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OpenTrials
Completed

NCT Number: NCT04967209

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Noom Inc.

Industry

Registry information

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jul 19, 2021
Registry last updated
Mar 31, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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