Natalia Mudarra Garcia
Madrid, 28609, Spain
NCT Number: NCT03726801
This is a non-blinded, randomized, controlled clinical trial consisting of 64 participants, which aims to assess the effectiveness of a nursing intervention for family members and patients prior to surgery to prevent body image disorder in breast cancer operated subjects. or colon (32 participants), compared to the intervention limited only to patients (32 participants).
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Interventional
Not applicable
Madrid, 28609, Spain
Cancer is one of the most important public health problems on a global scale in the 21st century. The National Institute of Neoplastic Diseases highlights, among the most frequent neoplasms, prostate cancer, colon-rectum, lung in men and breast, colon-rectum in women.
One of the main treatments to be able to approach this type of tumors, such as breast and colorectal, is surgery. There are different surgical procedures (conservative surgery, mastectomy, ostomy) that, in a forceful way, affect the body image of the individual, sometimes generating extreme and painful situations. They are procedures that carry biopsychosocial implications and that generate a change in lifestyle.
A better psychological preparation and an effective health education of the patient prior to surgery (consisting of providing the information of the intervention, providing psychological support during the entire surgical process and reporting on the changes that will occur), balance the characteristic stressful trait of surgery, thus decreasing the level of anxiety of the individual.
In order for the patient to overcome this change in his body image, the role played by his immediate family member is fundamental, not only because it helps him improve the quality of life that he will have during the course of his illness, but also because an adequate emotional state can improve the patient's therapeutic response.
The objective of this study was to evaluate the body image disorder suffered by patients with breast and colorectal cancer after undergoing surgery, comparing the group that received a previous nursing intervention with their immediate family member, compared to the patients who received this intervention without him.
A randomized, non-blinded, controlled clinical trial was conducted. The study consisted of performing a nursing intervention prior to breast and colon surgery to both groups, giving health education divided into four phases: providing information on the disease, showing surgeries and similar experiences, explaining coping methods and reporting on techniques of relaxing.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
MOM:
Inclusion criteria
Exclusion criteria
COLON:
The nursing intervention prior to surgery: (breast and colon cancer):
Time frame: 16 months
he alteration of the body image will be evaluated with the BIS SCALE after surgery, in the control group (patients who attend the nursing intervention prior to the same without family), and in the study group (patients who attend this intervention together with a direct family member). The Bis Scale has a score of 0 to 30 with 0 being no alteration of the body image and 30 a severe alteration.
Time frame: 16 months
Alterations of the body image with the BIS Scale are measured in all patients to check if these alterations are reduced when performing an intervention prior to surgery. The Bis Scale has a score of 0 to 30 with 0 being no alteration of the body image and 30 a severe alteration.
Time frame: 16 months
Percentage of patients who have high self-esteem, average self-esteem and low self-esteem, differentiating whether they go with a direct relative or without him to the nursing intervention prior to surgery. This measurement is made to check if the family influences the patient's self-esteem. The Rosenberg scale has a score of 10 to 40 points: 30-40 high self-esteem, 26-29 average self-esteem and less than 25 low self-esteem.
Time frame: 16 months
The percentages of self-esteem with the Rosenberg Scale are measured in all patients to see if self-esteem improves when performing a nursing intervention prior to surgery. The Rosenberg scale has a score of 10 to 40 points: 30-40 high self-esteem, 26-29 average self-esteem and less than 25 low self-esteem.
Time frame: 16 months
The average of the QLQ Scale is calculated. BR23 - quality of life (concern for the future, sex practice, enjoyment of sex, breast symptoms, arm symptoms), differentiating whether patients with direct family members or without them go to the nursing intervention prior to surgery. This measurement is made to check if the family influences their quality of life. The QLQ BR 23 Scale have a score of 0 to 100 points, with a lower score being better functionality for worry about the future, symptoms of the breast and arm symptoms, and a lower score for worse functionality in sex enjoyment and sex practice.
Time frame: 16 months
The percentages of the Rosenberg Scale and the means obtained with the BIS Scale are calculated. The relationship between these two scores obtained is checked to see if having greater alterations in body image is related to having low self-esteem. The Rosenberg scale has a score of 10 to 40 points: 30-40 high self-esteem, 26-29 average self-esteem and less than 25 low self-esteem. The Bis Scale has a score of 0 to 30 with 0 being no alteration of the body image and 30 a severe alteration.
Time frame: 16 months
The percentages of the Bis Scale and the QLQ BR23 Scale are calculated. The relationship between the two scores obtained is verified, to check if having greater alterations in body image is related to having quality of life. The Bis Scale has a score of 0 to 30 with 0 being no alteration of the body image and 30 a severe alteration.The QLQ BR 23 Scale have a score of 0 to 100 points, with a lower score being better functionality for worry about the future, symptoms of the breast and arm symptoms, and a lower score for worse functionality in sex enjoyment and sex practice.
Universidad Complutense de Madrid
Other
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