Meaning-Centered Supportive Care for Advanced Cancer

Overseen By Francesca Gany, MD, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Memorial Sloan Kettering Cancer Center

Disqualifiers: Major psychiatric illness, Brain tumors, HSCT, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: Up to 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores two types of supportive care for Muslim patients with advanced cancer. One group will use the American Cancer Society's patient education materials, while the other will participate in a program focusing on personal meaning and experiences related to cancer, known as "Masterful supportive care." The trial aims to determine which approach better aids patients in coping with their condition. It may suit Muslim individuals who understand English or Arabic, are managing stage III or IV cancer, and are not undergoing psychotherapy. As an unphased trial, it offers a unique opportunity to explore personalized supportive care options tailored to cultural and linguistic needs.

Will I have to stop taking my current medications?

The trial does not require you to stop taking your current medications. In fact, you can continue using antidepressants, anxiolytics, and other psychotropic medications as long as you are not currently in psychotherapy.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that supportive care treatments, like those in this study, are generally safe for people with advanced cancer. No specific reports of negative effects have emerged from these supportive care methods, which include discussions, exercises, and education about managing cancer.

Previous patients found that meeting one-on-one with a trained professional to discuss their experiences and challenges was well-tolerated. This approach proved practical and manageable for participants in earlier studies.

Supportive care focuses on providing emotional and mental support, rather than using medicines or physical treatments. As a result, the risk of side effects is usually lower compared to treatments involving drugs. Overall, participants can feel reassured about the safety of these interventions. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Meaning-Centered Supportive Care for advanced cancer because it takes a unique approach by focusing on personal meaning and identity in the cancer journey, which is different from traditional treatments that typically focus on symptom management and medical interventions. The "Masterful supportive care" arm is distinctive because it involves discussions and exercises about personal experiences and what is meaningful in life, offering a personalized touch that goes beyond standard educational materials. Meanwhile, the "Attention control supportive care" arm utilizes patient education resources from the American Cancer Society, but enhances them with personalized problem-solving sessions. Both treatments are delivered flexibly in English or Arabic, and participants can choose in-person or teleconference sessions, making it adaptable and accessible.

What evidence suggests that this trial's treatments could be effective for advanced cancer?

Research shows that supportive care can greatly benefit people with advanced cancer. Studies have found that early and focused supportive care can enhance quality of life and reduce pain. In this trial, participants may receive the Masterful supportive care program, which aims to help patients find meaning and hope during difficult times by focusing on personal experiences and discussions about life and identity. This approach could improve well-being by addressing emotional needs. Although specific data for the Masterful program is not yet available, similar supportive care methods have proven effective in other studies. ^{3 4 6 7 8}

Who Is on the Research Team?

Francesca Gany, MD, MPH

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

This trial is for adult Muslim patients with stage III or IV cancer who are currently in treatment. They must have a life expectancy of at least 6 months, be cognitively intact, and able to speak and read English or Arabic. Excluded are those with major psychiatric illnesses, primary brain tumors, undergoing stem cell transplantation, or currently in psychotherapy.

Inclusion Criteria

I speak English very well and prefer it for my healthcare.

I am currently being treated or monitored for stage III or IV cancer.

My thinking and memory skills are considered normal by my doctor.

Exclusion Criteria

I am not currently in psychotherapy but may be taking medication for anxiety or depression.

Major psychiatric illness or cognitive impairment that in the judgment of the study investigators or study staff would preclude study participation

I have been diagnosed with a primary brain tumor.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either the Masterful supportive care intervention or the non-faith-based active control supportive care intervention over 3 sessions

Up to 12 weeks

3 sessions (in-person or via teleconference)

Follow-up

Participants complete follow-up surveys to assess the effectiveness of the intervention

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Attention control supportive care
• Masterful supportive care

Trial Overview

The study compares Masterful supportive care tailored for Muslims against non-faith-based control care using American Cancer Society materials. Participants will undergo three sessions which can be spread out over one week or up to 12 weeks based on their preference.

How Is the Trial Designed?

Group I: Masterful supportive care Experimental Treatment 1 Intervention

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.

Group II: Attention control supportive care Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

UConn Health

Collaborator

Trials

218

Recruited

59,100+

Published Research Related to This Trial

Supportive care in cancer, as defined by the MASCC, plays a crucial role in managing the physical and psychological effects of cancer and its treatments, aiming to enhance quality of life throughout the entire cancer journey.

Evidence suggests that supportive care not only improves patient morbidity and quality of life but also has potential health economic benefits, highlighting its importance in cancer treatment and survivorship.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Supportive Care: The "Keystone" of Modern Oncology Practice. Scotté, F., Taylor, A., Davies, A.[2023]

Supportive cancer care encompasses comprehensive assistance for patients, including pain management, psychological support, and access to therapies, which is crucial for improving quality of life during treatment.

In France, the establishment of supportive care centers in hospitals aims to enhance coordination among multidisciplinary teams, particularly benefiting patients with bone metastasis through tailored interventions like bisphosphonates and physiotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Supportive care for urological metastatic patients]. Lebret, T., Di Palma, M., Ripoll, J., et al.[2008]

In a study of 125 breast cancer patients receiving high-dose chemotherapy, a comprehensive supportive care approach resulted in a low treatment-related mortality rate of less than 1%, indicating that this strategy can enhance safety during aggressive treatment.

Despite significant nonhematologic toxicities such as diarrhea (66%) and stomatitis (33%), infectious complications were rare, suggesting that with proper supportive care, high-dose chemotherapy can be administered with manageable risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Minimal toxicity and mortality in high-risk breast cancer patients receiving high-dose cyclophosphamide, thiotepa, and carboplatin plus autologous marrow/stem-cell transplantation and comprehensive supportive care. Holland, HK., Dix, SP., Geller, RB., et al.[2017]

A systematic review of 62 phase III breast cancer chemotherapy trials revealed that 66% did not report details on prophylactic antiemetic treatments, indicating a significant gap in supportive care documentation.

The lack of reporting on supportive care interventions, such as growth factors and antibiotics, could negatively affect patient management and increase healthcare costs, highlighting the need for better guidelines in clinical trial reporting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Filling in the gaps: reporting of concurrent supportive care therapies in breast cancer chemotherapy trials. Freedman, O., Amir, E., Zimmermann, C., et al.[2021]

Citations

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The Multinational Association of Supportive Care in Cancer and ASCO have developed standards and practice recommendations relevant to best-practice ...

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Enhanced supportive care for advanced cancer patients

This study protocol aims to evaluate the effect of “Enhanced Supportive Care”, an early primary palliative care provided by nurses.

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New Study Uncovers Low Uptake of Supportive Care at ...

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pmc.ncbi.nlm.nih.gov

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Evaluating the Implementation of Integrated Proactive ...

The objective of this master protocol is to evaluate the implementation of different integrated proactive SC pathways across the cancer care continuum.

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New ACS Research Finds Low Uptake of Supportive Care ...

Study results showed only one-quarter of patients diagnosed with advanced cancer ... Care for Patients With Advanced Cancers, New Data Suggests.