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Safety and Efficacy of Home-based Resistance Training in Colorectal Cancer Survivors


N/A
18 Years
N/A
Open (Enrolling)
Both
Colon Cancer

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Trial Information

Safety and Efficacy of Home-based Resistance Training in Colorectal Cancer Survivors


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.


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).

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care

Outcome Measure:

Feasibility of recruitment

Outcome 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

Outcome Time Frame:

14 months

Safety Issue:

No

Principal Investigator

Kathleen Wolin, ScD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Loyola University Chicago

Authority:

United States: Institutional Review Board

Study ID:

205243

NCT ID:

NCT01882972

Start Date:

June 2013

Completion Date:

Related Keywords:

  • Colon Cancer
  • Colonic Neoplasms

Name

Location

Loyola University Chicago Maywood, Illinois  60153