MelanomaNCT07379138
Studying Quality of Life Inclusive of Mental Health and Cognitive Behavioral Therapy for Cancer Distress for the Improvement of Quality of Life in Stage III-IV Melanoma Patients
A study testing Best Practice, Cognitive Behavior Therapy and Electronic Health Record Review in people with Melanoma, run by Mayo Clinic at 1 site in United States.
Trial summary
This clinical trial studies how people feel and live during the first two years after being treated for melanoma and whether cognitive behavioral therapy for cancer distress (CBT-C) works to improve quality of life in patients with stage III-IV melanoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma
- What is being tested?
- Best Practice, Cognitive Behavior Therapy and Electronic Health Record Review
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 350 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Dec 2025to 31 Dec 2031
- Phase
- Interventional
- 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
Who may be able to join
- Age >= 18-years
- Stage III-IV melanoma and =< 2 month duration of this diagnosis
- Able to read English sufficient to complete survey, informed consent
Who cannot join
- Does not meet inclusion criteria
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
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
Clinical Trials Referral Office, 855-776-0015, mayocliniccancerstudies@mayo.edu
Deanna Hofschulte, 507-255-2972
About this study
Official title: Launching the Era of Melanoma Survivorship: Defining Benchmarks in Quality of Life Inclusive of Mental Health (QOL-MH)
This clinical trial studies how people feel and live during the first two years after being treated for melanoma and whether cognitive behavioral therapy for cancer distress (CBT-C) works to improve quality of life in patients with stage III-IV melanoma. The melanoma survivorship population is rapidly growing, given the increasing survival rates due to treatment advancements. An urgent need to better define and optimize comprehensive quality of life inclusive of mental health (QOL-MH) has been identified. Cognitive behavioral therapy is a type of psychotherapy that helps patients change their behavior by changing the way they think and feel about certain things. CBT-C is a new type of care that helps patients cope with cancer-related stress, which can include problems like trouble sleeping, trouble focusing, or changes in social life and daily activities. Gathering information on how melanoma patients feel and live during the first two years after treatment may help promote improved care and continued scientific advancements in the understanding of melanoma specific QOL-MH and survivorship as a whole, and may also help determine whether CBT-C improves qualify of life in patients with stage III-IV melanoma.
- Conditions
- Melanoma
- Being tested
- Best Practice, Cognitive Behavior Therapy, Electronic Health Record 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.
Best PracticeOther
Also called standard of care, standard therapy
Receive SOC
Cognitive Behavior TherapyBehavioural
Also called CBT, cognitive therapy, CT
Attend CBT-C sessions
Electronic Health Record ReviewOther
Ancillary studies
Questionnaire AdministrationOther
Complete QOL-MH questionnaires
| Study group | Role | What they receive |
|---|---|---|
| Aim 1 (QOL-MH) | Experimental | Patients complete QOL-MH questionnaires at baseline and 3, 6, 9, 12, 18, and 24-months post-stage III-IV diagnosis. Patients living in Minnesota, Iowa, or Wisconsin may also optionally participate in aim 2. Receives: Other: Electronic Health Record Review; Other: Questionnaire Administration |
| Aim 2 arm I (CBT-C) | Experimental | Patients attend CBT-C sessions once a week for 6 weeks in the absence of unacceptable toxicity. Receives: Behavioral: Cognitive Behavior Therapy; Other: Electronic Health Record Review; Other: Questionnaire Administration |
| Aim 2 arm II (SOC) | Active comparator | Patients receive SOC for 6 weeks in the absence of unacceptable toxicity. Receives: Other: Best Practice; Other: Electronic Health Record Review; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in FACT-M total score (Aim 1)
The Functional Assessment of Cancer Therapy - Melanoma (FACT-M) is a 52-item questionnaire used to measures quality of life (QoL) in melanoma cancer patients. Responses to each item are scored on a 5-point Likert scale ranging from 0 (Not at all) to 4 (Very much). Scores range from 0-108 with higher scores indicating better quality of life. For this study, 8 items have been omitted, so the number of items is 44, with total scores ranging from 0-176. Descriptive statistics will be used to tabulate and graph the observed total scores and the change from baseline total scores over time.
