Neoplasms

All Conditions

Nutritional and Metabolic Diseases

Symptoms and General Pathology

Skin and Connective Tissue Diseases

Carcinoma

Overweight

Breast Neoplasms

Weight Loss

Obesity

Body Weight

Body Weight Changes

Breast Diseases

Skin Diseases

Patients will receive a standardized intervention focusing on healthy living. This will include mailings at study entry and one year later describing healthy lifestyle behaviors. All participants will also receive a 2-year subscription to a health magazine. In addition, all study participants will be invited to join twice-yearly Webinars/teleconferences that focus on breast cancer and other health topics, such as treatment updates in breast cancer, management of menopausal side effects, general cancer screening, etc. Finally, the study will also provide birthday and holiday greeting cards and a twice-yearly study newsletter with study updates and other general breast cancer news.

Patients will receive a standardized intervention focusing on healthy living as described in the Arm 1 (Health Education Program). In addition, patients will utilize a standardized, 2-year, telephone-based weight loss intervention. The intervention will include individual weight loss, caloric restriction, and physical activity goals for each participant. It will be administered through semi-structured phone calls delivered by trained coaches at the BWEL call center and supplemented through print and on-line materials. The intervention will utilize a toolbox approach that will allow for tailoring for the individual participant.

Health Education Program

Weight Loss Intervention

Jennifer Ligibel, MD

This randomized phase III trial studies whether weight loss in overweight and obese women may prevent breast cancer from coming back (recurrence). Previous studies have found that women who are overweight or obese when their breast cancer is found (diagnosed) have a greater risk of their breast cancer recurring, as compared to women who were thinner when their cancer was diagnosed. This study aims to test whether overweight or obese women who take part in a weight loss program after being diagnosed with breast cancer have a lower rate of cancer recurrence as compared to women who do not take part in the weight loss program. This study will help to show whether weight loss programs should be a part of breast cancer treatment.

This randomized controlled trial of weight loss interventions in overweight and obese women with early stage breast cancer consists of two arms, please see the arms section for more information. Patients will be randomized 1:1 within stratification factors: menopausal status (premenopausal vs. postmenopausal), hormone receptor status of the tumor (ER and/or PR positive vs. ER and PR negative), and race/ethnicity (African American vs. Hispanic vs. Other). The primary objective of this trial is to compare the effect of the telephone-based intervention versus a health educational control on invasive disease-free survival (IDFS). The total sample size is 3136 patients. Patient follow up for primary and secondary endpoints will continue to a maximum of 10 years, as per the standard protocol for cooperative group adjuvant trials.

The primary and secondary objectives of the study:

Primary objective To compare the effect of a supervised weight loss intervention plus health education materials versus health education materials alone upon invasive disease free survival (IDFS) in overweight (BMI 27-29.9 kg/m2) and obese (BMI ≥30kg/m2) women diagnosed with HER-2 negative, stage II and III breast cancer.

Secondary objectives

1. To determine the relationship between changes in weight and IDFS, and to explore interaction between the level of clinical benefit from weight loss and the intervention.
2. To evaluate the effect of a supervised weight loss intervention upon:

   1. Overall survival
   2. Distant disease free survival
   3. Weight
   4. Body composition (as measured by waist and hip circumference)
   5. Insulin Resistance Syndrome associated conditions - diabetes, hospitalization for CV disease
3. To determine the impact of a supervised weight loss intervention on IDFS within subgroups of women with 1) hormone receptor positive breast cancer and 2) hormone receptor negative breast cancer.
4. To determine the impact of a supervised weight loss intervention on IDFS within subgroups of 1) premenopausal women and 2) post-menopausal women.

Patients are to be followed every 6 months for the first 3 years after study enrollment and then annually until 10 years from registration. The intervention will last 2 years or until disease recurrence/progression, new invasive primary cancer as defined in the protocol or patient withdrawal.

Breast Cancer WEight Loss Study (BWEL Study)

Randomized Phase III Trial Evaluating the Role of Weight Loss in Adjuvant Treatment of Overweight and Obese Women With Early Breast Cancer

National Cancer Institute (NCI)

Division of Cancer Control

NIH Biomarker, Imaging and Quality of Life Studies Funding Program (BIQSFP)

Canadian Cancer Trials Group

Alliance for Clinical Trials in Oncology

Will attend lectures on health education.

Will be subjected to a supervised training program of combined exercises for 24 weeks, with a frequency of 3 times weekly and duration of 60 minutes, an unsupervised flexibility training program 2 times a week and Will attend lectures on health education.

