Breast CancerNCT00416780
Psychosocial Support in Treating Women With Recurrent Breast Cancer or Stage I, Stage II, or Stage IV Breast Cancer
A study testing counseling intervention, educational intervention and psychosocial assessment and care in people with Breast Cancer and Psychosocial Effects of Cancer and Its Treatment, run by Pittsburgh Mind-Body Center at Carnegie Mellon University.
Trial summary
RATIONALE: Meeting together with other breast cancer patients to receive psychosocial support and to learn to reduce stress may help patients cope with their diagnosis, have a better quality of life, and live more comfortably. Read more about this study
- Who is it for?
- Ages 25 years and older, women only
- Conditions the study is for
- Breast Cancer, Psychosocial Effects of Cancer and Its Treatment
- What is being tested?
- counseling intervention, educational intervention and psychosocial assessment and care
- Type of treatment
- Surgery or procedure
- How many people
- 350 participants
- Where
- No sites listed yet
- Study dates
- Start not givento Mar 2006
- 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 25 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Diagnosed with breast cancer
- First-time diagnosis of stage I or II disease
- No more than 2 months since prior breast cancer surgery
- Initial diagnosis of stage IV disease
- Distant recurrence of prior breast cancer
- Hormone receptor status not specified
PATIENT CHARACTERISTICS:
- Female
- Menopausal status not specified
- Reside within a 60-mile radius of the greater Pittsburgh metropolitan area
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
About this study
Official title: Psychobiological Pathways: Breast Cancer Interventions
RATIONALE: Meeting together with other breast cancer patients to receive psychosocial support and to learn to reduce stress may help patients cope with their diagnosis, have a better quality of life, and live more comfortably.
PURPOSE: This randomized clinical trial is studying how well psychosocial support works in treating women with recurrent breast cancer or stage I, stage II, or stage IV breast cancer.
Read the detailed description
OBJECTIVES:
- Evaluate theoretically derived psychosocial interventions (peer discussion support vs education and stress management vs usual-care control) targeted to enhance adjustment and functional status and lower morbidity among women diagnosed with and treated for recurrent or stage I, II, or IV breast cancer.
- Evaluate the psychological, behavioral, and biological pathways and their effects in patients treated with these interventions.
- Evaluate the efficacy of these intervention in these patients.
- Evaluate the nature and extent of coping strategies in these patients.
- Evaluate the differences in patients treated with these intervention vs those patients electing not to be treated with these interventions.
OUTLINE: This is a randomized study. Patients are stratified according to disease stage (early vs late). Patients with early-stage disease are randomized to 1 of 3 intervention arms. Patients with late-stage disease are randomized to 1 of 2 intervention arms (II or III).
- Arm I (education and stress management): Patients undergo a 1-hour group (6-10 patients per group) education session once a week for 8 weeks focusing on exchange of factual information between a facilitator and patients. The session includes a 45-minute lecture, discussing risks, diagnosis, and treatment of cancer; side effects from treatment; nutrition during treatment; and follow-up care, followed by a question/answer period and instruction in progressive relaxation techniques. Patients then receive 3 monthly phone calls from a project staff member to answer questions about cancer, treatment, and follow-up care and to discuss the relaxation exercises.
- Arm II (peer discussion): Patients undergo a 1-hour group (6-10 patients per group) peer support session once a week for 8 weeks focusing on the provision of emotional support among patients and the maintenance of purpose in life. The session emphasizes on the sharing of experiences, the development of a common bond, and the promotion of altruism to similar others. Patients then are given an opportunity to attend 3 monthly additional meetings to share critical experiences and problems they have experienced in the past month.
- Arm III (control): Patients receive usual care and are not asked to attend any meetings.
All patients undergo a 2-hour baseline interview, a 1.5-hour post intervention interview, and a 1.5-hour final interview 8 months after randomization.
PROJECTED ACCRUAL: A total of 350 patients will be accrued for this study.
