Physical Activity for Advanced Stage Cancer Patients
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|ClinicalTrials.gov Identifier: NCT02015936|
Recruitment Status : Active, not recruiting
First Posted : December 19, 2013
Last Update Posted : September 3, 2018
|Condition or disease||Intervention/treatment||Phase|
|Cancer||Behavioral: Six Week Physical Activity Intervention Other: Progress Reporting||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Physical Activity for Advanced Stage Cancer Patients|
|Actual Study Start Date :||December 12, 2013|
|Actual Primary Completion Date :||September 14, 2015|
|Estimated Study Completion Date :||October 2019|
Experimental: Prescriped Physical Activity
Physical fitness evaluation followed by prescribed physical activity and progress reporting.
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.
- 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.
- Rate of Positive Response to Participation [ Time Frame: 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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02015936
|United States, Florida|
|H. Lee Moffitt Cancer Center and Research Institute|
|Tampa, Florida, United States, 33612|
|Principal Investigator:||Hsiao-Lan Wang, Ph.D., RN||University of South Florida|