Physical Activity for Advanced Stage Cancer Patients

Cancer Clinical Trial

Official title:

Physical Activity for Advanced Stage Cancer Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02015936
• Other study ID #: MCC-17389
• Status: Completed
• Phase: N/A
• Start date: December 12, 2013
• Est. completion date: October 21, 2021

Study information

• Verified date: June 2022
• Source: H. Lee Moffitt Cancer Center and Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: October 21, 2021
• Est. primary completion date: September 14, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer

Intervention

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.

Locations

Country	Name	City	State
United States	H. Lee Moffitt Cancer Center and Research Institute	Tampa	Florida

Sponsors (2)

Lead Sponsor	Collaborator
H. Lee Moffitt Cancer Center and Research Institute	University of South Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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 (?2) 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

External Links

•   Moffitt Cancer Center Clinical Trials website