Recruiting

Anxiety Intervention

Sponsor:

Memorial Sloan Kettering Cancer Center

Code:

NCT06305741

Conditions

Cancer Patients

Care Givers

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Accepted

Interventions

Managing Anxiety from Cancer (MAC)

Study Details

Brief summary:

The purpose of this study is to find out if an anxiety treatment program is practical and effective for Latino older adults with cancer (OACs) and their caregivers.

Conditions

Cancer Patients

Care Givers

Study ID

NCT06305741

Start date

Mar 5, 2024

Status verified date

Mar, 2026

Completion date

Mar, 2027

Anticipated

Primary completion date

Mar, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Accepted

Inclusion Criteria:

Older Adults with Cancer (OAC)

  • As per medical record or self-report, is currently age 65 years or older
  • As per medical record or self-report, currently receiving active cancer treatment OR is within eighteen months of completing active treatment which includes surgery, chemotherapy, radiation, and immunotherapy.
  • As per self-report, identifies as Latino and/or Hispanic Ethnicity
  • Per self-report, has a primary informal caregiver (as defined by an unpaid individual who provides the patient with emotional, physical, and/or practical support) age 40 or older who is willing and able to participate in the study ; if a patient does not have a primary informal caregiver or if the caregiver does not or cannot participate, but meets all other inclusion criteria they will be allowed to enroll in the study
  • Scores ≥6 on the anxiety subscale of the Hospital Anxiety and Depression Scale (HADS)
  • Per self-report, fluent in English and/or Spanish\*\* \*\* Language verification: Prior to enrollment, patients will be asked the following two questions by a Clinical Research Coordinator (CRC) to verify language fluency necessary for participation in the study:

1. How well do you speak English and/or Spanish? (must respond "very well" or "well" when given the choices of Very well, Well, Not well, Not at all, Don't know, or Refused)
2. What is your preferred language for healthcare? (must respond English and/or Spanish)

Caregiver

  • Per OAC report, is primary informal caregiver (as defined by an unpaid individual who provides the patient with emotional, physical, and/or practical support) for the eligible OAC patient
  • As per self-report, is age 40 years or older
  • Per self-report, fluent in English and/or Spanish\*\* \*\* Language verification: Prior to enrollment, patients will be asked the following two questions by a Clinical Research Coordinator (CRC) to verify language fluency necessary for participation in the study:

1. How well do you speak English and/or Spanish? (must respond "very well" or "well" when given the choices of Very well, Well, Not well, Not at all, Don't know, or Refused)
2. What is your preferred language for healthcare? (must respond English and/or Spanish)

Exclusion Criteria:

OAC

  • As per medical record or self-report, currently receiving psychotherapy
  • As per medical record or self-report, taking psychotropic medications for < 8 weeks prior to MAC Session 1 and/or anticipates changing their medication during the study
  • As per medical record or self-report, currently being treated for schizophrenia, substance use or dependence, and/or bi-polar disorder
  • Severely cognitively impaired as demonstrated by Blessed Orientation Memory Concentration score ≥ 11
  • Per research staff judgment and/or self-report, too ill or weak to complete study procedures
  • Per medical record or self-report, receiving hospice care at the time of enrollment

Caregiver

  • As per self-report, currently receiving psychotherapy
  • As per self-report, taking psychotropic medications for < 8 weeks prior to MAC Session 1 and/or anticipates changing their medication during the study
  • As per self-report, currently being treated for schizophrenia, substance use or dependence, and/or bi-polar disorder
  • Severely cognitively impaired as demonstrated by Blessed Orientation Memory Concentration score ≥ 11
  • Per research staff judgment and/or self-report, too ill or weak to complete study procedures

Study Design

Enrollment

60 participants

Anticipated

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Latino caregivers and the Latino older adults with cancer (OACs)

The intervention, MAC, is a seven-session (45- 60 minutes per session) psychotherapy intervention delivered via videoconference and/or telephone by licensed social workers. All sessions will be audio-recorded. MAC content, structure, and length are consistent with core components of cognitive behavioral therapy (CBT) (Freeman, 2004).

Interventions

Managing Anxiety from Cancer (MAC)

The intervention, MAC, is a seven-session (45-60 minutes per session) psychotherapy intervention delivered via videoconference and/or telephone by licensed social workers OR at least a Master's level (or enrolled in a doctorate program) advanced trainees in mental health fields.

Primary outcome measure

  • percentage of participants to complete all study procedures [ Time Frame: 1 year ]

Central Contacts and Locations

Central contacts

Christian Nelson, PhD

646-888-0030

Locations

Memorial Sloan Kettering at Basking Ridge (All Protocol Activities)

Recruiting

Basking Ridge, New Jersey, United States, 07920

Contacts

Kelly McConnell, PhD

646-888-0026

Memorial Sloan Kettering Monmouth (All Protocol Activities)

Recruiting

Middletown, New Jersey, United States, 07748

Contacts

Kelly McConnell, PhD

646-888-0026

Memorial Sloan Kettering Bergen (All Protocol Activities)

Recruiting

Montvale, New Jersey, United States, 07645

Contacts

Kelly McConnell, PhD

646-888-0026

Memorial Sloan Kettering Suffolk - Commack (All Protocol Activities)

Recruiting

Commack, New York, United States, 11725

Contacts

Kelly McConnell, PhD

646-888-0026

Memorial Sloan Kettering Westchester (All Protocol Activities)

Recruiting

Harrison, New York, United States, 10604

Contacts

Kelly McConnell, PhD

646-888-0026

Memorial Sloan Kettering Cancer Center (All protocol activities)

Recruiting

New York, New York, United States, 10065

Contacts

Kelly McConnell, PhD

646-888-0026

Memorial Sloan Kettering Nassau (All Protocol Activities)

Recruiting

Rockville Centre, New York, United States, 11553

Contacts

Kelly McConnell, PhD

646-888-0026

More Information

Sponsor

Memorial Sloan Kettering Cancer Center

Last update posted

Mar 6, 2026

Last verified

Mar, 2026

Keywords

  • Anxiety Intervention
  • Latino caregivers
  • 24-060

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Memorial Sloan Kettering Cancer Center on 2026-03-06.