Breast NeoplasmsNCT00245219
Understanding Shared Psychobiological Pathways
A study testing Education and Peer support in people with Breast Neoplasms, run by Carnegie Mellon University.
Trial summary
The present study sought to investigate the efficacy of two psychosocial interventions for breast cancer patients, a peer support intervention and an education intervention. The present study also sought to identify mechanisms underlying the benefits of these interventions, and to determine if the efficacy of these… Read more about this study
- Who is it for?
- Ages 26 to 78 years, women only
- Conditions the study is for
- Breast Neoplasms
- What is being tested?
- Education and Peer support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 245 participants
- Where
- No sites listed yet
- Study dates
- Sep 1999to Aug 2005
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 26 to 78 years
- Women only
- No healthy volunteers
- Adult, Older adult
Eligible participants were:
- English speaking women,
- 25 years of age or older,
- Living within a 60 mile radius of Pittsburgh, Pennsylvania,
- either: a first time diagnosis of stage I or II breast cancer or if they had received an initial diagnosis of stage IV cancer or a distant recurrence of breast cancer,
- Patients with early stage cancer must have been diagnosed within the past 6 months,
- There was no window for enrollment for patients with late stage cancer.
About this study
Official title: Understanding Shared Psychobiological Pathways--Project 4. Psychobiological Pathways: Breast Cancer Interventions
The present study sought to investigate the efficacy of two psychosocial interventions for breast cancer patients, a peer support intervention and an education intervention. The present study also sought to identify mechanisms underlying the benefits of these interventions, and to determine if the efficacy of these interventions is moderated by cancer severity.
Read the detailed description
BACKGROUND:
The study was a subproject within a Mind-Body Center on Understanding Shared Psychobiological Pathways. The Center was in response to a Request for Applications issued by the Office of the Director, NIH. Dr. Scheier was the Co-Director of the Center as well as the subproject principal investigator. The major objective of the Center was to to identify, measure, and understand the shared psychological, behavioral, and psychobiological pathways that contributed to the onset of and recovery from diverse physical illnesses, which included infections, arthritis, cancer, and cardiovascular disease.
The subproject studied an important area of psychosocial research in cancer, specially the relative effectiveness of different psychosocial interventions for women with breast cancer, and the mechanisms that underlie the benefits of these interventions.
DESIGN NARRATIVE:
The specific aims of the project were to:
- implement and evaluate two psychosocial interventions, a peer support intervention and an education intervention, to enhance psychological adjustment and well-being among women with early- vs. late-stage breast cancer
- determine the psychological, behavioral, and biological mechanisms through which the interventions operate
- assess whether the two interventions were differentially effective for women with different characteristics, most importantly early- vs. late-stage disease
- use the baseline data collected prior to the intervention to determine the nature and extent of difficulties faced by early- vs. late-stage breast cancer patients
- determine how participants in the intervention differed from those who choose to participate.
Participants included 180 patients with early stage (I or II) and 65 patients with late stage (IV) breast cancer. The interventions were conducted in groups of 6-9 women, and groups met once a week for 8 weeks. The education group meetings focused on providing patients with information about their disease as well as methods to manage their illness and its side effects. Facilitators emphasized the theme of perceived control during all sessions, discussing how participants are in control of their illness experience and can have more control of their lives. The peer support group meetings focused on fostering purpose in life by providing participants with opportunities to support and care for one another. Participants were asked to share experiences and problems in group meetings and the group facilitator encouraged participants to help one another with these issues, and share how they had dealt with similar problems. Participants in the control condition received care as usual, and did not attend any group meetings.
Hypothesized predictors, mediators, and relevant outcome measures were assessed prior to the intervention. Mediators and outcomes were then reassessed, 2-weeks after intervention completion and 6-months later.
- Conditions
- Breast Neoplasms
- Being tested
- Education, Peer support
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EducationBehavioural
The education group meetings focused on providing patients with information about their disease as well as methods to manage their illness and its side effects. Facilitators emphasized the theme of perceived control during all sessions, discussing how participants are in control of their illness experience and can have more control of their lives. A different topic was addressed in each session. Weekly homework assignments asked patients to write down something new they had learned from the session regarding how to take control of their lives. Meeting topics were as follows: Overview of breast cancer, treatment types and side effects, nutrition and diet management, exercise, body image, communication issues, relationships, and sexuality.
