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Clinical Trials/NCT02015936
NCT02015936
Completed
Not Applicable

Physical Activity for Advanced Stage Cancer Patients

H. Lee Moffitt Cancer Center and Research Institute1 site in 1 country10 target enrollmentDecember 12, 2013
ConditionsCancer

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cancer
Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Enrollment
10
Locations
1
Primary Endpoint
Rate of Participation Among Eligible Patients
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

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.

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.

Registry
clinicaltrials.gov
Start Date
December 12, 2013
End Date
October 21, 2021
Last Updated
3 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Eligibility Criteria

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

Outcomes

Primary Outcomes

Rate of Participation Among Eligible Patients

Time Frame: 6 weeks per participant

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.

Secondary Outcomes

  • Rate of Positive Response to Participation(6 weeks per participant)

Study Sites (1)

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