Meaning-Centered Intervention for Muslim Patients Who Are Being Treated for Advanced Cancer

July 2, 2025 updated by: Memorial Sloan Kettering Cancer Center

Pilot of a Meaning-Centered Intervention for Muslims Undergoing Treatment for Stage III or IV Cancer

This study will compare the effectiveness of the Masterful supportive care intervention with that of the non-faith-based active control supportive care intervention, which uses the American Cancer Society's patient education materials, for Muslim patients who have advanced cancers.

All 3 sessions may occur within one week or over multiple weeks (nonconsecutively), depending on the participants preference. The participant will have up to 12 weeks from recruitment to complete all sessions and follow up surveys.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
19

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Locations

  • United States
    • New York
      • New York, New York, United States, 10065
        • Memorial Sloan Kettering Cancer Center

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • ≥ 18 years of age
  • identify, either as self-report or on the MSKCC EMR, as Muslim
  • are in treatment including surveillance, for a confirmed diagnosis of stage III or IV cancer (solid or liquid) as per clinician or pathology report
  • have an estimated life expectancy of at least 6 months, as determined by their primary oncologist
  • are cognitively intact (oncologist's clinical impression or judgement of study staff)
  • able to speak and read English or Arabic (self-reported preference or on the MSKCC EMR system).
  • To assess English proficiency, participants will be asked two questions: (1) the Census limited English proficient item "How well do you speak English?" with response options "Not at all, Not well, Well, or Very well" and (2) "What is your preferred language for healthcare?"
  • Participants who are eligible for the study and are fluent in English will be identified by the response "Very well" to the 1st question and a response indicating English as the preferred language for healthcare.

Exclusion Criteria:

  • Major psychiatric illness or cognitive impairment that in the judgment of the study investigators or study staff would preclude study participation
  • patients diagnosed with primary brain tumors as per clinician report, as they may have difficulty completing the intervention and answering the questionnaires
  • undergoing hematopoietic stem cell transplantation (HSCT) as per clinican report or the EMR
  • currently in psychotherapeutic treatment. Symptoms of anxiety and depression are common among patients with stage III or IV cancer. Antidepressants, anxiolytics, and other psychotropic medications do not diminish the effects of psychotherapy; thus we will not exclude patients who are being treated with these medications, as long as they are not in psychotherapy.

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: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Masterful supportive care
This intervention uses teachings, discussions, and exercises about personal experiences that focus on specific topics related to meaning and cancer. For example, we may discuss what is meaningful in your life, how you identify yourself before and after cancer, and your hopes for the future. The Masterful intervention is available in both English and Arabic, and it will be delivered by a trained bilingual member of the study team. It includes 3 weekly (or at participant's preference) 1-hour sessions with a member of the study team. The sessions for either the treatment or the control arm will take place in-person in a private room at MSKCC or via teleconference, depending on the patients preference. Meeting one-on-one with an interventionist was feasible in our pilot study and will enhance relationship-building between interventionist and patient. Participants will have the option to meet with the interventionist via teleconference in order to reduce in-person contact burden.
Other: Masterful supportive care

Three study questionnaires:

Functional Assessment of Cancer Therapy-General* (FACT-G), Functional Assessment of Chronic Illness Therapy- Spiritual Well-Being* (FACIT-Sp) Memorial Symptom Assessment Scale Short Form* (MSAS-SF)
Active Comparator: Attention control supportive care
This intervention uses the American Cancer Society's patient education materials. These sessions will include discussions about managing a self-identified current problem in your life. The attention control supportive care intervention is available in both English and Arabic, and it will be delivered by a trained bilingual member of the study team. It includes 3 weekly (or at participant's preference) 1-hour sessions with a member of the study team. The sessions for either the treatment or the control arm will take place in-person in a private room at MSKCC or via teleconference, depending on the patients preference. Meeting one-on-one with an interventionist was feasible in our pilot study and will enhance relationship-building between interventionist and patient. Participants will have the option to meet with the interventionist via teleconference in order to reduce in-person contact burden.
Other: Attention control supportive care

Three study questionnaires:

Functional Assessment of Cancer Therapy-General* (FACT-G), Functional Assessment of Chronic Illness Therapy- Spiritual Well-Being* (FACIT-Sp) Memorial Symptom Assessment Scale Short Form* (MSAS-SF)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
number of enrolled participants completing at least one psychotherapy session out of the planned three.
Time Frame: 1 year
1 year

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Memorial Sloan Kettering Cancer Center

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
UConn Health

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Francesca Gany, MD, PhD, Memorial Sloan Kettering 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 15, 2020

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 15, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 16, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 17, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 3, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 2, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 20-018

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

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.

Clinical Trials on Advanced Cancer

Clinical Trials on Masterful supportive care

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings