Web-based Study for Cancer Survivors

NCT ID: NCT02722850

Last Updated: 2016-12-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

258 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-30

Study Completion Date

2016-06-30

Brief Summary

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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

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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.

Conditions

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Physical Activity Dietary Modification

Keywords

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breast cancer cancer survivorship dietary intake physical activity quality of life

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

ALIVE

Intervention Type 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.

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.

Group Type EXPERIMENTAL

ALIVE

Intervention Type 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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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M.D. Anderson Cancer Center

OTHER

Sponsor Role collaborator

The University of Texas Health Science Center, Houston

OTHER

Sponsor Role collaborator

University of Houston

OTHER

Sponsor Role collaborator

University of Alberta

OTHER

Sponsor Role collaborator

University of North Texas Health Science Center

OTHER

Sponsor Role lead

Responsible Party

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Raheem Paxton

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Raheem Paxton, PhD

Role: PRINCIPAL_INVESTIGATOR

UNT - Health Science Center

References

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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.

Reference Type BACKGROUND
PMID: 19460655 (View on PubMed)

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.

Reference Type DERIVED
PMID: 28935620 (View on PubMed)

Other Identifiers

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001

Identifier Type: -

Identifier Source: org_study_id