Advanced Cancer
Conditions
Keywords
Meaning-Centered Intervention, Masterful intervention, 20-018
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.
Interventions
OTHERMasterful 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)
OTHERAttention 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)
Sponsors
Memorial Sloan Kettering Cancer Center
UConn Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| number of enrolled participants completing at least one psychotherapy session out of the planned three. | 1 year |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORFrancesca Gany, MD, PhD
Memorial Sloan Kettering Cancer Center
Outcome results
None listed