Measured: Baseline (at enrollment) and 3, 6, 9, 12, 18, and 24 months
Change in FACT-ICM total score (Aim 1)
The Functional Assessment of Cancer Therapy - Immune Checkpoint Modulator (FACT-ICM) is a 25-item subscale that measures symptom burden and health-related quality of life (HRQoL) over the past 7 days in patients receiving immune checkpoint inhibitors. Responses to each question are scored on a 5-point Likert scale ranging from 0 (Not at all) to 4 (Very much). Scores range from 0-100 with higher scores indicating greater symptom burden and poorer quality of life. Descriptive statistics will be used to tabulate and graph the observed total scores and the change from baseline total scores over time.
Measured: Baseline (at enrollment) and 3, 6, 9, 12, 18, and 24 months
Change in Impact of Events Scale-Revised (IES-R) score (Aim 1)
The Impact of Event Scale-Revised (IES-R) is a 22-item self-report measure designed to assess subjective distress related to stressful life events. The IES-R consists of 22 items for which participants rate how distressing each difficulty has been during the past 7 days with regard to their cancer diagnosis. Responses are scored on a 5-point Likert scale ranging from 0 (Not at all) to 4 (Extremely). Scores range from 0-88 with higher scores indicating greater distress. Descriptive statistics will be used to tabulate and graph the observed total scores and the change from baseline total scores over time.
Measured: Baseline (at enrollment) and 3, 6, 9, 12, 18, and 24 months
Change in IES-R score (Aim 2)
The Impact of Event Scale-Revised (IES-R) is a 22-item self-report measure designed to assess distress related to stressful life events. The IES-R consists of 22 items which participants rate distress over the past 7 days with regard to their cancer diagnosis. Responses are scored on a 5-point Likert scale ranging from 0 (Not at all) to 4 (Extremely). Scores range from 0-88 with higher scores indicating greater distress.
Measured: Baseline (at enrollment) and 3, 6, 9, 12, 18, and 24 months
Secondary outcomes (7)
Change in PHQ-8 score
The Patient Health Questionnaire-8 (PHQ-8) is a brief, self-report tool used to screen for and measure the severity of depression by asking about 8 depressive symptoms over the past two weeks, scoring from 0 (not at all) to 3 (nearly every day) for each, with total scores indicating severity (e.g., 0-4 minimal, 10-14 moderate) and a score of 10 or more often suggesting major depression.
Measured: Baseline (at enrollment) and 3, 6, 9, 12, 18, and 24 months
Change in GAD-7 Anxiety score
The General Anxiety Disorder 7-item (GAD-7) scale is used to assess symptoms and feelings of anxiety over the past two weeks. The GAD-7 consists of 7 questions answered on a scale of 0 (not at all) to 3 (nearly every day). The total score ranges from 0 to 21 where 0 indicates no anxiety, 1-4 indicates minimal anxiety, 5-9 indicates mild anxiety, 10-14 indicates moderate anxiety, and 15-21 indicates severe anxiety. If patients indicate any problems they are asked to indicate how difficult the problems have made daily life: not difficult at all, somewhat difficult, very difficult, or extremely difficult.
Measured: Baseline (at enrollment) and 3, 6, 9, 12, 18, and 24 months
Change in PSQI score
The Pittsburgh Sleep Quality Index (PSQI)measures the severity of sleep disturbances. Possible scores range from 0 to 21 with higher scores indicating a worse outcome/more severe symptoms of sleep disturbance.
Measured: Baseline (at enrollment) and 3, 6, 9, 12, 18, and 24 months
Change in PROMIS: Fatigue score
The Patient-Reported Outcomes Measurement Information System (PROMIS): Fatigue questionnaire, a subscale of the PROMIS-29, measures fatigue and related symptoms over the past seven days. It consists of four items rated on a scale of 1(not at all) to 5 (very much). A higher score indicates greater experience of fatigue.
Measured: Baseline (at enrollment) and 3, 6, 9, 12, 18, and 24 months
Change in PROMIS: Pain Interference score
The PROMIS: Pain Interference questionnaire, a subscale of the PROMIS-29, is used to assess pain interference in daily life over the past seven days. It consists of four items rated on a scale of 1(not at all) to 5 (very much). A higher score indicates greater levels of pain interference.