Peer supportBehavioural
The peer support group meetings focused on fostering purpose in life by providing participants with opportunities to support and care for one another. Patients completed a weekly diary of critical experiences or current life problems as homework, and were then encouraged to share these experiences in the group meetings. The group facilitator encouraged participants to help one another with these issues, and share how they had dealt with similar problems.
| Study group | Role | What they receive |
|---|---|---|
| Health Tracking (control) | No intervention | Participants assigned to the health-tracking condition received usual care and did not attend any meetings. |
| Peer support | Experimental | The peer support group meetings focused on fostering purpose in life by providing participants with opportunities to support and care for one another. Patients completed a weekly diary of critical experiences or current life problems as homework, and were then encouraged to share these experiences in the group meetings. The group facilitator encouraged participants to help one another with these issues, and share how they had dealt with similar problems. Receives: Behavioral: Peer support |
| Education | Experimental | The education group meetings focused on providing patients with information about their disease as well as methods to manage their illness and its side effects. Facilitators emphasized the theme of perceived control during all sessions, discussing how participants are in control of their illness experience and can have more control of their lives. A different topic was addressed in each session. Weekly homework assignments asked patients to write down something new they had learned from the session regarding how to take control of their lives. Meeting topics were as follows: Overview of breast cancer, treatment types and side effects, nutrition and diet management, exercise, body image, communication issues, relationships, and sexuality. Receives: Behavioral: Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mental Health (as Measured With the SF-36) at Baseline, Time 2 (2 Weeks Post-intervention) and Time 3 (6 Months Post-intervention)
The Mental Health Component Scale of the Medical Outcomes Study Short Form 36(SF-36) consists of a norm-based weighted average of the following subscales: Vitality, Social Functioning, Role Limitations due to Emotional Problems and Mental health. In the present study, scores ranged from a maximum of 72 (high levels of mental health) to a minimum of 12 (low levels of mental health).
Measured: Baseline, Time 2 (2 weeks post-intervention) and Time 3 (6 months post-intervention)
Perceived Physical Health (as Measured With the SF36) at Baseline, Time 2 (2 Weeks Post-intervention) and Time 3 (6 Months Post-intervention)
The Perceived Physical Health Component scale of the Medical Outcomes Study Short Form 36(SF-36) consists of a norm-based weighted average of the following subscales: Physical Functioning, Bodily Pain, Role Limitations due to Physical Problems and General Health. In the present study, scores ranged from a maximum of 70 (high levels of perceived health) to a minimum of 12 (low levels of perceived health).
Measured: Baseline, Time 2 (2 weeks post-intervention) and Time 3 (6 months post-intervention)
Depressive Symptoms (as Measured With the CES-D) at Baseline, Time 2 (2 Weeks Post-intervention) and Time 3 (6 Months Post-intervention)
Scores for the shortened form of the Center for Epidemiologic Studies Depression scale(CES-D) ranged from 0 (no depressive symptoms) to 29 (high levels of depressives symptoms) in the present sample. For the sake of analyses, CES-D scores were dichotomized (cutoff score of 8), because scores exhibited marked positive skew in the present sample.
Measured: Baseline, Time 2 (2 Weeks post-intervention) and Time 3 (6 months post-intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2005 (estimated)
- Study startSep 1999
- Primary completionAug 2005
- Study completionAug 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Breast NeoplasmsStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 245 participants (actual)
Sponsor and investigators
- Lead sponsor
- Carnegie Mellon University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Michael F. Scheier, Carnegie Mellon University
- Investigators
- Michael Scheier, Principal investigator, Carnegie Mellon University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00245219
- Sponsor's protocol ID
- 338
- Other IDs
- P50HL065111
- Status last verified
- Feb 2024
- First submitted
- 26 Oct 2005
- Last updated
- 26 Feb 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Ware JE Jr, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care. 1992 Jun;30(6):473-83.
