Bladder Cancer, Colorectal Adenoma, Telomere Shortening
Conditions
Brief summary
The goal of the research is to provide a first critical test of the novel scientific idea that a combined diet and exercise intervention may ameliorate shortening of leukocyte telomere length (LTL) in individuals with histories of successfully treated non-metastatic bladder cancer (BC) or colorectal adenoma (CRA) compared to a diet only intervention.
Interventions
BEHAVIORALDietary Intervention
The behavioral weight loss intervention strategies will not be limited to, self-monitoring, goal setting, problem solving, mastery skills, social support, and relapse prevention. Participants will receive a standard behavioral weight control program, delivered on a one-on-one basis. They will attend in-person sessions (\ 30-45 minutes) with time to: distribute intervention materials, interact with the participant, identify participants that need additional support, and conduct the intervention. Each in-person visit focuses on a specific behavioral topic related to weight loss to address eating behaviors. Subjects will also participate in phone calls with the interventionist (\ 10 minutes). Depending on the week, subjects will have between 10 and 45 minutes of total intervention contact.
BEHAVIORALPhysical Activity Intervention
The behavioral weight loss intervention strategies will not be limited to, self-monitoring, goal setting, problem solving, mastery skills, social support, and relapse prevention. Participants will receive a standard behavioral weight control program, delivered on a one-on-one basis. They will attend in-person sessions (\ 30-45 minutes) with time to: distribute intervention materials, interact with the participant, identify participants that need additional support, and conduct the intervention. Each in-person visit focuses on a specific behavioral topic related to weight loss to address physical activity behaviors. Subjects will also participate in phone calls with the interventionist (\ 10 minutes). Depending on the week, subjects will have 10 to 45 minutes of total intervention contact.
Sponsors
National Cancer Institute (NCI)
University of Pittsburgh
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 84 Years
Healthy volunteers
No
Inclusion criteria
* BMI between 25.0 to \<40 kg/m2 (allows for use of assessments such as DXA to be included) * History of histologically confirmed bladder cancer (non-metastatic) or colorectal adenoma * Under clinical surveillance with no evidence of disease
Exclusion criteria
* WHO performance status 3-4 or deemed physically unable to participate by physician * Currently pregnant or breastfeeding, were pregnant in the previous 6 months or breastfeeding in the previous 3 months, or planning pregnancy in the next year * History of bariatric surgery * Medical condition that could affect body weight (e.g., diabetes mellitus, hyperthyroidism, uncontrolled hypothyroidism, chronic renal insufficiency, chronic liver disease, gastrointestinal disorders including ulcerative colitis) * Cancer diagnosis (other than bladder cancer or non-melanoma skin cancer) in the previous 5 years * Current congestive heart failure, signs or symptoms indicative of an increased acute risk for a cardiovascular event * History of myocardial infarction, coronary artery bypass or angioplasty, conditions requiring chronic anticoagulation (recent or recurrent DVT) * Resting systolic blood pressure of \>160 mmHg or diastolic blood pressure \>100 mmHg * Eating disorder that would contraindicate weight loss or physical activity * Alcohol or substance abuse * Current treatment for psychiatric issues (e.g., depression, bipolar disorder) or taking daily or extended release psychotropic medications in the previous 12 months * Report exercising more than 100 minutes per week over the past 3 months (NOTE: includes physical activity performed for sport, fitness, or recreational activity; physical activity performed as part of occupation or household chores is not included) * Weight loss of greater than 5% or participating in a weight reduction diet in the past 3 months * Report plans to relocate to a location not accessible to the study site or having employment, personal, or travel commitments that prohibit attendance to at least 80 percent of the scheduled intervention sessions and all of the scheduled assessments
