Physical Activity for Advanced Stage Cancer Patients

NCT02015936 | Completed

• 1 other identifier: MCC-17389
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer

Keywords

stage III cancer; stage IV cancer; cancer; advanced stage cancer; Nintendo Wii training; exercise; physical training; physical function; physical fitness test

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Rate of Positive Response to Participation

  6 weeks per participant

Study Arms (1)

Prescriped Physical Activity

EXPERIMENTAL

Physical fitness evaluation followed by prescribed physical activity and progress reporting.

Behavioral: Six Week Physical Activity Intervention; Other: Progress Reporting

Interventions

Six Week Physical Activity Intervention BEHAVIORAL

Tailored Wii Fit prescription based on physical fitness assessments and a schedule of six home visits by an oncology RN.

Prescriped Physical Activity

Progress Reporting OTHER

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.

Also known as: documentation, self-reporting, questionnaire

Prescriped Physical Activity

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• H. Lee Moffitt Cancer Center and Research Institute: lead
• University of South Florida: collaborator

Study Sites (1)

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612, United States

Location

MeSH Terms

Conditions

Neoplasms; Motor Activity

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Hsiao-Lan Wang, Ph.D., RN

  University of South Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2013
• First Posted: December 19, 2013
• Study Start: December 12, 2013
• Primary Completion: September 14, 2015
• Study Completion: October 21, 2021
• Last Updated: June 14, 2022

Record last verified: 2022-06

Locations

US (1)