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

NCT03726801 | Completed DMC

• 1 other identifier: NATALIA MUDARRA GARCÍA
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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).

Conditions

Body Image Disorder

Keywords

Body image; Conservative surgery; Quality of life; Breast cancer; Mastectomy; Ostomy; Colon cancer; Self esteem

Outcome Measures

Primary Outcomes (1)

• 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.

  16 months

Secondary Outcomes (6)

• Average body image in all patients, to check the alterations that refer to perform a nursing intervention prior to surgery.

  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.

  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.

  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

  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.

  16 months

Study Arms (2)

Stratum C

EXPERIMENTAL

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

Stratum E

PLACEBO COMPARATOR

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

Interventions

HEALTH EDUCATION 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 C; Stratum E

Eligibility Criteria

• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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.

You may not qualify if:

• \- 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:
• 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.
• Rejection of surgical intervention.
• Non-cancer patient that will be operated on.

Sponsors & Collaborators

• Universidad Complutense de Madrid: lead

Study Sites (1)

Natalia Mudarra Garcia

Madrid, 28609, Spain

Location

Related Links

• Criteria and Procedures for Breast Conserving Surgery.
• Breast-conserving surgery versus modified radical mastectomy in treatment of early stage breast cancer: A retrospective study of 107 cases.
• \[Influence of the social context on the body image perception of women undergoing breast cancer surgery\].
• Imagen corporal y autoestima en mujeres con cáncer de mama participantes en un programa de intervención psicosocial.
• Quality-of-life outcomes between mastectomy alone and breast reconstruction: comparison of patient-reported BREAST-Q and other health-related quality-of-life measures.
• Percepción de la imagen corporal de la mujer intervenida de cáncer de mama y residente en la ciudad de Granada.
• The relationship between body image disturbance and distress in colorectal cancer patients with and without stomas.

MeSH Terms

Conditions

Body Dysmorphic Disorders; Breast Neoplasms; Colonic Neoplasms

Condition Hierarchy (Ancestors)

Somatoform Disorders; Mental Disorders; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: 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).
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Model Details: 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 Record Dates

• First Submitted: September 25, 2018
• First Posted: November 1, 2018
• Study Start: April 24, 2017
• Primary Completion: August 30, 2018
• Study Completion: August 30, 2018
• Last Updated: November 5, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)