Clinical trial NCT05198089: Development of a Digital Tool, MyInspiration, for the Improvement of Spiritual Well-Being in Patients with Cancer
Official title: The Development and Pilot of MyInSPO: an Individualized Spirituality Program for Oncology Patients to Improve Spiritual Well-Being
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Malignant Solid Neoplasm
Lead sponsor: Ohio State University Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2022-01-20
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study is to pilot a beta version of a digital resource that supports the religious and spiritual beliefs of cancer patients, "MyInspiration".After receiving a cancer diagnosis, survivors are encouraged to make major life-altering decisions related to their treatment and care. The availability of spiritual/religious resources during cancer treatment may positively impact patient outcomes, feelings of well-being, and be essential components of holistic, patient-centered care. MyInspiration is a digital tool focused on spiritual and/or religious guidance and support that can be customized based on patient preferences and administered to cancer patients and their family members during cancer treatment. MyInspiration may help improve spiritual well-being in patients with cancer.

Detailed description: PRIMARY OBJECTIVES:

I. Conduct a pilot of MyInspiration to determine acceptability, feasibility, and general satisfaction by its end-users.

II. Explore the qualitative opinions of patients who participated in the feasibility trial more in-depth using 1-on-1 interviews.

OUTLINE: Single-group feasibility pilot.

Eligibility criteria: Inclusion Criteria:

* \> 18 years of age
* Capacity to sign an informed consent form
* Eligible for a surgical procedure (defined with International Classification of Diseases \[ICD\]-10 codes) that will require an in-patient stay at the Ohio State University Comprehensive Cancer Center (OSUCCC)-James
* Diagnosed with cancer
* Ability to read English (however, we will make all possible considerations to include non-native English speakers)
* Access to some form of internet (webpage, smartphone, tablet, etc.)

Primary outcomes:
measure: Feasibility of MyInspiration:Recruitment
timeFrame: Up to 30 days
measure: Feasibility of MyInspiration:Data Collection
timeFrame: Up to 30 days
measure: Feasibility of MyInspiration:Usage Patterns
timeFrame: Up to 30 days
measure: Acceptability of MyInspiration
timeFrame: Up to 30 days
measure: General satisfaction of MyInspiration
timeFrame: Up to 30 days
Secondary outcomes:
measure: Decisional regret
timeFrame: Up to 30 days
measure: Spiritual well-being
timeFrame: Up to 30 days
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Ohio State University Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: Ohio State University Comprehensive Cancer Center
name: Timothy M Pawlik, MD
role: PRINCIPAL_INVESTIGATOR
References: