Feasibility, Acceptability and Preliminary Effects of the Spiritual Care Assessment and Intervention

Indiana University

Status

Completed

Conditions

Metastatic Cancer

Advanced Cancer

Treatments

Behavioral: SCAI (Spiritual Care Assessment and Intervention)

Study type

Interventional

Funder types

Other

Identifiers

NCT03823313

IUSCC-0665

Details and patient eligibility

About

The purpose of this study is to test a spiritual care intervention for adults with advanced cancer and their caregivers. This intervention will assess 4 areas of spiritual experience: meaning and purpose, relationships, transcendence and peace, self-worth and identity. Participants will be asked to complete questionnaires and participate in 4 sessions with research chaplains.

Full description

Several studies have shown that cancer affects multiple dimensions of a patient's life as well as the lives of caregivers and others close to the patient who, when faced with life crises, may use religion and spirituality (R/S) to cope. This study is the first of its kind to incorporate a semi-structured spiritual care and intervention (SCAI) framework into the spiritual care of advanced cancer patients while maintaining proper controls in order to investigate its feasibility, acceptability and potential effects on the emotional and spiritual outcomes of advanced cancer patients and their caregivers. This framework will assess 4 areas of spiritual experience: meaning and purpose, relationships, transcendence and peace, self-worth and identity. Additionally, not only will this study assess acceptability and feasibility of the intervention, it will also track and document coping, satisfaction, anxiety, depression, quality of life outcomes and follow-up with both patient and caregivers following Spiritual Care Assessment and Intervention (SCAI).

Specific Aim 1: To evaluate the feasibility and acceptability of the SCAI intervention for adults with advanced cancer and their caregivers.

Specific Aim 2: 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.

Specific Aim 3: To test the preliminary impact of the SCAI intervention on patient and caregiver spiritual wellbeing (primary outcome) and quality of life, religious coping, depression, and anxiety (secondary outcomes)

Enrollment

42 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Patient is at least 18 years of age.
Patient is at least 2 weeks post-diagnosis of an incurable and advanced stage (IV) lung, colorectal, GI neuroendocrine and Hepatobiliary, testicular and esophageal solid malignancy and receiving cancer care at IU Simon Cancer Center.
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 has a family member or eligible friend considered to be a caregiver and interested in participating in the study.
Patient has adequate English fluency for completion of data collection.
Family Caregiver (FCG) is at least 18 years of age.
Family Caregiver (FCG) has been invited to participate in the trial with a patient who meets eligibility criteria above.
Family Caregiver (FCG) is willing and able to consent and to participate in 4 sessions of 30 (+/- 5) minutes per session
Family Caregiver (FCG) has adequate English fluency for completion of data collection.

Exclusion criteria

Patient makes 3 or more errors on a validated 6-item cognitive screener (Appendix A) 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.
Currently receiving hospice care (patients who enroll in hospice during the trial will have the option of continuing trial participation).
Family Caregiver (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.