NCT00791375

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for not_applicable cancer

Timeline
Completed

Started May 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 12, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 14, 2008

Completed
6 months until next milestone

Study Start

First participant enrolled

May 1, 2009

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2011

Completed
Last Updated

April 20, 2012

Status Verified

April 1, 2012

Enrollment Period

1.9 years

First QC Date

November 12, 2008

Last Update Submit

April 19, 2012

Conditions

Keywords

young adultcancerexercisephysical activity

Outcome Measures

Primary Outcomes (2)

  • Feasibility measure: percentage of weeks that participants enter physical activity goals and information on the intervention website

    12 weeks

  • Acceptability measure: response to the item "In general how satisfied were you with the intervention?"

    12 weeks

Secondary Outcomes (1)

  • Minutes of moderate-intensity activity on Seven Day PAR

    12 weeks

Study Arms (2)

Physical Activity Intervention

EXPERIMENTAL

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

Cancer Website Control Group

PLACEBO COMPARATOR

Participants in this arm will be given information on cancer-related websites (that do not provide information on physical activity)

Behavioral: Physical activity intervention

Interventions

Comparison of providing access to a targeted physical activity web-site v. providing information on cancer-related websites

Cancer Website Control GroupPhysical Activity Intervention

Eligibility Criteria

Age18 Years - 39 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Miriam Hospital

Providence, Rhode Island, 02903, United States

Location

MeSH Terms

Conditions

NeoplasmsMotor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Carolyn Rabin

    The Miriam Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor (Research)

Study Record Dates

First Submitted

November 12, 2008

First Posted

November 14, 2008

Study Start

May 1, 2009

Primary Completion

April 1, 2011

Study Completion

April 1, 2011

Last Updated

April 20, 2012

Record last verified: 2012-04

Locations