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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04967209
• Other study ID #: 00055029
• Status: Completed
• Start date: July 5, 2021
• Est. completion date: August 12, 2021

Study information

• Verified date: March 2023
• Source: Noom Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: August 12, 2021
• Est. primary completion date: August 12, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Cancer
• Obesity
• Overweight
• Overweight and Obesity

Locations

Country	Name	City	State
United States	Noom, Inc	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Noom Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional Assessment of Cancer Therapy - Breast quality-of-life instrument	Self reported measure of multidimensional quality of life (QL) in patients with breast cancer.	4 weeks
Primary	Qualitative interviews	Data analyses will content analyze key themes in participants' experiences using the program, including their likes and dislikes for the program.	4 weeks