Quality of Life, Lifestyle, and Psychosocial Factors in Patients With Melanoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Medical Chart Review, Questionnaire Administration.
- Who it may be relevant to
- Registry conditions: Cutaneous Melanoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Other Medical Chart Review
Medical charts are reviewed - Other Questionnaire Administration
Complete questionnaires
Primary outcome measures
- Change in depression/distress [Time frame: Up to 10 years]
- Change in anxiety [Time frame: Up to 10 years]
- Change in cancer-related symptoms [Time frame: Up to 10 years]
- Change in social support [Time frame: Up to 10 years]
- Change in general eating habits [Time frame: Up to 10 years]
- Change in physical activity [Time frame: Up to 10 years]
- Associations between mental health, social support, diet and exercise behaviors, and quality of life and demographic variables [Time frame: Up to 10 years]
- Effect of diet, physical activity, depressive symptoms, distress, lifetime MDD, and social support on progression free survival [Time frame: Up to 10 years]
- Effect of diet, physical activity, depressive symptoms, distress, lifetime MDD, and social support on cancer mortality [Time frame: Up to 10 years]
- Response to treatment [Time frame: Up to 10 years]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- M D Anderson Cancer Center — Houston
Identifiers
NCT: NCT04778449 · PA15-0336 · NCI-2020-08200 · PA15-0336