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N/A
12 Years
19 Years
Open (Enrolling)
Both
Childhood Cancer

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Trial Information


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.


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;

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label

Outcome Measure:

Feasibility of the Mila Blooms Intervention at changing health behaviors.

Outcome Description:

Test the feasibility of the Mila Blooms intervention at changing diet, physical activity, body mass index (BMI), and social cognitive mediators of health behavior change.

Outcome Time Frame:

~9 weeks (from pre-intervention baseline to post-intervention follow-up)

Safety Issue:

No

Principal Investigator

Bernard F. Fuemmeler, Ph.D., MPH

Investigator Role:

Principal Investigator

Investigator Affiliation:

Duke University Health System

Authority:

United States: Institutional Review Board

Study ID:

Pro00029579

NCT ID:

NCT01473342

Start Date:

April 2011

Completion Date:

August 2013

Related Keywords:

  • Childhood Cancer
  • Healthy survivorship
  • Smartphones
  • Treatment

Name

Location

Duke University Medical Center, Dept. of Community and Family Medicine Durham, North Carolina  27705