Mila Blooms Intervention Study

Duke University

Status: Completed

Conditions: Childhood Cancer

Treatments: Behavioral: Mila Blooms

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01473342

1R21CA155965-01A1 (U.S. NIH Grant/Contract)

Pro00029579

Details and patient eligibility

About

This study is focused on the development and pilot/feasibility testing of a smartphone application to promote a healthy diet, increase physical activity, and prevent weight gain in adolescent survivors of childhood cancer.

Full description

While successful advancements in treatment for childhood Acute Lymphoblastic Leukemia (ALL) have resulted in a growing cohort of survivors, these survivors are at risk for a number of long-term health problems. This study proposes to develop and conduct feasibility testing for a smartphone application that would deliver a health behavior intervention to this population.

A formative phase focused on intervention and software development will be followed by a pilot/feasibility test of the intervention. Participants in the intervention will receive a customized study-designed mobile phone app with a social networking component in which users will be able to support one another. They will also receive personal support from a health counselor to help set goals and discuss areas of concern.

Enrollment: 21 patients

Sex: All

Ages: 12 to 19 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participants must speak & read/write fluent English;
• Adolescent must be between 12 and 19 years of age;
• Adolescent must have a previous diagnosis of childhood Acute Lymphoblastic Leukemia;
• Adolescent must be "off-therapy" (i.e., not in active or maintenance phase of cancer therapy) for at least 2 years;
• Adolescent must be cleared by his/her physician to participate (defined by obtaining a score of 80 or greater on the Karnofsky Scale as determined by their physician);
• Participants must have a working phone number;
• Adolescents must live at home with parents in order to facilitate parent involvement via support materials.

Exclusion criteria

• Physician reports that the patient has deficits in neurocognitive functioning that would preclude him/her from participating in a cognitive-oriented intervention;

Trial design

21 participants in 1 patient group

Control & Intervention Phases

Other group

Description:

The control phase will run for 8 weeks, including survey completion and accelerometer wear during Week 1 and Week 8. The intervention phase will run for the 9 weeks following the control phase; where participants are assigned a smartphone to interact with the Mila Blooms gaming app and integrated social network \& receive weekly supportive coaching phone calls from study staff for 8 weeks (Week 9 - Week 16) followed by accelerometer wear \& survey completion during the 9th and final week (Week 17).

Treatment:

Behavioral: Mila Blooms