Ovarian CancerNCT04458168
Feasibility and Evaluation of a Self-care App to Enhance Purposeful Living
A study testing Use of Purposeful app in people with Ovarian Cancer, run by University of Michigan Rogel Cancer Center at 1 site in United States.
Trial summary
In this pilot study, ovarian cancer survivors will be enrolled and followed for six months to evaluate usage of an eHealth app called "Purposeful". Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer
- What is being tested?
- Use of Purposeful app
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jun 2021to 10 Dec 2022
- Phase
- Interventional
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of ovarian cancer or treatment for ovarian cancer through the University of Michigan Gynecologic Oncology service
- Completed primary treatment (either surgery alone or surgery + chemotherapy)
- Ability to understand and the willingness to sign a written informed consent
- Ability to speak and read English
Who cannot join
- There are no additional exclusion criteria for participation in this study.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Michigan Rogel Cancer Center
Ann Arbor, Michigan, 48109
About this study
In this pilot study, ovarian cancer survivors will be enrolled and followed for six months to evaluate usage of an eHealth app called "Purposeful".
Read the detailed description
This study will determine the feasibility and acceptability of Purposeful, the eHealth app. First, feasibility of enrolling ovarian cancer survivors to use Purposeful will be assessed. Secondly, the acceptability of the app among ovarian cancer survivors will be assessed, based on frequency of use and validated acceptability measures. Participants will be asked to complete other validated questionnaires so investigators may explore whether further research on the Purposeful app among ovarian cancer survivors is warranted. This will include correlations between use of the Purposeful app and the life purpose questionnaire score. Lastly, correlation between life purpose and quality of life in ovarian cancer survivors will be explored.
- Conditions
- Ovarian Cancer
- Being tested
- Use of Purposeful app
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Use of Purposeful appBehavioural
Patients will be asked to use the Purposeful app every day, which should take no longer than 5 minutes. The app includes three key components: Explore, Act and Reflect. The Explore section provides thematically organized resources that suggest discrete actions users can try out and potentially incorporate into their lives. The app uses machine learning to customize resources presented to the user. The Act section is where users place actions they'd like to keep track of or build into a habit. Finally, the Reflect section includes daily "reflections" where the patient answers open ended questions regarding their alignment with their best self qualities, their sense of purpose, and more. Depending on whether users choose to allow push notifications, they will be notified daily to complete morning, afternoon, and/or evening reflections.
Participants will complete questionnaires at enrollment and at 1, 3, and 6 months after enrollment.
| Study group | Role | What they receive |
|---|---|---|
| Recently completed treatment | Experimental | 25 women who have just completed treatment Receives: Behavioral: Use of Purposeful app |
| No recurrence of ovarian cancer for at least one year | Experimental | 25 women who have not experienced a recurrence of their ovarian cancer at least one year after their initial diagnosis Receives: Behavioral: Use of Purposeful app |
| Recurrence of ovarian cancer | Experimental | 25 women who have experienced a recurrence of their ovarian cancer after primary treatment Receives: Behavioral: Use of Purposeful app |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility assessed by enrollment rate
The number of patients who enroll in the study, of the total number of patients approached for enrollment.
Measured: At time of enrollment
Feasibility assessed by percentage of days of app use
Percentage of days during a 6-month period on which each participant used the Purposeful app. Using the app during the day is defined as doing at least one of the following: setting an intention; completing a reflection; completing an action. Usage data will be provided by the Purposeful app.
Measured: 6 months
Feasibility assessed by trajectory of usage on a percent of days used on both a weekly and monthly time scale.
The average percentage of days of app use per week and per month during a 6-month period. Using the app during the day is defined as doing at least one of the following: setting an intention; completing a reflection; completing an action. Usage data will be provided by the Purposeful app.
Measured: 6 months
Acceptability assessed by percentage of patients who find the Purposeful app to be acceptable
A score of 3 or more on the acceptability summary score (assessed using a protocol-specific questionnaire) will indicate that the patient finds the Purposeful app to be acceptable.
Measured: 6 months
Secondary outcomes (4)
Change in life purpose from baseline
Assessed at baseline, 1, 3 and 6 months using the Modified Ryff and Keyes Scales of Psychological Well-being evaluation, a 7-item questionnaire that uses a Likert scale ranging from 1 to 6, with higher scores indicating greater purpose in life.
Measured: 6 months
Change in quality of life assessed using Functional Assessment of Cancer Therapy-Ovarian (FACT-O) Trial Outcome Index (TOI) (FACT-O TOI)
Assessed at baseline, 1, 3 and 6 months. FACT-O TOI is a 26-item questionnaire that sums the physical well-being, functional well-being, and additional health concerns with a 7-day recall period. All items will be rated on a 5 items (point) Likert Scale, from 0 (not at all) to 4 (very much so). To score the FACT-O TOI, all 26 items will be summed to create a single score with a range from 0 to 104. Items will be reverse scored when appropriate to provide a scale in which a higher score represent a higher quality of life.
Measured: 6 months
Change in quality of life assessed using Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F)
Assessed at baseline, 1, 3 and 6 months. The FACIT-fatigue scale is a 13-item patient-reported measure of fatigue with a 7-day recall period. All items will be rated on a 5 items (point) Likert Scale, from 0 (not at all) to 4 (very much so). To score the FACIT-fatigue, all 13 items will be summed to create a single fatigue score with a range from 0 to 52. Items will be reverse scored when appropriate to provide a scale in which a higher score represent less fatigue.
