Spiritual Care Assessment and Intervention Framework in Supporting Patients with Advanced Cancer and Their Caregivers

Status: Active

Description

This trial studies how well a religious and spiritual tool called spiritual care assessment and intervention (SCAI) framework works in supporting the emotional and spiritual well being of patients with cancer that has spread to other places in the body and their caregivers. SCAI framework is an approach to spiritual care delivered by skilled chaplains, that covers the spiritual dimensions of meaning and purpose, relationships, peace, and self-worth and identity. Participating in the SCAI framework may enable doctors to examine a participant’s spiritual strengths and distress and find out the most effective spiritual care intervention for that participant.

Eligibility Criteria

Inclusion Criteria

  • PATIENT: Patient is at least 2 weeks post-diagnosis of an incurable and advanced stage (IV) lung, colorectal, gastrointestinal (GI) neuroendocrine and hepatobiliary, testicular and esophageal solid malignancy and receiving cancer care at Indiana University (IU) Simon Cancer Center.
  • PATIENT: Patient is willing and able to consent, has a reliable phone and willing to participate in 4 sessions of 30 (+/- 5) minutes per session.
  • PATIENT: Patient has a family member or eligible friend considered to be a caregiver and interested in participating in the study.
  • PATIENT: Patient has adequate English fluency for completion of data collection (surveys utilized in this study are in English and interventionists therefore will only utilize the English language for this study.
  • FAMILY CAREGIVERS: Family caregivers (FCG) has been invited to participate in the trial with a patient who meets eligibility criteria above.
  • FAMILY CAREGIVERS: FCG is willing and able to consent and to participate in 4 sessions of 30 (+/- 5) minutes per session.
  • FAMILY CAREGIVERS: FCG has adequate English fluency for completion of data collection (surveys utilized this study are in English and interventionists therefore will only utilize the English language for this study).

Exclusion Criteria

  • PATIENT: Patient makes 3 or more errors on a validated 6-item cognitive screener or exhibits significant psychiatric or cognitive impairment (e.g., dementia/delirium, retardation, active psychosis) that in the judgment of the investigators would preclude providing informed consent and study participation.
  • PATIENT: Currently receiving hospice care (patients who enroll in hospice during the trial will have the option of continuing trial participation).
  • FAMILY CAREGIVERS: FCG exhibits significant psychiatric or cognitive impairment (e.g., dementia/delirium, retardation, active psychosis) that in the judgment of the investigators would preclude providing informed consent and study participation.

Locations & Contacts

Indiana

Indianapolis
Indiana University / Melvin and Bren Simon Cancer Center
Status: Active
Contact: Saneta M. Maiko
Phone: 317-962-3875
Email: smaiko@iuhealth.org

Trial Objectives and Outline

PRIMARY OBJECTIVES:

I. To evaluate the feasibility and acceptability of the SCAI intervention for adults with advanced cancer and their caregivers.

II. To establish our ability to collect outcome data to support a future efficacy trial for patients and their caregivers in the outpatient clinic and home setting.

III. To test the preliminary impact of the SCAI intervention on patient and caregiver spiritual wellbeing (primary outcome) and quality of life, religious coping, hope, depression, and anxiety (secondary outcomes).

OUTLINE:

Participants attend 4 weekly SCAI sessions with a chaplain over 30 minutes each. Each session focuses on one dimension (meaning and purpose, relationships, peace, and self-worth and identity) only.

After completion of study, participants are followed up within 7-14 days, 6-8 weeks, and 12-14 weeks.

Trial Phase & Type

Trial Phase

Phase I

Trial Type

Supportive care

Lead Organization

Lead Organization
Indiana University / Melvin and Bren Simon Cancer Center

Principal Investigator
Saneta M. Maiko

Trial IDs

Primary ID IUSCC-0665
Secondary IDs NCI-2019-02813
Clinicaltrials.gov ID NCT03823313