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Completed

NCT Number: NCT05198089

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

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.

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Key information

Conditions

Malignant Solid Neoplasm

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.)

Treatment and study plan

Internet-Based Intervention

Other

Use MyInspiration website

Primary outcomes

  1. Feasibility of MyInspiration:Recruitment

    Time frame: Up to 30 days

    Feasibility will be assessed by ratio of patients that enroll of the patients that indicate interest in the study

  2. Feasibility of MyInspiration:Data Collection

    Time frame: Up to 30 days

    Feasibility will be assessed by completion rates of both the baseline and follow-up measures

  3. Feasibility of MyInspiration:Usage Patterns

    Time frame: Up to 30 days

    Feasibility will be assessed by meta-analytics of website usage.

  4. Acceptability of MyInspiration

    Time frame: Up to 30 days

    Acceptability will be assessed by study attrition rates.

  5. General satisfaction of MyInspiration

    Time frame: Up to 30 days

    General Satisfaction will be assessed using an investigator-created 6-item scale assessing participants experience with MyInspo overall and its specific components

Secondary outcomes

  1. Decisional regret

    Time frame: Up to 30 days

    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.

  2. Spiritual well-being

    Time frame: Up to 30 days

    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.

Sponsors and collaborators

Lead sponsor

Ohio State University Comprehensive Cancer Center

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jan 20, 2022
Registry last updated
Oct 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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