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Web-based Study for Cancer Survivors

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ClinicalTrials.gov Identifier: NCT02722850
Recruitment Status : Completed
First Posted : March 30, 2016
Last Update Posted : December 1, 2016
Sponsor:
Collaborators:
M.D. Anderson Cancer Center
The University of Texas Health Science Center, Houston
University of Houston
University of Alberta
Information provided by (Responsible Party):
Raheem Paxton, University of North Texas Health Science Center

Brief 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.

Condition or disease Intervention/treatment Phase
Physical Activity Dietary Modification Behavioral: ALIVE Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 258 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: A Lifestyle Intervention Via Email (ALIVE) for Cancer Survivors
Study Start Date : November 2014
Actual Primary Completion Date : December 2015
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02722850


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

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Raheem Paxton, Assistant Professor, University of North Texas Health Science Center
ClinicalTrials.gov Identifier: NCT02722850     History of Changes
Other Study ID Numbers: 001
First Posted: March 30, 2016    Key Record Dates
Last Update Posted: December 1, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Once data are compiled, the investigators will decide whether it will be available for sharing

Keywords provided by Raheem Paxton, University of North Texas Health Science Center:
breast cancer
cancer survivorship
dietary intake
physical activity
quality of life