Cutaneous Melanoma
Conditions
Brief summary
This study investigates the extent to which lifestyle factors including mental health, social support, diet, and exercise are associated with quality of life and melanoma patient outcomes. Knowledge gained from this study may be used to guide the design of prospective clinical trials of lifestyle interventions to improve the outcomes of melanoma patients and assist doctors in counseling their patients.
Detailed description
PRIMARY OBJECTIVES: I. Collect systematic data on mental health, quality of life (QOL), social support, diet, and exercise behaviors in melanoma patients. II. Examine whether psychosocial factors and lifestyle are associated with clinical outcomes in melanoma patients. III. Examine the association between lifestyle and psychosocial factors and tissue and blood biomarkers in melanoma patients. IV. Examine whether psychosocial factors and lifestyle are associated with QOL adjustment in melanoma patients. OUTLINE: Patients complete a maximum of 3 paper or electronic questionnaires over 30 minutes within 2 weeks of presentation to MD Anderson, new diagnosis of melanoma, and/or initiating a new treatment, within 2 weeks of first restaging, and within 2 weeks of the end of treatment. Patients may complete an additional paper or electronic dietary questionnaire over 10 minutes for 3 days (30 minutes total) or a phone-based dietary recall. Patients who start a new treatment of interest may repeat the questionnaires at the same time points. Patients' medical records are also reviewed.
Interventions
OTHERMedical Chart Review
Medical charts are reviewed
OTHERQuestionnaire Administration
Complete questionnaires
Sponsors
M.D. Anderson Cancer Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of melanoma, precursor lesions, and associated cutaneous pathology * Able to read and understand English * Willing to complete an online or paper survey
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in depression/distress | Up to 10 years | Will be assessed using the Centers for Epidemiologic Studies - Depression. Lifetime history of Major Depressive Disorder (MDD) will be measured using the two cardinal items from the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders-IV Disorder. Multivariate methods, including repeated measures analyses, will be employed to further explore the potential changes in the measures over time. |
| Change in anxiety | Up to 10 years | Will be assessed using the Speilberger State/Trait Anxiety Inventory. Multivariate methods, including repeated measures analyses, will be employed to further explore the potential changes in the measures over time. |
| Change in cancer-related symptoms | Up to 10 years | Will be assessed using the MD Anderson Symptom Inventory. Multivariate methods, including repeated measures analyses, will be employed to further explore the potential changes in the measures over time. |
| Change in social support | Up to 10 years | Will be assessed using the 24-item Social Provisions Scale. Multivariate methods, including repeated measures analyses, will be employed to further explore the potential changes in the measures over time. |
| Change in general eating habits | Up to 10 years | Will be assessed using the National Cancer Institute National Health and Nutrition Examination Survey Dietary Screener Questionnaire, and optionally, the National Institutes of Health Automated Self-Administered 24-hour. |
| Change in physical activity | Up to 10 years | Will be assessed using the Godin Leisure -Time Exercise Questionnaire. Multivariate methods, including repeated measures analyses, will be employed to further explore the potential changes in the measures over time. |
| Associations between mental health, social support, diet and exercise behaviors, and quality of life and demographic variables | Up to 10 years | Will be evaluated using Pearson's product moment correlation coefficients together with scatterplots where appropriate. |
| Effect of diet, physical activity, depressive symptoms, distress, lifetime MDD, and social support on progression free survival | Up to 10 years | Will be evaluated using Pearson's product moment correlation coefficients together with scatterplots where appropriate. |
| Effect of diet, physical activity, depressive symptoms, distress, lifetime MDD, and social support on cancer mortality | Up to 10 years | Will be evaluated using Pearson's product moment correlation coefficients together with scatterplots where appropriate. |
| Response to treatment | Up to 10 years | Logistic regression models will be used to measure the association of diet, physical activity, diet, depressive symptoms, distress, lifetime MDD, and social support and response to treatment at each time point. |
Countries
United States
Contacts
CONTACTCarrie Daniel-MacDougall
PRINCIPAL_INVESTIGATORCarrie Daniel-MacDougall
M.D. Anderson Cancer Center
Outcome results
None listed