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Completed

NCT Number: NCT02722850

Web-based Study 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.

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Key information

Conditions

Physical Activity Behavior Breast Diseases Breast Neoplasms Dietary Modification Motor Activity Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

ALIVE

Behavioral

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.

Primary outcomes

  1. Mean metabolic equivalent minutes of physical activity

    Time frame: 3-months

    Physical activity and sedentary behavior were assessed with the Work and Home Activity Questionnaire at baseline and at 3-months

  2. Diet Quality

    Time frame: 3-month

    Dietary intake was assessed with Block health habits and history questionnaire. This instrument is a validated food frequency questionnaire

Secondary outcomes

  1. Mean health related quality of life scores

    Time frame: 3-months

    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.

Sponsors and collaborators

Lead sponsor

University of North Texas Health Science Center

Other

Collaborators

  • M.D. Anderson Cancer Center
  • The University of Texas Health Science Center, Houston
  • University of Alberta
  • University of Houston

Registry information

Official study title

A Lifestyle Intervention Via Email (ALIVE) for Cancer Survivors

Important dates

Study start
2014
Primary completion
2015
Study completion
2016
First posted
Mar 30, 2016
Registry last updated
Dec 1, 2016

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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