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Childhood Acute Lymphoblastic Leukemia in RemissionNCT02361047

Let's Play! Healthy Kids After Cancer

A study testing Phone Coaching Program in people with Childhood Acute Lymphoblastic Leukemia in Remission and Obesity, run by HealthPartners Institute at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 4 to 10 years
What is being tested?
Phone Coaching Program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
42 participants
Where
3 sitesUnited States
Study dates
Feb 2015to Oct 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 4 to 10 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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)

Who cannot join

  • 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

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • St. Jude Children's Research Hospital

    Memphis, Tennessee, 38105

  • Children's Hospitals and Clinics of Minnesota

    Minneapolis, Minnesota, 55404

  • Masonic Cancer Center, University of Minnesota

    Minneapolis, Minnesota, 55455

Other trials in United States

About this study

Official title: Healthy Kids After Cancer: A Physical Activity and Nutrition Intervention

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.

Read the 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.

Being tested
Phone Coaching Program
Medical subject headings
Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Phone Coaching ProgramBehavioural

    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.

Study groups in NCT02361047
Study groupRoleWhat they receive
Phone Coaching ProgramExperimentalParticipants 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.
Receives: Behavioral: Phone Coaching Program
Standard Care ControlNo interventionParticipants will receive standard-of-care physician counseling regarding lifestyle recommendations to achieve/maintain a healthy weight trajectory after cancer treatment.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Feasibility: Number of participants who complete 8 of 10 intervention sessions

    Measured by intervention session completion rates.

    Measured: 6 months

  2. Retention: Number of participants who complete 6-month outcome assessments

    Measured by completion of the 6-month outcome assessment.

    Measured: 6 months

  3. Acceptability: Number of participants who report high satisfaction with the intervention

    Measured by parent survey of satisfaction with intervention materials and sessions.

    Measured: 6 months

Secondary outcomes (5)

  1. Change in children's physical activity

    Measured by ActiGraph accelerometers

    Measured: 6 months

  2. Change in children's dietary intake

    Measured by Nutrition Data System for Research (NDSR) interview

    Measured: 6 months

  3. Change in children's BMI

    Staff-measured height and weight

    Measured: 6 months

  4. Change in children's biomarker outcome measures

    Measured by serum blood samples

    Measured: 6 months

  5. Change in children's energy level

    Measured by questionnaire: PedsQL Multidimensional Fatigue Scale

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Feb 2015 (estimated)
  2. Study startFeb 2015
  3. Primary completionOct 2016
  4. Study completionOct 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
42 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02361047
Sponsor's protocol ID
A13-175
Other IDs
1R21CA182727-01A1
Status last verified
Jun 2019
First submitted
23 Jan 2015
Last updated
10 Jun 2019
Results posted
No
Data monitoring committee
Yes

Publications

  • Rogers PC, Meacham LR, Oeffinger KC, Henry DW, Lange BJ. Obesity in pediatric oncology. Pediatr Blood Cancer. 2005 Dec;45(7):881-91. doi: 10.1002/pbc.20451.

    PubMed 16035086

  • Ness KK, Armenian SH, Kadan-Lottick N, Gurney JG. Adverse effects of treatment in childhood acute lymphoblastic leukemia: general overview and implications for long-term cardiac health. Expert Rev Hematol. 2011 Apr;4(2):185-97. doi: 10.1586/ehm.11.8.

    PubMed 21495928

  • Ness KK, Leisenring WM, Huang S, Hudson MM, Gurney JG, Whelan K, Hobbie WL, Armstrong GT, Robison LL, Oeffinger KC. Predictors of inactive lifestyle among adult survivors of childhood cancer: a report from the Childhood Cancer Survivor Study. Cancer. 2009 May 1;115(9):1984-94. doi: 10.1002/cncr.24209.

    PubMed 19224548

  • Cohen J, Wakefield CE, Fleming CA, Gawthorne R, Tapsell LC, Cohn RJ. Dietary intake after treatment in child cancer survivors. Pediatr Blood Cancer. 2012 May;58(5):752-7. doi: 10.1002/pbc.23280. Epub 2011 Aug 17.

    PubMed 21850679

  • Mayer EI, Reuter M, Dopfer RE, Ranke MB. Energy expenditure, energy intake and prevalence of obesity after therapy for acute lymphoblastic leukemia during childhood. Horm Res. 2000;53(4):193-9. doi: 10.1159/000023566.

    PubMed 11044803

  • Sherwood NE, Levy RL, Langer SL, Senso MM, Crain AL, Hayes MG, Anderson JD, Seburg EM, Jeffery RW. Healthy Homes/Healthy Kids: a randomized trial of a pediatric primary care-based obesity prevention intervention for at-risk 5-10 year olds. Contemp Clin Trials. 2013 Sep;36(1):228-43. doi: 10.1016/j.cct.2013.06.017. Epub 2013 Jun 28.

    PubMed 23816490

Questions about this trial

What is this clinical trial studying?

A study testing Phone Coaching Program in people with Childhood Acute Lymphoblastic Leukemia in Remission and Obesity, run by HealthPartners Institute at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility: Number of participants who complete 8 of 10 intervention sessions (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02361047, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2019.

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