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

NCT05198089 | Completed Phase 1 DMC

• 2 other identifiers: OSU-20390NCI-2021-00630
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Malignant Solid Neoplasm

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (2)

• Decisional regret

  Up to 30 days

• Spiritual well-being

  Up to 30 days

Study Arms (1)

Arm I (MyInspiration)

EXPERIMENTAL

Patients use MyInspiration for spiritual and/or religious guidance for 30 days.

Other: Internet-Based Intervention

Interventions

Internet-Based Intervention OTHER

Use MyInspiration website

Arm I (MyInspiration)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \> 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.)

Sponsors & Collaborators

• Ohio State University Comprehensive Cancer Center: lead

Study Sites (1)

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

Location

Related Links

• The Jamesline

Study Officials

• Timothy M Pawlik, MD

  Ohio State University Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 20, 2021
• First Posted: January 20, 2022
• Study Start: July 1, 2022
• Primary Completion: January 3, 2023
• Study Completion: January 3, 2023
• Last Updated: October 8, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)