Advanced CancerNCT04435444
Meaning-Centered Intervention for Muslim Patients Who Are Being Treated for Advanced Cancer
A study testing Masterful supportive care in people with Advanced Cancer, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Cancer
- What is being tested?
- Masterful supportive care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jun 2020to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
About this study
Official title: 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.
- Conditions
- Advanced Cancer
- Being tested
- Masterful supportive care, Attention control supportive care
- Keywords
- Meaning-Centered Intervention, Masterful intervention, 20-018
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Masterful supportive careOther
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 careOther
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)
| Study group | Role | What they receive |
|---|---|---|
| Masterful supportive care | Experimental | 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. Receives: Other: Masterful supportive care |
| Attention control supportive care | Active comparator | 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. Receives: Other: Attention control supportive care |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of enrolled participants completing at least one psychotherapy session out of the planned three.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2020
- Study start15 Jun 2020
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced CancerStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- UConn Health
- Responsible party
- Sponsor
- Investigators
- Francesca Gany, MD, PhD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04435444
- Sponsor's protocol ID
- 20-018
- Status last verified
- Jul 2026
- First submitted
- 15 Jun 2020
- Last updated
- 6 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot of a Meaning-Centered Intervention for Muslims Undergoing Treatment for Stage III or IV Cancer
- ClinicalTrials.gov ID
- NCT04435444
- Acronym / sponsor ID
- 20-018
- Conditions
- Advanced Cancer
- Keywords
- Meaning-Centered Intervention, Masterful intervention, 20-018
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- UConn Health
- Study start
- 15 Jun 2020 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 17 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Masterful supportive care | Experimental | Other: Masterful supportive careThis 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. |
| Attention control supportive care | Active comparator | Other: Attention control supportive careThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- ≥ 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)
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Masterful supportive careThree 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) | Other | Masterful supportive care |
| Attention control supportive careThree 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) | Other | Attention control supportive care |
Primary outcome
number of enrolled participants completing at least one psychotherapy session out of the planned three.
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Francesca Gany, MD, PhD principal investigator
Memorial Sloan Kettering Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Masterful supportive care in people with Advanced Cancer, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of enrolled participants completing at least one psychotherapy session out of the planned three. (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2026.