Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Behaviors and Mental Disorders

Breast Neoplasms

Neoplasms, Hormone-Dependent

Breast Diseases

Skin Diseases

Quality of Life

All Drugs and Chemicals

Hormones

OncoTool is a website intended to improve self-management practices for helping cancer patients cope with stress and improve health-related quality of life. OncoTool provides mindfulness-based education and management for dealing with the numerous physical and mental side effects associated with hormone therapy (e.g., muscle and joint pain, vaginal dryness, depressive symptoms). OncoTool is a website designed to improve hormone therapy adherence by improving quality of life, and hormone therapy associated symptom burden. Both intervention and active comparator conditions are administered to participants for 8 weeks.

"OncoTool" Intervention (MBSR + HT education)

OncoTool is a health promotion website with health education on subjects like nutrition and exercise specific to breast cancer survivors, as well as general advice on lifestyle choices and prevention. The Oncotool control has similar HT education content as the experimental content but without the CBT and MBSR state. Both intervention and active comparator conditions are administered to participants for 8 weeks.

"Oncotool" Control (health +HT education)

Betina Yanez, PhD

The purpose of this study is to examine the efficacy of a psychosocial eHealth intervention on the proposed primary outcomes, hormone therapy adherence and health related quality of life (HRQoL), in breast cancer survivors.

The intervention components include mindfulness-based stress reduction, breast cancer knowledge, stress awareness and management, social support, and enhanced communication. The intervention will be delivered via an online application over an 8-week period.

Participants are randomized into either an intervention application (described above) or a control application (health information and general health promotion strategies). Aside from having access to the online application for the recommended 8 weeks with weekly online focus groups, participation in this study includes four assessments: baseline (at the beginning of the research study), post-intervention (8 weeks after baseline), a 6-month follow-up and a 12-month follow-up.

Breast cancer is the most commonly diagnosed cancer among women in the U.S. Approximately 75% to 80% of breast cancer survivors are prescribed HT (hormone therapy) medication for 5 to 10 years following primary treatment. Five years of adjuvant HT among women with non-metastatic cancer reduces the risk of recurrences by 50%. Adherence to HT is also an independent predictor of breast cancer mortality, reducing the risk by up to 28%. HT-side effects, however, are not only a major source of distress but also among the most robust predictors of non-adherence to HT. Therefore, effective management and ability to reduce the burden of these side effects are critically important to achieve optimal HT adherence. Because HT side effects may persist for years and are not easily managed, MBSR's mind-body approach and emphasis on non-judgmental attitudes, acceptance, and uncertainty tolerance may be an especially beneficial approach to helping cancer survivors cope with the burdensome medication-related side effects, thus improving adherence to medication. The investigators propose that a mindfulness-based stress reduction (MBSR) intervention that has been efficacious in reducing HT side effects and improving HRQoL in cancer patients may also prove beneficial in improving HT adherence. After developing a web-based MBSR intervention and refining it via a usability trial, this study will establish the feasibility of a web-delivered, group based MBSR intervention to improve HT medication adherence and HRQoL in patients being treated for breast cancer. It is hypothesized that participants assigned to the MBSR intervention will have better primary outcomes than participants in the control group, which receives standard health information.

A Web-Based Tool to Improve Breast Cancer Survivorship

A Mindfulness-Based e-Health Intervention to Improve Medication Adherence Among Breast Cancer Survivors

Individual participant data (IPD) will not be shared with any researchers outside Northwestern.

The ARMS (Adherence to Refills and Medications Scale) survey is a previously validated patient-report measure of barriers to medication adherence and adherence-related behavior.

The FACT-ES has been used extensively to measure HRQoL. It assesses participant's wellbeing in physical, emotional, social, functional, and concerns specific to endocrine therapy in the last seven days using a five-point response scale.

A MEMS cap is an electronic bottle cap that tracks when participants open their medication bottle. MEMS cap data will be collected continuously during the duration of participation in the study.

Pharmacy data will be pulled once at approximately T4 when a participant finishes the study. This data will inform how frequently patients refill their hormone therapy medication.

The IES is made up of two subscales measuring the frequency of intrusion and avoidance experiences after a stressful event. The IES has been widely used among patients diagnosed with cancer.

This questionnaire has been tested and validated with breast cancer patients. It is made up of 16 true and false questions regarding general breast cancer knowledge.

The CASE-cancer questionnaire is made up various subscales measuring breast cancer related communication and attitudinal self-efficacy. Each question asks participants to use a four-point response scale to agree or disagree with statements regarding their level of confidence with different skills.

The Brief COPE is made up of various subscales measuring different ways of coping. Each question as participants to rate how often they have used each coping mechanism in response to their breast cancer experience.

The 11 point Beliefs about Medicines questionnaire assesses patients' beliefs about the efficacy of their treatment as well as their beliefs about how the benefits and side affects of hormone therapy affect their life.

The PROMIS Depression questionnaire is a computer adaptive assessment that measures patients' self-reported level of negative mood within the past 7 days.

The 8 question MOS-SSS scale was developed by RAND Healthcare to assess the degree of companionship, assistance, or other types of social support that participants have access to. This study will use the 8 question emotional-informational support subsection.