Will attend lectures on health education about Health and Physical Education, healthy eating, overcoming barriers, Back to routine, Physical Activity Options and Dealing with Stress and Depression

Health Education

Supervised physical training program of combined exercises for 24 weeks, with frequency of 3 times weekly and duration of 60 minutes, an unsupervised flexibility training program 2 times a week.

Physical Exercise

Mayra Trevisani

Luana Queiroga

The purpose of this study is to verify the effect of the intervention of a program of physical exercises and health education in women with breast cancer undergoing chemotherapy.

According to the National Cancer Institute (INCA), the estimate for Brazil, 2016-2017 biennium, points to the occurrence of about 600,000 new cases of cancer, and breast cancer (58000) in women will be the most frequent. One study revealed that only 12% of women undergoing chemotherapy in CM who participated in a physical exercise program had to readjusted the dose of the medications, while 34% of those who received the conventional treatment needed to readjust the Treatment doses, with neuropathy being one of the most present adverse effects that influenced this adjustment. In this sense, the conduct to keep the patient at rest during the treatment seems to potentiate her side effects, and sedentarism is another factor detrimental to the patient's health. Objective: To verify the effect of the intervention of a program of physical exercises and health education in women with breast cancer undergoing chemotherapy. Methodology: A sample will consist of 136 (136) Women, over 18 years of age, sedentary, diagnosed with non-metastatic breast cancer and initiating the first cycle of chemotherapy. They will be divided into two groups, randomly and stratified: control group: (CG n = 68) and exercise group: (eg n = 68) that will undergo a supervised training program of combined exercises for 24 weeks, with a frequency of 3 times Weekly and duration of 60 minutes, an unsupervised flexibility training program 2 times a week and both groups (GC and EG) will attend lectures on health education, which are held monthly.

Verificar o efeito de um Programa de exercicios fisicos e de educacao em saude em mulheres com cancer de mama submetidas a quimioterapia sobre a taxa de conclusao da quimioterapia e sobre as toxicidades do tratamento.

Effects of a Physical Exercise and Health Education Program for Women With Breast Cancer Undergoing Chemotherapy

Effect of physical training on the rate of chemotherapy completion in the anthropometric profile, habitual food consumption, prevalence of comorbidities, cardiovascular, neurofunctional, bone and respiratory toxicity, myelosuppression, sarcopenia induced by chemotherapy, myalgia, nausea and vomiting symptoms.

effect of physical training on the level of physical activity, perception of fatigue and pain, mood, sexual life, anxiety and depression and body image.

Effect of physical training during adjuvant and neoadjuvant chemotherapy on the levels of fragility, muscle strength, joint amplitude of the shoulder and cardiorespiratory capacity.

Hospital Israelita Albert Einstein

Behaviors and Mental Disorders

Anxiety Disorders

Mental Disorders

Psychotic Disorders

The presence and usage of Health Education Program.

The presence and usage of a CBT Mobile Application.

Participants in the control group will receive a health education program using a tablet computer identical to the intervention group. The content of this program is adapted from a health education intervention used as the control condition for a cognitive behavioral stress and affect management intervention in a NIH-funded randomized controlled trial of a quality of life intervention for patients with advanced prostate cancer (R21CA102761, PI: Penedo). The program consists of the same number of sessions as the intervention group and includes general information about health and well-being. Specifically, control participants will learn information about topics such as healthy eating, exercise, memory and cognition, and side effects in the context of a cancer diagnosis and treatment.

The CBT intervention is brief, consisting of 6 modules lasting approximately 30 minutes each. Sessions focus on skills for relaxation, coping with cancer-related worries, as well as activity planning and pacing. Prior to starting the program, a trained research assistant will meet with participants in a private office setting to orient them to the software and instruct them on the use of the mobile tablet device. Once patients are comfortable with the functions and features of the mobile app, they will be encouraged to self-administer the intervention on their study-issued tablet at home and during their regularly scheduled oncology visits, for example while receiving chemotherapy infusion or waiting for a doctor's appointment or tests.

CBT Mobile Application

Joseph A Greer, Ph.D.

The proposed study seeks to implement a randomized controlled trial to evaluate the effectiveness and generalizability of an efficacious cognitive-behavioral therapy (CBT) intervention for use as a self-administered mobile application (mobile app) to treat anxiety in patients with metastatic cancer.

