Clinical trial NCT01571401: Trying Activity in Kidney Cancer Survivors (TRACKS) Trial
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Supervised Physical Activity Plus Exercise Counseling
Supervised Physical Activity Plus Behavioural Counseling
Keywords: Kidney cancer survivors
Randomized Controlled Trial
Physical Activity
Theory of Planned Behaviour
Quality of life
Lead sponsor: University of Alberta
Sponsor class: OTHER
First posted: 2012-04-05
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

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.

Exclusion Criteria:

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.

Primary outcomes:
measure: self-reported moderate/vigorous physical activity
timeFrame: 12 weeks
Secondary outcomes:
measure: Quality of life (QoL)
timeFrame: 12 weeks
measure: Theory of Planned Behaviour (TPB)
timeFrame: 12 weeks
measure: Anthropometric measures
timeFrame: 12 weeks
measure: cardiorespiratory fitness
timeFrame: 12 weeks
measure: physical function
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: Behavioural Medicine Fitness Centre
state: Alberta
Study officials:
affiliation: University of Alberta
name: Linda Trinh, MA
role: PRINCIPAL_INVESTIGATOR
References:
citation: Trinh L, Plotnikoff RC, Rhodes RE, North S, Courneya KS. Associations between physical activity and quality of life in a population-based sample of kidney cancer survivors. Cancer Epidemiol Biomarkers Prev. 2011 May;20(5):859-68. doi: 10.1158/1055-9965.EPI-10-1319. Epub 2011 Apr 5.
citation: Trinh L, Plotnikoff RC, Rhodes RE, North S, Courneya KS. Physical activity preferences in a population-based sample of kidney cancer survivors. Support Care Cancer. 2012 Aug;20(8):1709-17. doi: 10.1007/s00520-011-1264-z. Epub 2011 Sep 24.