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

NCT ID: NCT04967209

Last Updated: 2023-03-31

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-07-05
• Study Completion Date: 2021-08-12

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.

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Noom Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Noom, Inc

New York, New York, United States

Countries

United States

Other Identifiers

00055029

Identifier Type: -

Identifier Source: org_study_id