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NCT Number: NCT04778449

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

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.

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Key information

Conditions

Cutaneous Melanoma Melanoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location status: Recruiting

Location contact

Carrie Daniel-MacDougall

CONTACT

[email protected]

713-563-5783

Carrie Daniel-MacDougall

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

medical chart review

Other

Medical charts are reviewed

Other names: Chart Review

Questionnaire Administration

Other

Complete questionnaires

Primary outcomes

  1. Change in depression/distress

    Time frame: 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.

  2. Change in anxiety

    Time frame: 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.

  3. Change in cancer-related symptoms

    Time frame: 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.

  4. Change in social support

    Time frame: 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.

  5. Change in general eating habits

    Time frame: 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.

  6. Change in physical activity

    Time frame: 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.

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

    Time frame: Up to 10 years

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

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

    Time frame: Up to 10 years

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

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

    Time frame: Up to 10 years

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

  10. Response to treatment

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Carrie Daniel-MacDougall

CONTACT

[email protected]

713-563-5783

Sponsors and collaborators

Lead sponsor

M.D. Anderson Cancer Center

Other

Registry information

Important dates

Study start
2015
Primary completion
2026
Study completion
2026
First posted
Mar 3, 2021
Registry last updated
May 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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