Clinical Trials Directory

Trials / Withdrawn

WithdrawnNCT07046481

Physical Activity and Quality of Life in Childhood Cancersurvivors- a Long-term Follow-up

Functional Capacity, Physical Activity, Health-related Quality of Life and Fatigue in Young Cancer Survivors, 5-10 Years After Diagnosis

Status
Withdrawn
Phase
N/A
Study type
Interventional
Enrollment
0 (actual)
Sponsor
Region Skane · Academic / Other
Sex
All
Age
5 Years – 17 Years
Healthy volunteers
Not accepted

Summary

The project intends to study physical functional capacity and degree of physical activity health related quality of life and fatigue. Also, we aim to study if the Physical Activity on Prescription (PAP) intervention is a useful method among physically inactive childhood cancer survivors to increase level of activity. The questions the study aim to answer: * What is the physical functional capacity, degree of physical activity, health related quality of life and fatigue among childhood cancer survivors 5- 10 yars after dignosis? * Is the Physical Activity on Prescription intervention feasible for physically inactive childhood cancer survivors and what effect do they experience in terms of physical functioning, physical activity, sedentary behavior, fatigue and health-related quality of life? Participants aged 5-17 years who have been treated for leukemia or brain tumor will be invited to participate. Physical functional capacity and degree of physical activity are assessed with standardized assessment instruments by a physiotherapist. Prior to the visit, participants are also asked to complete questionnaires on HRQoL and fatigue. Participants identified as physically inactive are offered to participate in a PAP intervention. Functional ability scores from previous studies are used as a baseline and are supplemented with objective measurements of physical activity and followed up after the intervention.

Detailed description

The challenges of childhood cancer survivors to incorporate exercise and physical activity into their lives need to be systematically studied so that health care professionals can provide adequate support during and after treatment. It is therefore of great clinical relevance to gather knowledge on how physiotherapists can design and support regular physical activity and exercise for childhood cancer survivors. The project intends to study the feasibility of the PAP intervention on physical functioning, physical activity, sedentary behavior, fatigue and health-related quality of life among physically inactive children and adolescents who have survived childhood cancer, and whether it is a suitable method for these patient groups. Methodology Participants must have been treated for brain tumor or acute lymphoblastic leukemia and be eligible for follow-up at the Pediatric Department at Skåne University Hospital before the age of 18. Physical functioning, level of physical activity/sedentary behavior, health-related quality of life and fatigue are studied in a descriptive cross-sectional study. All children and adolescents aged 5-17 years treated for leukemia or brain tumor and scheduled for their usual follow-up 5-10 years after diagnosis identified using registers from (Swedish national registry of long-term follow-up in childhood cancer) SALUB are invited to participate, the sample is consecutive over a three-year period. Assessments of physical functioning and physical activity are performed by a physiotherapist in conjunction with a visit to the pediatric clinic. Prior to the visit, participants will complete the questionnaires on health related quality of life and fatigue. Participants identified as physically inactive according to the WHO guidelines will be recruited to the intervention study where the PAP will be offered. The intervention study explores the feasibility of benefits and effects on physical functioning, physical activity/ sedentary behavior, fatigue and health related quality of life after a PAP intervention in physically inactive childhood cancer survivors in a feasibility study. Participants identified as physically inactive in the initial study are invited to participate. Data collection from the cross sectional study will be used as baseline and supplemented with objective measurements of physical activity using an accelerometer before the start of the three-month intervention. Participants will be allowed to choose one or two physical activities. The activity can either be an organized sport activity or an everyday task such as walking the dog or cycling to school. To facilitate the selection of an activity that the participants are motivated to perform, a standardized survey is conducted. During the intervention, participants complete an exercise diary regarding intensity and frequency but also other experiences related to the activity. Motivational interviewing is used to support participants to make changes in their physical activity level. At the end of the intervention, levels of physical activity, sedentary behavior, physical functioning, health-related quality of life and fatigue and accelerometer measurements are compared to baseline measurements. The total number of participants treated for brain tumor or leukemia and available for screening of inactivity over a three-year period corresponds to about 50-55 and 70 persons respectively. This means that in total there will be approximately 120 participants to invite to the screening study. Participants will be included until the total number of participants reaches 50. Those who are inactive will be recruited to the intervention study, where physical activity on prescription will be used in order to increase the participant's activity level. We estimate that twenty participants may be eligible for participating. The study is descriptive in nature, so a power calculation cannot be performed. Importance of the project The project will increase knowledge about young cancer survivors' functional capacity, physical activity level, health-related quality of life and prevalence of fatigue. In addition, the need for rehabilitative interventions will be identified, knowledge will be deepened on how physical activity can be promoted for young cancer survivors and how this can affect the individual's future functional capacity and quality of life.

Conditions

Interventions

TypeNameDescription
OTHERPhysical activityOne or two physical activities according to the participant´s preferences will be selected and prescribed and specified for frequence and intensity. The selected activity/-ies could be of any type, as long as they increase the heart rate. The activity/-ies should be performed regularly during 12 weeks, A training diary will be used to monitor and register the activities.

Timeline

Start date
2025-02-01
Primary completion
2029-12-31
Completion
2031-12-31
First posted
2025-07-01
Last updated
2025-07-01

Source: ClinicalTrials.gov record NCT07046481. Inclusion in this directory is not an endorsement.