Physical Activity for Advanced Stage Cancer Patients

Not Applicable

Completed

• Conditions: Cancer
• Interventions: Behavioral: Six Week Physical Activity Intervention; Other: Progress Reporting

• Registration Number: NCT02015936
• Lead Sponsor: H. Lee Moffitt Cancer Center and Research Institute

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.

Study Timeline

• Study Start: 2013-12-12
• Study First Submitted: 2013-12-13
• Study First Submitted QC: 2013-12-13
• Study First Posted: 2013-12-19
• Primary Completion: 2015-09-14
• Study Completion: 2021-10-21
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-10
• Last Update Posted: 2022-06-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Prescriped Physical Activity	Six Week Physical Activity Intervention	Physical fitness evaluation followed by prescribed physical activity and progress reporting.
Prescriped Physical Activity	Progress Reporting	Physical fitness evaluation followed by prescribed physical activity and progress reporting.

Primary Outcome Measures

Name	Time	Method
Rate of Participation Among Eligible Patients	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 Outcome Measures

Name	Time	Method
Rate of Positive Response to Participation	6 weeks per participant	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).

Trial Locations

Locations (1)

H. Lee Moffitt Cancer Center and Research Institute; 🇺🇸 Tampa, Florida, United States