The Effects of Parent-Child Activity Program on Physical Activity of Children With Cancer
Phase: NA
Conditions: Childhood Cancer, Physical Activity, Intervention Program, Parent-Child Relations
Sponsor: Ke Liu

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The Effects of Parent-Child Activity Program on Physical Activity of
Children With Cancer
March 31, 2024

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1. Summary
Study Population: Children diagnosed with malignant tumors aged 6 to 14 years.
Outcome measures: ①Main outcome measures: physical activity behavior in children
with cancer; ②secondary outcome indicators: height, weight, BMI, body fat, muscle,
self-efficacy of physical activity, physical activity enjoyment, perceived social support
in physical activity, and physical activity of parents.
Study Intervention: ①Control group: the children and their parents receive routine
care and health education guidance, receive physical activity guidelines and
suggestions for patients with malignant tumors provided by the researchers, and issue
health knowledge education manual. In addition, the researchers and other members of
the intervention team do not provide information about parent-child activities; ②
Experimental group: the experimental group receives online and offline family-based
parent-child physical activity intervention. It includes participating in offline group
parent-child activities during hospitalization, including family competitive games and
knowledge contests, etc., popularizing science of physical activity and parent-child
sports activities to children and parents regularly after discharge, and pushing tweets,
sports and practice videos related to physical activities and parent-child sports
activities. Exercise were followed every 4 weeks and assessed for the previous session.
The intervention protocol lasts 12 weeks and is followed up 3 months after the
intervention is completed.
Sample size: with physical activity as the outcome indicator, the sample content was
used to estimate the sample content calculation method, and the test level α was set to

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0.05, and the control degree was 90%. According to the results of the literature review,
20.8621 subjects in the experimental group and the control group, considering 20%
lost to follow up, so at least 27 subjects in the experimental group and the control
group.
2. Introduction
2.1 Background
According to statistics, there are an estimated 429000 new cases of childhood
malignancies each year[1]. In recent years, childhood malignancy has ranked sixth in
the total burden of world malignancy and ninth in the burden of childhood disease[2].
At the same time, the incidence of malignant tumors in children and adolescents in
China is also increasing, with a significant rate of 2.8% per year, which is the second
leading cause of death in children[3]. With the progress of modern medicine, the
five-year survival rate of childhood malignancies in developed countries is as high as
80%[1], The five-year survival rate of young children in China has also reached 72%[2].
Therefore, childhood malignancies are a large group, and more professional medical
personnel are needed to provide more and better quality treatment and care services.
Although the current treatment program has significantly improved the treatment and
survival of childhood malignancies in the past few decades, children still face a variety
of health problems, especially in economically underdeveloped developing
countries[4]These adverse effects may last for months to years, facing not only the
physical and psychological effects of malignant tumors, but also various long-term
adverse reactions such as growth and development disorders and secondary tumors

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caused by treatment[5]. Studies reported that 62.3% of patients with childhood
malignancy had at least one chronic disease, such as type 2 diabetes, obesity and
cardiovascular disease[4]; 95% of patients with childhood malignancy develop chronic
disease before the age of 45, and 80.5% develop disabling or life-threatening
complications[5]. Therefore, China launched the National Child Cancer Surveillance
Program in 2019[6]To promote the health of patients, prevent and reduce the above
health problems.
Physical activity (physical activity, PA) is any body activity caused by the skeletal
muscle that leads to energy expenditure[7]. Physical activity has been shown to have
many benefits for the physical and mental health of children with malignant ancies and
can reduce the occurrence of these health problems. The American Cancer Society
(Amarican Cancer Sociation, ACS) states that proper physical activity at all stages of
cancer is good for health[8]. However, the status of physical activity in children and
patients with malignant tumors is worrying. Data from Western countries show that
over 50% of children do not meet the recommended 60 minutes of moderate to high
physical intensity per day[9]; About 92.2% in Hong Kong, China did not meet the
physical activity level recommended by the guidelines[10]; 88.7% of children in
mainland China are far from the daily exercise recommended by WHO[11]. Physical
inactivity not only increases the risk of various health problems, but is also an
important cause of advanced cardiovascular disease and secondary tumors. Therefore,
it is necessary to explore the methods that can effectively improve and maintain the

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physical activity of children with cancer and reduce the occurrence of the above
adverse reactions.
Scholars have developed various intervention programs for the physical inactivity of
patients with childhood malignancy, Showing multiple health benefits, However, the
effects of various intervention programs are not the same: the intervention programs
supervised by professionals in the hospital has strict requirements on time, site and
personnel; Physical activity plans at home due to lack of knowledge, inadequate
supervision, Lead to low intervention compliance and no significant effect; With the
development of mobile health and electronic health devices in recent years, Such as
SMS, apps, real-time video calls, virtual reality technology, It offers broad prospects
for remote intervention of physical activity in childhood malignancies[12,13]. But home
physical activity programs for children still require parental participation, guidance
and supervision. The latest research shows that the parents to participate in the activity
plan to improve compliance and intervention effect has positive influence: in
professionals (such as medical staff or sports coach), under the guidance of
parent-child activity plan participation and completion rate is as high as 90%, after
intervention children with physical function, cardiopulmonary function, fatigue,
quality of life, etc[14]. However, such studies are still in the exploratory stage, the
number of related studies is small, and the long-term health effects of the intervention
are unknown, requiring more data to support them.
Cross-sectional studies show that physical activity in children with cancer is
associated with multiple factors, including physical and psychological factors, family

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support and participation, and peer support, among which children and family-related
factors are the most important factors. Welk[15] proposed the Youth Physical Activity
Promotion Model which provides researchers with a comprehensive approach to
promote adolescent physical activity by systematically understanding and improving
the multiple factors that adolescent physical activity behavior. From the perspective of
social ecology, the model constructed a framework including propensity factors
(psychological attributes), facilitator factors (environment), reinforcing factors (social
influence) and demographic variables. Validated by research[16], The three factors
covered by the model are able to effectively describe adolescent physical activity
behavior, where physical activity self-efficacy and physical activity enjoyment in the
tendency factors, and the influence of parents in the reinforcing factors are the most
important aspects of the promotion of physical activity in adolescents. The Youth
Physical Activity Promotion Model has been widely used in the physical activity
research of school-aged children at home and abroad[17], And reported good reliability
and effectiveness, but has not been applied to construct physical activity intervention
programs in children with tumors.
Therefore, this study is based on the Youth Physical Activity Promotion Model
suitable for children child malignant tumor physical activity plan, aims to provide
continuity care for children and their parents, by providing parents with physical
activity knowledge and skills, increase the participation and interaction, increase
social support for children and parents, improve the physical activity efficacy and
physical activity enjoyment, so as to improve their physical activity behavior, promote

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the life and health of children.
2.2 Risk / benefit evaluation
2.2.1 Potential risks
Due to the particularity of physical activity, children and parents may occur when
participating in the activity, or may be due to exercise: ①bleeding; ②serious soft
tissue injury; ③fracture; ④respiratory tract infection; ⑤severe pain, intolerable; ⑥
fatigue, physical exhaustion, etc.
Countermeasures: The researchers have been strictly trained to accurately assess the
health status of the subjects and timely treatment, and teach the parents common first
aid skills, minimize the injury to the children and their parents, and evaluate and report
according to the standard of adverse events.
2.2.2 Potential benefits
Studies have shown that effective and moderate physical activity has shown many
benefits in both children with acute treatment and children who have finished
treatment or are in long-term survival. Appropriate physical activity in children during
the treatment of malignant tumors can effectively improve their physical and
psychological conditions during the treatment period, such as the recovery of physical
activity level[18], And have increased muscle strength[19], To reduce the
cardiopulmonary injury caused by the treatment[20], To relieve physical pain and
fatigue[19]Other discomfort symptoms and reduce anxiety and depression; proper
physical activity can also effectively improve exercise ability and improve negative

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mood[21], And enhance the cardiopulmonary function[22], And reduce the all-cause
mortality rate[23], enhance the quality of life[21]。
3. Study objectives and outcomes
3.1 Purpose
This study is based on the Youth Physical Activity Promotion Model for children with
cancer, aims to provide continuity care for children and their parents, by providing
parents with physical activity knowledge and skills, increase the participation and
interaction, increase social support for children and parents, improve their physical
activity, and promote their life and health.
3.1.1 Main Purpose
Construct a parent-child activity intervention program suitable for children with
cancer.
3.1.2 Secondary Purpose
(1) Describe the status quo of the physical activity, physical activity self-efficacy,
physical activity enjoyment, family support and the physical activity of the parents of
the children with cancer, and analyze the influencing factors of the physical activity of
the children with cancer;
(2) To explore the effect of parent-child activity intervention in children with cancer
based on Youth Physical Activity Promotion Model on physical activity, physical
activity self-efficacy, physical activity enjoyment, family support and parental
physical activity of children with cancer.
3.1.3, exploratory purpose

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To explore
the
feasibility of
parent-child activity intervention in childhood
malignancies based on Youth Physical Activity Promotion Models.
3.2 Study indicators
3.2.1 Main Indicators and Definitions
Physical activity (physical activity, PA): any body activity caused by skeletal muscle
contraction higher than the basal metabolism[25], Including occupational work,
housework, leisure activities, sports, and physical exercise for fitness and health
purposes[26], Is divided into low (1.5~2.9MET), moderate (3.0~5.9MET) and intense
(6.0 MET). The physical activity mentioned in this study refers to the regular, planned
and organized physical activity to improve or maintain fitness, motor skills or health,
the Chinese leisure activity questionnaire (Children's Leisure Activities Study Survey
Chinese-version, CLASS-C) to measure the physical activity behavior of children with
cancer, and the international physical activity questionnaire measures the physical
activity behavior of parents.
3.2.2 Secondary indicators and Definitions
(1) Physiological indicators: height, weight, body mass index (BMI), body fat of
children. BMI is a simple index of height and weight, which is defined as the weight
by kilogram divided by the square of the height by meter (kg/m2). Body fat rate refers
to the proportion of the fat weight in the human body in the overall body weight, also
known as the body fat percentage, which reflects the content of fat in the human body.
(2) Self-efficacy: Self-efficacy is based on Bandura's social cognition theory[27],
Refers to the individual's judgment of confidence in his / she performing a specific

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behavior, and the individual's judgment of self-efficacy plays an important role in its
decision whether to perform the behavior, degree of effort invested, and length of
adherence. Physical activity self-efficacy is an individual's confidence in engaging and
maintaining physical activity when faced a challenge[28]. In this study, the simplified
Chinese version of physical activity self-efficacy scale (shortened Chinese version
physical activity self-efficacy scale, S-PASESC) was used to measure physical activity
self-efficacy in pediatric patients with cancer.
(3) Enjoyment of physical activity (PA Enjoyment): enjoyment is a process of
experiencing feelings such as happiness, interest and happiness, which is a subjective
feeling[29]. Physical activity enjoyment is a positive emotion for physical activity and
represents a positive attitude towards physical activity, and this psychological
experience can be driven by extrinsic support (e. g., social recognition) and internal
feeling (e. g., sensory experience)[30]. Enjoying is a key factor in motivating physical
activity behavior and sustained participation, especially in the adolescent population[31];
In turn, exercise was able to enhance participants' positive emotions. In this study, the
brief physical activity enjoyment scale (short-form Physical Activity Enjoyment Scale,
S-PACES) was used to measure the physical activity enjoyment in pediatric patients
with cancer.
3.2.3 Safety Indicators
The number of unexpected events during the exercise intervention, including but not
limited to fall, sprain, hypoglycemia, and infection during exercise.
4. study population

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4.1 Inclusion and exclusion criteria for young children with cancer
4.1.1 Inclusion Criteria
(1) Aged 6~14 years old;
(2) Diagnosed with cancer;
(3) Undergoing cancer treatment;
(4) Able to communicate in Chinese;
4.1.2 Exclusion criteria
Children with physical impairment, cognitive impairment, or impaired mental status
are excluded.
4.2 Inclusion and exclusion criteria for parents of children with cancer
4.2.1 Inclusion Criteria
(1) Able to communicate in Chinese and read Chinese;
(2) Able to use smartphone with WeChat;
4.2.2 Exclusion criteria
Parents with emotional or psychiatric disorders and cognitive problems are excluded.
4.3 Removal criteria
(1) Tumor recurrence, bone marrow transplantation, or death during the intervention;
(2) Transfer to a hospital for maintenance treatment;
(3) The child and their families request to withdraw.
Compliance with any of the above conditions can be removed.
4.4 Recruitment and retention strategies
(1) Children were recruited during hospitalization, and children diagnosed with

