Body Image DisorderNCT03726801
Prevention of Body Image Disorder by Nurse Intervention on the Patient and Family Prior to Breast and Colon Surgery
A study testing HEALTH EDUCATION in people with Body Image Disorder, run by Universidad Complutense de Madrid at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Body Image Disorder
- What is being tested?
- HEALTH EDUCATION
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteSpain
- Study dates
- 24 Apr 2017to 30 Aug 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- - 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.
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- 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.
Who cannot join
- - 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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).
Read the 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.
- Conditions
- Body Image Disorder
- Being tested
- HEALTH EDUCATION
- Keywords
- Body image, Conservative surgery, Quality of life, Breast cancer, Mastectomy, Ostomy, Colon cancer, Self esteem
- Medical subject headings
- Body Dysmorphic Disorders, Breast Neoplasms, Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HEALTH EDUCATIONOther
The nursing intervention prior to surgery: (breast and colon cancer):
- First phase: At first these subjects suffered a great emotional impact after knowing the diagnosis, which could generate intense anxiety reactions.
- 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, ...
- 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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: HEALTH EDUCATION |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 16 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2018
- Study start24 Apr 2017
- Primary completion30 Aug 2018
- Study completion30 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Body Image DisorderStudies of the same condition, open and under way.
- More trials run by Universidad Complutense de MadridThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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).
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Complutense de Madrid
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Natalia Mudarra García, Universidad Complutense de Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03726801
- Sponsor's protocol ID
- NATALIA MUDARRA GARCÍA
- Status last verified
- Nov 2018
- First submitted
- 25 Sep 2018
- Last updated
- 5 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Body Image Disorder by Nurse Intervention on the Patient and Family Prior to Breast and Colon Surgery
- ClinicalTrials.gov ID
- NCT03726801
- Acronym / sponsor ID
- NATALIA MUDARRA GARCÍA
- Conditions
- Body Image Disorder
- Keywords
- Body image, Conservative surgery, Quality of life, Breast cancer, Mastectomy, Ostomy, Colon cancer, Self esteem
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Universidad Complutense de MadridUniversity, hospital or other
- Study start
- 24 Apr 2017 (actual)
- Primary completion
- 30 Aug 2018 (actual)
- Study completion
- 30 Aug 2018 (actual)
- First posted
- 1 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- 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).
| Arm | Type | Receives |
|---|---|---|
| Stratum C | Experimental | Other: HEALTH EDUCATIONN 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 |
| Stratum E | Placebo comparator | Other: HEALTH EDUCATIONN 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 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (11 listed)
- - 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.
Key exclusion criteria (14 listed)
- - 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HEALTH EDUCATIONThe 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. | Other | Stratum C, Stratum E |
Primary outcome
Average result in patients who have a body image disorder accompanied with or without a direct family member evaluated by the BIS Scale.
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.
6 secondary outcomes
Average body image in all patients, to check the alterations that refer to perform a nursing intervention prior to surgery.
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.
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.
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
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.
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.
Time frame: 16 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2018.
- Criteria and Procedures for Breast Conserving Surgery.Link provided by the sponsor.
- Breast-conserving surgery versus modified radical mastectomy in treatment of early stage breast cancer: A retrospective study of 107 cases.Link provided by the sponsor.
- \[Influence of the social context on the body image perception of women undergoing breast cancer surgery\].Link provided by the sponsor.
- Imagen corporal y autoestima en mujeres con cáncer de mama participantes en un programa de intervención psicosocial.Link provided by the sponsor.
- Quality-of-life outcomes between mastectomy alone and breast reconstruction: comparison of patient-reported BREAST-Q and other health-related quality-of-life measures.Link provided by the sponsor.
- Percepción de la imagen corporal de la mujer intervenida de cáncer de mama y residente en la ciudad de Granada.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HEALTH EDUCATION in people with Body Image Disorder, run by Universidad Complutense de Madrid at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average result in patients who have a body image disorder accompanied with or without a direct family member evaluated by the BIS Scale. (time frame: 16 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2018.