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

Advanced Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04435444
• Other study ID #: 20-018
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 15, 2020
• Est. completion date: June 2024

Study information

• Verified date: August 2023
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 19
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Advanced Cancer
• Neoplasms

Intervention

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)
• 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)

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Cancer Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center	UConn Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of enrolled participants completing at least one psychotherapy session out of the planned three.		1 year

External Links

•   Memorial Sloan Kettering Cancer Center