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malignant tumors between 6 to 14 years in pediatric 1 and their parents were selected
as the research objects, and baseline data of children and their parents were collected
by questionnaire survey;
(2) Ask the children about their subjective feelings, opinions and suggestions on their
physical activity intervention, and timely improve the intervention forms, intervention
programs and intervention measures to meet the needs of the children and their parents
and improve the retention rate and compliance;
(3) In the offline group parent-child activities and knowledge competitions, reward
families, children and parents with outstanding performance and obvious progress,
including stationery, dolls, toys, candy, etc.
5. Research Design
5.1 Overall design
5.1.1 Study Hypotheses
(1) The physical activity of most children with cancer does not meet the guidelines
suggest that their physical activity is positively related to self-efficacy, enjoyment,
family support and the physical activity of their parents;
(2) Compared with the control group, parent-child activity intervention can improve
the physical activity of children with cancer and their parents, promote the
self-efficacy and physical enjoyment of physical activity, and enhance the family
support of children.
5.1.2 Study design
This study is a class of experimental study. The pediatric malignant tumor patients and

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the parents were selected by convenience sampling.
5.2 Study design process
Establish an intervention team composed of researchers and qualified doctors and
nurses, and evaluate the intervention members. Study subjects were recruited
according to the exclusion criteria, and after obtaining informed consent and signing
the consent form, the study subjects were included in the control group and
experimental group. In order to prevent contamination, it was divided into control
group and experimental group according to the chronological order, that is, the
experimental group was included first, and in the experimental group, the control
group was included after the sample size is sufficient. The control and experimental
groups received usual care and parent-child activity intervention. Data were collected
and analyzed at enrollment (T0), 1 month (T1), 2 months (T2), 3 months (T3), and 3
months (T4) after the intervention.
5.3 Methods to reduce the bias
(1) Adopt the research method of similar experiment, collect all the data of the
experimental group, and then recruit the control group to collect the data to avoid the
occurrence of contamination;
(2) The intervention team members shall receive unified physical activity training and
assessment before the intervention, jointly propose the possible situation during the
implementation
of
the
intervention,
unify
the
interpretation
method
of
the
questionnaire items, and give unified language answers to the questions about the
questionnaire;

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(3) In the process of collecting the questionnaire, collect the questionnaire on the spot,
evaluate and check the completion of the questionnaire, timely find and correct the
missing contents, ensure the integrity and effectiveness of the questionnaire
information, and timely input the data after collecting the questionnaire;
(4) When analyzing the data, check the integrity and validity of the data again, and
make remedial plan for the incomplete questionnaire; establish a database, and two
people jointly input and check the data to ensure the accuracy of data entry.
5.4 Statistical analysis
5.4.1 Sample size
The number of sample cases required for the study was estimated by two sample
content calculation using physical activity as the outcome measure. Taking the
medium and high intensity physical activity of the study subjects as the observed
outcome indicator, according to the results, the mean and standard deviation of
physical activity minutes of the control group was 35.88 ± 50,39, the mean and
standard deviation of the experimental group was 166.19 ± 116.92, and the test level
was set at 0.05 and the control was 90%. Calculate the formula according to the
sample size:
We calculated 20.8621 subjects in the experimental group and the control group,
considering 20% lost to follow-up, so n1=n2=21/0.8=26.2527 cases. At least 27
subjects were needed in the experimental and control groups.
5.4.2 Statistical Analysis

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The Epidata3.1 database was established, the data was entered by two people, and the
SPSS25.0 statistical software was used for statistical analysis, and the test level was
set at α =0.05.
(1) Description statistics: ①Data following normal distribution are described by mean
and standard deviation; ②data without normal distribution are described by median
and interquartile spacing.
(2) Data analysis: (3) Use Excel to establish the database, double input data, and use
SPSS25.0 statistical software for statistical analysis, as follows:
①Using frequency, composition ratio, mean, standard deviation to describe the
general data of children with tumors and their parents, the disease data of children and
other conditions;
②The t-test, chi-square test or rank sum test were balanced for general data, physical
activity, physical activity self-efficacy, physical activity enjoyment, and physical
activity social support between the experimental and control groups.
③One-way repeated measures analysis of variance was used to compare the number
of high intensity physical activity minutes between children and parents in the
experimental group.
④If the data of physical activity, physical activity self-efficacy, physical activity
enjoyment and physical activity social support meet the normal distribution
(Shapiro-Wilk test) and equal variance (scatter plot), the mixed design analysis of
variance shall be used to intervene the effects of main effect, time main effect,
intervention time effect and confounding factors; if not satisfied, the generalized

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estimation equation is used.
6. Research intervention
6.1 Study Intervention
(1) Implement routine care in the control group
Children in the control group and their parents received routine care and health
education guidance, as well as guidelines and suggestions on physical activity of
patients with malignant tumors provided by the investigator, and issued health
knowledge education manuals. In addition, the investigator and other members of the
intervention team did not provide information on parent-child activities;
(Ii) The experimental group received the family-based parent-child physical activity
intervention combining online and offline, specifically as follows:
(1) Information support:
I . Establish and use wechat groups
After obtaining the informed consent, the children with cancer and their parents were
invited to join the wechat group, and the popular science of physical activity related
knowledge was regularly pushed to the children and their parents every week.
Children and their parents have any questions can be asked to the intervention team
members in the group. In addition, every Monday, the researchers sent the physical
activity clock in the group, inviting the children and parents to record after completing
the physical activity.
II . Create and use a wechat official account
Create a wechat official account, and push tweets and video content related to physical

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activity every Thursday, Saturday and Sunday morning.
III . Offline group parent-child activities
Inform the children with cancer and their parents to follow up every 4 weeks, and
organize the follow-up children and their parents to participate in offline group
parent-child activities.
(2) Personnel support:
I . Promote parental participation
①Improve parents 'physical activity knowledge, belief and ability: through wechat
group, wechat public account and other ways, increase parents' understanding of
children's physical activity knowledge, improve their belief and ability to supervise
and participate in children's physical activity.
②Increase parent-child activities to promote parents' participation: push a variety of
parent-child physical activities, such as two-person aerobics, two-person ball sports,
and outdoor sports requiring family participation (such as mountain climbing), etc.
③Organize family competitive games to promote parent-child interest.
④Enhance parent-child communication, and jointly develop solutions to various
problems.
II . Strengthen the role between families —— peer influence
①WeChat group communication, enhance the information interaction and emotional
support between peers.
②Family competition, improve the role of role model.
III . Strengthen the role of medical staff —— Medical staff support

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①Information and technical support: medical staff shall provide relevant information,
venues and goods to the child and their parents.
②Emotional support: When children and parents have problems or emotional needs,
intervention team members should provide timely answers and encouragement online;
at monthly follow-up, researchers will provide separate face-to-face interviews to help
them solve their problems.
③Other support: In the offline activities, the medical staff also actively participate in
the demonstration for the children and their parents.
(3) The intervention program lasts for 12 weeks and is follow-up for 3 months after
the completion of the intervention.
6.2 Study Intervention Adherence
Compliance assessment method: Monday morning 08:00 researchers in WeChat group
send physical activity clock table, invite children and parents after complete physical
activity after the corresponding record, to calculate the amount of exercise per week, if
reach 3 times a week, 30 minutes of parent-child activity, is to complete the activity
plan this week.
7. Measurements
This study mainly adopts the form of paper questionnaire data collection, the tools to
be used including the children's socio-demographic data and disease related data,
parents general information, children's leisure activity questionnaire, international

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physical activity questionnaire, physical activity self-efficacy scale, physical activity
enjoyment scale and physical activity social support scale.
(1) Collect the questionnaire, researchers use unified guidelines and instructions to
encourage malignant children and their parents to fill in the questionnaire and scale;
For the participants who could not fill in the questionnaire by themselves, the
participants will answer the contents of the questionnaire items, and the data collectors
will fill in the questionnaire for them;
(2) After recruiting eligible children and their parents according to discharge standards
and obtaining informed consent, Collect the baseline (T0) data, Including children's
general data, physiopathological indicators, physical activity questionnaire, physical
activity self-efficacy scale, physical activity enjoyment scale, family support
questionnaire and general data of children's parents, physical activity questionnaire;
Physical activity questionnaires, physical activity self-efficacy scale, physical activity
enjoyment scale and physical activity questionnaires of parents were collected at the
end of intervention week 4 (T1) and week 8 (T2); At the end of the intervention (T3),
the physical activity indicators, physical activity questionnaire, physical activity
self-efficacy scale, physical activity enjoyment scale, family support questionnaire and
physical activity questionnaire of the parents were collected; Three months after the
intervention (T4), Phyopathological indicators, physical activity questionnaires, family
support questionnaires and physical activity questionnaires of parents were collected.

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