Clinical trial NCT04778449: Quality of Life, Lifestyle, and Psychosocial Factors in Patients With Melanoma
Official title: Quality of Life, Lifestyle, and Psychosocial Factors in Patients With Melanoma
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cutaneous Melanoma
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2021-03-03
Enrollment: 5000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with melanoma, precursor lesions, and associated cutaneous pathology

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.

Eligibility 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

Primary outcomes:
measure: Change in depression/distress
timeFrame: Up to 10 years
measure: Change in anxiety
timeFrame: Up to 10 years
measure: Change in cancer-related symptoms
timeFrame: Up to 10 years
measure: Change in social support
timeFrame: Up to 10 years
measure: Change in general eating habits
timeFrame: Up to 10 years
measure: Change in physical activity
timeFrame: Up to 10 years
measure: Associations between mental health, social support, diet and exercise behaviors, and quality of life and demographic variables
timeFrame: Up to 10 years
measure: Effect of diet, physical activity, depressive symptoms, distress, lifetime MDD, and social support on progression free survival
timeFrame: Up to 10 years
measure: Effect of diet, physical activity, depressive symptoms, distress, lifetime MDD, and social support on cancer mortality
timeFrame: Up to 10 years
measure: Response to treatment
timeFrame: Up to 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Jennifer L McQuade
role: PRINCIPAL_INVESTIGATOR
References: