Intervention to Motivate Standing &Walking in Gastrointestinal Cancer Surgical Patients

NCT01982994 | Completed DMC

• 1 other identifier: 41440
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

Observational research has linked physical activity with faster recovery, improved quality of life, and greater survival; however, little is known about the effects of physical activity in pre-operative, peri-operative, or post-operative treatment contexts and there is a need for interventions to improve patient outcomes across the cancer treatment continuum. Three propositions derived from basic research, epidemiological evidence, and clinical practice informed our intervention development efforts: (1) Patient outcomes will be enhanced by interventions that increase physical activity (i.e., standing, walking) across the cancer treatment continuum (i.e., pre-operative, peri-operative, post-operative). (2) Reducing sedentary behavior (i.e., seated or reclined activities involving minimal energy expenditure) will enhance patient outcomes both by increasing physical activity and by stimulating additional adaptive physiological responses to reduced sedentary time (responses which are independent of physical activity-induced responses). (3) Patients with gastrointestinal cancers often suffer functional limitations that limit their independence and their health behaviors are strongly influenced by the family environment so interventions that engage caregivers (e.g., spouses) will be more effective than those that target patients/survivors alone.

Conditions

Gastrointestinal Neoplasms

Keywords

Physical Activity Education; Caregivers

Outcome Measures

Primary Outcomes (1)

• Percentage of patients with diagnosed gastrointestinal cancer who showed daily compliance using activity monitors and tablet computers to measure physical activity.

  To demonstrate the feasibility and acceptability of using activity monitors and tablet computers to measure physical activity (standing, walking)/sedentary behavior (sitting) and deliver daily interventions in this patient population, we will evaluate daily compliance using activity monitors and tablet computers.

  up to 1 year

Secondary Outcomes (1)

• Percentage of patients with a diagnosis of gastrointestinal cancer that benefit from an intervention of physical activity daily planning and education.

  up to 1 year

Study Arms (2)

Education/Daily Planning

EXPERIMENTAL

Physical Activity Education and Daily Planning Tool

Behavioral: Education/Daily Planning

No Education/Daily Planning

NO INTERVENTION

No Physical Activity Education/ Daily Planning Tool

Interventions

Education/Daily Planning BEHAVIORAL

In this study, we will use educational materials delivered at the initial enrollment session and in daily "facts of the day" presented electronically to heighten awareness of (1) the risks of insufficient physical activity and excessive sedentary behavior, and (2) the expected beneficial outcomes of increased physical activity and reduced sedentary behavior. These messages should are designed to increase intentions to engage in physical activity and to limit sedentary behavior (motivational phase)

Education/Daily Planning

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of gastrointestinal tract cancer (hepatobiliary) requiring surgical resection. for treatment
• Failing to meet the aerobic component of national physical activity guidelines over past week (e.g., \< 150 min moderate-intensity physical activity or \< 75 min vigorous-intensity physical activity).
• Excessive sedentary behavior over the past week (\> 8 hrs/day sitting).
• Minimum age 18 years.
• A spouse or adult child serving as a caregiver who is also willing to participate.

You may not qualify if:

• Functional limitations that preclude normal physical activity.
• Patients who will be scheduled for surgery \< 10 days after their clinic visit.
• Medical contraindications to physical activity.

Sponsors & Collaborators

• Milton S. Hershey Medical Center: lead
• Penn State University: collaborator

Study Sites (1)

Penn State Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

Related Publications (9)

• Ballard-Barbash R, Friedenreich CM, Courneya KS, Siddiqi SM, McTiernan A, Alfano CM. Physical activity, biomarkers, and disease outcomes in cancer survivors: a systematic review. J Natl Cancer Inst. 2012 Jun 6;104(11):815-40. doi: 10.1093/jnci/djs207. Epub 2012 May 8.

  PMID: 22570317 BACKGROUND

• Lynch BM. Sedentary behavior and cancer: a systematic review of the literature and proposed biological mechanisms. Cancer Epidemiol Biomarkers Prev. 2010 Nov;19(11):2691-709. doi: 10.1158/1055-9965.EPI-10-0815. Epub 2010 Sep 10.

  PMID: 20833969 BACKGROUND

• Santos DA, Silva AM, Baptista F, Santos R, Vale S, Mota J, Sardinha LB. Sedentary behavior and physical activity are independently related to functional fitness in older adults. Exp Gerontol. 2012 Dec;47(12):908-12. doi: 10.1016/j.exger.2012.07.011. Epub 2012 Aug 1.

  PMID: 22884978 BACKGROUND

• Carlson SA, Fulton JE, Schoenborn CA, Loustalot F. Trend and prevalence estimates based on the 2008 Physical Activity Guidelines for Americans. Am J Prev Med. 2010 Oct;39(4):305-13. doi: 10.1016/j.amepre.2010.06.006.

  PMID: 20837280 BACKGROUND

• Matthews CE, Chen KY, Freedson PS, Buchowski MS, Beech BM, Pate RR, Troiano RP. Amount of time spent in sedentary behaviors in the United States, 2003-2004. Am J Epidemiol. 2008 Apr 1;167(7):875-81. doi: 10.1093/aje/kwm390. Epub 2008 Feb 25.

  PMID: 18303006 BACKGROUND

• Schwarzer R, Lippke S, Luszczynska A. Mechanisms of health behavior change in persons with chronic illness or disability: the Health Action Process Approach (HAPA). Rehabil Psychol. 2011 Aug;56(3):161-70. doi: 10.1037/a0024509.

  PMID: 21767036 BACKGROUND

• Gonzalez M, Guillaume JE, Laloux P, Mahieu P, Installe E. Strychnine poisoning, hypoxic damage, severe acidosis: a case report. Acta Clin Belg Suppl. 1990;13:94-5. No abstract available.

  PMID: 2239073 BACKGROUND

• Martire LM, Stephens MA, Mogle J, Schulz R, Brach J, Keefe FJ. Daily spousal influence on physical activity in knee osteoarthritis. Ann Behav Med. 2013 Apr;45(2):213-23. doi: 10.1007/s12160-012-9442-x.

  PMID: 23161472 BACKGROUND

• Martire LM, Schulz R, Helgeson VS, Small BJ, Saghafi EM. Review and meta-analysis of couple-oriented interventions for chronic illness. Ann Behav Med. 2010 Dec;40(3):325-42. doi: 10.1007/s12160-010-9216-2.

  PMID: 20697859 BACKGROUND

MeSH Terms

Conditions

Gastrointestinal Neoplasms

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics

Study Officials

• Niraj J Gusani, M.D., M.S.

  Milton S. Hershey Medical Center

  PRINCIPAL INVESTIGATOR

• David E Conroy, Ph.D

  Penn State University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Surgery and Public Health Sciences

Study Record Dates

• First Submitted: October 28, 2013
• First Posted: November 13, 2013
• Study Start: October 1, 2013
• Primary Completion: July 1, 2015
• Study Completion: December 1, 2018
• Last Updated: February 22, 2019

Record last verified: 2019-02

Locations

US (1)