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

Sponsor
Memorial Sloan Kettering Cancer Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT05215353
Collaborator
Patient-Centered Outcomes Research Institute (Other)
300
2
2
35.6
150
4.2

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Music Therapy
  • Other: Cognitive Behavioral Therapy
  • Other: assessments
Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
300 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
The proposed MELODY trial is a two-arm, parallel group, randomized clinical trial (RCT) to compare the effectiveness of music therapy (M) versus cognitive behavioral therapy (CBT) for anxiety and co-morbid symptoms in a diverse, heterogeneous sample of 300 cancer survivors.The proposed MELODY trial is a two-arm, parallel group, randomized clinical trial (RCT) to compare the effectiveness of music therapy (M) versus cognitive behavioral therapy (CBT) for anxiety and co-morbid symptoms in a diverse, heterogeneous sample of 300 cancer survivors.
Masking:
Double (Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Music Therapy vs. Cognitive-Behavioral Therapy for Cancer-related Anxiety (MELODY)
Actual Study Start Date :
Jan 14, 2022
Anticipated Primary Completion Date :
Jan 1, 2025
Anticipated Study Completion Date :
Jan 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Music Therapy (MT)

MT is a non-pharmacological, evidence-based intervention, in which board-certified music therapists engage patients in personally tailored experiences with music to achieve therapeutic goals. Patients will receive a workbook with materials for each session These experiences range from music-guided relaxation to more active forms of musical engagement, including singing and improvising music.

Other: Music Therapy
Participants will receive seven weekly 60-minute treatments of music therapy. All sessions will be delivered virtually through Zoom.

Other: assessments
Participants will complete study assessments prior to randomization (week 0) and at weeks 4, 8, 16, and 26. A subgroup of 60 survivors will complete optional semi-structured interviews after treatment to understand their unique experiences with MT or CBT. All participants will be followed for 26 weeks.

Active Comparator: Cognitive Behavioral Therapy (CBT)

Cognitive behavioral therapy (CBT) is an evidence-based, nonpharmacological intervention delivered by licensed mental health providers. Informed by the cognitive behavior model of anxiety, CBT focuses on the relationship between thoughts, behaviors, and emotions and how thoughts and behaviors can exacerbate or reduce anxiety.

Other: Cognitive Behavioral Therapy
Participants will receive seven weekly 60-minute treatment of cognitive behavioral therapy. All sessions will be delivered virtually through Zoom.

Other: assessments
Participants will complete study assessments prior to randomization (week 0) and at weeks 4, 8, 16, and 26. A subgroup of 60 survivors will complete optional semi-structured interviews after treatment to understand their unique experiences with MT or CBT. All participants will be followed for 26 weeks.

Outcome Measures

Primary Outcome Measures

  1. HADS anxiety score changes [8 weeks]

    Using the seven-item anxiety sub-scale of the Hospital Anxiety and Depression Scale (HADS). A score of ≥8 indicates presence of anxiety symptoms.

  2. HADS anxiety score changes [26 weeks]

    Using the seven-item anxiety sub-scale of the Hospital Anxiety and Depression Scale (HADS). A score of ≥8 indicates presence of anxiety symptoms.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • English- or Spanish-speaking

  • 18 years or older

  • Prior cancer diagnosis of any type or stage

  • Free of oncological disease

  • Score of ≥8 on the anxiety subscale of the Hospital Anxiety and Depression Scale (HADS)

  • Report anxiety symptoms lasting at least one month

  • Willing to adhere to all study-related procedures, including randomization to one of two treatment arms: MT or CBT

  • Access to Zoom and a quiet/private location

Exclusion Criteria:
  • Completed active cancer treatment (e.g., surgery, radiation, chemotherapy) less than one month prior to enrollment (maintenance hormonal or targeted therapies are allowed).

  • Active suicidal ideation, bipolar disorder, schizophrenia, or substance abuse

  • Score of ≥10 indicative of cognitive impairment on the Blessed Orientation-Memory-Concentration

  • Received a treatment course of seven or greater MT or CBT sessions for anxiety symptoms within the last six months

  • Unable to provide informed consent for themselves

Contacts and Locations

Locations

Site City State Country Postal Code
1 Baptist Alliance MCI Miami Florida United States 33143
2 Memorial Sloan Kettering Cancer Center New York New York United States 10065

Sponsors and Collaborators

  • Memorial Sloan Kettering Cancer Center
  • Patient-Centered Outcomes Research Institute

Investigators

  • Principal Investigator: Jun Mao, MD, MSCE, Memorial Sloan Kettering Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT05215353
Other Study ID Numbers:
  • 21-516
First Posted:
Jan 31, 2022
Last Update Posted:
Aug 15, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Memorial Sloan Kettering Cancer Center
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 15, 2022