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Leukocyte telomere length (LTL) at the 6 month assessment (controlling for appropriate covariates) | Blood samples will be collected as part of the 6 month assessment | LTL will be measured in blood samples from participants |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Leukocyte telomere length (LTL) at the 12 month assessment (controlling for appropriate covariates) | Blood samples will be collected as part of the 12 month assessment (as feasible) | LTL will be measured in blood samples from participants |
| Telomerase level at 3 months (controlling for appropriate covariates) | Blood samples will be collected as part of the 3 month assessment | Telomerase will be measured in blood samples from participants |
| Superoxide dismutase 1 (SOD1) at 3 months (controlling for appropriate covariates) | Samples will be collected as part of the 3 month assessment | SOD1 will be measured in samples from participants |
| Superoxide dismutase 1 (SOD1) at 6 months (controlling for appropriate covariates) | Samples will be collected as part of the 6 month assessment | SOD1 will be measured in samples from participants |
| Superoxide dismutase 2 (SOD2) at 3 months (controlling for appropriate covariates) | Samples will be collected as part of the 3 month assessment | SOD2 will be measured in samples from participants |
| Telomerase level at 6 months (controlling for appropriate covariates) | Blood samples will be collected as part of the 6 month assessment | Telomerase will be measured in blood samples from participants |
| Telomerase level at 12 months (controlling for appropriate covariates) | Blood samples will be collected as part of the 12 month assessment (as feasible) | Telomerase will be measured in blood samples from participants |
| Leukocyte telomere length (LTL) at the 3 month assessment (controlling for appropriate covariates) | Blood samples will be collected as part of the 3 month assessment | LTL will be measured in blood samples from participants |
| 8-OHdG level at 6 months (controlling for appropriate covariates) | Samples will be collected as part of the 6 month assessment | 8-OHdG will be measured in samples from participants |
| Superoxide dismutase 2 (SOD2) at 6 months (controlling for appropriate covariates) | Samples will be collected as part of the 6 month assessment | SOD2 will be measured in samples from participants |
| Glutathione peroxidase (Gpx) at 3 months (controlling for appropriate covariates) | Samples will be collected as part of the 3 month assessment | Gpx will be measured in samples from participants |
| Glutathione peroxidase (Gpx) at 6 months (controlling for appropriate covariates) | Samples will be collected as part of the 6 month assessment | Gpx will be measured in samples from participants |
| Systemic Inflammatory Response (SIR) at 3 months (controlling for appropriate covariates) | Samples will be collected as part of the 3 month assessment | SIR will be measured in samples from participants |
| Systemic Inflammatory Response (SIR) at 6 months (controlling for appropriate covariates) | Samples will be collected as part of the 6 month assessment | SIR will be measured in samples from participants |
| 8-OHdG level at 3 months (controlling for appropriate covariates) | Samples will be collected as part of the 3 month assessment | 8-OHdG will be measured in samples from participants |
Other
| Measure | Time frame | Description |
|---|---|---|
| Symptoms of anxiety at 3 months (controlling for appropriate covariates) | Questionnaires will be completed as part of the 3 month assessment | The State subscale of the State Trait Anxiety Inventory will be used to obtain a self-reported measure of acute anxiety |
| Symptoms of anxiety at 6 months (controlling for appropriate covariates) | Questionnaires will be completed as part of the 6 month assessment | The State subscale of the State Trait Anxiety Inventory will be used to obtain a self-reported measure of acute anxiety |
| Perceived stress at 3 months (controlling for appropriate covariates) | Questionnaires will be completed as part of the 3 month assessment | The Perceived Stress Scale will be used to obtain a self-reported measure of perceived stress |
| Perceived stress at 6 months (controlling for appropriate covariates) | Questionnaires will be completed as part of the 6 month assessment | The Perceived Stress Scale will be used to obtain a self-reported measure of perceived stress |
| Body Mass Index (BMI) at 3 months (controlling for appropriate covariates) | Measurements will be collected as part of the 3 month assessment | BMI will be calculated from height and weight measurements |
| Sleep quality at 6 months (controlling for appropriate covariates) | Questionnaires will be completed as part of the 6 month assessment | The Pittsburgh Sleep Quality Index will be used to obtain a self-reported measure of overall sleep quality |
