Developing a Culturally Relevant Supportive Care Program for Black Patients Dealing With Advanced Cancer

January 30, 2024 updated by: M.D. Anderson Cancer Center
To determine the feasibility of implementing a culturally adapted mind-body intervention (Meditation-Based Support-Adapted; MBS-A) as a supportive care strategy in Black patients diagnosed with a stage III-IV solid malignancy. To target the specific needs of Black advanced cancer patients, we will first conduct formative research that includes quantitative surveys and in-depth interviews of patients and their primary caregivers. The purpose of this formative research is to determine the intervention format for the MBS-A program (family- vs group-based) that promises the greatest likelihood of success and to solicit input on the original MBS intervention regarding content that needs adaptation. Once the intervention format is determined and content adapted, we will conduct a pilot randomized controlled trial (RCT) to examine the feasibility of the MBS-A intervention vs. a dose-matched attention control (AC) group receiving a psychoeducation intervention.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Primary Objectives:

The purpose of this RCT is to thoroughly determine the feasibility of the overall RCT design as well as specific intervention procedures in this underserved population to inform if a large efficacy trial is warranted. Our results will lead to future NIH R01 applications in which efficacy and mechanisms of the interventions will be tested using fully powered samples of Black patients with advanced cancer including multicenter trials. The long-term goal is to establish the effectiveness of the MBS-A intervention and widely disseminate the intervention. Ultimately, the intervention is intended to improve cancer control and reduce the double disparity in this underserved patient population.

We propose the following specific aims:

  1. Systematically and culturally adapt a meditation-based support intervention (MBS-A) and finalize the intervention components and delivery format that meet the needs of Black patients with advanced cancer.
  2. Identify the feasibility of conducting a supportive-care RCT in Black patients with advanced cancer as determined by recruitment and retention rates, randomization and blinding procedures, and intervention delivery.
  3. Identify the feasibility of implementing the MBS-A and AC interventions as determined by session attendance, intervention acceptability, and treatment fidelity.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • M D Anderson Cancer Center
        • Contact:
        • Principal Investigator:
          • Dalnim Cho, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

For Aim 1, in order to be eligible to participate in this study, a patient must meet all of the following criteria:

  • Self-identifies as Black/African American
  • Is ≥18 years old
  • Was diagnosed with a stage III-IV solid tumor
  • Is able to provide informed consent

For Aims 2 and 3, in order to be eligible to participate in this study, a patient must meet all of the following criteria:

  • Self-identifies as Black/African American
  • Is ≥18 years old
  • Was diagnosed with a stage III-IV solid tumor
  • Is on active treatment (any line)
  • Has an ECOG performance status of ≤2
  • Has access to the internet
  • Is able to provide informed consent

For Aims 2 and 3, if a family-based intervention is selected as the program format, a patient must meet the additional following criterion:

• Has a family caregiver (e.g., spouse, adult child) with whom they currently reside

Also, if a family-based intervention is selected as the program format, a caregiver must meet all of the following criteria:

  • Is ≥18 years old
  • Has access to the internet
  • Is able to provide informed consent

Exclusion Criteria:

For Aim 1, there are no exclusion criteria.

For Aims 2 and 3, a patient who meets any of the following criteria will be excluded from participation in this study:

  • Is pregnant
  • Has cognitive deficits that would impede the completion of self-report instruments as deemed by the clinical team
  • Participated in in the Aim 1 of this study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Aim 1 (individual interview)
Participants will be interviewed
Behavioral: Individual Interview

Group 1, participant will be in a supportive care program with other Black cancer patients in which you will practice meditation.

Group 2, participate will be in a supportive care program with other Black cancer patients that focuses on coping with cancer.

Participants will be asked to participate weekly sessions for 4 weeks (that is a total of 4 sessions) and each session will last about 60 minutes. Both groups will be delivered via Zoom (a web-based videoconferencing service) and led by a master's-level interventionist.

Behavioral: Meditation Exercise

Group 1, participant will be in a supportive care program with other Black cancer patients in which you will practice meditation.

Group 2, participate will be in a supportive care program with other Black cancer patients that focuses on coping with cancer.

Participants will be asked to participate weekly sessions for 4 weeks (that is a total of 4 sessions) and each session will last about 60 minutes. Both groups will be delivered via Zoom (a web-based videoconferencing service) and led by a master's-level interventionist.
Experimental: Aim 2 (supportive care program)
Participants will be assigned to one of two groups
Behavioral: Individual Interview

Group 1, participant will be in a supportive care program with other Black cancer patients in which you will practice meditation.

Group 2, participate will be in a supportive care program with other Black cancer patients that focuses on coping with cancer.

Participants will be asked to participate weekly sessions for 4 weeks (that is a total of 4 sessions) and each session will last about 60 minutes. Both groups will be delivered via Zoom (a web-based videoconferencing service) and led by a master's-level interventionist.

Behavioral: Meditation Exercise

Group 1, participant will be in a supportive care program with other Black cancer patients in which you will practice meditation.

Group 2, participate will be in a supportive care program with other Black cancer patients that focuses on coping with cancer.

Participants will be asked to participate weekly sessions for 4 weeks (that is a total of 4 sessions) and each session will last about 60 minutes. Both groups will be delivered via Zoom (a web-based videoconferencing service) and led by a master's-level interventionist.
Experimental: Aim 3 (supportive care program)
Participants will be assessed regarding their program participation
Behavioral: Individual Interview

Group 1, participant will be in a supportive care program with other Black cancer patients in which you will practice meditation.

Group 2, participate will be in a supportive care program with other Black cancer patients that focuses on coping with cancer.

Participants will be asked to participate weekly sessions for 4 weeks (that is a total of 4 sessions) and each session will last about 60 minutes. Both groups will be delivered via Zoom (a web-based videoconferencing service) and led by a master's-level interventionist.

Behavioral: Meditation Exercise

Group 1, participant will be in a supportive care program with other Black cancer patients in which you will practice meditation.

Group 2, participate will be in a supportive care program with other Black cancer patients that focuses on coping with cancer.

Participants will be asked to participate weekly sessions for 4 weeks (that is a total of 4 sessions) and each session will last about 60 minutes. Both groups will be delivered via Zoom (a web-based videoconferencing service) and led by a master's-level interventionist.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MD Anderson Symptom Inventory-Score Scale
Time Frame: through study completion; an average of 1 year.

MD Anderson Symptom Inventory, which consists of 13 core items assessing symptom severity and 6 items assessing symptom interference with daily living.71,72 If the family-based format is selected, patients and caregivers will complete the form as it applies to their own symptoms as well as their perceptions of each other's symptoms.73

MD Anderson Symptom Inventory-Score Scale "at its worst" using 0-10 numerical rating scales with 0 = "not present" and 10 = "as bad as you can imagine."
through study completion; an average of 1 year.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

M.D. Anderson Cancer Center

Collaborators

National Center for Complementary and Integrative Health (NCCIH)

Investigators

  • Principal Investigator: Dalnim Cho, PhD, M.D. Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 13, 2023

Primary Completion (Estimated)

March 31, 2027

Study Completion (Estimated)

March 31, 2029

Study Registration Dates

First Submitted

February 28, 2023

First Submitted That Met QC Criteria

February 28, 2023

First Posted (Actual)

March 10, 2023

Study Record Updates

Last Update Posted (Estimated)

February 1, 2024

Last Update Submitted That Met QC Criteria

January 30, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • 2022-1015
  • NCI-2023-01995 (Other Identifier: NCI-CTRP Clinical Trials Registry)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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