Delayed Intervention Group for Breast Cancer

Phase-Based Estimates
1
Effectiveness
1
Safety
Clinical Exercise Physiology Lab, Vancouver, Canada
Breast Cancer
Delayed Intervention Group - Behavioral
Eligibility
18+
Female
Eligible conditions
Breast Cancer

Study Summary

This study is evaluating whether a virtual exercise program can improve physical function for people with breast cancer.

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Treatment Effectiveness

Study Objectives

This trial is evaluating whether Delayed Intervention Group will improve 10 secondary outcomes in patients with Breast Cancer. Measurement will happen over the course of Change from baseline at week 8 (end of intervention), 16 weeks and 12-months.

Week 16
Body mass index
Health-related quality of life
Height in metres
Hip circumference
Medication adherence to endocrine therapy
Physical Function
Standing balance
Usual physical activity levels
Waist circumference
Weight in kilograms

Trial Safety

Trial Design

2 Treatment Groups

No Control Group
Delayed Intervention Group

This trial requires 132 total participants across 2 different treatment groups

This trial involves 2 different treatments. Delayed Intervention Group is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Delayed Intervention Group
Behavioral
Usual lifestyle control for 8 weeks and then invited to participate in the exercise intervention.
Immediate Intervention Group
Behavioral
The intervention is an 8-week combined aerobic and resistance program, with virtual, group-based, supervised exercise sessions twice per week (60 min). The intervention also includes optional education on healthy eating.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Immediate Intervention Group
2013
N/A
~350
Delayed Intervention Group
2007
N/A
~310

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: change from baseline at week 8 (end of intervention), 16 weeks and 12-months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly change from baseline at week 8 (end of intervention), 16 weeks and 12-months for reporting.

Who is running the study

Principal Investigator
K. C.
Prof. Kristin Campbell, Professor
University of British Columbia

Closest Location

Clinical Exercise Physiology Lab - Vancouver, Canada

Eligibility Criteria

This trial is for female patients aged 18 and older. There are 5 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
and have a pathologic complete response (pCR) to neoadjuvant chemotherapy have a significantly lower risk of disease recurrence and improved overall survival (OS) compared with patients who do not have a pCR show original
Currently receiving adjuvant endocrine therapy (Tamoxifen or an Aromatase Inhibitor) for at least 3 months (to allow for acclimatization), and within 3 years of starting endocrine therapy. show original
This text states that the person can read and speak English. show original
Can use the device to take a picture of yourself If you have access to a device with a built-in video camera, you can use it to take a picture of yourself. show original
After primary treatment, which may involve surgery, radiation therapy and/or chemotherapy, some people still experience cancer symptoms show original

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is breast cancer?

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Breast cancer is the most common cancer in middle-aged and older women. answer: While some breast cancer patients had not been properly screened, many patients with breast cancer do not have regular follow-ups and are not being properly treated. Data from a recent study of this study suggest that health care providers should be particularly aware of the risks of not screening, treating and tracking, with respect to breast cancer, women between the ages of 50 and 65 years of age.

Unverified Answer

How many people get breast cancer a year in the United States?

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This is the first article to report estimates of breast cancer in the United States for all years (1973-2016). These estimates are based on the annual incidence rates of invasive breast cancer calculated using the BCP classification system. The estimates for invasive breast cancer are the most accurate available from the National SEER Program. The incidence rates of invasive breast cancer vary year to year, and the rate is substantially lower in some years compared to others. If incidence rates of invasive breast cancer would have been kept constant year after year, an estimated 3.5 million American women would have been diagnosed with invasive breast cancer in 2016, and 9,000 new invasive breast cancer cases would have occurred among black women in the same period, compared to an estimated 3.

Unverified Answer

What causes breast cancer?

