Clinical trial · Interventional
Prevention of Body Image Disorder by Nurse Intervention on the Patient and Family Prior to Breast and Colon Surgery
NCT03726801CI-TRIAL-00035613completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Body Image Disorder | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| HEALTH EDUCATION | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Stratum C
- description
- 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
- interventionNames
- Other: HEALTH EDUCATION
- type
- PLACEBO_COMPARATOR
- label
- Stratum E
- description
- 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
- interventionNames
- Other: HEALTH EDUCATION
Primary outcomes (1)
- measure
- Average result in patients who have a body image disorder accompanied with or without a direct family member evaluated by the BIS Scale.
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.