NCT01440855

Brief Summary

This study was designed to provide a preliminary evaluation of the efficacy and usability of the 2004 revised version of the booklet, Facing Forward , Life After Cancer Treatment, (hereafter,Facing Forward) published by the National Cancer Institute. Facing Forward provides early stage cancer patients during the period after completing active treatment practical ways of dealing with common problems, including guidelines for managing physical, social, and emotional health. Assessments were completed at the patient's final cancer treatment visit. Follow-up assessments occurred eight weeks and 6 months later. The initial assessments covered background information (demographics, medical status), use of educational materials, survivorship activities, and psychological factors. The follow-up assessments included use of actions recommended in Facing Forward, ratings of Facing Forward with respect the booklet's informativeness, helpfulness, understandability, and extent read, the same psychological measures used initially, and a measure of self-efficacy.

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 prostate-cancer

Timeline
Completed

Started Feb 2005

Typical duration for not_applicable prostate-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

February 1, 2005

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

September 22, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 27, 2011

Completed
Last Updated

October 4, 2011

Status Verified

September 1, 2011

Enrollment Period

4.7 years

First QC Date

September 22, 2011

Last Update Submit

September 30, 2011

Conditions

Prostate CancerBreast CancerColorectal CancerThoracic Cancer

Keywords

Survivorshipcancer controlpsychosocial interventionsFacing Forward

Outcome Measures

Primary Outcomes (3)

  • Reported uptake of behavioral actions recommended in Facing Forward

    Items asked whether the respondent engaged in each recommended behavior (Yes or No); affirmative responses to the items comprising each subscale were summed to create four subscale scores:use of follow-up medical care (6 items; e.g., have you developed a wellness plan?), management of side effects of management (7 items; e.g., have you used any tips for regaining your appetite? ), uptake of stress management (8 items; e.g., have you used relaxation techniques? ), management of social and financial matters management (7 items; e.g., have you used suggested tips for dealing with family issues?.

    Baseline

  • Reported uptake of behavioral actions recommended in Facing Forward

    Items asked whether the respondent engaged in each recommended behavior (Yes or No); affirmative responses to the items comprising each subscale were summed to create four subscale scores:use of follow-up medical care (6 items; e.g., have you developed a wellness plan?), management of side effects of management (7 items; e.g., have you used any tips for regaining your appetite? ), uptake of stress management (8 items; e.g., have you used relaxation techniques? ), management of social and financial matters management (7 items; e.g., have you used suggested tips for dealing with family issues?.

    8-weeks post-baseline

  • Reported uptake of behavioral actions recommended in Facing Forward

    Items asked whether the respondent engaged in each recommended behavior (Yes or No); affirmative responses to the items comprising each subscale were summed to create four subscale scores:use of follow-up medical care (6 items; e.g., have you developed a wellness plan?), management of side effects of management (7 items; e.g., have you used any tips for regaining your appetite? ), uptake of stress management (8 items; e.g., have you used relaxation techniques? ), management of social and financial matters management (7 items; e.g., have you used suggested tips for dealing with family issues?.

    6-months post-baseline

Secondary Outcomes (2)

  • Usability of Facing Forward

    Eight weeks post-baseline

  • Usability of Facing Forward

    6 months post-baseline

Study Arms (2)

CIS Fact Sheet (CIS: Cancer Information Service)

ACTIVE COMPARATOR

CIS Fact Sheet, available on the Cancer Information Service website. Used to control for attention. 5-page document provides information about the CIS:What is it, How can CIS information specialists help me, How can I use CIS's services. Also includes definitions of glossary terms and a table of email and website addresses.

Other: CIS (Cancer Information Service) Information Sheet

Facing Forward booklet

EXPERIMENTAL

NCI's Facing Forward 61-page booklet, which describes common feelings and reactions that cancer survivors experience during the re-entry phase and offers behavioral recommendations to help them through this period, i.e., ways of dealing with common problems and guidelines for managing physical, social, and emotional health. Booklet sections: Congratulations on Finishing Your Cancer Treatment, Getting Follow-up Medical Care, Ways to Manage Physical Changes, Body Changes and Intimacy, Your Feelings, Social and Work Relationships, Reflection, 6-page Appendix, which provides information on Financial and Legal Matters, and Resource Organizations.

Other: Facing Forward booklet

Interventions

CIS (Cancer Information Service) Information SheetOTHER

CIS Fact Sheet, available on the Cancer Information Service website. Used to control for attention. 5-page document provides information about the CIS:What is it, How can CIS information specialists help me, How can I use CIS's services. Also includes definitions of glossary terms and a table of email and website addresses.

CIS Fact Sheet (CIS: Cancer Information Service)
Facing Forward bookletOTHER

NCI's (NCI: National Cancer Institute) Facing Forward 61-page booklet, which describes common feelings and reactions that cancer survivors experience during the re-entry phase and offers behavioral recommendations to help them through this period, i.e., ways of dealing with common problems and guidelines for managing physical, social, and emotional health. Booklet sections: Congratulations on Finishing Your Cancer Treatment, Getting Follow-up Medical Care, Ways to Manage Physical Changes, Body Changes and Intimacy, Your Feelings, Social and Work Relationships, Reflection, 6-page Appendix, which provides information on Financial and Legal Matters, and Resource Organizations.

Facing Forward booklet

Eligibility Criteria

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

You may qualify if:

  • current age at or above 18 years;
  • breast, colorectal, prostate, and/or thoracic cancer diagnosis,stage I, II, IIIa;
  • approaching or attending the last treatment appointment of chemotherapy and or radiation therapy for the cancer diagnosis
  • English speaking (able to read English at an 8th grade level);
  • have a mailing address;
  • have residential phone service;
  • able to give informed consent.

You may not qualify if:

  • patients who have received surgery only with no adjuvant therapy;
  • second primary cancer or recurrent disease;
  • patients receiving brachytherapy only

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location

MeSH Terms

Conditions

Prostatic NeoplasmsBreast NeoplasmsColorectal Neoplasms

Interventions

cytokine inducible SH2-containing protein

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital DiseasesBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Suzanne M Miller-Halegoua, PhD

    Fox Chase Cancer Center

    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

September 22, 2011

First Posted

September 27, 2011

Study Start

February 1, 2005

Primary Completion

October 1, 2009

Study Completion

October 1, 2009

Last Updated

October 4, 2011

Record last verified: 2011-09

Locations

US(1)