Web-based Physical Activity Intervention for Young Adult Cancer Survivors

April 19, 2012 updated by: Carolyn Rabin, The Miriam Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • Miriam Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 39 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Physical Activity Intervention
Participants in this arm will be given access to a website designed to help them increase their levels of physical activity
Behavioral: Physical activity intervention
Comparison of providing access to a targeted physical activity web-site v. providing information on cancer-related websites
Placebo Comparator: Cancer Website Control Group
Participants in this arm will be given information on cancer-related websites (that do not provide information on physical activity)
Behavioral: Physical activity intervention
Comparison of providing access to a targeted physical activity web-site v. providing information on cancer-related websites

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Acceptability measure: response to the item "In general how satisfied were you with the intervention?"
Time Frame: 12 weeks
12 weeks
Feasibility measure: percentage of weeks that participants enter physical activity goals and information on the intervention website
Time Frame: 12 weeks
12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Minutes of moderate-intensity activity on Seven Day PAR
Time Frame: 12 weeks
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Miriam Hospital

Collaborators

Brown University

Investigators

  • Principal Investigator: Carolyn Rabin, The Miriam Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2009

Primary Completion (Actual)

April 1, 2011

Study Completion (Actual)

April 1, 2011

Study Registration Dates

First Submitted

November 12, 2008

First Submitted That Met QC Criteria

November 13, 2008

First Posted (Estimate)

November 14, 2008

Study Record Updates

Last Update Posted (Estimate)

April 20, 2012

Last Update Submitted That Met QC Criteria

April 19, 2012

Last Verified

April 1, 2012

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CA134197
  • 1R03CA134197 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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