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Some risk factors for [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer) are known, but their exact nature is largely unknown. It remains unclear whether the increased risk of breast cancer after hormone therapy is due to a hormone imbalance between breast tissue and the body. Some risk factors for breast cancer also decrease the woman's risk of breast cancer; for example the use of folate after menopause has been linked to a 50% reduction in risk. For other risks factors and their relation to breast cancer, the evidence is less clear, as studies reporting an increased risk are often small in size and the result is disputed by others. Many environmental factors affect the risk of developing breast cancer, but the role of these are not well understood.

Unverified Answer

Can breast cancer be cured?

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Although most [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer)s are curable, there is a small percentage at high risk needing treatment for the disease, and about 15% of primary breast cancers require chemotherapy to control recurrent disease. In the United States, about 60,000 women will be diagnosed with breast cancer each year and about 8,000 will die from disease. Because many men in the United States develop prostate cancer more often than average, because of family history of prostate cancer, the fact that prostate cancer is curable means that there are about 15 million men at high risk. A cure for both breast and prostate cancer would save the U.S. health care system over $8 billion annually.

Unverified Answer

What are common treatments for breast cancer?

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There is increasing use of hormone therapy, such as progestins plus estrogens, in patients with postmenopausal breast cancer, and use of selective oestrogen receptor antagonists and aromatase inhibitors in postmenopausal women with breast cancer who have estrogen-receptor-positive tumors.

Unverified Answer

What are the signs of breast cancer?

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Symptoms are related to the stage of disease, cancer type, or hormonal status of the patient when they were first diagnosed with breast cancer. Signs and symptoms of breast cancer may not be present for the entire course of the disease. Although some signs and symptoms are more common in women than men, this does not imply that men and women differ in their susceptibility or ability to present signs and symptoms of breast cancer.

Unverified Answer

Does delayed intervention group improve quality of life for those with breast cancer?

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In delayed and intensified care trials, participants in the standard intervention group typically experienced a better quality of life over a longer period of time and the participants in the delayed intervention group experienced a better quality of life up to 1 year post diagnosis for those who had been previously assigned to the delayed intervention group as soon as they were diagnosed.

Unverified Answer

Have there been other clinical trials involving delayed intervention group?

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A large delay in initiating chemotherapy in clinical trials may help reduce survival due to treatment refusal. In breast cancer the prognosis is often worse in patients who voluntarily declined early adjuvant treatment. The same could happen in situations in which patients are offered delayed treatment after medical consultation. Hence a voluntary delay in treatment initiation reduces the benefit of chemotherapy in this population while increasing the risk. However, it is impossible to know in advance which treatment groups would need to be provided with treatment early after diagnosis to be more effective than standard care. Delaying treatment may therefore be acceptable in this clinical setting, provided an early intervention option is also available.

Unverified Answer

What are the chances of developing breast cancer?

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Based on the experience of our own patients, patients who had had [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer) before the age of 55, had had breast cancer in all stages before the age of 40, had children and had had no exposure to pregnancy, tobacco or artificial hormones were at increased risk of developing breast cancer. Breast cancer prevention in women like these is mandatory. Breast cancer has a high incidence among post-menopausal women of reproductive age (women who are between the ages of 45 and 51). A woman can be particularly advised for breast cancer screening for pre-menopausal women from the age of 40 onwards. Women should be advised to take regular screenings to rule out the cancer. The incidence of breast cancer is very high (1.

Unverified Answer

What is the primary cause of breast cancer?

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Women in the study had a breast cancer incidence that was similar to the world's annual global rate; no differences in lifetime risk of development of breast cancer were evident according to race or other demographic variables.

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How quickly does breast cancer spread?

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In our study, the tumour size at diagnosis predicts 5-year disease-free survival in ER-positive disease. In a recent study, findings of the study have implications for predicting treatment failure and prognosis, especially in case of small tumours that are treated surgically.

Unverified Answer

What are the latest developments in delayed intervention group for therapeutic use?

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A randomized trial of delayed intervention should be conducted in as much detail as possible in order to determine whether such an intervention is useful for patients with high-grade ductal carcinoma in situ (DCIS) or invasive carcinoma.

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