ClinicalTrials.gov
ClinicalTrials.gov Menu

Let's Play! Healthy Kids After Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02361047
Recruitment Status : Completed
First Posted : February 11, 2015
Last Update Posted : November 18, 2016
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Masonic Cancer Center, University of Minnesota
Children's Hospitals and Clinics of Minnesota
St. Jude Children's Research Hospital
Information provided by (Responsible Party):
HealthPartners Institute

Brief Summary:
This pilot study will evaluate the feasibility, acceptability, and potential efficacy of a parent-targeted, phone-based program to prevent unhealthy weight gain and improve biomarkers of oxidative stress and inflammation among childhood acute lymphoblastic leukemia survivors.

Condition or disease Intervention/treatment Phase
Childhood Acute Lymphoblastic Leukemia in Remission Obesity Behavioral: Phone Coaching Program Not Applicable

Detailed Description:
Acute lymphoblastic leukemia (ALL) is the most common childhood cancer, accounting for 25% of all childhood malignancies. Treatment of childhood ALL has a high success rate, with long-term event-free survival of >85%. Treatment success, however, has not come without cost. Recognition of long-term health problems related to childhood cancer therapies is growing. Both during and after therapy, children treated for ALL are at risk for fatigue, reduced physical activity, poor dietary intake, and excessive weight gain, which are driven by physiological (chemotherapy-induced) changes and social (home/environmental) factors. The goals of this pilot study are to evaluate the feasibility, acceptability, and potential efficacy of a parent-targeted, phone-delivered nutrition and physical activity program to prevent unhealthy weight gain among 60 childhood ALL survivors, 4-10 years of age. Participants will be randomly assigned to either the phone-delivered parent-targeted nutrition and physical activity intervention or a standard-of-care control group. Intervention success will be benchmarked by changes in key weight-related behaviors (physical activity and dietary intake) over the 6-month trial, and initial impact of the intervention on biomarkers of inflammation and oxidative stress, fatigue, and body composition will be examined.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Healthy Kids After Cancer: A Physical Activity and Nutrition Intervention
Study Start Date : February 2015
Actual Primary Completion Date : October 2016
Actual Study Completion Date : October 2016


Arm Intervention/treatment
Experimental: Phone Coaching Program
Participants will receive a nutrition and physical activity phone coaching program, in addition to standard-of-care physician counseling regarding lifestyle recommendations to achieve/maintain a healthy weight trajectory after cancer treatment.
Behavioral: Phone Coaching Program
Participants in this group will receive a 10-session nutrition and physical activity program delivered via phone by a health behavior coach to promote healthy lifestyle changes. Participants will also receive standard-of-care physician counseling regarding lifestyle recommendations to achieve/maintain a healthy weight trajectory after cancer treatment.

No Intervention: Standard Care Control
Participants will receive standard-of-care physician counseling regarding lifestyle recommendations to achieve/maintain a healthy weight trajectory after cancer treatment.



Primary Outcome Measures :
  1. Feasibility: Number of participants who complete 8 of 10 intervention sessions [ Time Frame: 6 months ]
    Measured by intervention session completion rates.

  2. Retention: Number of participants who complete 6-month outcome assessments [ Time Frame: 6 months ]
    Measured by completion of the 6-month outcome assessment.

  3. Acceptability: Number of participants who report high satisfaction with the intervention [ Time Frame: 6 months ]
    Measured by parent survey of satisfaction with intervention materials and sessions.


Secondary Outcome Measures :
  1. Change in children's physical activity [ Time Frame: 6 months ]
    Measured by ActiGraph accelerometers

  2. Change in children's dietary intake [ Time Frame: 6 months ]
    Measured by Nutrition Data System for Research (NDSR) interview

  3. Change in children's BMI [ Time Frame: 6 months ]
    Staff-measured height and weight

  4. Change in children's biomarker outcome measures [ Time Frame: 6 months ]
    Measured by serum blood samples

  5. Change in children's energy level [ Time Frame: 6 months ]
    Measured by questionnaire: PedsQL Multidimensional Fatigue Scale



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   4 Years to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Between 4.0 years and < 11.0 years of age at the time of recruitment
  • Previously diagnosed of ALL and currently in remission
  • Between 1-5 years post completion of chemotherapy
  • BMI ≥ 85 percentile for age and sex (overweight or obese) OR at risk for obesity (BMI between the 50th and 85th percentile and at least one overweight parent (BMI ≥ 25 kg/m2)

Exclusion Criteria:

  • History of cranial radiation therapy
  • History of bone marrow transplant
  • History of relapse of ALL
  • Diagnosis of Down's Syndrome
  • Comorbidities of obesity that require immediate subspecialist referral
  • Significant pulmonary, cardiovascular, orthopedic, or musculoskeletal problems that would, in their oncologist's judgment, limit their ability to participate in physical activity
  • Significant psychiatric or neurologic disorders that would impair compliance with study protocol
  • Current participation in a weight-loss program

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02361047


Locations
United States, Minnesota
Children's Hospitals and Clinics of Minnesota
Minneapolis, Minnesota, United States, 55404
Masonic Cancer Center, University of Minnesota
Minneapolis, Minnesota, United States, 55455
United States, Tennessee
St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105
Sponsors and Collaborators
HealthPartners Institute
National Cancer Institute (NCI)
Masonic Cancer Center, University of Minnesota
Children's Hospitals and Clinics of Minnesota
St. Jude Children's Research Hospital
Investigators
Principal Investigator: Alicia S Kunin-Batson, PhD HealthPartners Institute

Publications:
Responsible Party: HealthPartners Institute
ClinicalTrials.gov Identifier: NCT02361047     History of Changes
Other Study ID Numbers: A13-175
1R21CA182727-01A1 ( U.S. NIH Grant/Contract )
First Posted: February 11, 2015    Key Record Dates
Last Update Posted: November 18, 2016
Last Verified: August 2016

Additional relevant MeSH terms:
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Leukemia
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases