Investigation of a Digital Healthy Habits Program for Individuals With Breast Cancer

Sponsor
Noom Inc. (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT04967209
Collaborator
(none)
30
Enrollment
1
Location
9.3
Anticipated Duration (Months)
3.2
Patients Per Site Per Month

Study Details

Study Description

Brief 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 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.

Condition or DiseaseIntervention/TreatmentPhase

    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

    Study Type:
    Observational
    Actual Enrollment :
    30 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Investigation of a Digital Healthy Habits Program for Individuals With Breast Cancer
    Actual Study Start Date :
    Jul 5, 2021
    Anticipated Primary Completion Date :
    Jan 15, 2022
    Anticipated Study Completion Date :
    Apr 15, 2022

    Outcome Measures

    Primary Outcome Measures

    1. Functional Assessment of Cancer Therapy - Breast quality-of-life instrument [4 weeks]

      Self reported measure of multidimensional quality of life (QL) in patients with breast cancer.

    2. Qualitative interviews [4 weeks]

      Data analyses will content analyze key themes in participants' experiences using the program, including their likes and dislikes for the program.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • 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:

    • 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)

    Exclusion Criteria:
    • 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)

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1Noom, IncNew YorkNew YorkUnited States10001

    Sponsors and Collaborators

    • Noom Inc.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Noom Inc.
    ClinicalTrials.gov Identifier:
    NCT04967209
    Other Study ID Numbers:
    • 00055029
    First Posted:
    Jul 19, 2021
    Last Update Posted:
    Nov 18, 2021
    Last Verified:
    Nov 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Nov 18, 2021