Exercise for Advanced Prostate Cancer: a Multicomponent Feasibility Trial (EXACT)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03658486|
Recruitment Status : Recruiting
First Posted : September 5, 2018
Last Update Posted : April 5, 2019
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer Metastatic Castration-resistant Prostate Cancer||Other: Exercise||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Exercise for Advanced Prostate Cancer: a Multicomponent Feasibility Trial in Men With Metastatic Castrate-Resistant Prostate Cancer|
|Actual Study Start Date :||February 19, 2019|
|Estimated Primary Completion Date :||October 2021|
|Estimated Study Completion Date :||October 2021|
12 weeks of progressive, home-based, moderate intensity, aerobic and strengthening exercise. Aerobic exercise will be completed 5 days per week, commencing with a single 10 minute bout and progressing to 30 minutes of continuous brisk walking at week 12. Strengthening exercises will involve whole body activities and commence with 1 set of each exercise (8-15 repetitions) and progress to 3 sets. The strengthening exercises will gradually progress in difficulty throughout the program.
Exercise programs will be individually tailored to the capabilities of each participant and gradually progressed accordingly. Each patient will be assigned a moderate intensity walking and strengthening program to complete at home. At baseline, 12 and 24 weeks patients will wear an accelerometer to determine activity levels. At these time points, patients will also complete a physical fitness assessment (timed sit-to-stand and six minute walking tests) and a range of quality of life questionnaires. At baseline, patients will receive a behaviour change consultation and continued support throughout the intervention. Each patient will receive a pedometer during the home-based, unsupervised regime to monitor step count and they are expected to complete a daily physical activity diary. Upon completion of the 24 week follow-up, patients will be invited to partake in semi-structured interviews to determine the effectiveness of the program and their experience throughout.
- Feasibility - recruitment. [ Time Frame: At baseline. ]The number of participants that agree to participate or are excluded.
- Feasibility - adherence to the exercise intervention. [ Time Frame: Throughout the 24 week study period. ]Determine the percentage of patients adhering to the program and the weekly behavioral consultation sessions.
- Feasibility - attrition rates. [ Time Frame: Throughout the 24 week study period. ]The number of patients that withdraw.
- Feasibility - safety / adverse events. [ Time Frame: Monitored throughout the 24 week study period. ]Any safety / adverse events, in general or in relation to the exercise program, will be documented by the research team.
- Feasibility - patient experience. [ Time Frame: Following the study conclusion at 24 weeks. ]Determined by qualitative evaluation, using semi-structured interviews, to assess experiences, accessibility and acceptability of the exercise intervention.
- Anthropometric assessment. [ Time Frame: At baseline, 12 and 24 weeks. ]Height will be measured in cm and body weight in kg, which will be combined to report BMI in kg/m(squared).
- Hip and waist circumference analysis. [ Time Frame: At baseline, 12 and 24 weeks. ]Hip and waist circumference will be measured in cms.
- Functional ability assessment. [ Time Frame: At baseline, 12 and 24 weeks. ]The amount of repetitions achieved during a 30 second sit-to-stand test will be recorded.
- Physical fitness assessment. [ Time Frame: At baseline, 12 and 24 weeks. ]Distance covered in meters during a six minute walk test will be recorded.
- Objectively measure of physical activity levels. [ Time Frame: At baseline, 12 and 24 weeks. ]Patients will wear an accelerometer for 7 full days.
- Perceived physical activity levels. [ Time Frame: At baseline, 12 and 24 weeks. ]Patients will complete an International Physical Activity Questionnaire (IPAQ-SF). This questionnaire will comprise 4 generic items to obtain comparable health-related physical activity. Patients will detail the number of days, hours and minutes that they undertake (1) vigorous exercise (2) moderate exercise (3) walking exercise and (4) sitting. Total physical activity will be generated and monitored for improvement or decline.
- Cancer-related fatigue by questionnaire. [ Time Frame: At baseline, 12 and 24 weeks. ]Fatigue will be measured by the Functional Assessment of Cancer Therapy - Fatigue (FACIT-Fatigue) questionnaire. Patients will score several fatigue items over the past 7 days on a scale (0 = not at all; 4 = very much), generating a total (0 - 52) with higher scores linked to greater quality of life.
- Quality of life will be measured using a questionnaire. [ Time Frame: At baseline, 12 and 24 weeks. ]Quality of life will be measured by the Functional Assessment of Cancer Therapy - Prostate (FACT-P) questionnaire. Patients will score a series of questions (0 = not at all; 4 = very much) in five sections (physical well-being; social/family well-being; emotional well-being; functional well-being; additional concerns) for the past 7 days. Higher scores will suggest better quality of life.
- Quality of life will be measured using questionnaires. [ Time Frame: At baseline, 12 and 24 weeks. ]Quality of life will be measured by the EuroQOL Five Dimension Questionnaire (EQ5D). Patients will select a level of difficulty (I have no - I have extreme) on that particular days health for mobility, self-care, usual activities, pain / discomfort and anxiety / depression. Patients will then rate 'how good' or 'how bad' their health is on that day using a 100 point scale (0 = worst health you can imagine; 100 = best health you can imagine).
- Pain will be measured through a questionnaire. [ Time Frame: At baseline, 12 and 24 weeks. ]Bone pain will be monitored using the Brief Pain Inventory Short Form (BPI-SF).
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): NCT03658486