Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Behaviors and Mental Disorders

Symptoms and General Pathology

Wounds and Injuries

Breast Neoplasms

Adjustment Disorders

Genetic Predisposition to Disease

Disease Susceptibility

Breast Diseases

Skin Diseases

Disease Attributes

Trauma and Stressor Related Disorders

Mental Disorders

Psychotic Disorders

Quality of Life

Patients who have risk-reduction mastectomy of any type, per protocol inclusion and exclusion criteria.

Scott L. Spear, M.D.

This is a registry for patients who have a risk-reduction mastectomy ("prophylactic mastectomy") due to being at high risk for developing breast cancer, followed by breast reconstruction. Eligible patients include those who have a breast cancer-related gene, a strong family history of breast cancer, or a personal history of high-risk conditions such as cancer in the other breast or ductal carcinoma in situ (DCIS). Patients are enrolled in the registry before surgery, and are followed for up to ten years afterwards. In addition to studying medical outcomes, we will periodically survey patients for quality-of-life issues and psychological well-being. There is no compensation for being enrolled in this registry. This registry is conducted through the Department of Plastic Surgery at Georgetown University Hospital, and is a sub-registry to the Fisher Familial Cancer Registry at the Lombardi Comprehensive Cancer Center at Georgetown University.

Patient operative specimens, blood samples, and saliva samples.

Registry of Mastectomy for Breast Cancer Risk Reduction

Georgetown University

Chief Plastic Surgery

Subjects in this group receive the usual treatment only.

Consisting in a 12 weekly sessions with a therapist. Each session lasts 1 hour.

Consisting in a 12 weekly sessions with two therapists. Number of subjects in each group is from 5 to 10. Each session lasts 2 hours.

Over the past 2 years we developed a 12-week cognitive-existential intervention consisting of 12 modules. The first three modules essentially involve cognitive and behavioral techniques proposing reinforcement of the use of active behavioral (e.g., relaxation, activation) and emotional (cognitive reframing) strategies. This content comes from classical cognitive-behavioral techniques. The next 3 modules, inspired by empirically-tested interventions further explore emotional strategies. The last six modules specifically address the existential dimension. They are adapted from logotherapy techniques, which are also empirically-based, and have been adapted to a French-Canadian culture by our team. They aim to improve meaning-based and emotional coping strategies.

Cognitive-existential intervention

This group receive the usual treatment only.

Usual care

Pierre Gagnon, MD, FRCPC

The purpose of this study is to test the efficacy of a cognitive-existential intervention (using either an individual or a group format) to improve the existential and global quality of life of patients as compared to usual care in a population of adult non-metastatic cancer patients.

People diagnosed with cancer must learn to cope with loss of meaning and empowerment which compromises quality of life. Questions regarding "Why me?", along with universal existential concerns about death, search for meaning, and sense of control over one's life, often constitute the principal source of overall suffering. Since there is no single and identifiable cause for cancer, those existential questions are commonly observed among patients who demand specific interventions to properly address this central issue. The existential approach can be used to help patients find meaning in the midst of a crisis. It addresses a central issue of survivorship in cancer.

The conceptual model explains the relation between being exposed to a stressful and traumatic life event such as cancer and the risk of progressing toward adjustment difficulties which compromises quality of life and existential integrity. Cancer constitutes a major stressor involving significant losses that confronts the person's beliefs system. A set of therapeutic strategies can help to cope with this inevitable challenge: 1) cognitive-behavioral strategies; 2) direct existential intervention; and 3) social support through supportive-expressive strategies. Adjustment first involves cognitive reframing of the perception of the situation (situational meaning). Cognitive reframing also contributes to a readjustment of personal beliefs and values (global meaning and existential dimension). Existential strategies enable to further this process by including cognitive (beliefs, sense of coherence, expectations), motivational (choice, goal setting, and goal driving) and affective dimensions. The expressive-supportive strategy promotes active listening and non-judgmental support to encourage expression of emotions. The use of these active coping strategies (meaning-based) to the threatened-life challenge enables optimization of existential and global quality of life, as opposed to employing passive strategies such as avoidance.

Creating Meaning Following Cancer: An Intervention to Improve Existential and Global Quality of Life

Creating Meaning Following Cancer: An Cognitive-existential Intervention to Improve Existential and Global Quality of Life

At every time frame, we use two questionnaires to measure the primary outcome:

1. The McGill Quality of Life Questionnaire (MQOL): 16 items plus a single-item global scale.
2. Spiritual well-being (FACIT-SP): The FACIT-SP is a sub-scale of the FACT-G (Functional Assessment of Cancer Therapy-General) and a French version of the "FACIT-SP, FACIT-Spiritual well-being scale". This questionnaire has two sub-scales: Meaning/Peace (8 items) and Faith (4 items).

To measure the secondary outcome, The McGill Quality of Life Questionnaire (MQOL) is use at every time frames.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Registry of Mastectomy for Breast Cancer Risk Reduction	NCT00555503	Quality of Life Mastectomy Breast Neoplasm... Genetic Predisp... Adjustment Diso...		18 Years - 70 Years	Georgetown University
Creating Meaning Following Cancer: An Intervention to Improve Existential and Global Quality of Life	NCT01141933	Non-metastatic ... Adjustment Diso...	Cognitive-exist... Usual care	18 Years -	CHU de Quebec-Universite Laval
Creating Meaning Following Cancer: An Intervention to Improve Existential and Global Quality of Life	NCT01141933	Non-metastatic ... Adjustment Diso...	Cognitive-exist... Usual care	18 Years -	CHU de Quebec-Universite Laval
Registry of Mastectomy for Breast Cancer Risk Reduction	NCT00555503	Quality of Life Mastectomy Breast Neoplasm... Genetic Predisp... Adjustment Diso...		18 Years - 70 Years	Georgetown University

Spots Global Cancer Trial Database for adjustment disorder