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

M.D. Anderson Cancer Center

Status: Enrolling

Conditions: Cutaneous Melanoma

Treatments: Other: Medical Chart Review; Other: Questionnaire Administration

Study type: Observational

Funder types: Other

Identifiers

NCT04778449

NCI-2020-08200 (Registry Identifier)

PA15-0336 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 5,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

5,000 participants in 1 patient group

Observational (questionnaire, medical chart review)

Description:

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.

Treatment:

Other: Questionnaire Administration

Other: Medical Chart Review