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

NCT04967209 | Completed

• 1 other identifier: 00055029
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer; Breast Cancer; Obesity; Overweight and Obesity; Overweight

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women with breast cancer diagnosis currently undergoing hormone therapy for treatment

You may qualify if:

• Able to understand and provide informed consent
• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Noom Inc.: lead

Study Sites (1)

Noom, Inc

New York, New York, 10001, United States

Location

MeSH Terms

Conditions

Neoplasms; Breast Neoplasms; Obesity; Overweight

Condition Hierarchy (Ancestors)

Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2021
• First Posted: July 19, 2021
• Study Start: July 5, 2021
• Primary Completion: August 12, 2021
• Study Completion: August 12, 2021
• Last Updated: March 31, 2023

Record last verified: 2023-03

Locations

US (1)