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

Cutaneous Melanoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04778449
• Other study ID #: PA15-0336
• Secondary ID: NCI-2020-08200PA
• Status: Recruiting
• Start date: August 26, 2015
• Est. completion date: December 31, 2026

Study information

• Verified date: April 2024
• Source: M.D. Anderson Cancer Center
• Contact: Jennifer L McQuade
• Phone: 713-745-9947
• Email: jmcquade[@]mdanderson.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5000
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cutaneous Melanoma
• Melanoma

Intervention

Other:
• Medical Chart Review
Medical charts are reviewed
• Questionnaire Administration
Complete questionnaires

Locations

Country	Name	City	State
United States	M D Anderson Cancer Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Up to 10 years
Primary	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.	Up to 10 years
Primary	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.	Up to 10 years
Primary	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.	Up to 10 years
Primary	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.	Up to 10 years
Primary	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.	Up to 10 years
Primary	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.	Up to 10 years
Primary	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.	Up to 10 years
Primary	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.	Up to 10 years
Primary	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.	Up to 10 years

External Links

•   MD Anderson Cancer Center Website