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Mastectomy clinical trials

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NCT ID: NCT04872803 Not yet recruiting - Mastectomy Clinical Trials

Emotional Security and Quality of Life Among Breast Cancer Patient Who Have Undergo Mastectomy

Start date: June 1, 2021
Phase:
Study type: Observational

Breast cancer is the most common cause of cancer death among women worldwide. Incidence rates are high in more developed countries than rates in less developed countries In Egypt, standardized age of cancers are 166.6per 100.000 in both sexes cancer breast represent 32%in females and 15.4%in both sexes of all cancer Mastectomy is an important treatment method in Brest cancer. But, mastectomy has a deep and stable negative impact on a woman because, mastectomy as a treatment option, can result in a sense of mutilation and diminished self-worth and may threaten perceptions of femininity Body image of a woman includes the symbolic meaning and importance of her breasts. The more she values her breasts, more devastating effects of having a mastectomy can be. it has been reported that cutting off/amputating one or both breasts was associated with several problems in women such as loss of fertility, charm and sexuality, fear of recurrence Social support plays an important role in reducing the pressure and improving health. Cancer patients who lack social support may be more pessimistic and desperate as they are constantly looking for support from others Therefore, it is critical for health care professionals to become familiar with the impact of a breast cancer diagnosis and its treatment on patient's quality of life .

NCT ID: NCT04860843 Recruiting - Nerve Block Clinical Trials

Nerve Blocks in Alloplastic Breast Reconstruction

Start date: May 1, 2021
Phase: N/A
Study type: Interventional

Pain management is a major concern in oncologic breast surgery and reconstruction. Significant risks for acute and chronic pain after surgery might be reduced through improved pain control pre-operatively. Addition of regional anesthesia to a multimodal peri-operative pain management protocol offers a promising solution for improved recovery. For patients undergoing mastectomy with immediate alloplastic breast reconstruction, this RCT compares TPVB+Pecs local anesthetic block with TPVB local anesthetic block and Pecs placebo normal saline block for their effect on acute pain, chronic pain, opioid consumption, opioid-related side effects, patient-reported quality of recovery after surgery, and length of stay.

NCT ID: NCT04858282 Completed - Breast Cancer Clinical Trials

Application-Enabled Shared Decision-Making

Start date: August 1, 2019
Phase: N/A
Study type: Interventional

To develop application-enabled shared decision-making among patients with early breast cancer and evaluate the preliminary effects of the interventions.

NCT ID: NCT04824183 Completed - Breast Cancer Clinical Trials

Music Intervention for Preoperative Anxiety and Acute Pain Among Mastectomy Patients

Start date: June 5, 2021
Phase: N/A
Study type: Interventional

Anxiety is a common thing that patients experience when they are preparing to have a surgery. When this anxiety is not properly treated, the patients tend to consume more drugs in the operating room and it also cause their pain to increase after surgery. Pain after surgery is common among patients who have just had surgery. The pain that women who have had mastectomy feels after surgery is usually treated using pain killers. Yet, the pain killers are not enough to reduce the pain or cause some unwanted outcomes for the patients. Therefore, supplementing pain killers with music therapy appears to be a good way to reduce the pain and the unwanted outcomes that may arise from taking too much pain killers. This research is aimed to test how effective music that is selected by patients, considers their culture and psychological needs can be helpful in reducing anxiety before surgery and pain after surgery. Also its effect on blood pressure, breathing rate and pulse will be tested. The researcher also hope to know how satisfied patients who consent to participate in the study are with their pain management. The study will be done in two Nigerian hospitals and will mainly include women who have cancer, are above the age of 18, scheduled to have mastectomy, can read or write English or Pidgin, without any mental health challenge and agrees to participate in the study. This study hope to enrol up to 112 women and put them into two groups randomly, one group will receive the music intervention and the other group will receive the normal care provided by the hospital. Participants in the music intervention group will be added to a WhatsApp group on the week of their surgery. The WhatsApp session will be three times within the week of the surgery and each session will be about 30 minutes long. This study will use a combination of very short videos and voice notes (3 minutes) as well as real time chats and pictures to enhance communication on the group chat. The researcher will initiate discussions about participant's experience with breast cancer diagnosis, teach them about anxiety before surgery and pain after surgery. Then, they will ask questions that will be answered and also choose their type of music and send it to the group. The songs will be downloaded into a device and given to them on the day of surgery. They will continue to listen to the music after their surgery for the next two days. Before participants receive the music on the day of surgery, anxiety level and vital signs will be assessed. After the surgery, participant's pain level, vital signs and satisfaction with pain management before and after the intervention will be assessed. Those in the second group will receive a one-on-one chat with the researcher about pain after surgery. For all the participants, the study will be completed two days after the surgery.

NCT ID: NCT04741737 Recruiting - Mastectomy Clinical Trials

Repeat Sentinel Lymph Node Biopsy in Ipsilateral Breast Tumor Recurrence

Start date: March 1, 2020
Phase: N/A
Study type: Interventional

According to the standard treatment guidelines established until recently, in the case of ipsilateral breast tumor recurrence without systemic metastasis, salvage mastectomy or lumpectomy can be performed when either partial or whole breast radiation therapy is possible. On the other hand, there are currently no standard treatment guidelines for axillary treatment, and the evidence for this is limited. Axillary lymph node metastasis was reported to occur in about 26% of breast cancer patients who had negative sentinel lymph nodes from previous surgery for primary breast cancer and only local recurrence occurred. It is still important in the decision of treatment or adjuvant radiation therapy. However, it is known that most of the patients with ipsilateral breast recurrence do not have axillary lymph node metastasis. Therefore, performing axillary axillary surgery in all of these patients does not help the patient's survival in many cases, but rather can lead to complications such as lymphedema and seroma and postoperative wound infection. A question about the implementation of axillary lymph node resection has been raised and for this reason, it is necessary to study whether surveillance lymph node biopsy is still effective in patients with recurrence in the ipsilateral breast. Most of the studies on ipsilateral breast tumor recurrence without systemic metastasis reported to date are case reports or small retrospective studies. In addition, the combined meta-analysis also has limitations in that the study design is not uniform, and there are many cases in which primary breast cancer surgery performed total mastectomy or axillary lymph node dissection. This study is a multicenter prospective study designed to validate the clinical effectiveness of repeat-SLNB conducted in patients with ipsilateral breast tumor recurrence among patients who previously underwent breast conservation and sentinel lymph node biopsy for unilateral primary breast cancer.

