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

Trial Summary

What is the purpose of this trial?

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 patients with advanced cancer recruited from outpatient settings to determine the feasibility of conducting a larger trial of effects of early integration of spiritual care into outpatient oncology care on patient outcomes.

Will I have to stop taking my current medications?

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

What data supports the effectiveness of the treatment Spiritual Care Intervention #1 and Spiritual Care Intervention #2 for cancer patients?

Research shows that spiritual interventions can improve hope and spiritual well-being in cancer patients, and addressing spiritual needs is recommended by major oncology organizations. Studies also suggest that spiritual care can enhance psychological and spiritual outcomes, such as reducing anxiety and depression. ^{1 2 3 4 5}

How does the Spiritual Care Intervention treatment for cancer differ from other treatments?

Spiritual Care Interventions for cancer focus on enhancing hope and spiritual well-being, which is different from traditional treatments that primarily target physical symptoms. These interventions often involve structured reflection on life events and goals, aiming to improve the overall quality of life for cancer patients. ^{1 2 6 7 8}

Research Team

Paul K Maciejewski, Ph.D.

Principal Investigator

Weill Medical College of Cornell University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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 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 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]

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]

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]

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]

References

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

The effects of spiritual interventions in patients with cancer: a meta-analysis. [2014]

2. Colombia 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. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Interprofessional spiritual care in oncology: a literature review. [2021]

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

Screening for spiritual distress in the oncology inpatient: a quality improvement pilot project between nurses and chaplains. [2012]

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

Spiritual Interventions Delivered by Nurses to Address Patients' Needs in Hospitals or Long-Term Care Facilities: A Systematic Review. [2023]

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

Meaning-Centered Interventions for Patients With Advanced or Terminal Cancer: A Meta-analysis. [2020]

7. England 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. [2021]

8. Egypt pubmed.ncbi.nlm.nih.gov

Translation and Validation of the Spiritual Care Intervention-Provision Scale in the Greek Language. [2022]