Web-based Study for Cancer Survivors

A Lifestyle Intervention Via Email (ALIVE) for Cancer Survivors

In this parallel group study, participants were randomized to either 1 of 3 conditions (a) fruit and vegetable consumption, (b) dietary fat and added sugars, or (c) physical activity.

Study Overview

• Status: Completed
• Conditions: Physical Activity; Dietary Modification
• Intervention / Treatment: Behavioral: ALIVE

Detailed Description

In this study, the investigators will evaluate the feasibility and preliminary results of a 3-month web-based lifestyle intervention 500 female cancer survivors.

Specific aim 1: to determine the rates of recruitment, retention, attendance, satisfaction, adverse events, and barriers to participation in the proposed intervention.

Specific aim 2: to determine whether a home-based intervention is associated with greater improvements in mean minutes of moderate to vigorous physical activity, diet quality, body size, constructs of Social Cognitive Theory, and health-related quality of life than participants randomized to a sedentary behavior reduction condition.

• Study Type: Interventional
• Enrollment (Actual): 258
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Previously diagnosed with breast cancer;
• 18-80 years old at time of cancer diagnosis;
• English-Speaking;
• Have access to high-speed internet.

Exclusion Criteria:

• Be currently enrolled in another intervention study or recently completed a study promoting healthy lifestyle behaviors (diet and/or exercise).
• Participants answering 'Yes' to one or more of the questions on the physical activity readiness questionnaire (PAR-Q) will need to obtain approval from a physician before they can participate in the intervention.
• Pregnant women will be excluded from the protocol.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: ALIVE - Physical Activity; PA CONDITION: The goal of the PA condition is to encourage participants to gradually increase moderate to vigorous PA to 150 minutes per week and to increase resistance training to a total of 15 minutes per day twice per week.	Behavioral: ALIVE; ALIVE is an email-based platform designed to help participants increase their physical activity, increase fruit and vegetable consumption, and decrease their intake of saturated and trans fats and added sugars. This automated system contains content and tailoring that is delivered in the form of emails obtained directly from cancer patients. Additional information they will receive included: tips for achieving those goals, health information, and opportunities for interaction and engagement.
EXPERIMENTAL: ALIVE - Dietary Modification; DIET CONDITION: The goal of the dietary condition includes increasing intake of fruit and vegetable to 5-servings per day. The program also encourages participants to increase the consumption of colorful fruits and vegetables. The fat goals consist of reducing saturated fats to <10% of total kilocalories per day, trans fats to <3 grams per day, and added sugar to <50 grams per day.	Behavioral: ALIVE; ALIVE is an email-based platform designed to help participants increase their physical activity, increase fruit and vegetable consumption, and decrease their intake of saturated and trans fats and added sugars. This automated system contains content and tailoring that is delivered in the form of emails obtained directly from cancer patients. Additional information they will receive included: tips for achieving those goals, health information, and opportunities for interaction and engagement.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean metabolic equivalent minutes of physical activity	Physical activity and sedentary behavior were assessed with the Work and Home Activity Questionnaire at baseline and at 3-months	3-months
Diet Quality	Dietary intake was assessed with Block health habits and history questionnaire. This instrument is a validated food frequency questionnaire	3-month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean health related quality of life scores	Health-related quality of life will be assessed with instruments measuring functional status, pain and fatigue interference, and cognitive function at baseline and at 3-months.	3-months

Collaborators and Investigators

• Sponsor: University of North Texas Health Science Center
• Collaborators: M.D. Anderson Cancer Center; The University of Texas Health Science Center, Houston; University of Alberta; University of Houston
• Investigators: Principal Investigator: Raheem Paxton, PhD, UNT - Health Science Center

Publications and helpful links

General Publications

• Sternfeld B, Block C, Quesenberry CP Jr, Block TJ, Husson G, Norris JC, Nelson M, Block G. Improving diet and physical activity with ALIVE: a worksite randomized trial. Am J Prev Med. 2009 Jun;36(6):475-83. doi: 10.1016/j.amepre.2009.01.036.
• Paxton RJ, Hajek R, Newcomb P, Dobhal M, Borra S, Taylor WC, Parra-Medina D, Chang S, Courneya KS, Block G, Block T, Jones LA. A Lifestyle Intervention via Email in Minority Breast Cancer Survivors: Randomized Parallel-Group Feasibility Study. JMIR Cancer. 2017 Sep 21;3(2):e13. doi: 10.2196/cancer.7495.

Study record dates

Study Major Dates

• Study Start: November 1, 2014
• Primary Completion (ACTUAL): December 1, 2015
• Study Completion (ACTUAL): June 1, 2016

Study Registration Dates

• First Submitted: March 20, 2016
• First Submitted That Met QC Criteria: March 23, 2016
• First Posted (ESTIMATE): March 30, 2016

Study Record Updates

• Last Update Posted (ESTIMATE): December 1, 2016
• Last Update Submitted That Met QC Criteria: November 29, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Keywords: physical activity; breast cancer; quality of life; dietary intake; cancer survivorship
• Other Study ID Numbers: 001 (Buy Pharma Ecza Deposu San. Tic. Ltd.)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Once data are compiled, the investigators will decide whether it will be available for sharing