Web-based Physical Activity Intervention for Young Adult Cancer Survivors

Cancer Clinical Trial

Official title:

Web-based Physical Activity Intervention for Young Adult Cancer Survivors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00791375
• Other study ID #: CA134197
• Secondary ID: 1R03CA134197
• Status: Completed
• Phase: N/A
• First received: November 12, 2008
• Last updated: April 19, 2012
• Start date: May 2009
• Est. completion date: April 2011

Study information

• Verified date: April 2012
• Source: The Miriam Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The goal of this study is to adapt a previously developed web-based physical activity intervention so that the intervention targets young adult cancer survivors(age 18 to 39). The web-based intervention will then be pilot tested to determine whether it is feasible for and acceptable to young adult cancer survivors; we hypothesize that the intervention will be both feasible and acceptable. Preliminary data on the effects of the intervention on physical activity level, mood and fatigue will also be collected.

Description:

Young adults diagnosed with cancer constitute a particularly vulnerable population whose medical and psychosocial needs are often overlooked. Those diagnosed with cancer between the ages of 18 and 39 face a number of increased risks including an increased risk of cardiovascular disease, second cancers, and emotional distress. Despite this, only a very small percentage of cancer research has focused on the survivorship issues of young adults. The goal of the proposed research is to address some of the unmet needs among young adult cancer survivors by developing and pilot testing a physical activity intervention for this population. Physical activity was selected as the target behavior as: 1. a high percentage of young adult cancer survivors have a sedentary lifestyle and 2. research has shown that cancer survivors who increase their physical activity experience improved cardiopulmonary function, reduced fatigue, enhanced mood and superior cancer outcomes. The intervention will be based on a previously developed, theoretically-grounded, tailored Internet intervention for sedentary adults. This previously developed intervention uses components of the Transtheoretical Model and Social Cognitive Theory to promote physical activity; for example, participants complete monthly questionnaires online and received tailored feedback reports addressing their self-efficacy, decisional balance and processes of change. The intervention website also includes features such as tips for exercising while caring for young children and local physical activity resources. Two key enhancements will be added to the intervention website in order to target the young adult cancer survivor population— 1. information pertinent to cancer survivors initiating an exercise program and 2. a peer-to-peer support component. Once these enhancements have been added, 10 young adult cancer survivors will evaluate the intervention and provide qualitative feedback. Additional revisions will be made to the intervention, as needed, based on this feedback. The intervention will then be pilot tested with a sample of 40 young adult cancer survivors. Participants will be randomly assigned to an intervention group (receiving 12 weeks of access to the intervention website) or a comparison group (receiving information on three cancer-specific Internet sites). Data on intervention feasibility and acceptability will be collected along with preliminary data on intervention effects (i.e., on physical activity level, mood, and fatigue). The latter will be used for effect size estimates when designing a future efficacy trial.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: April 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 39 Years

Eligibility

Inclusion Criteria:

• age 18 to 39

• diagnosed with any form of cancer (except non-melanoma skin cancer) between the ages of 18 and 39 in the past 10 years

• completed all surgery, chemotherapy and radiation therapy

• currently in a cancer remission

• able to speak and write fluently in English

• able to access the Internet (at home, school, or work)

• sedentary.

Exclusion Criteria:

• currently pregnant or the intention to get pregnant

• the presence of a known medical condition (e.g., history of CVD) or history of severe psychiatric illness (e.g., psychotic disorder) making participation dangerous or very difficult

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Cancer

Intervention

Behavioral:
• Physical activity intervention
Comparison of providing access to a targeted physical activity web-site v. providing information on cancer-related websites

Locations

Country	Name	City	State
United States	Miriam Hospital	Providence	Rhode Island

Sponsors (2)

Lead Sponsor	Collaborator
The Miriam Hospital	Brown University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility measure: percentage of weeks that participants enter physical activity goals and information on the intervention website		12 weeks	No
Primary	Acceptability measure: response to the item "In general how satisfied were you with the intervention?"		12 weeks	No
Secondary	Minutes of moderate-intensity activity on Seven Day PAR		12 weeks	No