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

NCT ID: NCT05181228

Last Updated: 2023-06-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 76 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-20
• Study Completion Date: 2023-05-01

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.

Conditions

Pediatric Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Intervention Group (Web-based family-centered empowerment program intervention)

Intervention group participants will receive the web-based family-centered empowerment intervention for 10 weeks.

Group Type: EXPERIMENTAL

Web-Based Education Based on Family-Centered Empowerment Model

Intervention Type: BEHAVIORAL

Parents in the intervention group will receive care for ten weeks using the family-centered empowerment model (FCEM). The first step (two weeks) is to increase knowledge. For this purpose, they will receive web-based training on cancer. The second step (four weeks) is to develop parents' self-efficacy and problem-solving skills. A web-based training and group meeting will be held to share information and experiences on the evaluation and control of the side effects of the treatment and to increase their self-efficacy in care. The third step (three week) was to increase self-esteem through participation in the training. At this stage, each participant will be asked to teach one of the family members responsible for the child's care what they have learned in the last two sessions. In the fourth step (one week), all participants in the intervention group will be evaluated by asking questions about the topics discussed in the second and third sessions and the overall content taught.

Control Group

No intervention was applied to the control group.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Web-Based Education Based on Family-Centered Empowerment Model

Parents in the intervention group will receive care for ten weeks using the family-centered empowerment model (FCEM). The first step (two weeks) is to increase knowledge. For this purpose, they will receive web-based training on cancer. The second step (four weeks) is to develop parents' self-efficacy and problem-solving skills. A web-based training and group meeting will be held to share information and experiences on the evaluation and control of the side effects of the treatment and to increase their self-efficacy in care. The third step (three week) was to increase self-esteem through participation in the training. At this stage, each participant will be asked to teach one of the family members responsible for the child's care what they have learned in the last two sessions. In the fourth step (one week), all participants in the intervention group will be evaluated by asking questions about the topics discussed in the second and third sessions and the overall content taught.

Intervention Type: BEHAVIORAL

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,

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Mersin University

OTHER

Sponsor Role: lead

Responsible Party

Derya AKDENIZ UYSAL

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rana Yiğit, Professor

Role: STUDY_DIRECTOR

Mersin University

Locations

Mersin University

Mersin, Ciftlikkoy, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

DAU_01

Identifier Type: -

Identifier Source: org_study_id