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

March 29, 2023 updated by: Noom Inc.
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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10001
        • Noom, Inc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Women with breast cancer diagnosis currently undergoing hormone therapy for treatment

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
4 weeks
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.
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Noom Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 5, 2021

Primary Completion (Actual)

August 12, 2021

Study Completion (Actual)

August 12, 2021

Study Registration Dates

First Submitted

July 8, 2021

First Submitted That Met QC Criteria

July 8, 2021

First Posted (Actual)

July 19, 2021

Study Record Updates

Last Update Posted (Actual)

March 31, 2023

Last Update Submitted That Met QC Criteria

March 29, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 00055029

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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