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Efficacy and Feasibility of a Psychosocial Intervention Within CCOP Context: Evaluation of the Facing Forward Guide to Facilitate Life After Active Cancer Treatment (CCOP:Community Clinical Oncology Program)


N/A
18 Years
N/A
Not Enrolling
Both
Prostate Cancer, Breast Cancer, Colorectal Cancer, Thoracic Cancer

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Trial Information

Efficacy and Feasibility of a Psychosocial Intervention Within CCOP Context: Evaluation of the Facing Forward Guide to Facilitate Life After Active Cancer Treatment (CCOP:Community Clinical Oncology Program)


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. The study employed a randomized controlled repeated measures
design and compared Facing Forward with a control document published by the National Cancer
Institute, The Cancer Information Service: Questions and Answers. The intervention arm
received both Facing Forward and the control document and the control arm received only the
latter. Assessments were completed at baseline, which occurred at the patient's final cancer
treatment visit or alternatively at the first follow-up visit for those scheduled to be
evaluated and/or restaged within 28 days of their last treatment visit. The first follow-up
assessment occurred eight weeks following the baseline assessment via mail-home materials,
and the second occurred 6 months following the baseline assessment, again via mail-home
materials. Baseline measures included background information (demographics, medical status),
use of educational materials, survivorship activities engaged in, and psychological factors.
The 8-week and 6-month assessments included uptake of actions recommended in Facing
Forward, and ratings of Facing Forward with respect to its usability, including the
booklet's informativeness, helpfulness, understandability, and extent read, and the same
psychological factors assessed at baseline.


Inclusion Criteria:



- 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.

Exclusion Criteria:

- patients who have received surgery only with no adjuvant therapy;

- second primary cancer or recurrent disease;

- patients receiving brachytherapy only

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care

Outcome Measure:

Reported uptake of behavioral actions recommended in Facing Forward

Outcome Description:

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?.

Outcome Time Frame:

Baseline

Safety Issue:

No

Principal Investigator

Suzanne M Miller-Halegoua, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Fox Chase Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

IRB06803

NCT ID:

NCT01440855

Start Date:

February 2005

Completion Date:

October 2009

Related Keywords:

  • Prostate Cancer
  • Breast Cancer
  • Colorectal Cancer
  • Thoracic Cancer
  • Survivorship
  • cancer control
  • psychosocial interventions
  • Facing Forward
  • Breast Neoplasms
  • Colorectal Neoplasms
  • Prostatic Neoplasms
  • Thoracic Neoplasms

Name

Location

Fox Chase Cancer Center Philadelphia, Pennsylvania  19111