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Efficacy and Feasibility of a Psychosocial Intervention Within the CCOP Context: Evaluation of the Facing Forward Guide to Facilitate Life After Active Cancer Treatment


N/A
18 Years
N/A
Open (Enrolling)
Both
Breast Cancer, Colorectal Cancer, Lung Cancer, Malignant Mesothelioma, Prostate Cancer, Psychosocial Effects of Cancer and Its Treatment, Thymoma and Thymic Carcinoma

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Trial Information

Efficacy and Feasibility of a Psychosocial Intervention Within the CCOP Context: Evaluation of the Facing Forward Guide to Facilitate Life After Active Cancer Treatment


OBJECTIVES:

Primary

- Determine the efficacy of a psychoeducational intervention comprising a specific print
intervention manual (Facing Forward Series: Life After Cancer Treatment [Facing Forward
manual]) and a general print intervention fact sheet (The Cancer Information Service,
Questions and Answers) vs the general print intervention fact sheet only on the uptake
of recommended actions (e.g., developing a wellness plan after treatment, dealing with
pain and fatigue, finding support groups to deal with feelings after treatment, and
dealing with family issues after treatment) in patients completing active treatment for
stage I-IIIA breast, prostate, colorectal, or thoracic cancer.

- Explore patient process evaluations of the Facing Forward manual in terms of its
usability, comprehension, and satisfaction.

Secondary

- Examine psychological outcomes (i.e., depressive symptoms, fear of recurrence,
health-related quality of life, and self-efficacy) as a function of exposure to the
Facing Forward manual.

OUTLINE: This is a multicenter, randomized, controlled, open-label, cohort study. Patients
are stratified according to participating center, prior chemotherapy (yes vs no), and type
of cancer (breast vs colorectal vs prostate vs thoracic). Patients are randomized to 1 of 2
arms.

- Arm I (intervention): 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.

- Arm II (control): Patients receive the general print intervention fact sheet entitled
The Cancer Information Service, Questions and Answers.

In both arms, patients are evaluated at baseline (within 18 days of the patient's final
cancer treatment visit), 8 weeks (via mailed home materials), and then at 6 months (via
mailed home materials). Baseline evaluations include background information (i.e.,
demographics and medical status), baseline use of educational materials, survivorship
activities, and psychological factors (i.e., depressive symptoms, quality of life, fear of
recurrence, and self-efficacy). Psychological factors are also reassessed at 8 weeks and 6
months, as well as use of educational materials and survivorship activities.

For patients in both arms, uptake of recommended actions are reassessed. Patients in arm I
complete ratings of the Facing Forward Series: Life After Cancer Treatment manual usability,
comprehension, and satisfaction at 8 weeks and 6 months.

PROJECTED ACCRUAL: A total of 332 patients will be accrued for this study.

Inclusion Criteria


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)

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Masking: Open Label

Outcome Measure:

Uptake of recommended actions

Safety Issue:

No

Principal Investigator

Suzanne M. Miller, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Fox Chase Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000464245

NCT ID:

NCT00372840

Start Date:

May 2006

Completion Date:

Related Keywords:

  • Breast Cancer
  • Colorectal Cancer
  • Lung Cancer
  • Malignant Mesothelioma
  • Prostate Cancer
  • Psychosocial Effects of Cancer and Its Treatment
  • Thymoma and Thymic Carcinoma
  • psychosocial effects of cancer and its treatment
  • stage I breast cancer
  • stage II breast cancer
  • stage IIIA breast cancer
  • stage IIIA colon cancer
  • stage I prostate cancer
  • stage IIB prostate cancer
  • stage IIA prostate cancer
  • stage III prostate cancer
  • stage I non-small cell lung cancer
  • stage II non-small cell lung cancer
  • stage IIIA non-small cell lung cancer
  • limited stage small cell lung cancer
  • stage I rectal cancer
  • stage IIA rectal cancer
  • stage IIB rectal cancer
  • stage IIC rectal cancer
  • stage IIIA rectal cancer
  • pulmonary carcinoid tumor
  • stage I thymoma
  • stage II thymoma
  • stage III thymoma
  • stage I colon cancer
  • stage IIA colon cancer
  • stage IIB colon cancer
  • stage IIC colon cancer
  • stage IA malignant mesothelioma
  • stage IB malignant mesothelioma
  • stage II malignant mesothelioma
  • stage III malignant mesothelioma
  • Breast Neoplasms
  • Carcinoma
  • Colorectal Neoplasms
  • Lung Neoplasms
  • Mesothelioma
  • Prostatic Neoplasms
  • Thymoma

Name

Location

Fox Chase Cancer Center - PhiladelphiaPhiladelphia, Pennsylvania  19111-2497