Let's Play! Healthy Kids After Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-28

Study Completion Date

2016-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Physical Activity to Modify Sequelae and Quality of Life in Childhood Acute Lymphoblastic Leukemia

NCT00902213

Acute Lymphoblastic Leukemia

COMPLETED NA

Health Counseling and Exercise in Patients With Acute Leukemia - Pilot Study

NCT01557686

Acute Leukemia

COMPLETED EARLY_PHASE1

Web-Based Physical Activity Intervention in Improving Long Term Health in Children and Adolescents With Cancer

NCT03223753

Carcinoma In Situ Hematopoietic and Lymphatic System Neoplasm Malignant Solid Neoplasm

ACTIVE_NOT_RECRUITING PHASE3

Physical Activity Program in Children and Adolescents With Cancer : Assessment of Benefits on Physical, Psychological and Social Health.

NCT02284061

Cancer

UNKNOWN NA

Effects of Home-Based Exercise Program in Children After Acute Lymphoblastic Leukemia

NCT06664736

Acute Lymphoblastic Leukemia

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Childhood Acute Lymphoblastic Leukemia in Remission Obesity

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Phone Coaching Program

Intervention Type BEHAVIORAL

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.

Standard Care Control

Participants will receive standard-of-care physician counseling regarding lifestyle recommendations to achieve/maintain a healthy weight trajectory after cancer treatment.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

4 Years

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No