Online Physical Activity and Health Counseling for Survivors of Childhood Acute Lymphoblastic Leukemia (OPAC-ALL)

Rigshospitalet

Status: Not yet enrolling

Conditions: Acute Lymphoblastic Leukemia ALL; Childhood Cancer Survivors; Exercise; Rehabilitation Exercise

Treatments: Other: Exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT07042932

P-2024-15388

Details and patient eligibility

About

Advances in the medical treatment of childhood acute lymphoblastic leukemia (ALL) have resulted in 5-year survival rates above 90%- however, the success is not without consequences. Childhood ALL survivors experience markedly impaired physical capacity - reducing their opportunity to engage in everyday activities including leisure activities, sports, and school - affecting their quality of life. Furthermore, Childhood ALL survivors have markedly increased risk of chronic medical conditions including cardiometabolic diseases - that can be prevented through an active lifestyle. Thus, it is imperative to develop novel interventions that can mitigate these treatment-related late-effects. In this RCT, including 82 childhood ALL survivors (10-21 years-old), we will investigate a 26-week online exercise intervention combined with access to a lifestyle physical activity webpage, and health consultations on cardiorespiratory fitness (primary outcome) markers of metabolic syndrome, and physical activity habits.

While other pilot studies have investigated the effects of exercise for childhood ALL survivors, this study is the first RCT internationally to investigate the effects of online exercise combined with education through an app and health counselling for childhood ALL survivor. Using this approach, we are geographically able to reach every survivor in our targeted population, thereby, minimizing logistic challenges like travel distances.

This study has the potential to radically change the way physical rehabilitation is approached in childhood ALL survivors - Potentially changing the workflow of health professionals from referring only survivors with specific deficits to local physiotherapy to referring all survivors to an exercise program tailored to their needs. By improving the children's general physical capacity, we can give the children the required tools to re-enter everyday life activities, including school physical education, leisure activities, and sports earlier after treatment has ended - ultimately minimizing the social complications of treatment. This study will also answer the government´s call to digitalize 30% of rehabilitation by the 2030.

Enrollment: 82 estimated patients

Sex: All

Ages: 10 to 21 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• aged 10-21 years old,
• at least one year from ended treatment of acute lymphoplastic leukemia
• not adhering to WHO's recommendations for physical activity (i.e., 60 minutes of daily moderate-to-vigorous intensity physical activity including two weekly sessions of strength training for children and 150 minutes of moderate-to-vigorous intensity weekly for adults),
• followed at the pediatric oncology out-patient clinic at Copenhagen University Hospital, Rigshospitalet.

Exclusion criteria

• Children with a mental disability,
• other severe physical co-morbidity contradicting physical exercise,
• and/or terminal illness

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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82 participants in 2 patient groups

Usual care

No Intervention group

Description:

This arm will receive institutional follow-up care during the first 26 weeks. afterward they will receive the intervention

Exercise

Other group

Description:

the intervention group will receive 26 weeks of online supervised exercise (1-2 sessions per week) + access to an 8 modele educational material on a webpage + weekly motivational counseling sessions

Treatment:

Other: Exercise