Strength for Health
Primary Purpose
Colon Cancer
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Exercise
Meditation
Sponsored by
About this trial
This is an interventional supportive care trial for Colon Cancer
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).
Sites / Locations
- Loyola University Chicago
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Exercise
control
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Feasibility of recruitment
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
Retention of at least 80% of randomized patients to the follow-up visit. A drop-out rate of less than 20%
Secondary Outcome Measures
Pain
Change in participant reported pain from baseline to 12 weeks
quality of life
Change in Quality of life score as measured by the FACT-C and FACT-F from baseline to 12 weeks
Surgical Complications
Difference in rate of reported surgical complications between arms at 12 weeks
Self-reported Exercise-related Injury
difference in self reported exercise-related injury rate between arms at 12 weeks
Full Information
NCT ID
NCT01882972
First Posted
June 18, 2013
Last Updated
April 14, 2015
Sponsor
Loyola University
Collaborators
Hygenic Corporation
1. Study Identification
Unique Protocol Identification Number
NCT01882972
Brief Title
Strength for Health
Official Title
Safety and Efficacy of Home-based Resistance Training in Colorectal Cancer Survivors
Study Type
Interventional
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Withdrawn
Why Stopped
investigator left Loyola
Study Start Date
June 2013 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
September 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Loyola University
Collaborators
Hygenic Corporation
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colon Cancer
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Exercise
Arm Type
Experimental
Arm Description
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.
Arm Title
control
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Exercise
Other Intervention Name(s)
Home-based exercise using Therabands
Intervention Type
Behavioral
Intervention Name(s)
Meditation
Other Intervention Name(s)
A healing meditation for cancer patients CD
Primary Outcome Measure Information:
Title
Feasibility of recruitment
Description
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
Time Frame
14 months
Title
Retention feasibility
Description
Retention of at least 80% of randomized patients to the follow-up visit. A drop-out rate of less than 20%
Time Frame
14 months
Secondary Outcome Measure Information:
Title
Pain
Description
Change in participant reported pain from baseline to 12 weeks
Time Frame
12 weeks
Title
quality of life
Description
Change in Quality of life score as measured by the FACT-C and FACT-F from baseline to 12 weeks
Time Frame
12 weeks
Title
Surgical Complications
Description
Difference in rate of reported surgical complications between arms at 12 weeks
Time Frame
12 weeks
Title
Self-reported Exercise-related Injury
Description
difference in self reported exercise-related injury rate between arms at 12 weeks
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kathleen Wolin, ScD
Organizational Affiliation
Loyola University Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
Loyola University Chicago
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
12. IPD Sharing Statement
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Strength for Health
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