Background: Patients with advanced cancer often experience marked anxiety symptoms that are associated with poor quality of life, high physical symptom burden, and complications with medical treatment. We have demonstrated in prior NCI-funded research that individual cognitive-behavioral therapy (CBT), delivered in-person at a tertiary cancer center, is efficacious for treating heightened anxiety in this population. In our randomized-controlled trial of 40 patients with incurable solid tumors, we observed significant reductions in anxiety symptoms per self-report and blind clinician evaluation, with a large effect size underscoring the clinical benefit of the CBT intervention (Cohen's d=0.80). However, timely access to CBT, especially for patients in community clinic settings, is severely limited by shortened life expectancy, scheduling challenges associated with poor functional status, and the lack of trained clinicians and onsite mental health services.

Objective/Hypothesis: The goals of this study are to assess the feasibility and efficacy of delivering CBT for anxiety via mobile application (app) tailored to patients with advanced cancer. We will administer the intervention at two cancer centers, hypothesizing that patients with advanced cancer who receive CBT via mobile app will report significantly greater reductions in anxiety compared to those assigned to a time-matched control group using an online health educational program.

Specific Aims: The primary aims for the proposed project are 1) to adapt our successful CBT intervention for use as a self-administered, mobile application to treat anxiety in patients with advanced cancer; and, 2) to demonstrate the feasibility, efficacy, and generalizability of the CBT mobile app intervention for anxiety compared to an online health education program across two cancer centers (one academic and one community).

Study Design: We will employ sequential mixed qualitative and quantitative methods for intervention adaptation and testing. Specifically, we will dedicate year one of the award to creating and scripting the CBT mobile app intervention for anxiety, which will include multiple electronic features that enhance specificity to patients' individual cancer-related concerns. Up to six patients with metastatic cancer will participate in an initial open pilot study to explore the usability and acceptability of the prototype application. Data from qualitative interviews with these participants will be used to refine and adapt the intervention further. In year two, we will enroll and randomly assign patients with anxiety and metastatic cancer to receive either the CBT mobile app intervention or an online health education program. Patients will self-administer the intervention protocol using a tablet. The target enrollment for the randomized-controlled trial is 120 patients (CBT Mobile App N=60; Control N=60). Randomization will be stratified by study site and disease severity to demonstrate the generalizability of the intervention among patients with diverse malignancies in both academic and community cancer care settings.

Cancer Relevance: According to the American College of Surgeons Commission on Cancer Report (2011), an essential criterion for accreditation as a cancer center is timely patient access to screening and referral for treatment of psychological distress. Yet, most academic and community cancer clinics lack appropriate resources, staff, and training in evidence-based mental health therapies. The proposed project has the potential to address this critical unmet need by adapting an efficacious and clinically-meaningful CBT intervention to a patient-centered and user-friendly platform that can be accessed at home and while patients receive routine oncology care. If successful, our approach could be widely disseminated in a cost-effective manner across multiple oncology settings, greatly improving access to mental health services, especially for patients with cancer in resource-poor communities.

Mobile App of CBT for Anxiety and Cancer

Mobile Application of Cognitive-Behavioral Therapy (CBT) for Anxiety and Cancer

Hamilton Anxiety Rating Scale (HAM-A): The HAM-A is a clinician-administered interview used widely in psychiatry research to evaluate anxiety symptoms. Consisting of 14 items that are scored on a scale from 0 (not present) to 4 (very severe), the HAM-A total score ranges from 0 to 56, with higher scores indicating worse anxiety symptoms.

Functional Assessment of Cancer Therapy-General: The FACT-G is a valid and reliable self-report, 27-item instrument, consisting of 4 subscales that evaluate physical, functional, emotional and social wellbeing during the past 7 days. Items are scored using a 5-point Likert scale ranging from 0 (Not at all) to 4 (Very much). The overall score is the sum of the four subscale scores (range 0-108). Higher scores indicate better quality of life, while lower scores indicate worse quality of life.

Hospital Anxiety \& Depression Scale (HADS): The HADS is a self-report instrument that was designed for medical patients and demonstrates adequate psychometric properties for use among individuals with cancer. Comprised of 14-items that are scored on a 4-point Likert scale, the instrument contains two subscales that measure anxiety and depression symptoms in the past week. Total scores for each subscale range from 0 (no distress) to 21 (maximum distress).

Patient Health Questionnaire-9 (PHQ-9): The PHQ-9 is a brief, validated measure of major depression per the criteria of the Diagnostic and Statistical Manual of Mental Disorders. Patients respond to 9 questions on a scale of 0 (not at all) to 3 (nearly every day). The total scale score ranges from 0 to 27, with higher scores indicating worse depression symptoms.

