Metabolomic Evaluation of Psycho-surgical Synergy on Body Image Restoration After Breast Cancer
NCT05616988 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80
Last updated 2024-12-13
Summary
The aim of the present study is to verify the effects of a psychological-clinical intervention supported by the technique of expressive writing, on the post-operative course in terms of mental and physical health in patients undergoing surgical mastectomy treatment with post-oncological breast reconstruction. In particular, it is hypothesised that patients undergoing psychological, emotional and social well-being in the phase following surgical treatment, together with an improvement in the inflammatory profile and a possible change in the tryptophan/kynurenine ratio and cortisol.
For this purpose, the recruited patients will be randomly divided into two groups. The first experimental group will consist of 10 patients with an indication for reconstruction using autologous tissues (DIEP, FALD) and 10 patients with an indication for reconstruction using the immediate prosthesis technique who will carry out the psychological-clinical intervention focusing on expressive writing about their experience of the surgical treatment.
The psychological-clinical intervention includes five interviews interspersed with three days of expressive writing by Pennebaker (1986).
The writing task consists of writing about a traumatic experience or an event significant to the person, for a controlled period of time (usually 15 to 30 minutes) and on consecutive days (2 to 3 days).
The second control group will consist of 10 patients with an indication for reconstruction using autologous tissues (DIEP, FALD) and 10 patients with an indication for reconstruction using the immediate prosthesis technique who will not undergo any kind of psychological-clinical intervention and will be able to apply for the latter at the end of the research.
In order to verify the effectiveness of the psychological-clinical intervention, the patients will undergo a psychological evaluation (anxiety, depression, alexithymia, distress, resilience, hope for the future, quality of life, body image, psychological and affective experiences related to breast reconstruction) and a survey of physiological variables (inflammatory response, ratio tryptophan/kynurenine ratio and salivary cortisol) at the various times envisaged in the study: T0 (1 month pre-surgery mastectomy with breast reconstruction), T1(the day after the end of the psychological-clinical intervention), T2 (3 months post psychological-clinical intervention) and T3 (6 months post psychological-clinical intervention).
Conditions
- Psychological
Interventions
- OTHER
-
psychological-clinical intervention with three days of expressive writing by Pennebaker
The psychological-clinical intervention involves five interviews with three days of expressive writing by Pennebaker. During the psychological-clinical interviews the following aspects will be explored: * Emotions and expectations related to the breast reconstruction process. * Feelings related to the perception of one's own body image to promote an integration between the image of one's body and the aspects related to one's own identity and femininity. * Thoughts and feelings related to one's relational and social life. Expressive writing is a technique devised by Pennebaker (1986), who states that expressing deeper thoughts and feelings through writing can improve the physical and psychological health of the individual. The writing task consists of writing about a traumatic experience or a significant event for the person, for a controlled period (usually 15-30 minutes) and on consecutive days (from 2 to 3 days).
Sponsors & Collaborators
-
University of Roma La Sapienza
lead OTHER
Principal Investigators
-
Carlo Lai · Department of Dynamic and Clinical Psychology, and Health Studies Sapienza University of Rome
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-10-26
- Primary Completion
- 2025-11-30
- Completion
- 2026-11-30
Countries
- Italy
Study Locations
More Related Trials
-
Expressive Writing in Improving Quality of Life in Patients With Breast Cancer and Lymphedema
NCT00679185 ·Status: COMPLETED ·Phase: NA
-
Neuropathic Pain in Survivors of Breast Cancer
NCT00535067 ·Status: COMPLETED
-
Acupressure for Pain and Opioid Use Among Breast Cancer Patients
NCT03655600 ·Status: TERMINATED ·Phase: NA
-
Consequences of Eccentric Cycling on Exercise-related Neuromuscular Responses and Biomarkers in Breast Cancer Patients
NCT05166148 ·Status: COMPLETED ·Phase: NA
-
Physical Exercise, Motor Activity on Sleep Disorders in Post-Mastectomy Pain Syndrome
NCT06803563 ·Status: COMPLETED
-
Sexual Well-being of Women Undergoing Mastectomy and Reconstruction
NCT07234461 ·Status: RECRUITING ·Phase: NA
-
Genetic, Neurophysiological and Psychological Predictive Factors of Chronic Neuropathic Pain After Surgery for Breast Cancer
NCT02944721 ·Status: WITHDRAWN ·Phase: NA
-
Post-treatment Care of Breast Cancer Survivors
NCT00821288 ·Status: COMPLETED ·Phase: NA
-
The Study is Observational and Retrospective: Lifestyle, BMI and Activity Physical.
NCT06866093 ·Status: ACTIVE_NOT_RECRUITING
-
Breast Reconstruction in Previously Irradiated Breast
NCT04854525 ·Status: COMPLETED
-
Physical Exercise, Motor Activity and Depression in Post-mastectomy Pain Syndrome
NCT06123559 ·Status: COMPLETED
-
Quality of Life After Conservative Oncoplastic Surgery in Breast Cancer Patients (IRONY: lIfe afteR ONcoplastic surgerY)
NCT05842148 ·Status: RECRUITING
-
The Sequelae of Mastectomy and Quadrantectomy Respect to the Reaching Movement in Breast Cancer Survivors
NCT04145739 ·Status: COMPLETED ·Phase: NA
-
Dance Study for Post-surgical Pain in Breast Cancer Survivors
NCT06758102 ·Status: RECRUITING ·Phase: NA
-
Pectoral Nerve Block During Mastectomy
NCT05699902 ·Status: UNKNOWN ·Phase: NA
-
Oxidative Stress, Anxiety and Depression in Breast Cancer Patients: Impact of Music Therapy
NCT04446624 ·Status: COMPLETED ·Phase: NA
-
Biomarkers of Neuropathic Pain in Women Treated for Breast Cancer
NCT02487524 ·Status: COMPLETED ·Phase: NA
-
Feasibility and Metabolic Effects of a 5:2 Fasting Intervention in Women With Breast Cancer During Radiotherapy
NCT05861362 ·Status: COMPLETED ·Phase: NA
-
Socio-aesthetic Intervention on Body Image and Quality of Life in Women With Breast Cancer.
NCT00210145 ·Status: WITHDRAWN
-
Yoga for Symptoms of Nerve Damage Caused by Chemotherapy
NCT03292328 ·Status: COMPLETED ·Phase: NA
-
Precision Acupuncture in the Treatment of Peripheral Neuropathy After Taxanes Chemotherapy in Breast Cancer
NCT05099562 ·Status: UNKNOWN ·Phase: NA
-
Effectiveness of Acupuncture in Post-Mastectomy Patients With Tissue Expanders
NCT02639611 ·Status: WITHDRAWN ·Phase: NA
-
Effect of Seated Exercises and Psychoeducational Rehabilitation on Fatigue and Coping of Women Postmastectomy
NCT06360276 ·Status: COMPLETED ·Phase: NA
-
Developing a New Questionnaire About Patient Expectations of Breast Conserving Therapy
NCT02753673 ·Status: COMPLETED
-
Effects of Diet and Osteopathy on Quality of Life and Inflammation in Breast Cancer Patients Under Hormonal Therapy
NCT06164119 ·Status: RECRUITING ·Phase: NA