Spiritual Care for Cancer

Recruiting at 1 trial location

Overseen By Madison K Pavao, B.S.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Weill Medical College of Cornell University

Disqualifiers: Recent spiritual care, DNR order, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

64 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how spiritual care interventions can support black patients with advanced cancer in their spiritual well-being and readiness to plan for future care. Researchers aim to determine if integrating spiritual care early in outpatient oncology settings can improve patient outcomes. Two different spiritual care approaches are being tested: Spiritual Care Intervention #1 and Spiritual Care Intervention #2. Individuals who identify as black or African American, have advanced cancer, and are fluent in English might be a good fit. As an unphased trial, this study offers participants a unique opportunity to contribute to innovative approaches in spiritual care that could enhance future cancer care for their community.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

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

Research has shown that spiritual care plays a crucial role in cancer treatment, improving quality of life and alleviating symptoms. Studies have found it to be highly beneficial for patients with serious illnesses like cancer, with no reports of negative effects from these interventions.

For Spiritual Care Intervention #1, evidence suggests it enhances quality of life and helps patients achieve a sense of peace. This approach is generally well-received and considered a positive addition to cancer care.

For Spiritual Care Intervention #2, research also indicates positive outcomes. Patients and their families have observed improvements in well-being and emotional support. Like the first intervention, it is safe and well-tolerated.

Overall, both interventions appear safe and can enhance the care experience for cancer patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Spiritual Care Interventions because they explore how spiritual support can enhance well-being for cancer patients, a focus not typically prioritized in standard cancer treatments like chemotherapy, radiation, or surgery. Unlike conventional methods that target the physical aspects of cancer, these interventions aim to address the emotional and spiritual needs of patients, potentially improving their overall quality of life. By investigating the impact of spiritual care, researchers hope to uncover new ways to support patients' mental health and resilience during their cancer journey.

What evidence suggests that this trial's spiritual care interventions could be effective for cancer patients?

Research has shown that spiritual care can significantly improve the well-being of cancer patients. Studies have found that spiritual group therapy enhances spiritual health, providing patients with a sense of peace and faith. This type of care also helps cancer patients feel calmer and more prepared to continue their treatment. A review of multiple studies found that spiritual support improves spiritual well-being, gives life more meaning, and enhances overall quality of life for cancer patients. Spirituality is also linked to better symptom management, highlighting its important role in cancer care. In this trial, participants will receive either Spiritual Care Intervention #1 or Spiritual Care Intervention #2, both designed to provide these benefits and improve the overall experience and outlook of patients with advanced cancer. ^{2 6 7 8 9}

Who Is on the Research Team?

Paul K Maciejewski, Ph.D.

Principal Investigator

Weill Medical College of Cornell University

Are You a Good Fit for This Trial?

This trial is for black or African American patients with advanced, life-limiting cancer who speak English. It's not for those who've had spiritual care from a medical system in the last 2 months, completed a DNR order, or are too weak or cognitively impaired to participate.

Inclusion Criteria

Is fluent in English

Identifies racially as black or African American

My cancer is advanced and considered life-limiting.

Exclusion Criteria

I am too weak or have cognitive issues to participate in study activities.

Have received medical system-based spiritual care within the past 2 months

Have already completed a DNR order

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive spiritual care interventions to assess effects on spiritual well-being and readiness to engage in advance care planning

8 weeks

Follow-up

Participants are monitored for spiritual well-being and readiness to engage in advance care planning after the intervention

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Spiritual Care Intervention #1
• Spiritual Care Intervention #2

Trial Overview The study tests two different spiritual care interventions on patients' spiritual well-being and their readiness for advance care planning. The goal is to see if it's possible to do a larger trial on how early spiritual care affects patient outcomes in outpatient oncology.

How Is the Trial Designed?

Group I: Spiritual Care Intervention #1 Experimental Treatment 1 Intervention

This is the experimental condition arm. Intervention details are being withheld until the trial concludes to protect the scientific integrity of the study.

Group II: Spiritual Care Intervention #2 Active Control 1 Intervention

This is the active comparator condition arm. Intervention details are being withheld until the trial concludes to protect the scientific integrity of the study.

Who Is Running the Clinical Trial?

Weill Medical College of Cornell University

Lead Sponsor

Trials

1,103

Recruited

1,157,000+

New York Presbyterian Brooklyn Methodist Hospital

Collaborator

Trials

21

Recruited

3,900+

The University of Texas Medical Branch, Galveston

Collaborator

Trials

263

Recruited

55,400+

National Institute on Minority Health and Health Disparities (NIMHD)

Collaborator

Trials

473

Recruited

1,374,000+

Published Research Related to This Trial

A meta-analysis of 10 controlled trials involving 623 cancer patients showed that meaning-centered interventions (MCI) significantly improve various aspects of well-being, including meaning in life, spiritual well-being, and quality of life.

MCI also reduced anxiety and physical symptoms in patients, suggesting that spiritual care can be an effective component of hospice and palliative care for those with advanced or terminal cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Meaning-Centered Interventions for Patients With Advanced or Terminal Cancer: A Meta-analysis. Kang, KA., Han, SJ., Lim, YS., et al.[2020]

A systematic review of 16 studies found that spiritual interventions delivered by nurses in palliative care can improve patient outcomes, including spiritual well-being, anxiety, and depression.

