Clinical trial NCT03726801: Prevention of Body Image Disorder by Nurse Intervention on the Patient and Family Prior to Breast and Colon Surgery
Official title: Prevention of Body Image Disorder by Nurse Intervention on the Patient and Family Prior to Breast and Colon Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Body Image Disorder
Keywords: Body image
Conservative surgery
Quality of life
Breast cancer
Mastectomy
Ostomy
Colon cancer
Self esteem
Lead sponsor: Universidad Complutense de Madrid
Sponsor class: OTHER
First posted: 2018-11-01
Enrollment: 64
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: OTHER

Brief summary: 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).

Detailed description: 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.

Eligibility criteria: MOM:

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.

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:

* Inclusion criteria:

  * 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:

  * 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.

Primary outcomes:
measure: Average result in patients who have a body image disorder accompanied with or without a direct family member evaluated by the BIS Scale.
timeFrame: 16 months
Secondary outcomes:
measure: Average body image in all patients, to check the alterations that refer to perform a nursing intervention prior to surgery.
timeFrame: 16 months
measure: Percentage of the self-esteem of the patients, differentiating whether or not they go with a direct family member, evaluated by the Rosenberg Scale.
timeFrame: 16 months
measure: 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.
timeFrame: 16 months
measure: 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
timeFrame: 16 months
measure: 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.
timeFrame: 16 months
measure: 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.
timeFrame: 16 months
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Natalia Mudarra Garcia
Study officials:
References: