Clinical trial NCT04435444: Meaning-Centered Intervention for Muslim Patients Who Are Being Treated for Advanced Cancer
Official title: Pilot of a Meaning-Centered Intervention for Muslims Undergoing Treatment for Stage III or IV Cancer
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Advanced Cancer
Keywords: Meaning-Centered Intervention
Masterful intervention
20-018
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: UConn Health
First posted: 2020-06-17
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 2-group randomized controlled trial (RCT). Using a consecutive patient sampling scheme, we will randomize Muslim patients with stage III or IV cancer.
Primary purpose: SUPPORTIVE_CARE

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: number of enrolled participants completing at least one psychotherapy session out of the planned three.
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Francesca Gany, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: