FatiguePhase 3NCT00513136
Fatigue Intervention Trial for Breast Cancer Survivors
A Phase 3 study testing Group based mind body medicine intervention and Group-based mind body medicine intervention + family focus in people with Fatigue, run by Mercy Medical Center at 1 site in United States.
Trial summary
Thirty to forty percent of breast cancer survivors suffer from persistent fatigue lingering months to years after adjuvant therapy is completed. Although researchers have developed some effective interventions (exercise or group-based holistic program) to treat fatigue, none have addressed the role of the family in… Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Fatigue
- What is being tested?
- Group based mind body medicine intervention and Group-based mind body medicine intervention + family focus
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- May 2007to Feb 2009
- Phase
- Phase 3
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Stage I-III Breast Cancer
- At least 3 months since last breast cancer treatment (excluding hormonal therapy or Herceptin).
- 4 week history of persistent moderate to severe fatigue
- Competent to sign informed consent
- Willing to be randomized
Who cannot join
- Metastatic breast cancer
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Trial to Evaluate a Family-focused Mind Body Medicine Intervention to Reduce Fatigue Among Breast Cancer Survivors
Thirty to forty percent of breast cancer survivors suffer from persistent fatigue lingering months to years after adjuvant therapy is completed. Although researchers have developed some effective interventions (exercise or group-based holistic program) to treat fatigue, none have addressed the role of the family in the patient's long-term recovery.
The investigators hypothesize that a family-focused intervention in combination with a mind-body group intervention will be more effective in reducing fatigue, improving quality of life, and enhancing family relationships for breast cancer survivors than a group intervention with an individual focus.
Read the detailed description
We propose to address the persistent fatigue experienced by brest cancer survivors by using a 10 week group-based mind body medicine intervention that includes the family in the process. We believe that this family-centered approach can facilitate better communication, create shared illness experience and relieve conflict. Reducing this pervasive source of stress will not only reduce the survivor's fatigue, but also foster an opposite family dynamic with positive effects in many other aspects of post-treatment recovery. We will compare the effectiveness of a 10 week group intervention to a 10 week group intervention that includes a family focus.
Breast cancer survivors with moderate to severe fatigue will be randomly assigned to one of the two groups and we will measure change in fatigue, quality of life, mood and social support from baseline to end-of-program and then two and six months after program completion.
- Conditions
- Fatigue
- Being tested
- Group based mind body medicine intervention, Group-based mind body medicine intervention + family focus
- Keywords
- Fatigue, Breast Cancer, Behavioral Research, Quality of Life
- Medical subject headings
- Fatigue, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group based mind body medicine interventionBehavioural
Small groups of women (5-15) will participate in 10 weekly sessions that will include learning relaxation and yoga techniques, principles of exercise and nutrition, cognitive behavioral therapy and exploration of common issues and concerns
Group-based mind body medicine intervention + family focusBehavioural
In addition to the 10 weekly group-based sessions, women and their key family members will meet twice with a cognitive therapist and family members will participate in selected aspects of the 10 week program.
| Study group | Role | What they receive |
|---|---|---|
| I | Active comparator | 10 week group-based mind body medicine intervention Receives: Behavioral: Group based mind body medicine intervention |
| II | Experimental | Group-based mind body medicine intervention with a family focus Receives: Behavioral: Group-based mind body medicine intervention + family focus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fatigue
Measured: Change from baseline to end-of-intervention and 2 and 6 months post-intervention
Secondary outcomes (1)
Quality of Life; Mood; Social Support
Measured: Change from baseline to end-of-intervention and 2 and 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 posted8 Aug 2007 (estimated)
- Study startMay 2007
- Primary completionFeb 2009
- Study completionFeb 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FatigueStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mercy Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Mullen, Mercy Medical Center
- Investigators
- Kathy J Helzlsouer, MD, MHS, Principal investigator, Mercy Medical CenterJulianne Oktay, PhD, MSW, Principal investigator, University of Maryland School of Social Work
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00513136
- Sponsor's protocol ID
- MMC2007-46
- Status last verified
- Dec 2019
- First submitted
- 7 Aug 2007
- Last updated
- 13 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial to Evaluate a Family-focused Mind Body Medicine Intervention to Reduce Fatigue Among Breast Cancer Survivors
- ClinicalTrials.gov ID
- NCT00513136
- Acronym / sponsor ID
- MMC2007-46
- Conditions
- Fatigue
- Keywords
- Fatigue, Breast Cancer, Behavioral Research, Quality of Life
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Mercy Medical CenterUniversity, hospital or other
- Study start
- May 2007
- Primary completion
- Feb 2009 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 8 Aug 2007 (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.
