Clinical trial NCT02722850: Web-based Study for Cancer Survivors
Official title: A Lifestyle Intervention Via Email (ALIVE) for Cancer Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physical Activity
Dietary Modification
Keywords: breast cancer
cancer survivorship
dietary intake
physical activity
quality of life
Lead sponsor: University of North Texas Health Science Center
Sponsor class: OTHER
Collaborators: name: M.D. Anderson Cancer Center
name: The University of Texas Health Science Center, Houston
name: University of Houston
name: University of Alberta
First posted: 2016-03-30
Enrollment: 258
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility 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.

Primary outcomes:
measure: Mean metabolic equivalent minutes of physical activity
timeFrame: 3-months
measure: Diet Quality
timeFrame: 3-month
Secondary outcomes:
measure: Mean health related quality of life scores
timeFrame: 3-months
Other outcomes:
Locations:
Study officials:
affiliation: UNT - Health Science Center
name: Raheem Paxton, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.