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NCT05198089 Clinical Trial

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

Malignant Solid Neoplasm Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT05198089
Other study ID # OSU-20390
Secondary ID NCI-2021-00630
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date July 1, 2022
Est. completion date December 31, 2023

Study information
Verified date July 2023
Source Ohio State University Comprehensive Cancer Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 52
Est. completion date December 31, 2023
Est. primary completion date December 31, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Other:
• Internet-Based Intervention
Use MyInspiration website

Locations
Country Name City State
United States Ohio State University Comprehensive Cancer Center Columbus Ohio

Sponsors (1)
Lead Sponsor Collaborator
Ohio State University Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
Primary Feasibility of MyInspiration:Data Collection Feasibility will be assessed by completion rates of both the baseline and follow-up measures Up to 30 days
Primary Feasibility of MyInspiration:Usage Patterns Feasibility will be assessed by meta-analytics of website usage. Up to 30 days
Primary Acceptability of MyInspiration Acceptability will be assessed by study attrition rates. Up to 30 days
Primary 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 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
Secondary 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
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