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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Malignant Solid Neoplasm

Intervention / Treatment
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* Other: Internet-Based Intervention


Participation Criteria
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Eligibility Criteria
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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.)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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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 |