
Study Start Date: February 2013
Estimated Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Needs Analysis Focus Group
8 hematopoietic stem cell transplantation (HSCT) survivors (between 1-3 years after HSCT hospital discharge) from the greater Houston area.
Behavioral: Needs Analysis
Focus group discussion lasting about 1½ hours. Several weeks after focus group, return visit to provide opinions on game development.
Feasibility Evaluation Group
22 hematopoietic stem cell transplantation (HSCT) recipients who are within 1 year of hospital discharge for HSCT for the feasibility evaluation. These patients will be recruited through the Children's Cancer Hospital (CCH) clinics.
Behavioral: Video game
Instructions given at clinic visit on using video game through the internet. Participant asked to play game at home for 3 weeks.
Behavioral: Interview
1 week after the 3-week period ends, interview conducted over the phone or at a clinic visit.

Detailed Description:

Feasibility Evaluation Phase:

If you agree to take part in this study, you will meet with the study staff during a clinic visit.

You will receive instructions on using the video game through the internet. During the game, you will complete many different "real world" tasks that relate to things you should do to help with your recovery from HSCT. You will also be able to communicate with and compete against other participants in the study.

You can use your own computer to play the game or one will be loaned to you for use during the study. You will be asked to play the game at home for 3 weeks. The number of times you will play during the 3 weeks will depend on your treatment schedule.

You will be given contact information to report any problems or questions you may have to the study staff. You will also be called by phone after your appointment with your doctor or asked at a clinic visit if you have any problems or questions.

Within 1 week after the 3-week period ends, you will have an interview over the phone or at a clinic visit. You will be asked about what you liked or did not like about the game.

If you have been loaned a computer, you will return it at the end of the study.

This is an investigational study.

Up to 30 participants will be enrolled in this study. Up to 22 will take part in this phase of the study. All will be enrolled at MD Anderson.

Needs Analysis Phase:

If you agree to take part in this study, you will take part in a focus group discussion. During the discussion, you will be asked questions about your likes and dislikes about a video game being designed by researchers. The game will be designed around tasks you should do to help with your recovery from HSCT. You will be asked questions about what features you might like to see in the game and what you think it should look like. The focus group session may last up to 1½ hours. The session may be audiotaped and researchers may take notes during the session.

Several weeks after the focus group session, you will be asked to return and provide your opinions on documents and drawings researchers created about the game. This may be done one-on-one or in a small group session.

This is an investigational study.

Up to 30 participants will be enrolled in this study. Up to 8 will take part in this phase of the study. All will be enrolled at MD Anderson.

  Eligibility

Ages Eligible for Study:   15 Years to 29 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Hematopoietic stem cell transplantation (HSCTs) patients in recovery in the Houston, Texas area.

Criteria

Inclusion Criteria:

  • Age 15-29 years
  • Diagnosis of leukemia or lymphoma
  • Able to speak, read and write English
  • First time allogeneic stem cell transplant recipient

Exclusion Criteria:

  • Unable to participate in the study due to language, vision, cognitive or other difficulties, as advised by their health care provider (s)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01608152

Contacts
Contact: Susan Peterson, PHD, MPH 713-792-8267

Locations
United States, Texas
UT MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Susan Peterson, PHD, MPH UT MD Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01608152     History of Changes
Other Study ID Numbers: 2012-0362, 1R41CA168107-01
Study First Received: May 25, 2012
Last Updated: February 21, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Leukemia
Lymphoma
Game mechanics
Stem cell transplant survivors
Hematopoietic stem cell transplantation
HSCT
Internet-based
Interactive and personalized intervention
Questionnaires
Focus groups
Interviews

Additional relevant MeSH terms:
Leukemia
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on August 20, 2014