A Study of Music Therapy for Anxiety in People With Cancer
Virtual AI-Assisted Music Therapy for Anxiety Symptoms in People With Advanced Cancer (VIRTUOSO)
The researchers are doing this study to compare two different music-based treatment approaches and see if one may work better to reduce anxiety. The researchers will also study whether these music-based treatment approaches help people feel socially connected and change how they cope with anxiety, and whether these changes are linked to lower anxiety levels. Both approaches use music-based activities to treat anxiety. One of the approaches uses an artificial intelligence (AI)-powered song creation platform to write songs with a music therapist. The other approach involves music listening exercises and music-based discussions with research staff, during which you will learn about music culture and history.
Przegląd badań
Status
Warunki
Typ studiów
Zapisy (Szacowany)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Jun Mao, MD, MSCE
- Numer telefonu: 646-608-8552
Kopia zapasowa kontaktu do badania
- Nazwa: Kevin Liou, MD
- Numer telefonu: 646-608-8558
- E-mail: liouk@mskcc.org
Lokalizacje studiów
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New Jersey
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Basking Ridge, New Jersey, Stany Zjednoczone, 07920
- Rekrutacyjny
- Memorial Sloan Kettering Basking Ridge (All protocol activities)
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Kontakt:
- Kevin Liou, MD
- Numer telefonu: 646-608-8558
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Middletown, New Jersey, Stany Zjednoczone, 07748
- Rekrutacyjny
- Memorial Sloan Kettering Monmouth (All protocol activities)
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Kontakt:
- Kevin Liou, MD
- Numer telefonu: 646-608-8558
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Montvale, New Jersey, Stany Zjednoczone, 07645
- Rekrutacyjny
- Memorial Sloan Kettering Bergen (All protocol activities)
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Kontakt:
- Kevin Liou, MD
- Numer telefonu: 646-608-8558
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New York
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Commack, New York, Stany Zjednoczone, 11725
- Rekrutacyjny
- Memorial Sloan Kettering Cancer Center Suffolk - Commack (All protocol activities)
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Kontakt:
- Kevin Liou, MD
- Numer telefonu: 646-608-8558
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Harrison, New York, Stany Zjednoczone, 10604
- Rekrutacyjny
- Memorial Sloan Kettering Westchester (All protocol activities)
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Kontakt:
- Kevin Liou, MD
- Numer telefonu: 646-608-8558
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New York, New York, Stany Zjednoczone, 10065
- Rekrutacyjny
- Memorial Sloan Kettering Cancer Center (All protocol activites)
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Kontakt:
- Kevin Liou, MD
- Numer telefonu: 646-608-8558
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Uniondale, New York, Stany Zjednoczone, 11553
- Rekrutacyjny
- Memorial Sloan Kettering Nassau (All protocol activities)
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Kontakt:
- Kevin Liou, MD
- Numer telefonu: 646-608-8558
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
Criteria:
- Patients must have a pathologically confirmed 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
- Currently receiving oncological treatment
- Age ≥ 18; English speaking
- Ambulatory as indicated by a Karnofsky performance score of 60 or higher
- Score of 8 or higher on the Hospital Anxiety and Depression Scale (HADS) anxiety subscale
- Anxiety symptoms lasting for at least 1 month
- Greater than 6-month expected survival as judged by the treating oncologist or clinician on the study team
- No diagnosis of bipolar disorder, schizophrenia, or substance abuse
- Score of 10 or lower on Blessed Orientation-Memory-Concentration
- No prior receipt of music therapy within the past six months
- Not currently receiving any form of psychotherapy
- Concomitant Medications
- No initiation or change in scheduled anxiety medications (e.g., anxiolytics, sedatives, hypnotics, antidepressants) within the past 4 weeks
- Initiation or change in PRN anxiety medications are allowed within the past 4 weeks
- No plan to initiate or change scheduled anxiety medications during the study
- Initiation or change in PRN anxiety medications are allowed during the study
- Access to an internet-connected device
- Able to provide informed consent
- Willing to adhere to study procedures, including randomization, session attendance, and completion of assessments
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Potroić
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
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Eksperymentalny: AI-assisted collaborative songwriting (ARTIST)
ARTIST intervention is designed to reduce anxiety by facilitating social connection and cognitive processing of cancer-related experience. The active "ingredient" of our intervention is collaborative songwriting, during which music therapists work with participants to brainstorm themes, draft lyrics, create melodies and harmonies, and produce an original song with personal meaning. Eight weekly 60-minute sessions. Post-Session Feedback: Participants will complete a five-question post-session survey after each of the 8 sessions. |
Patients will complete outcome measures of anxiety, social-cognitive outcomes, and co-morbid symptoms at baseline, week 4, week 8, week 16, and week 26. |
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Aktywny komparator: Time and attention matched-music listening (TAME)
TAME control will involve Collaborative Institutional Training Initiative (CITI)-trained research staff guiding participants through passive music listening exercises.Research staff will facilitate passive listening experiences of pre-selected songs, with each session focusing on a different genre. These music listening exercises will be purely receptive with no behavioral skill training or active music engagement. Research staff will prepare discussion points for each pre-selected song, focusing on academic topics (e.g., music theory, artist biography, historical context, genre characteristics), designed to minimize personal reflection or cognitive processing of cancer-related experiences. Eight weekly 60-minute sessions and all sessions will be delivered via Zoom. Post-Session Feedback: Participants will complete a five-question post-session survey after each of the 8 sessions. |
TAME control will involve Collaborative Institutional Training Initiative (CITI)-trained research staff guiding participants through passive music listening exercises. This control group is designed to match therapist attention and contact time of ARTIST, as well as control for music engagement unrelated to the active ingredient of ARTIST. Patients will complete outcome measures of anxiety, social-cognitive outcomes, and co-morbid symptoms at baseline, week 4, week 8, week 16, and week 26. |
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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anxiety change
Ramy czasowe: 26 weeks
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anxiety reduction at week 26 being the primary endpoint greater reduction in the Hospital Anxiety and Depression Scale (HADS) anxiety subscale |
26 weeks
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Współpracownicy i badacze
Współpracownicy
Śledczy
- Główny śledczy: Kevin Liou, MD, Memorial Sloan Kettering Cancer Center
Publikacje i pomocne linki
Przydatne linki
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- 26-214
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu IPD
Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made following one year after publication and for up to 36 months later. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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