Life After Cancer: Behavioral Treatment Study to Improve... | NCT00473941

Studies
Life After Cancer: Behavioral Treatment Study to Improve Quality of Life

NCT00473941

Sponsor

Temple University

Status

Completed

Last Update Posted

Aug 2, 2022Actual

Enrollment

193Actual

Phase

Not Applicable

Conditions

Colorectal Cancer

Interventions

Expressive writing

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2005

Primary Completion Date

Aug 2008Actual

Completion Date

Aug 2008Actual

First Submitted Date

May 15, 2007

First Submission Date that Met QC Criteria

May 15, 2007

First Posted Date

May 16, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 29, 2022

Last Update Posted Date

Aug 2, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Individuals who take part in the study can expect:

Two Interviews:

To be interviewed by our research staff over the phone. The interviews will include questions about your current quality of life and health.

Brief Writing in a Journal:

To write for 15 minutes twice a week for two weeks about aspects of your life.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

193Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Expressive writing	Behavioral	Behavioral intervention using writing about cancer to improve quality of life outcomes	1 2

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Depressive symptoms	self-report depressive symptoms	2-Weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Stephen Lepore, Ph.D.	Temple University	Principal Investigator
Tracey A Revenson, Ph.D	Graduate College, City University of New York	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Temple University		Philadelphia	Pennsylvania	19122	United States

Label	URL
Colon Cancer Alliance	View source
Cancer Information Network	View source

Condition Browse Module

MeSH Terms

ID	Term
D015179	Colorectal Neoplasms
D003110	Colonic Neoplasms
D012004	Rectal Neoplasms

Ancestor Terms

ID	Term
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site

Browse Leaves

Not provided

Browse Branches

Not provided