Massachusetts General Hospital

Clinical Assistant in Psychology

The presence and usage of a CBT Mobile Application.

CBT Mobile Application: The CBT intervention is brief, consisting of 6 modules lasting approximately 30 minutes each. Sessions focus on skills for relaxation, coping with cancer-related worries, as well as activity planning and pacing. Prior to starting the program, a trained research assistant will meet with participants in a private office setting to orient them to the software and instruct them on the use of the mobile tablet device. Once patients are comfortable with the functions and features of the mobile app, they will be encouraged to self-administer the intervention on their study-issued tablet at home and during their regularly scheduled oncology visits, for example while receiving chemotherapy infusion or waiting for a doctor's appointment or tests.

The presence and usage of Health Education Program.

Health Education Program: Participants in the control group will receive a health education program using a tablet computer identical to the intervention group. The content of this program is adapted from a health education intervention used as the control condition for a cognitive behavioral stress and affect management intervention in a NIH-funded randomized controlled trial of a quality of life intervention for patients with advanced prostate cancer (R21CA102761, PI: Penedo). The program consists of the same number of sessions as the intervention group and includes general information about health and well-being. Specifically, control participants will learn information about topics such as healthy eating, exercise, memory and cognition, and side effects in the context of a cancer diagnosis and treatment.

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race

Race/Ethnicity, Customized

Grade 0 -- Asymptomatic (Fully active, able to carry on all pre-disease performance without restriction)

Grade 1 -- Symptomatic but completely ambulatory (Restricted in psychically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g. light house work, office work)

Grade 2 -- Symptomatic, \<50% in bed during the day (Ambulatory and capable of all self care but unable to carry out any work activities. Up and about more than 50% of waking hours)

Higher score indicates worse performance status.

Eastern Cooperative Oncology Group (ECOG) Performance Status

Cancer type

Joseph Greer, PhD

Analysis comparing the change in anxiety symptoms (HAM-A) from baseline to post-assessment between groups adjusting for baseline values of criterion outcome and psychotropic medication use.

Analysis population is the number of participants who completed both baseline and post-assessment measures of the Hamilton Anxiety Rating Scale (HAM-A).

Change in Anxiety Symptoms From Baseline to Post-assessment

Analysis comparing the change in quality of life (FACT-G) from baseline to post-assessment between groups adjusting for baseline values of criterion outcome and psychotropic medication use

Analysis population is the number of participants who completed both baseline and post-assessment measures of the Functional Assessment of Cancer Therapy-General (FACT-G).

Change in Quality of Life From Baseline to Post-assessment

Analysis comparing the change in self-report anxiety symptoms on the HADS-Anxiety Subscale from baseline to post-assessment between groups adjusting for baseline values of criterion outcome and psychotropic medication use.

Analysis comparing the change in self-report depression symptoms on the HADS-Depression Subscale from baseline to post-assessment between groups adjusting for baseline values of criterion outcome and psychotropic medication use.

HADS-Anxiety Subscale

HADS-Depression Subscale

Analysis population is the number of participants who completed both baseline and post-assessment measures of the Hospital Anxiety \& Depression Scale (HADS).

Change in Mood Symptoms From Baseline to Post-assessment

Analysis comparing the change in depression symptoms on the PHQ-9 from baseline to post-assessment between groups adjusting for baseline values of criterion outcome and psychotropic medication use.

Analysis population is the number of participants who completed both baseline and post-assessment measures of the Patient Health Questionnaire-9 (PHQ-9).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Breast Cancer WEight Loss Study (BWEL Study)	NCT02750826	Breast Carcinom...	Health Educatio... Weight Loss Int...	18 Years -	Alliance for Clinical Trials in Oncology
Effects of a Physical Exercise and Health Education Program for Women With Breast Cancer Undergoing Chemotherapy	NCT04554823	Cancer, Breast	Health Educatio... Physical Exerci...	18 Years - 75 Years	Hospital Israelita Albert Einstein
Mobile App of CBT for Anxiety and Cancer	NCT02286466	Cancer Anxiety	Health Educatio... CBT Mobile Appl...	18 Years -	Massachusetts General Hospital
Effects of a Physical Exercise and Health Education Program for Women With Breast Cancer Undergoing Chemotherapy	NCT04554823	Cancer, Breast	Health Educatio... Physical Exerci...	18 Years - 75 Years	Hospital Israelita Albert Einstein

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