Prevention of Body Image Disorder by Nurse Intervention on the Patient and Family Prior to Breast and Colon Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-24

Study Completion Date

2018-08-30

Brief Summary

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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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Detailed Description

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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.

Conditions

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Body Image Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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).

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Investigators

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).

Study Groups

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Stratum C

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

Group Type EXPERIMENTAL

HEALTH EDUCATION

Intervention Type OTHER

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.

Stratum E

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

Group Type PLACEBO_COMPARATOR

HEALTH EDUCATION

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* \- Women over 18 years old.
* Oncological patients diagnosed with breast cancer (ductal carcinoma in situ, infiltrating ductal carcinoma, infiltrating lobular carcinoma, multicentric carcinoma, paget tumor ...), which are going to be subjected to surgery (mastectomy, lymphadenectomy, sentinel lymph node biopsy, surgery conservative ...).
* Not having received chemotherapy before surgery.
* Live with a direct family member.
* Not having received radiotherapy before surgery.
* Receive or not neoadjuvant hormone therapy.

* Women and men over 18 years of age.
* Oncological patients diagnosed with colorectal cancer (adenocarcinoma of the lower rectum, adenocarcinoma of the middle rectum, colloid or mucinous adenocarcinoma), who are going to undergo surgery (colostomy, ileostomy ...).
* Receive chemotherapy before or after surgery.
* Receive radiotherapy before or after surgery.
* Live with a direct family member.

Exclusion Criteria

* \- Mens.
* Rejection of the surgical intervention.
* Non-cancer patient that will be operated on.
* Performing surgery in another hospital.
* Cancer patient diagnosed with breast cancer without surgical intervention.
* Refusal of the patient to know his diagnosis or impossibility to give his consent.
* Be submitted to tumor biopsy, without surgical intervention.

COLON:

* Rejection of surgical intervention.
* Non-cancer patient that will be operated on.
* Performing surgery in another hospital.
* Oncological patient diagnosed with colon cancer without surgical intervention.
* Refusal of patients to know their diagnosis or inability to give their consent.
* Be submitted to tumor biopsy, without surgical intervention.

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes