Breast CancerNCT00372840
Printed Education Materials in Patients Who Are Finishing Treatment for Stage I, Stage II, or Stage IIIA Breast Cancer, Colorectal Cancer, Prostate Cancer, or Chest Cancer
A study testing educational intervention, psychosocial assessment and care and quality-of-life assessment in people with Breast Cancer and Colorectal Cancer, run by Fox Chase Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Breast Cancer, Colorectal Cancer, Lung Cancer
- What is being tested?
- educational intervention, psychosocial assessment and care and quality-of-life assessment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 340 participants
- Where
- 1 siteUnited States
- Study dates
- May 2006to Mar 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Fox Chase Cancer Center - Philadelphia
Philadelphia, Pennsylvania, 19111-2497
About this study
Official title: Efficacy and Feasibility of a Psychosocial Intervention Within the CCOP Context: Evaluation of the Facing Forward Guide to Facilitate Life After Active Cancer Treatment
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.
Read the detailed description
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.
- Conditions
- Breast Cancer, Colorectal Cancer, Lung Cancer, Malignant Mesothelioma, Prostate Cancer, Psychosocial Effects of Cancer and Its Treatment
- Being tested
- educational intervention, psychosocial assessment and care, quality-of-life assessment
- Keywords
- 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
- Medical subject headings
- Breast Neoplasms, Colorectal Neoplasms, Lung Neoplasms, Mesothelioma, Malignant, Prostatic Neoplasms, Thymoma, Colonic Neoplasms, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
educational interventionOther
psychosocial assessment and careProcedure or surgery
quality-of-life assessmentProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: educational intervention |
| Arm II | Active comparator | Patients receive the general print intervention fact sheet entitled The Cancer Information Service, Questions and Answers. Receives: Procedure: psychosocial assessment and care; Procedure: quality-of-life assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Uptake of recommended actions
Measured: 18 days, 8 weeks, 6 months after completion of treatment
Number of sections of the Facing Forward manual read with satisfaction and comprehension
Measured: 18 days, 8 weeks, 6 months after completion of treatment
Secondary outcomes (1)
Changes in psychological outcomes from baseline to 8-week follow-up
Measured: 8 weeks, 6 months after completion of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2006 (estimated)
- Study startMay 2006
- Primary completionNov 2010
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Fox Chase Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 340 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fox Chase Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Suzanne M. Miller, PhD, Principal investigator, Fox Chase Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00372840
- Sponsor's protocol ID
- FCCC-FCRB-04-002-P
- Other IDs
- CDR0000464245, NCI-2009-00569, 06-803
- Status last verified
- Feb 2020
- First submitted
- 6 Sep 2006
- Last updated
- 2 Mar 2020
- Results posted
- No
Publications
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.
PubMed 10694561
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Feasibility of a Psychosocial Intervention Within the CCOP Context: Evaluation of the Facing Forward Guide to Facilitate Life After Active Cancer Treatment
- ClinicalTrials.gov ID
- NCT00372840
- Acronym / sponsor ID
- FCCC-FCRB-04-002-P
- Conditions
- Breast Cancer, Colorectal Cancer, Lung Cancer, Malignant Mesothelioma, Prostate Cancer, Psychosocial Effects of Cancer and Its Treatment
- Keywords
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 340 participants (actual)
- Lead sponsor
- Fox Chase Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- May 2006
- Primary completion
- Nov 2010 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 7 Sep 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I | Experimental | Other: educational interventionPatients 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 | Active comparator | Procedure: psychosocial assessment and care, Procedure: quality-of-life assessmentPatients receive the general print intervention fact sheet entitled The Cancer Information Service, Questions and Answers. |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| educational intervention | Other | Arm I |
| psychosocial assessment and care | Procedure or surgery | Arm II |
| quality-of-life assessment | Procedure or surgery | Arm II |
Primary outcome
Uptake of recommended actions
Time frame: 18 days, 8 weeks, 6 months after completion of treatment
Number of sections of the Facing Forward manual read with satisfaction and comprehension
Time frame: 18 days, 8 weeks, 6 months after completion of treatment
1 secondary outcome
Changes in psychological outcomes from baseline to 8-week follow-up
Time frame: 8 weeks, 6 months after completion of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2020.
- Background: PubMed 10694561Green 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Suzanne M. Miller, PhD principal investigator
Fox Chase Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing educational intervention, psychosocial assessment and care and quality-of-life assessment in people with Breast Cancer and Colorectal Cancer, run by Fox Chase Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Uptake of recommended actions (time frame: 18 days, 8 weeks, 6 months after completion of treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00372840, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2020.