The types of spiritual interventions varied widely, including existential, religious, and mixed approaches, but the lack of standardized methods made it difficult to compare their effectiveness across different settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spiritual Interventions Delivered by Nurses to Address Patients' Needs in Hospitals or Long-Term Care Facilities: A Systematic Review. Dos Santos, FC., Macieira, TGR., Yao, Y., et al.[2023]

This study will be the first randomized controlled trial to assess the impact of structured spiritual care on the quality of life of cancer patients, specifically those with advanced cancer who are not receiving curative treatment.

Patients in the intervention group will engage in two consultations with a spiritual counsellor using a specially designed e-application to reflect on life events and goals, with outcomes measured at baseline, one month, and three months post-intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The life in sight application study (LISA): design of a randomized controlled trial to assess the role of an assisted structured reflection on life events and ultimate life goals to improve quality of life of cancer patients. Kruizinga, R., Scherer-Rath, M., Schilderman, JB., et al.[2021]

Spiritual care is crucial for patients with serious illnesses like cancer, as addressing spiritual distress can lead to better health outcomes and improved quality of life.

The paper reviews existing literature and suggests that interprofessional collaboration is necessary to effectively meet the spiritual needs of patients in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interprofessional spiritual care in oncology: a literature review. Puchalski, CM., Sbrana, A., Ferrell, B., et al.[2021]

A study involving 74 cancer patients showed that a spiritual intervention significantly increased hope and spiritual well-being after 5 sessions, compared to a control group that received usual care.

Post-intervention scores revealed a notable difference, with the intervention group scoring 60.9 in hope and 94.3 in spiritual well-being, while the control group scored 39.8 and 71.6, respectively, indicating the effectiveness of spiritual support in enhancing emotional health during cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized Controlled Trial Study of the Impact of a Spiritual Intervention on Hope and Spiritual Well-Being of Persons with Cancer. Afrasiabifar, A., Mosavi, A., Jahromi, AT., et al.[2022]

A quality improvement initiative trained oncology nurses to use a two-question screening tool, leading to the identification of 28% of patients at risk for spiritual distress, which is often overlooked.

Implementing this brief spiritual screening protocol can enhance nurse referrals to chaplains, potentially improving patient trust, satisfaction, and health outcomes by addressing spiritual needs more effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Screening for spiritual distress in the oncology inpatient: a quality improvement pilot project between nurses and chaplains. Blanchard, JH., Dunlap, DA., Fitchett, G.[2012]

A meta-analysis of 15 studies involving 889 cancer patients found that spiritual interventions significantly improved spiritual well-being, meaning of life, and reduced anxiety and depression, indicating their potential benefit in cancer care.

Despite these positive effects, the evidence is considered weak due to mixed study designs and high variability among the studies, suggesting that further research is needed to solidify these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of spiritual interventions in patients with cancer: a meta-analysis. Oh, PJ., Kim, SH.[2014]

A new Greek version of the Spiritual Care Intervention-Provision (SCIP) scale was successfully developed and validated, allowing for the assessment of spiritual care provided by nurses in Greece.

The scale demonstrated high reliability with an internal consistency of 0.887 and excellent test-retest reliability (r = 0.997), making it a robust tool for evaluating spiritual care in Greek healthcare settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Translation and Validation of the Spiritual Care Intervention-Provision Scale in the Greek Language. Fradelos, EC., Papathanasiou, IV., Tzavella, F.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12317903/

Interventions to support spirituality among adults with cancer Spiritual group therapy interventions were found to increase spiritual health and spiritual well-being (meaning, peace, and faith) [30, 37], and ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1462388924001443

Impact of spiritual interventions in individuals with cancer This meta-analysis aimed to determine how spiritual interventions affect cancer patients' physical, emotional, and spiritual outcomes and quality of life.

3. esmoopen.com esmoopen.com/article/S2059-7029(20)30190-3/fulltext

Interprofessional spiritual care in oncology: a literature review Based on the aforementioned data, it is clear that spirituality plays a fundamental role in care of patients with cancer and may offer a positive impact on ...

4. medrxiv.org medrxiv.org/content/10.1101/2023.10.31.23297645v1

THE EFFECTIVENESS OF SPIRITUAL SUPPORT FOR ... Spiritual support has a positive impact on a cancer patient is quality of life by giving them a sense of calm and desire to keep going through the treatment.

5. clinicaltrials.gov clinicaltrials.gov/study/NCT06811376

Pilot Trial of Spiritual Care Interventions for Patients With ... This is a pilot trial of the effects of spiritual care interventions on spiritual well-being and readiness to engage in advance care planning (ACP) among black ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6435249/

Interprofessional spiritual care in oncology: a literature review Spiritual care is recognised as an essential element of the care of patients with serious illness such as cancer. Spiritual distress can result in poorer health ...

7. cureus.com cureus.com/articles/384028-the-role-of-a-spiritual-approach-in-patients-with-cancer-a-systematic-review

The Role of a Spiritual Approach in Patients With Cancer All studies reported statistically significant improvements in at least one outcome related to quality of life (QoL), symptom control (e.g., ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3791610/

Provision of Spiritual Support to Patients With Advanced ... Data suggest that provision of spiritual care by medical teams to terminally ill patients is associated with better patient quality of life (QoL), greater ...

9. jamanetwork.com jamanetwork.com/journals/jamainternalmedicine/fullarticle/1685898

Provision of Spiritual Support to Patients With Advanced ... Data suggest that provision of spiritual care by medical teams to terminally ill patients is associated with better patient quality of life (QoL) ...