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

Mayo Clinic

Status

Enrolling

Conditions

Melanoma

Treatments

Other: Best Practice

Behavioral: Cognitive Behavior Therapy

Other: Questionnaire Administration

Other: Electronic Health Record Review

Study type

Interventional

Funder types

Other

Identifiers

NCT07379138

25-007199 (Other Identifier)

HT9425-25-1-0802 (Other Grant/Funding Number)

NCI-2026-00039 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment

350 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Age >= 18-years
Stage III-IV melanoma and =< 2 month duration of this diagnosis
Able to read English sufficient to complete survey, informed consent

Exclusion criteria

Does not meet inclusion criteria

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

350 participants in 3 patient groups

Aim 1 (QOL-MH)

Experimental group

Description:

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.

Treatment:

Other: Questionnaire Administration

Other: Electronic Health Record Review

Aim 2 arm I (CBT-C)

Experimental group

Description:

Patients attend CBT-C sessions once a week for 6 weeks in the absence of unacceptable toxicity.

Treatment:

Other: Questionnaire Administration

Other: Electronic Health Record Review

Behavioral: Cognitive Behavior Therapy

Aim 2 arm II (SOC)