Overview

This trial is active, not recruiting.

Condition cancer
Treatments six week physical activity intervention, progress reporting
Sponsor H. Lee Moffitt Cancer Center and Research Institute
Collaborator University of South Florida
Start date December 2013
End date September 2015
Trial size 10 participants
Trial identifier NCT02015936, MCC-17389

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose supportive care
Arm
(Experimental)
Physical fitness evaluation followed by prescribed physical activity and progress reporting.
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.
progress reporting documentation
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.

Primary Outcomes

Measure
Rate of Participation Among Eligible Patients
time frame: 6 weeks per participant

Secondary Outcomes

Measure
Rate of Positive Response to Participation
time frame: 6 weeks per participant

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Physical Activity for Advanced Stage Cancer Patients
Principal investigator Hsiao-Lan Wang, Ph.D., RN
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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by H. Lee Moffitt Cancer Center and Research Institute.
Location data was received from the National Cancer Institute and was last updated in July 2016.