Malignant Solid NeoplasmPhase 1NCT05198089
Development of a Digital Tool, MyInspiration, for the Improvement of Spiritual Well-Being in Patients with Cancer
A Phase 1 study testing Internet-Based Intervention in people with Malignant Solid Neoplasm, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Solid Neoplasm
- What is being tested?
- Internet-Based Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2022to 3 Jan 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- > 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.)
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
About this study
Official title: 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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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.
- Conditions
- Malignant Solid Neoplasm
- Being tested
- Internet-Based Intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internet-Based InterventionOther
Use MyInspiration website
| Study group | Role | What they receive |
|---|---|---|
| Arm I (MyInspiration) | Experimental | Patients use MyInspiration for spiritual and/or religious guidance for 30 days. Receives: Other: Internet-Based Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of MyInspiration:Recruitment
Feasibility will be assessed by ratio of patients that enroll of the patients that indicate interest in the study
Measured: Up to 30 days
Feasibility of MyInspiration:Data Collection
Feasibility will be assessed by completion rates of both the baseline and follow-up measures
Measured: Up to 30 days
Feasibility of MyInspiration:Usage Patterns
Feasibility will be assessed by meta-analytics of website usage.
Measured: Up to 30 days
Acceptability of MyInspiration
Acceptability will be assessed by study attrition rates.
Measured: 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
Measured: Up to 30 days
Secondary outcomes (2)
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.
Measured: 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.
Measured: Up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2022
- Study start1 Jul 2022
- Primary completion3 Jan 2023
- Study completion3 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Solid NeoplasmStudies of the same condition, open and under way.
- More trials run by Ohio State University Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Timothy Pawlik, Ohio State University Comprehensive Cancer Center
- Investigators
- Timothy M Pawlik, MD, Principal investigator, Ohio State University Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05198089
- Sponsor's protocol ID
- OSU-20390
- Other IDs
- NCI-2021-00630
- Status last verified
- Oct 2024
- First submitted
- 20 Dec 2021
- Last updated
- 8 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Development and Pilot of MyInSPO: an Individualized Spirituality Program for Oncology Patients to Improve Spiritual Well-Being
- ClinicalTrials.gov ID
- NCT05198089
- Acronym / sponsor ID
- OSU-20390
- Conditions
- Malignant Solid Neoplasm
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Ohio State University Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 3 Jan 2023 (actual)
- Study completion
- 3 Jan 2023 (actual)
- First posted
- 20 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
PRIMARY OBJECTIVES:
- 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 design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm I (MyInspiration) | Experimental | Other: Internet-Based InterventionPatients use MyInspiration for spiritual and/or religious guidance for 30 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- > 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)
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Internet-Based InterventionUse MyInspiration website | Other | Arm I (MyInspiration) |
Primary outcome
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
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
Feasibility of MyInspiration:Usage Patterns
Time frame: Up to 30 days
Feasibility will be assessed by meta-analytics of website usage.
Acceptability of MyInspiration
Time frame: Up to 30 days
Acceptability will be assessed by study attrition rates.
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
2 secondary outcomes
Decisional regret
Time frame: Up to 30 days
Spiritual well-being
Time frame: Up to 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2024.
- The JameslineLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Timothy M Pawlik, MD principal investigator
Ohio State University Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Internet-Based Intervention in people with Malignant Solid Neoplasm, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of MyInspiration:Recruitment (time frame: Up to 30 days). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2024.