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Physical Activity for Advanced Stage Cancer Patients

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by H. Lee Moffitt Cancer Center and Research Institute
Sponsor:
Collaborator:
The Center for Hospice, Palliative Care and End-of-Life Studies at USF
Information provided by (Responsible Party):
H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier:
NCT02015936
First received: December 13, 2013
Last updated: October 8, 2014
Last verified: October 2014
  Purpose

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.


Condition Intervention
Cancer
Behavioral: Six Week Physical Activity Intervention
Other: Progress Reporting

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Physical Activity for Advanced Stage Cancer Patients

Resource links provided by NLM:


Further study details as provided by H. Lee Moffitt Cancer Center and Research Institute:

Primary Outcome Measures:
  • Rate of Participation Among Eligible Patients [ Time Frame: 6 weeks per participant ] [ Designated as safety issue: No ]

    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:
  • Rate of Positive Response to Participation [ Time Frame: 6 weeks per participant ] [ Designated as safety issue: No ]

    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).



Estimated Enrollment: 20
Study Start Date: December 2013
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Other Names:
  • documentation
  • self-reporting
  • questionnaire

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02015936

Locations
United States, Florida
H. Lee Moffitt Cancer Center and Research Institute Recruiting
Tampa, Florida, United States, 33612
Contact: Hsiao-Lan Wang, Ph.D., RN    813-974-5216    hwang5@health.usf.edu   
Principal Investigator: Hsiao-Lan Want, Ph.D., RN         
Sub-Investigator: Shirley Codada, M.D.         
Sub-Investigator: Sahana Rajasekhara, M.D.         
Sponsors and Collaborators
H. Lee Moffitt Cancer Center and Research Institute
The Center for Hospice, Palliative Care and End-of-Life Studies at USF
Investigators
Principal Investigator: Hsiao-Lan Wang, Ph.D., RN University of South Florida
  More Information

Additional Information:
No publications provided

Responsible Party: H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier: NCT02015936     History of Changes
Other Study ID Numbers: MCC-17389
Study First Received: December 13, 2013
Last Updated: October 8, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by H. Lee Moffitt Cancer Center and Research Institute:
stage III cancer
stage IV cancer
cancer
advanced stage cancer
Nintendo Wii training
exercise
physical training
physical function
physical fitness test

ClinicalTrials.gov processed this record on November 25, 2014