RECRUITING

A Study Comparing Music Therapy and Cognitive Behavioral Therapy for Anxiety in Cancer Survivors

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The researchers are doing this study to compare how music therapy and cognitive behavioral therapy, given virtually, may be able to reduce anxiety in people who have had cancer. In addition, this study will see if certain factors affect how well participants respond to music therapy or cognitive behavioral therapy. For example, the researchers will see if personal characteristics (like age, sex, race, and education) and ways of thinking (like expectations of therapy) may affect how well participants respond.

Official Title

Music Therapy vs. Cognitive-Behavioral Therapy for Cancer-related Anxiety (MELODY)

Quick Facts

Study Start:2022-01-14
Study Completion:2025-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05215353

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * English- or Spanish-speaking
  2. * 18 years or older
  3. * Prior cancer diagnosis of any type or stage
  4. * Free of oncological disease, or stable disease with no evidence of progression
  5. * Score of ≥8 on the anxiety subscale of the Hospital Anxiety and Depression Scale (HADS)
  6. * Report anxiety symptoms lasting at least one month
  7. * Willing to adhere to all study-related procedures, including randomization to one of two treatment arms: MT or CBT
  8. * Access to Zoom and a quiet/private location
  9. * English-speaking
  10. * 18 years or older
  11. * Advanced cancer diagnosis: stage III or IV lung cancer; any stage pancreatic cancer, unresectable cholangiocarcinoma, unresectable liver cancer, unresectable ampullary or peri-ampullary cancer, or other stage IV gastrointestinal cancer; stage III or IV ovarian or fallopian tube cancers or other stage IV gynecologic cancer; stage IV breast cancer; stage III testicular cancer or any stage IV genitourinary cancer; stage IV sarcoma; stage IV melanoma; stage IV endocrine cancer; lymphoma, myeloma, or leukemia
  12. * Currently receiving oncological treatment or on active surveillance
  13. * Karnofsky performance score of ≥60
  14. * Score of ≥8 on the HADS anxiety subscale
  15. * Anxiety symptoms lasting for at least 1 month
  16. * Greater than 6-month expected survival as judged by the treating oncologist
  17. * Willing to adhere to all study procedures
  18. * Access to Zoom and a quiet/private location
  1. * Completed active cancer treatment (e.g., surgery, radiation, chemotherapy) less than one month prior to enrollment (maintenance hormonal or targeted therapies are allowed).
  2. * Active suicidal ideation, bipolar disorder, schizophrenia, or substance abuse
  3. * Score of ≥10 indicative of cognitive impairment on the Blessed Orientation-Memory-Concentration
  4. * Received a treatment course of seven or greater MT or CBT sessions for anxiety symptoms within the last six months
  5. * Unable to provide informed consent for themselves
  6. * Active suicidal ideation; bipolar disorder, schizophrenia, or substance abuse
  7. * Score of ≥10 on Blessed Orientation-Memory-Concentration
  8. * Prior receipt of MT within the past six months
  9. * Plan to receive any form of psychotherapy in the coming 8 weeks
  10. * Initiation or change in anxiety medications within the past 4 weeks
  11. * Plan to initiate or change anxiety medications in the coming 8 weeks
  12. * Unable to provide informed consent for themselves

Contacts and Locations

Study Contact

Jun Mao, MD, MSCE
CONTACT
646-608-8552
maoj@mskcc.org
Kevin Liou, MD
CONTACT
646-608-8558

Principal Investigator

Jun Mao, MD, MSCE
PRINCIPAL_INVESTIGATOR
Memorial Sloan Kettering Cancer Center

Study Locations (Sites)

Baptist Alliance MCI
Miami, Florida, 33143
United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
United States
Drexel University
Philadelphia, Pennsylvania, 19104
United States

Collaborators and Investigators

Sponsor: Memorial Sloan Kettering Cancer Center

  • Jun Mao, MD, MSCE, PRINCIPAL_INVESTIGATOR, Memorial Sloan Kettering Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-01-14
Study Completion Date2025-01

Study Record Updates

Study Start Date2022-01-14
Study Completion Date2025-01

Terms related to this study

Keywords Provided by Researchers

  • Music Therapy
  • Cognitive Behavioral Therapy
  • Anxiety
  • 21-516

Additional Relevant MeSH Terms

  • Survivorship