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

NCT05181228 | Completed

• 1 other identifier: DAU_01
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

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.

Conditions

Pediatric Cancer

Keywords

Cancer; Care Ability; Family-Centered Empowerment Model; Web-Based Education; Children

Outcome Measures

Primary Outcomes (4)

• Caring Ability Of Family Caregivers Of Patients With Cancer Scale

  It was developed by Nemati et al in 2020 to evaluate the care skills of caregivers involved in the care process of cancer patients and the effectiveness of empowerment interventions according to their care needs. Scale; It is a Likert-type scale consisting of 31 items, five sub-dimensions, and scored between 31 and 155. As the scale score increases, the care ability score also increases. The total scale Cronbach's alpha reliability coefficient obtained from the validity and reliability study of the scale is 0.934. The validity and reliability study of the scale in Turkey was carried out by the researcher.

  8 weeks

• General Self-Efficacy Scale

  Schwarzer and Jerusalem established the General Self-Efficacy Scale in Germany in 1981. The scale's Cronbach alpha coefficient, which was adapted into Turkish in our country by Aypay (2010), was determined to be.83. The scale, which is used with people aged 12 and up, is a four-point Likert-type scale with ten items that contain statements about how well the person believes himself/herself to deal with problems in general. The score range of the scale theoretically spans between 10 and 40. If the individual achieves a high score on the scale, it suggests that his/her self-efficacy is high.

  8 weeks

• Rosenberg Self-Esteem Scale

  It was developed by Morris Rosenberg in 1963 to assess self-esteem. The scale is used in adolescents, adults, and late adult individuals. In the validity and reliability study conducted by Çuhadaroğlu in Turkey in 1986, the validity coefficient was determined as 0.71. The first ten items form the self-esteem subscale and are used to evaluate self-esteem. On the scale, 0-1 points were scored as high self-esteem, 2-4 points as medium self-esteem, and 5-6 points as low self-esteem. A low score in scale scoring means high self-esteem; A high score indicates low self-esteem.

  8 weeks

• Depression Anxiety and Stress Scale

  It is used to determine the depression, anxiety and stress levels of parents. Developed by Lovibond and Lovibond (1995), the first version consists of a total of 42 items. Afterwards, Henry and Crawford (2005) converted the scale into a 21-item short form. The Turkish adaptation study of the scale was conducted by Yılmaz et al. (2017) made by The scale consists of 21 items and three sub-dimensions. There are 7 questions each to measure the dimensions of depression, stress and anxiety. Each item in the scale has a 4-point scoring system that corresponds to 0, 1, 2 or 3 points according to the severity of the symptom. A minimum of 0 and a maximum of 21 points can be obtained in each dimension. High scores obtained from the sub-dimensions mean that the individual has intense feelings for the relevant sub-dimension. Cronbach's alpha internal consistency coefficients for depression, anxiety and stress sub-dimensions are .80, .81 and .75, respectively.

  8 weeks

Study Arms (2)

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

EXPERIMENTAL

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

Behavioral: Web-Based Education Based on Family-Centered Empowerment Model

Control Group

NO INTERVENTION

No intervention was applied to the control group.

Interventions

Web-Based Education Based on Family-Centered Empowerment Model 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.

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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Mersin University: lead

Study Sites (1)

Mersin University

Mersin, Ciftlikkoy, 33343, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

• Rana Yiğit, Professor

  Mersin University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The participants were unaware of which group they were assigned to. The data will be entered using A and B codes, and the researcher doing the statistical analysis will be blind to the participants' groups.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: December 18, 2021
• First Posted: January 6, 2022
• Study Start: May 20, 2022
• Primary Completion: December 1, 2022
• Study Completion: May 1, 2023
• Last Updated: June 13, 2023

Record last verified: 2023-06

Locations

TU (1)