A Web-based Tailored Health Behavior Intervention for Breast and Colon Cancer Survivors (eWellness)

NCT04188002 | Completed DMC

• 1 other identifier: 16-1897
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this study is to compare the differences in fruits and vegetable intake and physical activity from pre- to post- study between the intervention and control groups (i.e. the difference in differences). The study involves the use of web-based educational materials over a four week period. The investigators hypothesize that those in the intervention group will show a greater increase in fruit and vegetable intake and engage in more physical activity than those randomized to the control group. Eligible breast and colorectal cancer survivors from the UNC Health Registry/Cancer Survivorship Cohort (UNC HR/CSC) will be selected, consented, and randomized to either the intervention or control group. Both groups will fill out baseline surveys. The intervention group will receive a total to 4 newsletters for 4 weeks and at the beginning of week 5, they will asked to complete the follow-up survey online. The intervention newsletters focus on increasing physical activity and healthy diets. The control group will receive 4 newsletters in the same time frame as the intervention. The focus of the control group's newsletters will be on topics relevant to cancer survivors (e.g. getting back to work after treatment, managing finances) but will not focus on physical activity or diet. All contact with participants will take place online (i.e. surveys and newsletter delivery) from the study web site.

Conditions

Nutrition; Physical Activity

Outcome Measures

Primary Outcomes (3)

• Mean Fruit and Vegetable Score

  Fruit and vegetable consumption will be adapted from a 35-item measure used in a trial for US Blacks adapted from a 35-item measure for US Southern blacks that measures frequency of intake during the previous month. Score measures can range from 2-24. Positive or better outcomes are reflected by higher mean fruit and vegetable scores.

  Month 6

• Summary Fruit and Vegetable Score

  The frequency of fruit and vegetable intake will be measured during the previous month, using a 2-item measure (How many servings of fruits do you eat each day?) and a similar question for vegetables that assesses usual vegetable intake. Scores can range from 0-N with higher scores indicating more fruit and/or vegetable intake.

  Month 6

• Metabolic Equivalent Task Hours (METs) for Physical Activity

  Moderate to physical activity will be assessed and frequency of different types of activity, with response options of: don't do, 1-3 times/month, 1-2 times/week, 3-4 times/week, or 5 or more times/week. Items include various types of activities gathered from an 11-item instrument modified for cultural appropriateness from a previous study. For each activity, participants estimate duration as either \<20 minutes or 20 or more minutes per session. Physical activity is then calculated in terms of metabolic equivalent task hours (METs) per week. MET values for energy expenditure were assigned to each activity based on validated instruments.21 MET-hours are computed by multiplying frequency times duration (converted to hours/week) times the MET value. Reported physical activity time can range from 0 minutes - 6 hours or more for reported sedentary behaviors. Higher reported values equate to better reported outcomes of increased physical activity for participants.

  Month 6

Secondary Outcomes (5)

• Recruitment rate

  Month 6

• Percentage of Participants Completing the Intervention and Follow-Up Assessments

  Month 6

• Number of Newsletters Read/Downloaded

  Month 6

• Program Process Evaluation

  6 months

• Number of Times Visiting the Site

  6 months

Study Arms (2)

Control - Fruit and Vegetable

OTHER

Participants in this arm will receive usual care.

Other: Usual Care

Physical Activity Intervention

OTHER

Participants in this arm will be encouraged via tailored newsletters and email/or text reminders to improve diet and physical activities.

Behavioral: Intervention Physical Activity

Interventions

Intervention Physical Activity BEHAVIORAL

4 tailored newsletters focused on improving healthy diet and physical activity delivered at weekly intervals.

Physical Activity Intervention

Usual Care OTHER

4 non-tailored newsletters focused on issues relevant to cancer survivors (e.g. returning to work)

Control - Fruit and Vegetable

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥18 years of age
• primary language is English
• histologically confirmed stage 1-111A invasive breast cancer or stage 1-3 colorectal cancer
• between at least 6 months to 5 years since completion of all primary cancer treatments (e.g. surgery, radiation, chemotherapy with the exception of women on adjuvant Herceptin therapy)
• have access to the internet; have an email and/or cell phone (to accept text message reminders from the study).

You may not qualify if:

• Include women that may be pregnant and anyone that is/has:
• A history of another cancer (exception for non-melanoma skin cancers)
• Self-reported comorbidities that would preclude engaging in physical activity safely (e.g. functional limitations or symptomatic cardiovascular or pulmonary disease)
• Plans or scheduled for major surgery (including breast reconstruction) during the intervention time frame
• Any psychiatric illness that would make it difficult to participate in the study

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• University of Texas: collaborator

Study Sites (1)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Related Publications (1)

• Resnicow K, Morabia A. The relation between body mass index and plasma total cholesterol in a multiracial sample of US schoolchildren. Am J Epidemiol. 1990 Dec;132(6):1083-90. doi: 10.1093/oxfordjournals.aje.a115751.

  PMID: 2260540 BACKGROUND

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Carmina Valle, PhD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a single institution, randomized clinical trial designed to evaluate a four week web-based tailored health behavior intervention in breast and colon cancer survivors.

Study Record Dates

• First Submitted: December 3, 2019
• First Posted: December 5, 2019
• Study Start: March 25, 2017
• Primary Completion: July 31, 2018
• Study Completion: August 1, 2018
• Last Updated: December 5, 2019

Record last verified: 2019-11

Locations

US (1)