Development of a Digital Tool, MyInspiration, for the Improvement of Spiritual Well-Being in Patients With Cancer

The Development and Pilot of MyInSPO: An Individualized Spirituality Program for Oncology Patients to Improve Spiritual Well-Being

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Malignant Solid Neoplasm
• Intervention / Treatment: Other: Internet-Based Intervention

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.

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Ohio State University Comprehensive Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm I (MyInspiration); Patients use MyInspiration for spiritual and/or religious guidance for 30 days.	Other: Internet-Based Intervention; Use MyInspiration website

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of MyInspiration:Recruitment	Feasibility will be assessed by ratio of patients that enroll of the patients that indicate interest in the study	Up to 30 days
Feasibility of MyInspiration:Data Collection	Feasibility will be assessed by completion rates of both the baseline and follow-up measures	Up to 30 days
Feasibility of MyInspiration:Usage Patterns	Feasibility will be assessed by meta-analytics of website usage.	Up to 30 days
Acceptability of MyInspiration	Acceptability will be assessed by study attrition rates.	Up to 30 days
General satisfaction of MyInspiration	General Satisfaction will be assessed using an investigator-created 6-item scale assessing participants experience with MyInspo overall and its specific components	Up to 30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Decisional regret	Decisional regret will be assessed post cancer-directed surgery using The Decisional Regret Scale.Items will also be adapted from scales developed by Clark et al. regarding the perceptions of one's treatment decisions, their outcomes, and the inherent uncertainty of decision making and cancer control.	Up to 30 days
Spiritual well-being	Spiritual well-being will be assessed using the Functional Assessment of Chronic Illness Therapy - Spiritual Well-Being, the Meaning of Cancer Subscale from the Impact of Cancer scale, and 1-item assessing spiritual distress. The Functional Assessment of Chronic Illness Therapy - Spiritual Well-Being is a 12-item scale with a minimum score of 0 and a maximum score of 48; higher scores indicate a greater sense of spiritual well-being.	Up to 30 days

Collaborators and Investigators

• Sponsor: Ohio State University Comprehensive Cancer Center
• Investigators: Principal Investigator: Timothy M Pawlik, MD, Ohio State University Comprehensive Cancer Center

Publications and helpful links

Helpful Links

• The Jamesline

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2022
• Primary Completion (Estimated): December 31, 2023
• Study Completion (Estimated): December 31, 2023

Study Registration Dates

• First Submitted: December 20, 2021
• First Submitted That Met QC Criteria: January 14, 2022
• First Posted (Actual): January 20, 2022

Study Record Updates

• Last Update Posted (Actual): July 12, 2023
• Last Update Submitted That Met QC Criteria: July 11, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: OSU-20390; NCI-2021-00630 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No