| Quality of life at 3 months (controlling for appropriate covariates) | Questionnaires will be completed as part of the 3 month assessment | The Functional Assessment of Cancer Therapy - Bladder Cancer will be used to obtain a self-reported measure of health-related quality of life |
| Quality of life at 6 months (controlling for appropriate covariates) | Questionnaires will be completed as part of the 6 month assessment | The Functional Assessment of Cancer Therapy - Bladder Cancer will be used to obtain a self-reported measure of health-related quality of life |
| Sleep quality at 3 months (controlling for appropriate covariates) | Questionnaires will be completed as part of the 3 month assessment | The Pittsburgh Sleep Quality Index will be used to obtain a self-reported measure of overall sleep quality |
| Body Mass Index (BMI) at 6 months (controlling for appropriate covariates) | Measurements will be collected as part of the 6 month assessment | BMI will be calculated from height and weight measurements |
| Body composition at 3 months (controlling for appropriate covariates) | Measurements will be collected as part of the 3 month assessment | Body composition will be measured by dual-energy x-ray absorptiometry (DXA) |
| Body composition at 6 months (controlling for appropriate covariates) | Measurements will be collected as part of the 6 month assessment | Body composition will be measured by dual-energy x-ray absorptiometry (DXA) |
| Regional adiposity (DXA) at 3 months (controlling for appropriate covariates) | Measurements will be collected as part of the 3 month assessment | Regional adiposity will be measured by dual-energy x-ray absorptiometry (DXA) |
| Regional adiposity (DXA) at 6 months (controlling for appropriate covariates) | Measurements will be collected as part of the 6 month assessment | Regional adiposity will be measured by dual-energy x-ray absorptiometry (DXA) |
| Waist-to-hip ratio at 3 months (controlling for appropriate covariates) | Measurements will be collected as part of the 3 month assessment | Waist-to-hip ratio will be calculated from waist and hip measurements |
| Waist-to-hip ratio at 6 months (controlling for appropriate covariates) | Measurements will be collected as part of the 6 month assessment | Waist-to-hip ratio will be calculated from waist and hip measurements |
| Objective physical activity level at 3 months (controlling for appropriate covariates) | Total physical activity will be calculated from measurements collected for 7 consecutive days following the 3 month assessment | Physical Activity will be objectively measured with SenseWear BodyMedia |
| Objective physical activity level at 6 months (controlling for appropriate covariates) | Total physical activity will be calculated from measurements collected for 7 consecutive days following the 6 month assessment | Physical Activity will be objectively measured with SenseWear BodyMedia |
| Self-reported physical activity level at 3 months (controlling for appropriate covariates) | Self-reports will be obtained as part of the 3 month assessment | The Paffenbarger Physical Activity Questionnaire will be used to obtain a self-reported measure of physical activity |
| Self-reported physical activity level at 6 months (controlling for appropriate covariates) | Self-reports will be obtained as part of the 6 month assessment | The Paffenbarger Physical Activity Questionnaire will be used to obtain a self-reported measure of physical activity |
| Cardiorespiratory fitness at 3 months (controlling for appropriate covariates) | Measurements will be collected as part of the 3 month assessment | Cardiorespiratory Fitness (oxygen consumption) will be measured by submaximal treadmill test |
| Cardiorespiratory fitness at 6 months (controlling for appropriate covariates) | Measurements will be collected as part of the 6 month assessment | Cardiorespiratory Fitness (oxygen consumption) will be measured by submaximal treadmill test |
| Depressive symptoms at 3 months (controlling for appropriate covariates) | Questionnaires will be completed as part of the 3 month assessment | The Center for Epidemiologic Studies Depression Scale will be used to obtain a self-reported measure of depressive symptoms |
| Depressive symptoms at 6 months (controlling for appropriate covariates) | Questionnaires will be completed as part of the 6 month assessment | The Center for Epidemiologic Studies Depression Scale will be used to obtain a self-reported measure of depressive symptoms |
Countries
United States
Outcome results
None listed