Phase 4 Depression and Anxiety Trial, Recruiting NCT05215353 Sponsor: Memorial Sloan Kettering Cancer Center Condition: Depression and Anxiety
Back to Depression And Anxiety

Phase 4 Depression and Anxiety Trial, Recruiting

NCT05215353
Recruiting Phase 4

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

Main Study

  • People who speak English or Spanish
  • People aged 18 or older
  • People who have previously been diagnosed with cancer of any type or stage
  • People whose cancer is either gone or stable with no signs of getting worse
  • People whose anxiety scores at least 8 out of 21 on a standard anxiety screening tool called the Hospital Anxiety and Depression Scale
  • People who have been experiencing anxiety symptoms for at least one month
  • People who are willing to follow all study procedures, including being randomly assigned to one of two treatment groups: Music Therapy (MT) or Cognitive Behavioural Therapy (CBT)
  • People who have access to Zoom and a quiet, private space

Advanced Cancer Sub-Study (up to 50 people)

  • People who speak English
  • People aged 18 or older
  • People diagnosed with an advanced cancer, including: stage III or IV lung cancer; any stage pancreatic cancer; certain unresectable liver, bile duct, or related cancers; stage IV gastrointestinal cancers; stage III or IV ovarian or fallopian tube cancer or other stage IV gynaecologic 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; or blood cancers such as lymphoma, myeloma, or leukaemia
  • People who are currently receiving cancer treatment or being closely monitored by their oncology team
  • People whose general physical functioning scores at least 60 on a standard scale used by doctors to assess how well a person can carry out daily activities (confirm with trial site)
  • People whose anxiety scores at least 8 on the standard anxiety screening tool described above
  • People who have been experiencing anxiety symptoms for at least one month
  • People whose treating oncologist estimates they have more than 6 months life expectancy
  • People who are willing to follow all study procedures
  • People who have access to Zoom and a quiet, private space

Group Music Therapy Sub-Study (up to 18 people)

  • People who speak English
  • People aged 18 or older
  • People who have previously been diagnosed with cancer of any type or stage
  • People whose cancer is either gone or stable with no signs of getting worse
  • People whose anxiety scores at least 8 on the standard anxiety screening tool described above
  • People who have been experiencing anxiety symptoms for at least one month
  • People who are willing to follow all study procedures
  • People who have access to Zoom and a quiet, private space

Who may not be able to join:

Main Study

  • People who finished active cancer treatment such as surgery, radiation, or chemotherapy less than one month before enrolling (note: ongoing hormonal or targeted maintenance therapies are permitted)
  • People with active suicidal thoughts, bipolar disorder, schizophrenia, or substance abuse
  • People who score 10 or higher on a standard test used to screen for significant memory or thinking difficulties
  • People who have already received seven or more sessions of Music Therapy or CBT specifically for anxiety within the past six months
  • People who are not able to give their own informed consent to participate

Advanced Cancer Sub-Study

  • People with active suicidal thoughts, bipolar disorder, schizophrenia, or substance abuse
  • People who score 10 or higher on the standard memory and thinking screening test described above
  • People who have received Music Therapy within the past six months
  • People who plan to receive any form of talking therapy or psychotherapy in the next 8 weeks
  • People whose anxiety medication has been started or changed in the past 4 weeks
  • People who plan to start or change anxiety medication in the next 8 weeks
  • People who are not able to give their own informed consent to participate

Group Music Therapy Sub-Study

  • People who finished active cancer treatment such as surgery, radiation, or chemotherapy less than one month before enrolling (note: ongoing hormonal or targeted maintenance therapies are permitted)
  • People with active suicidal thoughts, bipolar disorder, schizophrenia, or substance abuse
  • People who score 10 or higher on the standard memory and thinking screening test described above
  • People who have received Music Therapy within the past six months
  • People who plan to receive any form of talking therapy or psychotherapy in the next 8 weeks
  • People whose anxiety medication has been started or changed in the past 4 weeks
  • People who are not able to give their own informed consent to participate

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 20 July 2026
Phase 4 trials study a drug that has already been approved, monitoring long-term safety and effectiveness in real-world use.

Contact this trial

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

Phone: 646-608-8552

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 4
Registry
ClinicalTrials.gov
Start date
14 January 2022
Est. completion
1 January 2027

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

HADS anxiety score changes; HADS anxiety score changes

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 20 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov