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Web-based Physical Activity Intervention for Young Adult Cancer Survivors

This study has been completed.
Sponsor:
Collaborator:
Brown University
Information provided by (Responsible Party):
Carolyn Rabin, The Miriam Hospital
ClinicalTrials.gov Identifier:
NCT00791375
First received: November 12, 2008
Last updated: April 19, 2012
Last verified: April 2012
  Purpose

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.


Condition Intervention
Cancer
Behavioral: Physical activity intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Web-based Physical Activity Intervention for Young Adult Cancer Survivors

Resource links provided by NLM:


Further study details as provided by The Miriam Hospital:

Primary Outcome Measures:
  • Feasibility measure: percentage of weeks that participants enter physical activity goals and information on the intervention website [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Acceptability measure: response to the item "In general how satisfied were you with the intervention?" [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Minutes of moderate-intensity activity on Seven Day PAR [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 18
Study Start Date: May 2009
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 39 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00791375

Locations
United States, Rhode Island
Miriam Hospital
Providence, Rhode Island, United States, 02903
Sponsors and Collaborators
The Miriam Hospital
Brown University
Investigators
Principal Investigator: Carolyn Rabin The Miriam Hospital
  More Information

No publications provided

Responsible Party: Carolyn Rabin, Assistant Professor (Research), The Miriam Hospital
ClinicalTrials.gov Identifier: NCT00791375     History of Changes
Other Study ID Numbers: CA134197, 1 R03 CA134197
Study First Received: November 12, 2008
Last Updated: April 19, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by The Miriam Hospital:
young adult
cancer
exercise
physical activity

ClinicalTrials.gov processed this record on November 20, 2014