Quality of Life, Lifestyle, and Psychosocial Factors in Patients With Melanoma
2 other identifiers
observational
5,000
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2015
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 26, 2015
CompletedFirst Submitted
Initial submission to the registry
November 19, 2020
CompletedFirst Posted
Study publicly available on registry
March 3, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2026
May 5, 2026
April 1, 2026
11.4 years
November 19, 2020
April 29, 2026
Conditions
Outcome Measures
Primary Outcomes (10)
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
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
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
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
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
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
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
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
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
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
Study Arms (1)
Observational (questionnaire, medical chart review)
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
Medical charts are reviewed
Complete questionnaires
Eligibility Criteria
Patients with melanoma, precursor lesions, and associated cutaneous pathology
You may qualify if:
- Diagnosis of melanoma, precursor lesions, and associated cutaneous pathology
- Able to read and understand English
- Willing to complete an online or paper survey
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
M D Anderson Cancer Center
Houston, Texas, 77030, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Carrie Daniel-MacDougall
M.D. Anderson Cancer Center
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 19, 2020
First Posted
March 3, 2021
Study Start
August 26, 2015
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
December 31, 2026
Last Updated
May 5, 2026
Record last verified: 2026-04