The PROMIS Self Efficacy for Managing Symptoms survey is a validated, computer adaptive survey to assess how confident participants are in their ability to manage their symptoms and side effects

The Intolerance of Uncertainty, Rumination and Reassure Me survey assesses participants' development in MBSR intervention targets, which will help isolate and assess the effect of MBSR treatment

The Concerns about Recurrence scale is a 4 question scale that assesses the frequency and intensity of patients' concerns about cancer recurrence.

Northwestern University

Assistant Professor

Antineoplastic Agents

Bone Density Conservation Agents

Micronutrients

Vitamins

Letrozole

Vitamin D

Calcium

Calcium, Dietary

Aromatase Inhibitors

Enzyme Inhibitors

Estrogens

Estrogen Antagonists

Estrogen Receptor Antagonists

Hormone Antagonists

Calciferol

Female patients of 50 and above y.o. shall initiate hormone therapy (Letrozol 2.5 mg or Anastrazol 1 mg) immediately after the diagnosis until surgery.

Female patients of 50 and above y.o. that follow standard protocol (no pre-surgery (Letrozol 2.5 mg or Anastrazol 1 mg))

Female patients of 50 and above y.o. that refuse surgery and therefor follow standard protocol (only Letrozol 2.5mg or Anastrazol 1 mg) until disease progression, death or will of surgery In this subgroup we are going to include, under HT, female patients with CDis,that refuse the standard treatment with surgery plus eventual rt and/or ht

emale patients of 50 and above y.o. that refuse surgery and therefor follow standard protocol (only Letrozol 2.5mg or Anastrazol 1 mg plus acetilsalicilic acid) until disease progression, death or will of surgery In this subgroup we are going to include, under HT, female patients with CDis,that refuse the standard treatment with surgery plus eventual rt and/or ht

Aromatase Inhibitor to start immediately after diagnosis of a Luminal Invasive Breast Carcinoma Patients will be given Letrozol 2.5 mg or Anastrazol1 mg, every 24H and all of them will be given Calcium + Vit D supplement.

Venlafaxin 75 mg is to be administrated cases indicated

Vasco Fonseca, MD

Margarida Brito, MD

Zacharoula Sidiropoulou

Breast Cancer is a public health issue worldwide. The time from diagnosis to treatment initiation varies from country to country and regionally within a country. Early diagnosis and prompt treatment initiation are key factors in patient survival rates.

Currently there is a rising trend, with a high percentage of patients with "Luminal" like breast cancer only undergoing adjuvant endocrine therapy.

Authors argue that tumor biology alterations after introducing very early endocrine therapy might have a prognostic and therapeutic impact and should be studied.

Selected patients of female gender, above 50 y.o, and after a biopsy of Luminal-like Breast Cancer will go under aromatase inhibitor, from the diagnosis day till the surgical therapy to be decided (if so).In this study are going to be included patients that refuse surgical treatment, remaining this way in an "active surveillance". This last group is going to be randomised in order to recieve hormontherapy plus placebo vs hormontherapy plus acetolisalicilic acid.

In this way, authors want to investigate if:

1. st This approach influences the tumor biology
2. nd This approach influences tumor pathologic response and progression free survival.
3. rd It is a valid approach and in which grade, for patients that refuse surgical treatment

Aromatase inibitor therapy to start immediately after biopsy results are available Letrozole 2.5mg or Anastrazol 1 mg

HOrmone Therapy Immediately After Histological Diagnosis of Breast Cancer

Hormone Therapy Initiation Immediately After Histological Diagnosis of Breast Cancer, Can it Make Any Difference?

Eventual influence of the aromatase inibitor in the surgical procedure (time, bleeding, scaring, infections, seroma formation, sentinel node detection and axillary response) is to be evaluated

Effects of neoadjuvant aromatase inibitors on tumor biology in terms of RE,PR,Ki 67 measuring the after IA presurgical values

Effects of neoadjuvant aromatase inibitors on tumor pathologic response , in terms of breast imaging re-avaliation before surgical intervention. For patients that refuse surgery or extend hormone therapy for other reasons

Effects of neoadjuvant aromatase inibitors on disease free survival the first, fifth and tenth years of follow-up

Disease stability or progression under Hormone treatment in patients under active surveillance. Clinical and immaging follow up

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Web-Based Tool to Improve Breast Cancer Survivorship	NCT03849573	Breast Cancer Hormone Depende... Adherence to Ho...	"OncoTool" Inte... "Oncotool" Cont...	18 Years -	Northwestern University
A Web-Based Tool to Improve Breast Cancer Survivorship	NCT03849573	Breast Cancer Hormone Depende... Adherence to Ho...	"OncoTool" Inte... "Oncotool" Cont...	18 Years -	Northwestern University
HOrmone Therapy Immediately After Histological Diagnosis of Breast Cancer	NCT03111615	Hormone Depende... Breast Cancer F...	Aromatase Inhib...	50 Years -	Centro Hospitalar Lisboa Ocidental

Spots Global Cancer Trial Database for hormone dependent neoplasms