Clinical trial NCT05763797: Developing a Culturally Relevant Supportive Care Program for Black Patients Dealing With Advanced Cancer
Official title: Developing a Culturally Relevant Supportive Care Program for Black Patients Dealing With Advanced Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cancer
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2023-03-10
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: MD Anderson Symptom Inventory-Score Scale
timeFrame: through study completion; an average of 1 year.
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Dalnim Cho, PhD
role: PRINCIPAL_INVESTIGATOR
References: