Web-based Study for Cancer Survivors

University of North Texas Health Science Center

Status: Completed

Conditions: Physical Activity; Dietary Modification

Treatments: Behavioral: ALIVE

Study type: Interventional

Funder types: Other

Identifiers

NCT02722850

001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 258 patients

Sex: Female

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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258 participants in 2 patient groups

ALIVE - Physical Activity

Experimental group

Description:

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.

Treatment:

Behavioral: ALIVE

ALIVE - Dietary Modification

Experimental group

Description:

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.

Treatment:

Behavioral: ALIVE