An interventional study of HEALTH EDUCATION in Body Image Disorder, sponsored by Universidad Complutense de Madrid. Completed at 1 site in Spain. Per ClinicalTrials.gov, last updated 2018-11-05.
Sponsored by Universidad Complutense de Madrid · Not applicable, Interventional, and Other
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).
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.
56 studies on the registry are indexed under Body Dysmorphic Disorders; 11 are open to participants now.
This study's enrollment of 64 is above the median of 52 across 44 interventional studies indexed under Body Dysmorphic Disorders.
Browse Body Dysmorphic Disorders studies →Universidad Complutense de Madrid is the lead sponsor of 206 studies on the registry; 64 are open to participants now.
Counted across the registry records on this site, refreshed daily.
MOM:
Inclusion criteria:
Exclusion criteria:
COLON:
Inclusion criteria:
Exclusion criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
N 32 C Women who are going to be mastectomized, conservate surgery and ostomy who attend the health education together with their immediate family member prior to surgery
Other: HEALTH EDUCATION
N 32 E Patients who are going to be subjected to a mastectomized, conservate surgery and ostomy who come alone to the health education prior to surgery
Other: HEALTH EDUCATION
The nursing intervention prior to surgery: (breast and colon cancer): 1. First phase: At first these subjects suffered a great emotional impact after knowing the diagnosis, which could generate intense anxiety reactions. 2. Second phase or phase of coping, in which they begin to be aware of their illness and the future changes they will suffer in their body. In this phase they react with fear, anger, anger, denial, ... 3. Third phase or phase of adaptation to the new situation, where there is a decrease in previous emotional reactions, the patient being able to start up the resources learned to reduce their psychological discomfort.
Average result in patients who have a body image disorder accompanied with or without a direct family member evaluated by the BIS Scale.
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
Average body image in all patients, to check the alterations that refer to perform a nursing intervention prior to surgery.
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 the self-esteem of the patients, differentiating whether or not they go with a direct family member, evaluated by the Rosenberg Scale.
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
Percentage of the Rosenberg scale in all patients, to check the self-esteem that patients refer to when performing a nursing intervention prior to surgery.
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
Average of the quality of life that patients have, differentiating whether or not they go with a direct family member, evaluated by the QLQBR23 Scale
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
Percentages of the Rosenberg Scale and average of the Bis Scale in all patients, to check whether the body image is related to self-esteem.
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
Percentages in the Bis Scale and in the QLQ BR23 scale in all patients, to check if the body image is related to the quality of life.
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.
Time frame: 16 months
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
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