NCT ID: NCT04687956 Recruiting - Breast Cancer Clinical Trials

Primary Surgical Prevention of Breast Cancer-related Lymphedema

LYMPHA
Start date: February 1, 2021
Phase: N/A
Study type: Interventional

Lymphedema refers to edema caused by insufficient drainage of interstitial fluid through the lymphatic circulation system. It occurs mainly in the upper and lower extremities and causes chronic inflammation, and finally fibrous adipose tissue is replaced. In this study, the'LYMPHA' (Lymphatic microsurgical preventing healing approach) procedure, which connects lymphatic vessels drained from the arm to the side branches of the axillary vein, contributes to the prevention of lymphedema in patients undergoing axillary lymph node dissection for breast cancer. Investigator aim to help patients' quality of life by prospectively analyzing the effects and applying them to clinical practice, reducing the incidence of lymphedema.

NCT ID: NCT04666961 Recruiting - Mastectomy Clinical Trials

Impact of Neoadjuvant Hormonal Therapy on the Surgical Management of Extensive Ductal Carcinomas in Situ

HORNEO01
Start date: February 3, 2021
Phase: Phase 2
Study type: Interventional

Ductal carcinoma in situ (DCIS) accounts for approximately 20% of newly diagnosed breast cancer cases. Of these women, 20% require radical management in the form of mastectomy because of the extent of the lesions, which most often manifest as diffuse microcalcifications. This mutilating surgical management contrasts with the excellent prognosis of this pathology and considerably alters the quality of life of patients. Neoadjuvant hormone therapy has shown its efficacy in hormone-dependent infiltrating ductal carcinomas and offers the possibility of conservative surgery after hormone therapy. Adjuvant hormone therapy with Tamoxifen or anti-aromatase drugs has shown its efficacy in the prevention of homo or contralateral recurrence. The HORNEO 01 trial fits perfectly in the current context of surgical de-escalation of ductal carcinomas in situ. The objective of the study is to evaluate the impact of neoadjuvant hormone therapy on the surgical management of extensive DCIS.

NCT ID: NCT04607460 Recruiting - Migraine Clinical Trials

EMG Biofeedback Treatment for Chronic Low Back Pain, Cancer Pain and Migraines

BEAT-Pain
Start date: December 3, 2020
Phase: N/A
Study type: Interventional

The purpose of this pilot efficacy study is to examine the effects of EMG-biofeedback (EMG-BF) on pain-related outcomes in Chronic Low Back Pain (CLBP) patients, Recent mastectomy and lumpectomy patients, and patients with episodic migraine. EMG-BF facilitates neuromuscular retraining and muscle relaxation by using audio and visual stimuli using an EMG surface electrode-based biosensor and a software installed on a tablet or smart phone. For this pilot efficacy study, we will recruit 125 patients with chronic low back pain, 125 patients who are expected to undergo mastectomy and 80 patients with episodic migraine. Participants will be randomly assigned to either the JOGO Digital Therapeutics EMG Biofeedback device or treatment as usual control group. Patients assigned to the intervention group will be asked to complete self-report questionnaires assessing demographics, pain intensity, negative affect, physical function, pain catastrophizing and sleep, will undergo QST and will be asked to wear Actiwatches to keep track of health behaviors, prior to and after completing the intervention. The intervention consists of weekly sessions during which participants will be instructed on how to use the device by a trained biofeedback instructor. Patients in the control group will undergo sensory testing procedures at baseline and after treatment period but will receive no active treatment. The aims of this study are to examine the impact of EMG-BF on pain and QST and the impact of EMG-BF on psychosocial function. We hypothesize that patients that will undergo the EMG-BF will demonstrate reductions in pain, physical functioning, sleep, pain catastrophizing, anxiety and depression.

NCT ID: NCT04558138 Recruiting - Mastectomy Clinical Trials

RCT Implant Based Breast Reconstruction

Start date: August 20, 2020
Phase: N/A
Study type: Interventional

The main objective of this study is to evaluate patients undergoing mastectomy with immediate implant-based breast reconstruction and compare the outcomes of patients who are discharged the day of surgery versus patients who are discharged on post-operative day one. The primary aim of the study will be to compare the postoperative outcomes and complications between the two study groups within 30 days of discharge. The secondary aims of the study will be to compare patient satisfaction, quality of life and discharge perceptions.

NCT ID: NCT04457167 Not yet recruiting - Clinical trials for Breast Reconstruction

Mastectomy With Retention of the Nipple-areola Complex, Robot-assisted or Not, and / or Immediate or Seconday Reconstruction by Latissimus Dorsi Flap, Robot-assisted or Not.

RMR
Start date: November 1, 2020
Phase: N/A
Study type: Interventional

Phase III, non-randomized, monocentric, observational, prospective trial. It is planned to recruit a total of 480 patients, including 240 patients receiving mastectomy with preservation of the nipple-areola complex and 240 patients with a reconstruction with latissimus dorsi flap, or in immediate reconstruction, or during secondary reconstruction.