Clinical trial NCT05132296: Mobile-Health Delivery of Lifestyle Interventions for Women With Breast Cancer
Official title: Mobile-Health Delivery of Lifestyle Interventions for Women With Breast Cancer Multicenter Pilot Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Breast Carcinoma
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2021-11-24
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: This clinical trial aims to develop a lifestyle program to improve clinical outcomes in women with breast cancer who do not have a healthy diet, regular exercise habits, or ways to manage their stress well. The program will include support and counseling in healthy eating, physical activity, stress management and mindfulness, learning sleep hygiene techniques, and behavioral counseling in addition to social support. Developing a lifestyle program may help improve quality of life and encourage healthy lifestyle choices among patients diagnosed with breast cancer.

Detailed description: PRIMARY OBJECTIVE:

I. Assess the feasibility of delivering a mobile, standardized, comprehensive lifestyle program in women with breast cancer (BCa).

SECONDARY OBJECTIVES:

I. Determine whether the comprehensive lifestyle intervention program (CLIP) group has reduction in body mass index (BMI) and percent body fat and weight over time.

II. Determine whether the CLIP group has improved outcomes in anthropometric measures, dietary patterns, and fitness measures and patient-reported outcomes including quality of life (QOL), fatigue, sleep disturbances, mental health, social support, and mindfulness.

OUTLINE: Patients are randomized into 1 of 2 groups.

GROUP I: Patients undergo 60 minute sessions of nutrition education for 12 weeks and behavioral intervention 26 weeks. Patients receive FitBit and undergo physical activity for 30-60 minutes 5 days a week (aerobic activity) and 2 days a week (resistance training).

GROUP II: Patients have access to all usual care supportive services.

Eligibility criteria: Inclusion Criteria:

* Women with stage I-III BCa scheduled to undergo radiation therapy (RT) or within the first 12 months of having completed primary treatment (they do not need to have undergone RT)
* Underwent chemotherapy and surgery
* Able to read, write, and speak English
* BMI of 25 or higher
* 18 years of age or older
* Oriented to person, place, and time
* Participants must meet at least two of the following criteria related to their lifestyle at the time of diagnosis:

  * Consume less than 3 servings of fruit and vegetable/day
  * Engage in less than 75 minutes of moderate/vigorous intensity activity per week, defined as anything that causes small increases in breathing or heart rate for a sustained amount of time (e.g., brisk walking, bicycling)
  * Engage in a mind-body practice less than 4 times a month
* Access to internet connection
* Access to a tablet, laptop or computer
* Able to come to University of Texas (UT) MD Anderson or Wake Forest for blood collection
* Able to perform light physical activity. if any medical issues exist or arise that may limit performing physical activity, a medical release will be required

Exclusion Criteria:

* Have not completed chemotherapy; have a recurrent BCa diagnosis; another primary cancer diagnosis within past 5 years (not including non-melanoma skin cancers)
* Any major thought disorder (e.g., schizophrenia, dementia)
* Any major communication barriers that would preclude being able to complete the intervention (e.g., visually or hearing impaired)
* Poorly or uncontrolled diabetes in the opinion of the physician(s)
* Extreme mobility issues (e.g., unable to get in and out of a chair unassisted)

Primary outcomes:
measure: Assess the feasibility of delivering a mobile, standardized, comprehensive lifestyle program in women with BCa.
timeFrame: up to 9 months after study baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Lorenzo Cohen, MD
role: PRINCIPAL_INVESTIGATOR
References: