NCT00372840

Brief Summary

RATIONALE: Printed educational materials, such as the Facing Forward Series: Life After Cancer Treatment manual, may help make the transition from cancer patient to cancer survivor easier in patients who are finishing treatment for cancer. It is not yet known if the Facing Forward Series: Life After Cancer Treatment manual and The Cancer Information Service, Questions and Answers fact sheet is more effective than the The Cancer Information Service, Questions and Answers fact sheet alone in helping to make life after cancer treatment easier and to improve quality of life in patients with breast cancer, colorectal cancer, prostate cancer, or chest cancer. PURPOSE: This randomized clinical trial is studying how well printed education materials work in assisting patients who are finishing treatment for stage I, stage II, or stage IIIA breast cancer, colorectal cancer, prostate cancer, or chest cancer to make the transition from cancer patient to cancer survivor easier.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
340

participants targeted

Target at P75+ for not_applicable breast-cancer

Timeline
Completed

Started May 2006

Longer than P75 for not_applicable breast-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

May 1, 2006

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 6, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 7, 2006

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2010

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
Last Updated

March 2, 2020

Status Verified

February 1, 2020

Enrollment Period

4.5 years

First QC Date

September 6, 2006

Last Update Submit

February 27, 2020

Conditions

Breast CancerColorectal CancerLung CancerMalignant MesotheliomaProstate CancerPsychosocial Effects of Cancer and Its TreatmentThymoma and Thymic Carcinoma

Keywords

psychosocial effects of cancer and its treatmentstage I breast cancerstage II breast cancerstage IIIA breast cancerstage IIIA colon cancerstage I prostate cancerstage IIB prostate cancerstage IIA prostate cancerstage III prostate cancerstage I non-small cell lung cancerstage II non-small cell lung cancerstage IIIA non-small cell lung cancerlimited stage small cell lung cancerstage I rectal cancerstage IIA rectal cancerstage IIB rectal cancerstage IIC rectal cancerstage IIIA rectal cancerpulmonary carcinoid tumorstage I thymomastage II thymomastage III thymomastage I colon cancerstage IIA colon cancerstage IIB colon cancerstage IIC colon cancerstage IA malignant mesotheliomastage IB malignant mesotheliomastage II malignant mesotheliomastage III malignant mesothelioma

Outcome Measures

Primary Outcomes (2)

  • Uptake of recommended actions

    18 days, 8 weeks, 6 months after completion of treatment

  • Number of sections of the Facing Forward manual read with satisfaction and comprehension

    18 days, 8 weeks, 6 months after completion of treatment

Secondary Outcomes (1)

  • Changes in psychological outcomes from baseline to 8-week follow-up

    8 weeks, 6 months after completion of treatment

Study Arms (2)

Arm I

EXPERIMENTAL

Patients receive a specific print intervention manual entitled Facing Forward Series: Life After Cancer Treatment and a general print intervention fact sheet entitled The Cancer Information Service, Questions and Answers.

Other: educational intervention

Arm II

ACTIVE COMPARATOR

Patients receive the general print intervention fact sheet entitled The Cancer Information Service, Questions and Answers.

Procedure: psychosocial assessment and careProcedure: quality-of-life assessment

Interventions

educational interventionOTHER
Arm I
psychosocial assessment and carePROCEDURE
Arm II
quality-of-life assessmentPROCEDURE
Arm II

Eligibility Criteria

Age18 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Diagnosis of breast, colorectal, prostate, or thoracic cancer\* * Stage I-III disease * Approaching, attending, or already attended with the past 28 days, the last treatment appointment of chemotherapy and/or radiotherapy NOTE: \*Stage IIIA disease for thoracic cancer and excluded mesothelioma; if small cell lung cancer is present must be limited stage disease * No more than 1 primary cancer * No recurrent disease * Hormone receptor status not specified PATIENT CHARACTERISTICS: * Male or female * Menopausal status not specified * Able to speak/read English at an 8th grade level PRIOR CONCURRENT THERAPY: * See Disease Characteristics * No prior brachytherapy only * No prior surgery only (i.e., must have received prior adjuvant therapy and surgery)

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Fox Chase Cancer Center - Philadelphia

Philadelphia, Pennsylvania, 19111-2497, United States

Location

Related Publications (1)

  • Green BL, Krupnick JL, Rowland JH, Epstein SA, Stockton P, Spertus I, Stern N. Trauma history as a predictor of psychologic symptoms in women with breast cancer. J Clin Oncol. 2000 Mar;18(5):1084-93. doi: 10.1200/JCO.2000.18.5.1084.

    PMID: 10694561BACKGROUND

MeSH Terms

Conditions

Breast NeoplasmsColorectal NeoplasmsLung NeoplasmsMesothelioma, MalignantProstatic NeoplasmsThymomaColonic NeoplasmsCarcinoma, Non-Small-Cell LungRectal Neoplasms

Interventions

Early Intervention, EducationalPsychiatric Rehabilitation

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesRespiratory Tract NeoplasmsThoracic NeoplasmsLung DiseasesRespiratory Tract DiseasesMesotheliomaAdenomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasms, MesothelialPleural NeoplasmsGenital Neoplasms, MaleUrogenital NeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital DiseasesNeoplasms, Complex and MixedThymus NeoplasmsLymphatic DiseasesHemic and Lymphatic DiseasesCarcinoma, BronchogenicBronchial Neoplasms

Intervention Hierarchy (Ancestors)

Child Health ServicesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesPreventive Health ServicesRehabilitationTherapeutics

Study Officials

  • Suzanne M. Miller, PhD

    Fox Chase Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 6, 2006

First Posted

September 7, 2006

Study Start

May 1, 2006

Primary Completion

November 1, 2010

Study Completion

March 1, 2013

Last Updated

March 2, 2020

Record last verified: 2020-02

Locations

US(1)