CancerNCT04967209
Investigation of a Digital Healthy Habits Program for Individuals With Breast Cancer
An observational study of Cancer and Breast Cancer, run by Noom Inc. at 1 site in United States.
Trial summary
This mixed methods study will involve obtaining user feedback on the first 4 weeks of the Healthy Habits for Cancer (HCC) Program. Short pre and post surveys and in-depth qualitative interviews will be conducted exploring their views on the app (features they liked and didn't like), the extent to which they believe… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cancer, Breast Cancer, Obesity
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jul 2021to 12 Aug 2021
- Phase
- Observational
- 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
Study population: Women with breast cancer diagnosis currently undergoing hormone therapy for treatment
Who may be able to join
- Able to understand and provide informed consent
- 18 years and older
- Female
- > 6 months postpartum
- Not currently pregnant or planning to become pregnant in the next 5 months
- Diagnosed with stage I-IV breast cancer < 5 years ago:
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- Completed active breast cancer treatment (e.g., chemotherapy, radiation, surgery) 1 month to 5 years ago, with the exception of hormonal/endocrine therapy
- Currently prescribed hormone therapy (e.g. Tamoxifen) as a breast cancer treatment
- Not diagnosed with an eating disorder
- Healthy weight, overweight, or obesity (BMI ≥ 18.5)
- Willingness to use the program over the course of the 4 weeks in order to enable them to provide feedback on its features
- Own a smartphone with iOS operating system (i.e., Apple iPhone)
Who cannot join
- Inability or unwillingness of a participant to give written informed consent
- Underweight (BMI < 18.5)
- Currently pregnant or <6 months postpartum
- Presence of a diagnosed physical or mental health condition or abnormality that impacts the ability to participate in a program that involves asking participants to monitor diet, physical activity, or weight (e.g., eating disorder, bipolar disorder). If there is any doubt at initial screening the investigator will recommend that the patient receives sign off from their clinical team.
- Currently undergoing IV chemotherapy or radiation
- Plans for surgery in the next 6 weeks
- Currently diagnosed or being treated for a second primary cancer (i.e. cancer of another organ, not due to breast cancer metastasis), with the exception of non-melanoma skin cancers (e.g. basal cell carcinoma)
Trial locations and contacts
1 site in 1 country.
About this study
This mixed methods study will involve obtaining user feedback on the first 4 weeks of the Healthy Habits for Cancer (HCC) Program. Short pre and post surveys and in-depth qualitative interviews will be conducted exploring their views on the app (features they liked and didn't like), the extent to which they believe the app would have to be further adapted, how they would feel about such an app being embedded in their cancer care and when in their care pathway they would like to be offered it.
Read the detailed description
This mixed methods study will involve obtaining user feedback on the first 4 weeks of the Healthy Habits for Cancer (HCC) Program. Participants will be recruited and asked to try the HCC app for 4 weeks. Short pre and post surveys and in-depth qualitative interviews will be conducted exploring their views on the app, the extent to which they believe the app would have to be further adapted, how they would feel about such an app being embedded in their cancer care and when in their care pathway they would like to be offered it.
- Conditions
- Cancer, Breast Cancer, Obesity, Overweight and Obesity, Overweight
- Medical subject headings
- Neoplasms, Breast Neoplasms, Obesity, Overweight
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Assessment of Cancer Therapy - Breast quality-of-life instrument
Self reported measure of multidimensional quality of life (QL) in patients with breast cancer.
Measured: 4 weeks
Qualitative interviews
Data analyses will content analyze key themes in participants' experiences using the program, including their likes and dislikes for the program.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2021
- Study start5 Jul 2021
- Primary completion12 Aug 2021
- Study completion12 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Noom Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04967209
- Sponsor's protocol ID
- 00055029
- Status last verified
- Mar 2023
- First submitted
- 8 Jul 2021
- Last updated
- 31 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of a Digital Healthy Habits Program for Individuals With Breast Cancer
- ClinicalTrials.gov ID
- NCT04967209
- Acronym / sponsor ID
- 00055029
- Conditions
- Cancer, Breast Cancer, Obesity, Overweight and Obesity, Overweight
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Noom Inc.Industry (pharma, biotech, devices)
- Study start
- 5 Jul 2021 (actual)
- Primary completion
- 12 Aug 2021 (actual)
- Study completion
- 12 Aug 2021 (actual)
- First posted
- 19 Jul 2021 (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.
This mixed methods study will involve obtaining user feedback on the first 4 weeks of the Healthy Habits for Cancer (HCC) Program. Short pre and post surveys and in-depth qualitative interviews will be conducted exploring their views on the app (features they liked and didn't like), the extent to which they believe the app would have to be further adapted, how they would feel about such an app being embedded in their cancer care and when in their care pathway they would like to be offered it.
Detailed description
This mixed methods study will involve obtaining user feedback on the first 4 weeks of the Healthy Habits for Cancer (HCC) Program. Participants will be recruited and asked to try the HCC app for 4 weeks. Short pre and post surveys and in-depth qualitative interviews will be conducted exploring their views on the app, the extent to which they believe the app would have to be further adapted, how they would feel about such an app being embedded in their cancer care and when in their care pathway they would like to be offered it.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women with breast cancer diagnosis currently undergoing hormone therapy for treatment
Key inclusion criteria (12 listed)
- Able to understand and provide informed consent
- 18 years and older
- Female
- > 6 months postpartum
- Not currently pregnant or planning to become pregnant in the next 5 months
Key exclusion criteria (7 listed)
- Inability or unwillingness of a participant to give written informed consent
- Underweight (BMI < 18.5)
- Currently pregnant or <6 months postpartum
- Presence of a diagnosed physical or mental health condition or abnormality that impacts the ability to participate in a program that involves asking participants to monitor diet, physical activity, or weight (e.g., eating disorder, bipolar disorder). If there is any doubt at initial screening the investigator will recommend that the patient receives sign off from their clinical team.
- Currently undergoing IV chemotherapy or radiation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Functional Assessment of Cancer Therapy - Breast quality-of-life instrument
Time frame: 4 weeks
Self reported measure of multidimensional quality of life (QL) in patients with breast cancer.
Qualitative interviews
Time frame: 4 weeks
Data analyses will content analyze key themes in participants' experiences using the program, including their likes and dislikes for the program.
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 31 Mar 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer and Breast Cancer, run by Noom Inc. 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 12 inclusion and 7 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 31 Mar 2023. 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?
Functional Assessment of Cancer Therapy - Breast quality-of-life instrument (time frame: 4 weeks). The study lists 2 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 31 Mar 2023.