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Web-based Study for Cancer Survivors

A Lifestyle Intervention Via Email (ALIVE) for Cancer Survivors

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02722850
Enrollment
258
Registered
2016-03-30
Start date
2014-11-30
Completion date
2016-06-30
Last updated
2016-12-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dietary Modification, Physical Activity

Keywords

breast cancer, cancer survivorship, dietary intake, physical activity, quality of life

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.

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.

Interventions

BEHAVIORALALIVE

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.

Sponsors

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

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 80 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Mean metabolic equivalent minutes of physical activity3-monthsPhysical activity and sedentary behavior were assessed with the Work and Home Activity Questionnaire at baseline and at 3-months
Diet Quality3-monthDietary intake was assessed with Block health habits and history questionnaire. This instrument is a validated food frequency questionnaire

Secondary

MeasureTime frameDescription
Mean health related quality of life scores3-monthsHealth-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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 26, 2026