PubMed 1593914Andresen EM, Malmgren JA, Carter WB, Patrick DL. Screening for depression in well older adults: evaluation of a short form of the CES-D (Center for Epidemiologic Studies Depression Scale). Am J Prev Med. 1994 Mar-Apr;10(2):77-84.
PubMed 8037935
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding Shared Psychobiological Pathways--Project 4. Psychobiological Pathways: Breast Cancer Interventions
- ClinicalTrials.gov ID
- NCT00245219
- Acronym / sponsor ID
- 338
- Conditions
- Breast Neoplasms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 245 participants (actual)
- Lead sponsor
- Carnegie Mellon UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Sep 1999
- Primary completion
- Aug 2005 (actual)
- Study completion
- Aug 2005 (actual)
- First posted
- 27 Oct 2005 (estimated)
- Results
- Posted 3 Mar 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The present study sought to investigate the efficacy of two psychosocial interventions for breast cancer patients, a peer support intervention and an education intervention. The present study also sought to identify mechanisms underlying the benefits of these interventions, and to determine if the efficacy of these interventions is moderated by cancer severity.
Detailed description
BACKGROUND:
The study was a subproject within a Mind-Body Center on Understanding Shared Psychobiological Pathways. The Center was in response to a Request for Applications issued by the Office of the Director, NIH. Dr. Scheier was the Co-Director of the Center as well as the subproject principal investigator. The major objective of the Center was to to identify, measure, and understand the shared psychological, behavioral, and psychobiological pathways that contributed to the onset of and recovery from diverse physical illnesses, which included infections, arthritis, cancer, and cardiovascular disease.
The subproject studied an important area of psychosocial research in cancer, specially the relative effectiveness of different psychosocial interventions for women with breast cancer, and the mechanisms that underlie the benefits of these interventions.
DESIGN NARRATIVE:
The specific aims of the project were to:
- implement and evaluate two psychosocial interventions, a peer support intervention and an education intervention, to enhance psychological adjustment and well-being among women with early- vs. late-stage breast cancer
- determine the psychological, behavioral, and biological mechanisms through which the interventions operate
- assess whether the two interventions were differentially effective for women with different characteristics, most importantly early- vs. late-stage disease
- use the baseline data collected prior to the intervention to determine the nature and extent of difficulties faced by early- vs. late-stage breast cancer patients
- determine how participants in the intervention differed from those who choose to participate.
Participants included 180 patients with early stage (I or II) and 65 patients with late stage (IV) breast cancer. The interventions were conducted in groups of 6-9 women, and groups met once a week for 8 weeks. The education group meetings focused on providing patients with information about their disease as well as methods to manage their illness and its side effects. Facilitators emphasized the theme of perceived control during all sessions, discussing how participants are in control of their illness experience and can have more control of their lives. The peer support group meetings focused on fostering purpose in life by providing participants with opportunities to support and care for one another. Participants were asked to share experiences and problems in group meetings and the group facilitator encouraged participants to help one another with these issues, and share how they had dealt with similar problems. Participants in the control condition received care as usual, and did not attend any group meetings.