Measured: Baseline (at enrollment) and 3, 6, 9, 12, 18, and 24 months
Change in COST-FACIT score
The Comprehensive Score for Financial Toxicity-Functional Assessment of Chronic Illness Therapy (COSTFACIT) measures financial toxicity among cancer patients. This measure reflects five themes of financial toxicity which include: financial, resource, affect, coping, and effect on family. It consists of 12 questions, each answered on a scale of 0 (not at all) to 5 (very much), with higher scores indicating greater financial toxicity.
Measured: Baseline (at enrollment) and 3, 6, 9, 12, 18, and 24 months
Change in MEPS score
The Medical Expenditures Survey (MEPS) measures the financial impact of cancer, its treatment, or the lasting effects of that treatment. It consists of 5 multiple choice questions, including free text/ / fill-in options where appropriate. Results are reported descriptively. .
Measured: Baseline (at enrollment) and 3, 6, 9, 12, 18, and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2026
- Study start10 Dec 2025
- Primary completion31 Dec 2031 (estimated)
- Study completion31 Dec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MelanomaStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shawna L. Ehlers, PhD, LP, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07379138
- Sponsor's protocol ID
- 25-007199
- Other IDs
- HT9425-25-1-0802
- Status last verified
- Jun 2026
- First submitted
- 23 Jan 2026
- Last updated
- 22 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Launching the Era of Melanoma Survivorship: Defining Benchmarks in Quality of Life Inclusive of Mental Health (QOL-MH)
- ClinicalTrials.gov ID
- NCT07379138
- Acronym / sponsor ID
- 25-007199
- Conditions
- Melanoma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 10 Dec 2025 (actual)
- Primary completion
- 31 Dec 2031 (estimated)
- Study completion
- 31 Dec 2031 (estimated)
- First posted
- 30 Jan 2026 (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 clinical trial studies how people feel and live during the first two years after being treated for melanoma and whether cognitive behavioral therapy for cancer distress (CBT-C) works to improve quality of life in patients with stage III-IV melanoma. The melanoma survivorship population is rapidly growing, given the increasing survival rates due to treatment advancements. An urgent need to better define and optimize comprehensive quality of life inclusive of mental health (QOL-MH) has been identified. Cognitive behavioral therapy is a type of psychotherapy that helps patients change their behavior by changing the way they think and feel about certain things. CBT-C is a new type of care that helps patients cope with cancer-related stress, which can include problems like trouble sleeping, trouble focusing, or changes in social life and daily activities. Gathering information on how melanoma patients feel and live during the first two years after treatment may help promote improved care and continued scientific advancements in the understanding of melanoma specific QOL-MH and survivorship as a whole, and may also help determine whether CBT-C improves qualify of life in patients with stage III-IV melanoma.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Aim 1 (QOL-MH) | Experimental | Other: Electronic Health Record Review, Other: Questionnaire AdministrationPatients complete QOL-MH questionnaires at baseline and 3, 6, 9, 12, 18, and 24-months post-stage III-IV diagnosis. Patients living in Minnesota, Iowa, or Wisconsin may also optionally participate in aim 2. |
| Aim 2 arm I (CBT-C) | Experimental | Behavioral: Cognitive Behavior Therapy, Other: Electronic Health Record Review, Other: Questionnaire AdministrationPatients attend CBT-C sessions once a week for 6 weeks in the absence of unacceptable toxicity. |
| Aim 2 arm II (SOC) | Active comparator | Other: Best Practice, Other: Electronic Health Record Review, Other: Questionnaire AdministrationPatients receive SOC for 6 weeks in the absence of unacceptable toxicity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age >= 18-years
- Stage III-IV melanoma and =< 2 month duration of this diagnosis
- Able to read English sufficient to complete survey, informed consent
Key exclusion criteria (1 listed)
- Does not meet inclusion criteria
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 |
|---|---|---|
| Best PracticeAlso: standard of care, standard therapyReceive SOC | Other | Aim 2 arm II (SOC) |
| Cognitive Behavior TherapyAlso: CBT, cognitive therapy, CTAttend CBT-C sessions | Behavioural | Aim 2 arm I (CBT-C) |
| Electronic Health Record ReviewAncillary studies | Other | Aim 1 (QOL-MH), Aim 2 arm I (CBT-C), Aim 2 arm II (SOC) |
| Questionnaire AdministrationComplete QOL-MH questionnaires | Other | Aim 1 (QOL-MH), Aim 2 arm I (CBT-C), Aim 2 arm II (SOC) |
Primary outcome
Change in FACT-M total score (Aim 1)
Time frame: Baseline (at enrollment) and 3, 6, 9, 12, 18, and 24 months
The Functional Assessment of Cancer Therapy - Melanoma (FACT-M) is a 52-item questionnaire used to measures quality of life (QoL) in melanoma cancer patients. Responses to each item are scored on a 5-point Likert scale ranging from 0 (Not at all) to 4 (Very much). Scores range from 0-108 with higher scores indicating better quality of life. For this study, 8 items have been omitted, so the number of items is 44, with total scores ranging from 0-176. Descriptive statistics will be used to tabulate and graph the observed total scores and the change from baseline total scores over time.
