Strength for Health

Not Applicable

Withdrawn

• Conditions: Colon Cancer
• Interventions: Behavioral: Meditation; Behavioral: Exercise

• Registration Number: NCT01882972
• Lead Sponsor: Loyola University

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2013-06
• Study First Submitted: 2013-06-18
• Study First Submitted QC: 2013-06-20
• Study First Posted: 2013-06-21
• Primary Completion: 2013-09
• Study Completion: 2013-09
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-14
• Last Update Posted: 2015-04-15

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control	Meditation	Participants in the attention control arm will not be asked to cease activity they already participate in but will be instructed not to begin a new exercise program for 12 weeks. Participants will receive a meditation CD to use daily to account for the time intervention arm participants are engaged in exercise.
Exercise	Exercise	Exercise 12 week home-based resistance exercise training intervention. Participants will be coached to engage in resistance training 3 days per week and aerobic exercise for 30 minutes at least 5 days per week for 12 weeks.

Primary Outcome Measures

Name	Time	Method
Feasibility of recruitment	14 months	Ability to meet the recruitment goal of 30 subjects in a 14 month period, reflecting a participation rate of at least 20% among approached and eligible patients
Retention feasibility	14 months	Retention of at least 80% of randomized patients to the follow-up visit. A drop-out rate of less than 20%

Secondary Outcome Measures

Name	Time	Method
Pain	12 weeks	Change in participant reported pain from baseline to 12 weeks
Self-reported Exercise-related Injury	12 weeks	difference in self reported exercise-related injury rate between arms at 12 weeks
quality of life	12 weeks	Change in Quality of life score as measured by the FACT-C and FACT-F from baseline to 12 weeks
Surgical Complications	12 weeks	Difference in rate of reported surgical complications between arms at 12 weeks

Trial Locations

Locations (1)

Loyola University Chicago; 🇺🇸 Maywood, Illinois, United States