Hypothesized predictors, mediators, and relevant outcome measures were assessed prior to the intervention. Mediators and outcomes were then reassessed, 2-weeks after intervention completion and 6-months later.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Health Tracking (control) | No intervention | –Participants assigned to the health-tracking condition received usual care and did not attend any meetings. |
| Peer support | Experimental | Behavioral: Peer supportThe peer support group meetings focused on fostering purpose in life by providing participants with opportunities to support and care for one another. Patients completed a weekly diary of critical experiences or current life problems as homework, and were then encouraged to share these experiences in the group meetings. The group facilitator encouraged participants to help one another with these issues, and share how they had dealt with similar problems. |
| Education | Experimental | Behavioral: EducationThe education group meetings focused on providing patients with information about their disease as well as methods to manage their illness and its side effects. Facilitators emphasized the theme of perceived control during all sessions, discussing how participants are in control of their illness experience and can have more control of their lives. A different topic was addressed in each session. Weekly homework assignments asked patients to write down something new they had learned from the session regarding how to take control of their lives. Meeting topics were as follows: Overview of breast cancer, treatment types and side effects, nutrition and diet management, exercise, body image, communication issues, relationships, and sexuality. |
Who may qualify
- Ages
- 26 to 78 years
- 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 |
|---|---|---|
| EducationThe education group meetings focused on providing patients with information about their disease as well as methods to manage their illness and its side effects. Facilitators emphasized the theme of perceived control during all sessions, discussing how participants are in control of their illness experience and can have more control of their lives. A different topic was addressed in each session. Weekly homework assignments asked patients to write down something new they had learned from the session regarding how to take control of their lives. Meeting topics were as follows: Overview of breast cancer, treatment types and side effects, nutrition and diet management, exercise, body image, communication issues, relationships, and sexuality. | Behavioural | Education |
| Peer supportThe peer support group meetings focused on fostering purpose in life by providing participants with opportunities to support and care for one another. Patients completed a weekly diary of critical experiences or current life problems as homework, and were then encouraged to share these experiences in the group meetings. The group facilitator encouraged participants to help one another with these issues, and share how they had dealt with similar problems. | Behavioural | Peer support |
Primary outcome
Mental Health (as Measured With the SF-36) at Baseline, Time 2 (2 Weeks Post-intervention) and Time 3 (6 Months Post-intervention)
Time frame: Baseline, Time 2 (2 weeks post-intervention) and Time 3 (6 months post-intervention)
The Mental Health Component Scale of the Medical Outcomes Study Short Form 36(SF-36) consists of a norm-based weighted average of the following subscales: Vitality, Social Functioning, Role Limitations due to Emotional Problems and Mental health. In the present study, scores ranged from a maximum of 72 (high levels of mental health) to a minimum of 12 (low levels of mental health).
Perceived Physical Health (as Measured With the SF36) at Baseline, Time 2 (2 Weeks Post-intervention) and Time 3 (6 Months Post-intervention)
Time frame: Baseline, Time 2 (2 weeks post-intervention) and Time 3 (6 months post-intervention)
The Perceived Physical Health Component scale of the Medical Outcomes Study Short Form 36(SF-36) consists of a norm-based weighted average of the following subscales: Physical Functioning, Bodily Pain, Role Limitations due to Physical Problems and General Health. In the present study, scores ranged from a maximum of 70 (high levels of perceived health) to a minimum of 12 (low levels of perceived health).
Depressive Symptoms (as Measured With the CES-D) at Baseline, Time 2 (2 Weeks Post-intervention) and Time 3 (6 Months Post-intervention)
Time frame: Baseline, Time 2 (2 Weeks post-intervention) and Time 3 (6 months post-intervention)
Scores for the shortened form of the Center for Epidemiologic Studies Depression scale(CES-D) ranged from 0 (no depressive symptoms) to 29 (high levels of depressives symptoms) in the present sample. For the sake of analyses, CES-D scores were dichotomized (cutoff score of 8), because scores exhibited marked positive skew in the present sample.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 1593914Ware JE Jr, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care. 1992 Jun;30(6):473-83.
- Background: PubMed 8037935Andresen EM, Malmgren JA, Carter WB, Patrick DL. Screening for depression in well older adults: evaluation of a short form of the CES-D (Center for Epidemiologic Studies Depression Scale). Am J Prev Med. 1994 Mar-Apr;10(2):77-84.
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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 principal investigator
Carnegie Mellon University
Questions about this trial
What is this clinical trial studying?
A study testing Education and Peer support in people with Breast Neoplasms, run by 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 26 Feb 2024. 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?
Yes. Results are posted in the registry (first posted 3 Mar 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Mental Health (as Measured With the SF-36) at Baseline, Time 2 (2 Weeks Post-intervention) and Time 3 (6 Months Post-intervention) (time frame: Baseline, Time 2 (2 weeks post-intervention) and Time 3 (6 months post-intervention)). The study lists 3 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 NCT00245219, which also lists 2 linked publications.
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 26 Feb 2024.