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NCT Number: NCT06305741

A Study of an Anxiety Intervention for Latino/Latina/Hispanic Older Adults With Cancer and Their Caregivers

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.

Recruiting

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Key information

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Memorial Sloan Kettering at Basking Ridge (All Protocol Activities), Basking Ridge, New Jersey, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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:
  • 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)
  • 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:
  • 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)
  • 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

Treatment and study plan

Managing Anxiety from Cancer (MAC)

Other

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 outcomes

  1. percentage of participants to complete all study procedures

    Time frame: 1 year

Study contacts

Contact information is provided by the study sponsor or research team.

Christian Nelson, PhD

CONTACT

646-888-0030

Kelly McConnell, PhD

CONTACT

[email protected]

646-888-0026

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Registry information

Official study title

Managing Anxiety From Cancer (MAC): Evaluation of a Tailored Anxiety Intervention for Latino Older Adults With Cancer and Their Caregivers

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Mar 12, 2024
Registry last updated
Mar 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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