- Being tested
- counseling intervention, educational intervention, psychosocial assessment and care
- Keywords
- psychosocial effects of cancer and its treatment, recurrent breast cancer, stage I breast cancer, stage II breast cancer, stage IV breast cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
counseling interventionOther
educational interventionOther
psychosocial assessment and careProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2006 (estimated)
- Study completionMar 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pittsburgh Mind-Body Center at Carnegie Mellon University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Michael Scheier, PhD, Study chair, Pittsburgh Mind-Body Center at Carnegie Mellon University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00416780
- Sponsor's protocol ID
- PMBC-HS05-182
- Other IDs
- CMU-00000603, MWH-99-062, CDR0000459773, FWA00004206
- Status last verified
- Mar 2006
- First submitted
- 27 Dec 2006
- Last updated
- 30 May 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychobiological Pathways: Breast Cancer Interventions
- ClinicalTrials.gov ID
- NCT00416780
- Acronym / sponsor ID
- PMBC-HS05-182
- Keywords
- psychosocial effects of cancer and its treatment, recurrent breast cancer, stage I breast cancer, stage II breast cancer, stage IV breast cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Pittsburgh Mind-Body Center at Carnegie Mellon UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study completion
- Mar 2006 (actual)
- First posted
- 28 Dec 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: Meeting together with other breast cancer patients to receive psychosocial support and to learn to reduce stress may help patients cope with their diagnosis, have a better quality of life, and live more comfortably.
PURPOSE: This randomized clinical trial is studying how well psychosocial support works in treating women with recurrent breast cancer or stage I, stage II, or stage IV breast cancer.
Detailed description
OBJECTIVES:
- Evaluate theoretically derived psychosocial interventions (peer discussion support vs education and stress management vs usual-care control) targeted to enhance adjustment and functional status and lower morbidity among women diagnosed with and treated for recurrent or stage I, II, or IV breast cancer.
- Evaluate the psychological, behavioral, and biological pathways and their effects in patients treated with these interventions.
- Evaluate the efficacy of these intervention in these patients.
- Evaluate the nature and extent of coping strategies in these patients.
- Evaluate the differences in patients treated with these intervention vs those patients electing not to be treated with these interventions.
OUTLINE: This is a randomized study. Patients are stratified according to disease stage (early vs late). Patients with early-stage disease are randomized to 1 of 3 intervention arms. Patients with late-stage disease are randomized to 1 of 2 intervention arms (II or III).
- Arm I (education and stress management): Patients undergo a 1-hour group (6-10 patients per group) education session once a week for 8 weeks focusing on exchange of factual information between a facilitator and patients. The session includes a 45-minute lecture, discussing risks, diagnosis, and treatment of cancer; side effects from treatment; nutrition during treatment; and follow-up care, followed by a question/answer period and instruction in progressive relaxation techniques. Patients then receive 3 monthly phone calls from a project staff member to answer questions about cancer, treatment, and follow-up care and to discuss the relaxation exercises.
- Arm II (peer discussion): Patients undergo a 1-hour group (6-10 patients per group) peer support session once a week for 8 weeks focusing on the provision of emotional support among patients and the maintenance of purpose in life. The session emphasizes on the sharing of experiences, the development of a common bond, and the promotion of altruism to similar others. Patients then are given an opportunity to attend 3 monthly additional meetings to share critical experiences and problems they have experienced in the past month.
- Arm III (control): Patients receive usual care and are not asked to attend any meetings.
All patients undergo a 2-hour baseline interview, a 1.5-hour post intervention interview, and a 1.5-hour final interview 8 months after randomization.
PROJECTED ACCRUAL: A total of 350 patients will be accrued for this study.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
Who may qualify
- Ages
- 25 years and older
- Sex
- Female only
- 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 |
|---|---|---|
| counseling intervention | Other | – |
| educational intervention | Other | – |
| psychosocial assessment and care | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
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 30 May 2013.
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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.
Michael Scheier, PhD study chair
Pittsburgh Mind-Body Center at Carnegie Mellon University
Questions about this trial
What is this clinical trial studying?
A study testing counseling intervention, educational intervention and psychosocial assessment and care in people with Breast Cancer and Psychosocial Effects of Cancer and Its Treatment, run by Pittsburgh Mind-Body Center at Carnegie Mellon University.
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 30 May 2013. Status can change between updates, so confirm with the study contact before making plans.
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.
Where can I read the original study information?
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 30 May 2013.