Thirty to forty percent of breast cancer survivors suffer from persistent fatigue lingering months to years after adjuvant therapy is completed. Although researchers have developed some effective interventions (exercise or group-based holistic program) to treat fatigue, none have addressed the role of the family in the patient's long-term recovery.
The investigators hypothesize that a family-focused intervention in combination with a mind-body group intervention will be more effective in reducing fatigue, improving quality of life, and enhancing family relationships for breast cancer survivors than a group intervention with an individual focus.
Detailed description
We propose to address the persistent fatigue experienced by brest cancer survivors by using a 10 week group-based mind body medicine intervention that includes the family in the process. We believe that this family-centered approach can facilitate better communication, create shared illness experience and relieve conflict. Reducing this pervasive source of stress will not only reduce the survivor's fatigue, but also foster an opposite family dynamic with positive effects in many other aspects of post-treatment recovery. We will compare the effectiveness of a 10 week group intervention to a 10 week group intervention that includes a family focus.
Breast cancer survivors with moderate to severe fatigue will be randomly assigned to one of the two groups and we will measure change in fatigue, quality of life, mood and social support from baseline to end-of-program and then two and six months after program completion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| I | Active comparator | Behavioral: Group based mind body medicine intervention10 week group-based mind body medicine intervention |
| II | Experimental | Behavioral: Group-based mind body medicine intervention + family focusGroup-based mind body medicine intervention with a family focus |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Stage I-III Breast Cancer
- At least 3 months since last breast cancer treatment (excluding hormonal therapy or Herceptin).
- 4 week history of persistent moderate to severe fatigue
- Competent to sign informed consent
- Willing to be randomized
Key exclusion criteria (1 listed)
- Metastatic breast cancer
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 |
|---|---|---|
| Group based mind body medicine interventionSmall groups of women (5-15) will participate in 10 weekly sessions that will include learning relaxation and yoga techniques, principles of exercise and nutrition, cognitive behavioral therapy and exploration of common issues and concerns | Behavioural | I |
| Group-based mind body medicine intervention + family focusIn addition to the 10 weekly group-based sessions, women and their key family members will meet twice with a cognitive therapist and family members will participate in selected aspects of the 10 week program. | Behavioural | II |
Primary outcome
Fatigue
Time frame: Change from baseline to end-of-intervention and 2 and 6 months post-intervention
1 secondary outcome
Quality of Life; Mood; Social Support
Time frame: Change from baseline to end-of-intervention and 2 and 6 months post intervention
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 13 Dec 2019.
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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.
Kathy J Helzlsouer, MD, MHS principal investigator
Mercy Medical Center
Julianne Oktay, PhD, MSW principal investigator
University of Maryland School of Social Work
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Group based mind body medicine intervention and Group-based mind body medicine intervention + family focus in people with Fatigue, run by Mercy Medical 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?
The sponsor lists 5 inclusion and 1 exclusion criteria. 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 13 Dec 2019. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Fatigue (time frame: Change from baseline to end-of-intervention and 2 and 6 months post-intervention). It is what the study was designed to measure, not a finding.
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 13 Dec 2019.