Web-based Study for Cancer Survivors

Physical Activity Clinical Trial

Official title:

A Lifestyle Intervention Via Email (ALIVE) for Cancer Survivors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02722850
• Other study ID #: 001
• Status: Completed
• Phase: N/A
• First received: March 20, 2016
• Last updated: November 29, 2016
• Start date: November 2014
• Est. completion date: June 2016

Study information

• Verified date: November 2016
• Source: University of North Texas Health Science Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 258
• Est. completion date: June 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Dietary Modification
• Physical Activity

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (5)

Lead Sponsor	Collaborator
University of North Texas Health Science Center	M.D. Anderson Cancer Center, The University of Texas Health Science Center, Houston, University of Alberta, University of Houston

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	Diet Quality	Dietary intake was assessed with Block health habits and history questionnaire. This instrument is a validated food frequency questionnaire	3-month	No
Secondary	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	No