Cutaneous MelanomaNCT04778449
Quality of Life, Lifestyle, and Psychosocial Factors in Patients With Melanoma
An observational study of Cutaneous Melanoma, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cutaneous Melanoma
- What is being tested?
- Medical Chart Review and Questionnaire Administration
- How many people
- 5,000 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Aug 2015to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with melanoma, precursor lesions, and associated cutaneous pathology
Who may be able to join
- Diagnosis of melanoma, precursor lesions, and associated cutaneous pathology
- Able to read and understand English
- Willing to complete an online or paper survey
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
M D Anderson Cancer Center
Houston, Texas, 77030
Carrie Daniel-MacDougall, 713-563-5783, cdaniel@mdanderson.org
Carrie Daniel-MacDougall
About this study
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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.
- Conditions
- Cutaneous Melanoma
- Being tested
- Medical Chart Review, Questionnaire Administration
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medical Chart ReviewOther
Also called Chart Review
Medical charts are reviewed
Questionnaire AdministrationOther
Complete questionnaires
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Medical Chart Review; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2021
- Study start26 Aug 2015
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cutaneous MelanomaStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Carrie Daniel-MacDougall, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04778449
- Sponsor's protocol ID
- PA15-0336
- Other IDs
- NCI-2020-08200, PA15-0336
- Status last verified
- Apr 2026
- First submitted
- 19 Nov 2020
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality of Life, Lifestyle, and Psychosocial Factors in Patients With Melanoma
- ClinicalTrials.gov ID
- NCT04778449
- Acronym / sponsor ID
- PA15-0336
- Conditions
- Cutaneous Melanoma
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 26 Aug 2015 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 3 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational (questionnaire, medical chart review) | – | Other: Medical Chart Review, Other: Questionnaire AdministrationPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with melanoma, precursor lesions, and associated cutaneous pathology
Key inclusion criteria (3 listed)
- Diagnosis of melanoma, precursor lesions, and associated cutaneous pathology
- Able to read and understand English
- Willing to complete an online or paper survey
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medical Chart ReviewAlso: Chart ReviewMedical charts are reviewed | Other | Observational (questionnaire, medical chart review) |
| Questionnaire AdministrationComplete questionnaires | Other | Observational (questionnaire, medical chart review) |
Primary outcome
Change in depression/distress
Time frame: Up to 10 years
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.
Change in anxiety
Time frame: Up to 10 years
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.
Change in cancer-related symptoms
Time frame: Up to 10 years
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.
Change in social support
Time frame: Up to 10 years
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.
Change in general eating habits
Time frame: Up to 10 years
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.
Change in physical activity
Time frame: Up to 10 years
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.
Associations between mental health, social support, diet and exercise behaviors, and quality of life and demographic variables
Time frame: Up to 10 years
Will be evaluated using Pearson's product moment correlation coefficients together with scatterplots where appropriate.
Effect of diet, physical activity, depressive symptoms, distress, lifetime MDD, and social support on progression free survival
Time frame: Up to 10 years
Will be evaluated using Pearson's product moment correlation coefficients together with scatterplots where appropriate.
Effect of diet, physical activity, depressive symptoms, distress, lifetime MDD, and social support on cancer mortality
Time frame: Up to 10 years
Will be evaluated using Pearson's product moment correlation coefficients together with scatterplots where appropriate.
Response to treatment
Time frame: Up to 10 years
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
- MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Carrie Daniel-MacDougall principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cutaneous Melanoma, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Carrie Daniel-MacDougall (713-563-5783, cdaniel@mdanderson.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in depression/distress (time frame: Up to 10 years). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2026.