Measured: 6 months
Change in quality of life using Comprehensive Measure of Meaning (Well-being questionnaire Part 10)
Assessed at baseline, 1, 3 and 6 months. The Comprehensive Measure of Meaning (Well-being questionnaire Part 10) is a 21-item questionnaire that uses a Likert scale ranging from 1 to 7, with higher scores indicating greater well-being.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2020
- Study start28 Jun 2021
- Primary completion10 Dec 2022
- Study completion10 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- More trials run by University of Michigan Rogel 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan Rogel Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Rogel Cancer Center Cancer Control and Population Sciences O-SURE initiative
- Responsible party
- Sponsor
- Investigators
- Celeste Leigh Pearce, PhD, MPH, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04458168
- Sponsor's protocol ID
- UMCC 2018.153
- Other IDs
- HUM00140226
- Status last verified
- Nov 2024
- First submitted
- 30 Jun 2020
- Last updated
- 6 Nov 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Evaluation of a Self-care App to Enhance Purposeful Living
- ClinicalTrials.gov ID
- NCT04458168
- Acronym / sponsor ID
- UMCC 2018.153
- Conditions
- Ovarian Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University of Michigan Rogel Cancer CenterUniversity, hospital or other
- Collaborators
- Rogel Cancer Center Cancer Control and Population Sciences O-SURE initiative
- Study start
- 28 Jun 2021 (actual)
- Primary completion
- 10 Dec 2022 (actual)
- Study completion
- 10 Dec 2022 (actual)
- First posted
- 7 Jul 2020 (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.
In this pilot study, ovarian cancer survivors will be enrolled and followed for six months to evaluate usage of an eHealth app called "Purposeful".
Detailed description
This study will determine the feasibility and acceptability of Purposeful, the eHealth app. First, feasibility of enrolling ovarian cancer survivors to use Purposeful will be assessed. Secondly, the acceptability of the app among ovarian cancer survivors will be assessed, based on frequency of use and validated acceptability measures. Participants will be asked to complete other validated questionnaires so investigators may explore whether further research on the Purposeful app among ovarian cancer survivors is warranted. This will include correlations between use of the Purposeful app and the life purpose questionnaire score. Lastly, correlation between life purpose and quality of life in ovarian cancer survivors will be explored.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Recently completed treatment | Experimental | Behavioral: Use of Purposeful app25 women who have just completed treatment |
| No recurrence of ovarian cancer for at least one year | Experimental | Behavioral: Use of Purposeful app25 women who have not experienced a recurrence of their ovarian cancer at least one year after their initial diagnosis |
| Recurrence of ovarian cancer | Experimental | Behavioral: Use of Purposeful app25 women who have experienced a recurrence of their ovarian cancer after primary treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of ovarian cancer or treatment for ovarian cancer through the University of Michigan Gynecologic Oncology service
- Completed primary treatment (either surgery alone or surgery + chemotherapy)
- Ability to understand and the willingness to sign a written informed consent
- Ability to speak and read English
Key exclusion criteria (1 listed)
- There are no additional exclusion criteria for participation in this study.
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 |
|---|---|---|
| Use of Purposeful appPatients will be asked to use the Purposeful app every day, which should take no longer than 5 minutes. The app includes three key components: Explore, Act and Reflect. The Explore section provides thematically organized resources that suggest discrete actions users can try out and potentially incorporate into their lives. The app uses machine learning to customize resources presented to the user. The Act section is where users place actions they'd like to keep track of or build into a habit. Finally, the Reflect section includes daily "reflections" where the patient answers open ended questions regarding their alignment with their best self qualities, their sense of purpose, and more. Depending on whether users choose to allow push notifications, they will be notified daily to complete morning, afternoon, and/or evening reflections. Participants will complete questionnaires at enrollment and at 1, 3, and 6 months after enrollment. | Behavioural | No recurrence of ovarian cancer for at least one year, Recently completed treatment, Recurrence of ovarian cancer |
Primary outcome
Feasibility assessed by enrollment rate
Time frame: At time of enrollment
The number of patients who enroll in the study, of the total number of patients approached for enrollment.
Feasibility assessed by percentage of days of app use
Time frame: 6 months
Percentage of days during a 6-month period on which each participant used the Purposeful app. Using the app during the day is defined as doing at least one of the following: setting an intention; completing a reflection; completing an action. Usage data will be provided by the Purposeful app.
Feasibility assessed by trajectory of usage on a percent of days used on both a weekly and monthly time scale.
Time frame: 6 months
The average percentage of days of app use per week and per month during a 6-month period. Using the app during the day is defined as doing at least one of the following: setting an intention; completing a reflection; completing an action. Usage data will be provided by the Purposeful app.
Acceptability assessed by percentage of patients who find the Purposeful app to be acceptable
Time frame: 6 months
A score of 3 or more on the acceptability summary score (assessed using a protocol-specific questionnaire) will indicate that the patient finds the Purposeful app to be acceptable.
4 secondary outcomes
Change in life purpose from baseline
Time frame: 6 months
Change in quality of life assessed using Functional Assessment of Cancer Therapy-Ovarian (FACT-O) Trial Outcome Index (TOI) (FACT-O TOI)
Time frame: 6 months
Change in quality of life assessed using Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F)
Time frame: 6 months
Change in quality of life using Comprehensive Measure of Meaning (Well-being questionnaire Part 10)
Time frame: 6 months
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 6 Nov 2024.
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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.
Celeste Leigh Pearce, PhD, MPH principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Use of Purposeful app in people with Ovarian Cancer, run by University of Michigan Rogel 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 4 inclusion and 1 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 6 Nov 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.
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 assessed by enrollment rate (time frame: At time of enrollment). The study lists 4 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 6 Nov 2024.