Change in FACT-ICM total score (Aim 1)
Time frame: Baseline (at enrollment) and 3, 6, 9, 12, 18, and 24 months
The Functional Assessment of Cancer Therapy - Immune Checkpoint Modulator (FACT-ICM) is a 25-item subscale that measures symptom burden and health-related quality of life (HRQoL) over the past 7 days in patients receiving immune checkpoint inhibitors. Responses to each question are scored on a 5-point Likert scale ranging from 0 (Not at all) to 4 (Very much). Scores range from 0-100 with higher scores indicating greater symptom burden and poorer quality of life. Descriptive statistics will be used to tabulate and graph the observed total scores and the change from baseline total scores over time.
Change in Impact of Events Scale-Revised (IES-R) score (Aim 1)
Time frame: Baseline (at enrollment) and 3, 6, 9, 12, 18, and 24 months
The Impact of Event Scale-Revised (IES-R) is a 22-item self-report measure designed to assess subjective distress related to stressful life events. The IES-R consists of 22 items for which participants rate how distressing each difficulty has been during the past 7 days with regard to their cancer diagnosis. Responses are scored on a 5-point Likert scale ranging from 0 (Not at all) to 4 (Extremely). Scores range from 0-88 with higher scores indicating greater distress. Descriptive statistics will be used to tabulate and graph the observed total scores and the change from baseline total scores over time.
Change in IES-R score (Aim 2)
Time frame: Baseline (at enrollment) and 3, 6, 9, 12, 18, and 24 months
The Impact of Event Scale-Revised (IES-R) is a 22-item self-report measure designed to assess distress related to stressful life events. The IES-R consists of 22 items which participants rate distress over the past 7 days with regard to their cancer diagnosis. Responses are scored on a 5-point Likert scale ranging from 0 (Not at all) to 4 (Extremely). Scores range from 0-88 with higher scores indicating greater distress.
7 secondary outcomes
Change in PHQ-8 score
Time frame: Baseline (at enrollment) and 3, 6, 9, 12, 18, and 24 months
Change in GAD-7 Anxiety score
Time frame: Baseline (at enrollment) and 3, 6, 9, 12, 18, and 24 months
Change in PSQI score
Time frame: Baseline (at enrollment) and 3, 6, 9, 12, 18, and 24 months
Change in PROMIS: Fatigue score
Time frame: Baseline (at enrollment) and 3, 6, 9, 12, 18, and 24 months
Change in PROMIS: Pain Interference score
Time frame: Baseline (at enrollment) and 3, 6, 9, 12, 18, and 24 months
Change in COST-FACIT score
Time frame: Baseline (at enrollment) and 3, 6, 9, 12, 18, and 24 months
Change in MEPS score
Time frame: Baseline (at enrollment) and 3, 6, 9, 12, 18, and 24 months
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 22 Jun 2026.
- Mayo Clinic Clinical TrialsLink 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.
Shawna L. Ehlers, PhD, LP principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Best Practice, Cognitive Behavior Therapy and Electronic Health Record Review in people with Melanoma, run by Mayo Clinic 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 1 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 22 Jun 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 Clinical Trials Referral Office (855-776-0015, mayocliniccancerstudies@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in FACT-M total score (Aim 1) (time frame: Baseline (at enrollment) and 3, 6, 9, 12, 18, and 24 months). The study lists 4 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 22 Jun 2026.