Trying Activity in Kidney Cancer Survivors (TRACKS) Trial
|First Received Date ICMJE||April 2, 2012|
|Last Updated Date||June 17, 2013|
|Start Date ICMJE||April 2012|
|Primary Completion Date||November 2012 (final data collection date for primary outcome measure)|
|Current Primary Outcome Measures ICMJE
||self-reported moderate/vigorous physical activity [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
A modified version of the validated Leisure Score Index (LSI) from the Godin Leisure-Time Exercise Questionnaire (GLTEQ), that has been extensively validated, will be used to assess PA behavior. Participants will be asked to recall their average weekly frequency and duration of light (minimal effort, no perspiration), moderate (not exhausting, light perspiration), and vigorous (heart beats rapidly, sweating) PA that lasted at least 10 minutes and was done during free time in the past month.
|Original Primary Outcome Measures ICMJE||Same as current|
|Change History||Complete list of historical versions of study NCT01571401 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE
|Original Secondary Outcome Measures ICMJE||Same as current|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Trying Activity in Kidney Cancer Survivors (TRACKS) Trial|
|Official Title ICMJE||Trying Activity in Kidney Cancer Survivors (TRACKS) Trial: A Randomized Controlled Trial Comparing the Effects of Supervised Physical Activity Versus Supervised Physical Activity Plus Behavioural Counselling|
Objectives: The purpose of this study is to find out if a new program can help kidney cancer survivors (KCS) increase their physical activity (PA) and improve their quality of life (QoL).
Methods: Fifty KCS will be recruited from a previous study using the Alberta Cancer Registry. Participants will undergo submaximal exercise testing, a physical function test and measures of height and weight, which will be completed at baseline and the end of the physical activity program (at 12 weeks). Participants will also complete questionnaires on PA and QoL at the baseline, after the supervised portion of the program (at 4 weeks), and at the end of the entire program (at 12 weeks). Following baseline assessments, participants will be randomly assigned to either: (1) supervised physical activity plus traditional exercise counseling or (2) supervised physical activity plus behavioural counseling. Participants will be asked to attend six individual supervised exercise and counseling sessions over a 4-week period with a PA specialist that eventually tapers to a home-based program by the end of the program.
Implications: The investigators hope that this PA intervention for KCS is feasible and results in meaningful improvements in health outcomes that can be translated to public health practice.
Background: Despite the reported benefits of physical activity (PA), the majority of cancer survivors are not meeting public health PA guidelines. Most PA intervention studies have used supervised exercise and demonstrated benefits. However, these studies have also found that PA declines significantly after the supervised intervention is completed. Consequently, interventions are needed to ensure longer term adherence after short term supervised exercise interventions. Although several of behaviour change interventions have supported positive increases in PA, no study to date has examined the effects of adding behavioural counseling to a standard supervised exercise program and no study has focused on kidney cancer survivors (KCS).
Objectives: The primary purpose of the Trying Activity in Kidney Cancer Survivors (TRACKS) Trial is to compare the effects of a supervised physical activity program plus traditional exercise counseling (SPA) versus a supervised physical activity plus motivationally-enhanced behavioural counseling (SPA+BC) on change in self-reported moderate/vigorous PA between baseline, post-intervention, and 12-week follow-up among KCS. The secondary outcomes are changes in self-reported quality of life (QoL), body composition (anthropometric measures), cardiorespiratory fitness, physical function, and motivational constructs from the Theory of Planned Behaviour (TPB) constructs.
Methods: The study will pilot a two-armed, randomized controlled trial of 50 KCS. KCS will be recruited from a previous study using the Alberta Cancer Registry. Eligibility will include: a) between 18-80 years of age, b) diagnosed with Stage I-IIIa kidney cancer, and g) interested in increasing their physical activity. Following the screening procedure and prior to randomization, participants will undergo submaximal exercise testing on a treadmill to ensure that they are able to exercise safely at a moderate-to-vigorous intensity. Randomization will occur after all baseline measurements have been completed. The goal of the intervention, based on current public health recommendations, will be to gradually increase all participants by at least 60 minutes of moderate intensity PA or 30 minutes of vigorous intensity PA to a minimum of 150 minutes of moderate intensity PA or 75 minutes of vigorous intensity PA per week. Participants in both arms will be provided with six individual supervised exercise sessions with a physical activity specialist that will taper to an unsupervised program by the end of the intervention. Participants assigned to the SPA group will be given an individualized prescription at a moderate-to-vigorous intensity. They will also receive traditional exercise counseling to teach proper PA technique, how to monitor intensity, and to progress PA safely and effectively to achieve the public health PA guidelines. For the SPA+BC group, participants will receive the same supervised PA sessions with the addition of six individual "face-to-face" behavioural counseling sessions with a physical activity specialist. These behaviour counseling sessions will include training in behavioural strategies to promote the adoption and long-term maintenance of PA. Measurements for the primary and secondary endpoints will be assessed at baseline (pre-intervention), 4 weeks (post-intervention), and 12 weeks follow-up.
Conclusion: The study results can be used to determine if a behavior change intervention for KCS based on the TPB results in potentially meaningful improvements in PA and selected health outcomes.
|Study Type ICMJE||Interventional|
|Study Phase||Phase 2|
|Study Design ICMJE||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind (Subject)
Primary Purpose: Supportive Care
|Intervention ICMJE||Behavioral: Trying Activity for Kidney Cancer Survivors (TRACKS) Trial
Participants in both arms will be provided with six individual supervised exercise sessions with a physical activity specialist that will taper to an unsupervised program by the end of the intervention. Over the 4-week period, both groups will be required to attend two sessions per week for weeks 1-2, and one session per week for weeks 3-4 at the Behavioural Medicine Fitness Centre at the University of Alberta. In order to achieve the PA guidelines established by the current public health recommendations, additional unsupervised sessions will be prescribed.
|Study Arm (s)||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Completion Date||November 2012|
|Primary Completion Date||November 2012 (final data collection date for primary outcome measure)|
|Eligibility Criteria ICMJE||
Screening evaluations will be conducted on interested participants and eligibility criteria include the following: a) between the ages of 18 to 80 years of age, histologically confirmed kidney cancer (Stage I-IIIa); b) ability and willingness to effectively communicate with the study coordinator and complete all questionnaires involved in the study in English; c) able to attend the supervised PA sessions and not planning to be away for three consecutive days for the duration of the program; and d) interested in increasing their PA by at least 60 minutes of moderate PA or 30 minutes of vigorous PA. Following the screening procedure and prior to randomization, consenting participants that are deemed eligible will undergo submaximal exercise testing to ensure that they are able to exercise safely at a moderate-to-vigorous intensity. Two stages of the treadmill test must be successfully completed with acceptable heart rate and blood pressure responses before any remaining baseline tests will be conducted including a physical function test, anthropometric testing, and PA behaviour, quality of life, and determinants questionnaire.
The researchers can remove the participants from the study early for reasons such as a cancer recurrence, doctor feels that the participant is unable to participate in a physical activity program and/or participate in the follow up fitness testing, and/or two stages of the treadmill test cannot be completed.
|Ages||18 Years to 80 Years|
|Accepts Healthy Volunteers||Yes|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Location Countries ICMJE||Canada|
|NCT Number ICMJE||NCT01571401|
|Other Study ID Numbers ICMJE||TRACKS Trial for Kidney Cancer|
|Has Data Monitoring Committee||Yes|
|Responsible Party||University of Alberta|
|Study Sponsor ICMJE||University of Alberta|
|Collaborators ICMJE||Not Provided|
|Information Provided By||University of Alberta|
|Verification Date||April 2012|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP