Cancerify Logo
Log inSign up
Back to clinical trials
RecruitingObservational

Quality of Life, Lifestyle, and Psychosocial Factors in Patients With Melanoma

NCT ID: NCT04778449Sponsor: M.D. Anderson Cancer CenterLast updated: 2026-05-05

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.

Arms & interventions

  • OtherMedical Chart Review

    Medical charts are reviewed

  • OtherQuestionnaire Administration

    Complete questionnaires

Outcome measures

Primary

  • Change in depression/distress

    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.

    Time frame: Up to 10 years

  • Change in anxiety

    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.

    Time frame: Up to 10 years

  • Change in cancer-related symptoms

    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.

    Time frame: Up to 10 years

  • Change in social support

    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.

    Time frame: Up to 10 years

  • Change in general eating habits

    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.

    Time frame: Up to 10 years

  • Change in physical activity

    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.

    Time frame: Up to 10 years

  • Associations between mental health, social support, diet and exercise behaviors, and quality of life and demographic variables

    Will be evaluated using Pearson's product moment correlation coefficients together with scatterplots where appropriate.

    Time frame: Up to 10 years

  • Effect of diet, physical activity, depressive symptoms, distress, lifetime MDD, and social support on progression free survival

    Will be evaluated using Pearson's product moment correlation coefficients together with scatterplots where appropriate.

    Time frame: Up to 10 years

  • Effect of diet, physical activity, depressive symptoms, distress, lifetime MDD, and social support on cancer mortality

    Will be evaluated using Pearson's product moment correlation coefficients together with scatterplots where appropriate.

    Time frame: Up to 10 years

  • Response to treatment

    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.

    Time frame: Up to 10 years

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy 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

Study locations (1)

M D Anderson Cancer Center

Houston, Texas, 77030

Recruiting
Carrie Daniel-MacDougall · Contact
Carrie Daniel-MacDougall · Principal Investigator