Clinical trial NCT05181228: Evaluation of the Impact of a Family-Centered Empowerment Program on Self-Efficacy, Self-Esteem, Depression, Anxiety, Stress Level, and Care Skills in Parents of Children With Oncological Problems
Official title: Evaluating The Effectiveness of A Family-Centered Empowerment Program Applied to Parents of Children With Oncological Problems
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pediatric Cancer
Keywords: Cancer
Care Ability
Family-Centered Empowerment Model
Web-Based Education
Children
Lead sponsor: Mersin University
Sponsor class: OTHER
First posted: 2022-01-06
Enrollment: 76
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The research has a randomized controlled interventional study design. An impartial investigator who is not participating in the study will conduct the randomization. Six alternative combinations with a block size of four (ABAB(1), ABBA(2),...) containing codes A and B will be constructed using the block randomization method. From 1 to 6, combinations will be numbered. By sorting the integers (1-6) via randomizer.org 21 times in a random order, a random assignment sequence will be formed. By drawing lots with coins, it will be established which of the A and B codes is the intervention group and which is the control group. Participants who meet the inclusion criteria will be asked to sign an informed consent form, and their group will be shared with the researcher after the pre-tests (T1) are completed. In the intervention group, participants will get a web-based training based on the family-centered approach.
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study aims to develop a web-based education program based on family centered empowerment model for parents of children with oncological problems and to evaluate the effect of the program on parents' self-efficacy, self-esteem, depression, anxiety, stress level and care abilities.

Detailed description: Cancer, one of the most important health problems of today, affects children as well as adults and the number of children diagnosed with cancer is increasing all over the world. Cancer management is generally a more complex process than other diseases and requires the caregiver family to have knowledge and skills. Because; Parents, who are the most important persons to contribute to the care of children with oncological problems, need to be supported and strengthened not only in the hospital but also in the home environment in order to manage and solve the problems and cope with this situation. One of the methods used in the empowerment of caregivers; is the family-centered empowerment model (FCEM). Model; It consists of four stages: increasing knowledge, self-efficacy and self-esteem, and evaluation. The purpose of this model; to protect the health of the family and their children, to manage the disease and symptoms, to reduce the incidence of acute attacks, to improve the quality of care by improving the quality of life of children and their parents. Because of technological advancements and growth in the number of internet users, web-based education (WBE) has become one of the most popular ways patient and family education. There is research in the literature that illustrates the benefits of web-based treatments in family strengthening.The web-based training content will be prepared based on the Family-Centered Empowerment Model. For ten weeks, parents will receive a web-based training based on the family-centered empowerment model. For the control group, routine patient education and routine hospital follow-ups will be performed by their nurses during the ten weeks follow-up period. The study's sample size; A priori power analysis was used to determine the minimum sample size. The sample size for the intervention and control groups was 38 parents, and the double-sided hypothesis was calculated as n1=n2, the effect size of 0.659, with 5% Type I error and 80% power. Research data; It was collected using the Parent and Child Information Form, the General Self-Efficacy Scale, the Rosenberg Self-Esteem Scale, the Depression Anxiety and Stress Scale, and the Care Ability Scale of Family Caregivers of Cancer Patients. A statistical package program will be used in the analysis of the data. The conformity of the mean scores of the scale to the normal distribution will be evaluated with the coefficients of kurtosis and skewness, and the means will be compared with parametric or nonparametric test techniques. The similarity of the groups in terms of demographic and clinical characteristics will be evaluated with the relevant tests. Cohen's d effect size will be calculated to express the size of the difference between the means.

Eligibility criteria: Inclusion Criteria:

* Being a parent (mother or father) of a child with a hematology/oncological diagnosis
* At least 1 months have passed since the child was diagnosed
* Being a parent of a child undergoing chemotherapy
* Parent who were literate
* Parents who has Internet at home
* Parents who has computer or mobile phone
* Parents who no barriers to written or verbal communication
* Parents who agree to participate in the study

Exclusion Criteria:

* Patients who do not agree to participate in the study,
* Internet not access in the home environment,

Primary outcomes:
measure: Caring Ability Of Family Caregivers Of Patients With Cancer Scale
timeFrame: 8 weeks
measure: General Self-Efficacy Scale
timeFrame: 8 weeks
measure: Rosenberg Self-Esteem Scale
timeFrame: 8 weeks
measure: Depression Anxiety and Stress Scale
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Mersin
country: Turkey
facility: Mersin University
state: Ciftlikkoy
Study officials:
affiliation: Mersin University
name: Rana Yiğit, Professor
role: STUDY_DIRECTOR
References: