NCT00473941

Brief Summary

The purpose of the study is to find new ways to improve the quality of life of people who have been treated for colon or rectal cancer.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
193

participants targeted

Target at P50-P75 for not_applicable colorectal-cancer

Timeline
Completed

Started Sep 2005

Typical duration for not_applicable colorectal-cancer

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2005

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

May 15, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 16, 2007

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2008

Completed
Last Updated

August 2, 2022

Status Verified

July 1, 2022

Enrollment Period

2.9 years

First QC Date

May 15, 2007

Last Update Submit

July 29, 2022

Conditions

Colorectal Cancer

Keywords

colorectal cancercolon cancerrectal cancer

Outcome Measures

Primary Outcomes (1)

  • Depressive symptoms

    self-report depressive symptoms

    2-Weeks

Study Arms (2)

1

EXPERIMENTAL

Writing in a journal 15 minutes a day

Behavioral: Expressive writing

2

PLACEBO COMPARATOR

Control Writing in a journal 15 minutes a day

Behavioral: Expressive writing

Interventions

Expressive writingBEHAVIORAL

Behavioral intervention using writing about cancer to improve quality of life outcomes

12

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Treated for stage I, II or III colon or rectal cancer in the past 5 years
  • Completed surgical treatment
  • Must be able to read and write in English

You may not qualify if:

  • History of other cancers, with the exception of non-melanoma skin cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Temple University

Philadelphia, Pennsylvania, 19122, United States

Location

Related Links

MeSH Terms

Conditions

Colorectal NeoplasmsColonic NeoplasmsRectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Stephen Lepore, Ph.D.

    Temple University

    PRINCIPAL INVESTIGATOR

  • Tracey A Revenson, Ph.D

    Graduate College, City University of New York

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 15, 2007

First Posted

May 16, 2007

Study Start

September 1, 2005

Primary Completion

August 1, 2008

Study Completion

August 1, 2008

Last Updated

August 2, 2022

Record last verified: 2022-07

Locations

US(1)