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

19 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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.

What data supports the effectiveness of the treatment Attention control supportive care, Masterful supportive care for advanced cancer?

Supportive care, which includes managing physical and psychological symptoms, has been shown to improve the quality of life and reduce the side effects of cancer treatment. Enhanced supportive care has also been found to positively impact patient and caregiver experiences in cancer care. ^{1 2 3 4 5}

Is Meaning-Centered Supportive Care for Advanced Cancer safe for humans?

Supportive care in cancer, which includes managing physical and psychological symptoms, is generally considered safe and aims to improve quality of life. Studies show that comprehensive supportive care can minimize side effects and improve outcomes in cancer patients. ^{1 5 6 7 8}

How is Meaning-Centered Supportive Care for Advanced Cancer different from other treatments?

Meaning-Centered Supportive Care is unique because it focuses on improving the quality of life for cancer patients by addressing both physical and psychological symptoms throughout their cancer journey. Unlike standard treatments that primarily target the cancer itself, this approach aims to enhance overall well-being and support patients in finding meaning and purpose during their illness. ^{1 2 9 10 11}

Research Team

Francesca Gany, MD, MPH

Principal Investigator

Memorial Sloan Kettering Cancer Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Supportive Care: The "Keystone" of Modern Oncology Practice. [2023]

2. England pubmed.ncbi.nlm.nih.gov

'Best supportive care' has had its day. [2014]

3. Germany pubmed.ncbi.nlm.nih.gov

The quality of supportive care among inpatients dying with advanced cancer. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Enhanced supportive care: prospective cohort study of oncology patients and caregivers. [2023]

5. United States 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. [2017]

6. France pubmed.ncbi.nlm.nih.gov

[Supportive care in oncology: definition, organization, limits]. [2019]

7. Germany pubmed.ncbi.nlm.nih.gov

Filling in the gaps: reporting of concurrent supportive care therapies in breast cancer chemotherapy trials. [2021]

8. Canada pubmed.ncbi.nlm.nih.gov

Unmet Supportive Cancer Care Needs: An Exploratory Quantitative Study in Rural Australia. [2020]

9. Germany pubmed.ncbi.nlm.nih.gov

Concepts and definitions for "supportive care," "best supportive care," "palliative care," and "hospice care" in the published literature, dictionaries, and textbooks. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Summary of presentations from the 46th annual meeting of the American Society of Clinical Oncology (2010): focus on supportive care issues related to lung cancer. [2018]

11. France pubmed.ncbi.nlm.nih.gov

[Supportive care for urological metastatic patients]. [2008]