Physical Activity for Advanced Stage Cancer Patients

The purpose of this study is to understand if a home-based physical activity program can improve symptoms and physical function among patients with advanced stage cancer.

Study Overview

• Status: Completed
• Conditions: Cancer
• Intervention / Treatment: Behavioral: Six Week Physical Activity Intervention; Other: Progress Reporting

Detailed Description

This program includes use of the Nintendo Wii Fit™Plus (Wii Fit) and home visits by a nurse. The same nurse will attend all of the visits.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Tampa, Florida, United States, 33612
      • H. Lee Moffitt Cancer Center and Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• have stage III or IV cancer diagnosis
• able to understand English
• have a Karnofsky Performance Status (KPS) score of 60% (able to care for most of the personal needs)
• have fatigue and/or two other target symptoms
• have been cleared by their provider to engage low to moderate intensity physical activities

Exclusion Criteria:

• are hospitalized
• have lesion or metastasis of bone
• have a cardiac pacemaker
• have a history of seizure or loss of consciousness
• have been using a Wii Fit
• diagnosed cognitive impairment

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Prescriped Physical Activity; Physical fitness evaluation followed by prescribed physical activity and progress reporting.

Behavioral: Six Week Physical Activity Intervention; Tailored Wii Fit prescription based on physical fitness assessments and a schedule of six home visits by an oncology RN.; Other: Progress Reporting; Participants will keep a log to record the physical activities they have done with the Wii Fit during the 6-week period. Audio-recording may be included for quality control. Self-report data will be collected by Internet surveys through the University of South Florida (USF) Health Qualtrics application at baseline (T1) and at 6 weeks post-intervention (T2). The nurse will take small amount of the participant's hair (20 strands) for a hormone test during the first visit and last visit.; Other Names: questionnaire; documentation; self-reporting

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of Participation Among Eligible Patients	Feasibility and acceptability of a tailored Wii Fit intervention. Hypothesis1.1: 60% of eligible patients will enroll; 1.2: 60% of participants will adhere to their tailored physical activity prescriptions; 1.3: 70% of participants will agree that Wii Fit is easy to use, enjoyable, convenient, and helpful. Enrollment rate: ratio of number of advanced stage cancer patients enrolled in the study to total number of patients meeting eligibility criteria invited to participate in the study. Adherence rate: ratio of the number of participants who adhere to the tailored Wii Fit prescription (i.e., expend at least 60% of prescribed kilocalories each week) to the total number of participants in the study. Acceptability of and satisfaction with the intervention: ratio of number of participants whose mean scores of Wii Fit and RN Visiting Surveys are equal to or more than 3 on 1-4 Likert-type scale to the total number of participants in the study.	6 weeks per participant

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of Positive Response to Participation	Examine changes in outcomes (fatigue, pain, depression, anxiety, sleep quality, physical function, perceived stress, and chronic Hypothalamus-Pituitary-Adrenal (HPA) activation) over 6 weeks among patients who have the intervention. Hypothesis 2.1: There will be positive changes in the outcomes. Repeated measures ANOVA will be used to compare T1 with T2 scores in fatigue, pain, depression, anxiety, sleep quality, physical function, perceived stress, and hair cortisol. Twenty participants will provide 80% power to detect only large effect sizes (d>.60), which cannot be anticipated. Because the purposes of this study are to inform future larger studies, the ANOVA will be used to calculate effect sizes (η2) for future power estimations. Because effect size calculation will be the central purpose of the ANOVAs, no adjustment will be made to reduce the possibility of Type 1 errors (p<.05).	6 weeks per participant

Collaborators and Investigators

• Sponsor: H. Lee Moffitt Cancer Center and Research Institute
• Collaborators: University of South Florida
• Investigators: Principal Investigator: Hsiao-Lan Wang, Ph.D., RN, University of South Florida

Publications and helpful links

Helpful Links

• Moffitt Cancer Center Clinical Trials website

Study record dates

Study Major Dates

• Study Start (Actual): December 12, 2013
• Primary Completion (Actual): September 14, 2015
• Study Completion (Actual): October 21, 2021

Study Registration Dates

• First Submitted: December 13, 2013
• First Submitted That Met QC Criteria: December 13, 2013
• First Posted (Estimate): December 19, 2013

Study Record Updates

• Last Update Posted (Actual): June 14, 2022
• Last Update Submitted That Met QC Criteria: June 10, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: exercise; cancer; physical function; physical training; stage III cancer; stage IV cancer; advanced stage cancer; Nintendo Wii training; physical fitness test
• Other Study ID Numbers: MCC-17389

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No