Breast Cancer Clinical Trial

Strength for Health

Summary

Despite a robust literature on the benefits of exercise for cancer survivors, most of the research to date falls in two primary areas - aerobic exercise and breast cancer survivors. The focus on aerobic training alone is a concern as resistance training is critical for building the muscle mass necessary to maintain physical function. However, concerns have been raised about the potential for higher than tolerated adverse event rates during resistance training, particularly that which is unsupervised, despite a history of safe use of resistance training in other chronically diseased patient populations. The aim of this pilot study is to demonstrate the feasibility, safety and quality of life benefit of a home-based resistance-training program among colorectal cancer survivors. The investigators will recruit n=30 men and women with stage I-III colon cancer. Participants will be randomized to a home-based exercise intervention that combines aerobic and resistance exercise. Control arm participants will receive a home-based meditation program.

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Full Description

The investigators will recruit n=30 patients with stage I-III colorectal cancer and randomize them to a 12-week resistance training intervention with Theraband and existing evidence- based materials or attention control using a meditation intervention. Using an electronic survey tool, patients will complete a baseline questionnaire on key outcomes (quality of life, fatigue, side effects) and potential confounders and will consent to a medical record review. These will also be assessed via at 4 weeks post randomization and 12 weeks post randomization. Participants in the intervention group will receive one-time in person instruction in the exercises derived from the existing evidence base of home-based resistance training programs for older adults and cancer survivors. They will be sent home with a book demonstrating the exercises, a log and a set of appropriate resistance bands. Weekly follow-up calls will occur for the duration of the intervention and updates on the call results will be provided to the colon cancer clinic nurse so that care is integrated. Participants in the attention control group will be mailed a meditation CD. Follow-up in the control group will parallel that of the intervention group, with weekly calls.

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Eligibility Criteria

Inclusion Criteria:

stage I-III colorectal cancer
completed surgical treatment
at least 12 weeks post-surgery.
at least 4 weeks post adjuvant therapy.
age 18 and older.

Exclusion Criteria:

patients who had surgery more than 24 months ago.
patients with related pre-existing conditions (i.e., Crohn's disease, ulcerative colitis, familial polyposis syndromes).

Study is for people with:

Breast Cancer

Study ID:

NCT01882972

Recruitment Status:

Withdrawn

Sponsor:

Loyola University

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There is 1 Location for this study

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Loyola University Chicago
Maywood Illinois, 60153, United States

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Study is for people with:

Breast Cancer

Study ID:

NCT01882972

Recruitment Status:

Withdrawn

Sponsor:


Loyola University

How clear is this clinincal trial information?

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