Recruiting

Observational Study

Sponsor:

M.D. Anderson Cancer Center

Code:

NCT04778449

Conditions

Cutaneous Melanoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Medical Chart Review

Questionnaire Administration

Study Details

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.

Conditions

Cutaneous Melanoma

Study ID

NCT04778449

Start date

Aug 26, 2015

Status verified date

Apr, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

5000 participants

Anticipated

Interventions and Outcome Measures

Arms

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 Chart Review

Medical charts are reviewed

Questionnaire Administration

Complete questionnaires

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Carrie Daniel-MacDougall

713-563-5783cdaniel@mdanderson.org

Locations

M D Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Carrie Daniel-MacDougall

713-563-5783cdaniel@mdanderson.org

Principal Investigator:

Carrie Daniel-MacDougall

More Information

Sponsor

M.D. Anderson Cancer Center

Last update posted

May 5, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by M.D. Anderson Cancer Center on 2026-05-05.