The Effect of Training Given by Mobile Application to Women Undergoing Breast Surgery

NCT04914780 | Completed

• 1 other identifier: KaratayUHaticeTEZ
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

Brief Summary

In a metanalysis study examining the effects of mobile health applications on the quality of life and psychological outcomes of patients with breast cancer, it was concluded that the quality of life increased, the level of self-efficacy was high, and the perceived stress, depression and anxiety were low compared to standard care. It has been stated that there is a need for well-designed randomized studies on the subject due to the heterogeneity of the study results. In a study examining the effects of exercise training given by mobile health application and traditional brochure on physical function, physical activity and quality of life in breast cancer patients, improvement was observed in both groups, but no significant difference was found between the groups. In the study conducted to evaluate the effect of the information transmitted via the mobile application on preoperative breast cancer patients, it was concluded that control patients who did not have access to additional information provided by the mobile application had significantly lower anxiety and depression scores at seven days before surgery compared to the intervention group, and thus, when less information was accessed. It has been reported that anxiety decreases. Surgical treatments applied to women with breast cancer, although there are different treatment options depending on the stage of the disease and the results of the diagnostic procedures; breast-conserving surgery (lumpectomy / tumorectomy, partial mastectomy, segmental mastectomy / quadranectomy) and non-breast-conserving surgery (simple mastectomy, bilateral mastectomy, skin-sparing mastectomy, nipple-sparing mastectomy, modified radical mastectomy, radical mastectomy). When the literature is examined; It was stated that negative emotions such as body image deterioration, decreased self-esteem, hopelessness, guilt, anxiety, and depression were experienced less in patients who underwent breast conserving surgery (BCS) compared to patients who received other breast surgical treatments. Compared to other patients, those who undergo BCS adapt better to the treatment and care process. There are some disadvantages for patients in BCS, which is preferred in the early stage, which aims to protect the integrity of the breast. Some of the disadvantages are the long-term treatment process, the expensive treatments and the difficult access for those living far from the radiotherapy treatment, which is mostly applied in large centers. In addition to these disadvantages, women experience intense psychosocial problems, symptoms experienced during the treatment process negatively affect their compliance with treatment and quality of life. In order to improve the affected quality of life, besides nursing interventions specially planned for each patient, trainings that will facilitate their adaptation to the disease during the diagnosis and treatment process should be planned.

Conditions

Breast Cancer

Keywords

Breast Cancer; Mobil Application; Quality of life; supportive Care Requirements

Outcome Measures

Primary Outcomes (1)

• Change from baseline in supportive care needs at 4 weeks and 8 weeks

  After the training given by the mobile application, the supportive care needs scores of the patients are checked. It has been stated that the DBGÖ-SF is a measurement tool with sufficient validity and reliability indicators. Your scale; There are 9 items in the "spiritual / psychological" sub-dimension and the minimum score from this dimension is 9; maximum score is 45. There are 10 items in the "Health system and information dimension" and the minimum score obtained from this dimension is 10; maximum score is 50. There are 5 items in the "Physical and daily life" dimension and the minimum score obtained from this dimension is 5; maximum score is 25. There are 4 items in the "patient care and support" dimension and the minimum score obtained from this dimension is 4; maximum score is 20. There are 3 items in the "sexuality" dimension and the minimum score obtained from this dimension is 3; maximum score is 15.

  Baseline, 4 weeks and 8 weeks

Secondary Outcomes (1)

• Change from baseline in life quality at 4 weeks and 8 weeks

  Baseline, 4 weeks and 8 weeks

Study Arms (2)

Intervention group

EXPERIMENTAL

4 weeks training with mobile application

Behavioral: Education

Control group

NO INTERVENTION

No intervention will be made for 4 weeks

Interventions

Education BEHAVIORAL

Education intervention with mobile application for 4 weeks

Intervention group

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age and over,
• Breast Conserving Surgery is applied,
• Only diagnosed with breast cancer and not having metastases,
• Participating voluntarily in the research,
• Signed the informed consent form,
• Patients who have a smart phone on them or near them will be included in the study.

You may not qualify if:

• Not operated after the diagnosis of breast cancer and / or surgery other than Breast Conserving Surgery,
• Another type of cancer other than breast cancer,
• Having a disability to answer questions such as dementia, Alzheimer's, hearing and vision loss,
• Illiterate,
• Do not have a smart phone and / or do not know how to use it,
• Patients in the terminal period will not be included in the study.

Sponsors & Collaborators

• KTO Karatay University: lead

Study Sites (1)

Necmettin Erbakan University Medical Faculty Hospital Oncology Clinic

Konya, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2021
• First Posted: June 7, 2021
• Study Start: June 1, 2022
• Primary Completion: October 1, 2022
• Study Completion: December 1, 2022
• Last Updated: March 9, 2023

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)