Breast CancerEarly Phase 109-IM-01NCT00945607
Guided Relaxation Training for the Reduction of Self-Reported Stress in Individuals With Newly Diagnosed Breast Cancer
A Early Phase 1 study testing GRT (Guided Relaxation Training) in people with Breast Cancer, run by Trinitas Comprehensive Cancer Center at 1 site in United States.
Trial summary
The primary objectives of this study are to determine if the use of Guided Relaxation Training (GRT) during cancer treatment in individuals with newly diagnosed breast cancer increases their ability to cope as measured by the Coping Self-Efficacy Scale (CSES) and reduces their perceived stress as measured by the… Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- GRT (Guided Relaxation Training)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2009to Jul 2013
- Phase
- Early Phase 1
- 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 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able to speak and understand English
- At or between the ages of 18 and 75
- Newly diagnosed with breast cancer (within 12 weeks of study entry)
- Expected to receive chemotherapy and/or radiation
- Willingness to complete CSES, PSS-14 and FACIT-F scales
- Minimum score of 4 on the 0-10 Visual Analog Scale for stress
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- Willingness to participate for the 18 week duration of study and follow-up
- Ability to travel to cancer center weekly specifically for on-site guided relaxation training sessions
- Access to a CD player
Who cannot join
- Cognitive or mental status affecting ability to follow directions
- Previous or current use of complementary therapies for their cancer diagnosis, except herbal supplements
- Brain metastasis
- Treatment for any other diagnosis of cancer within the previous 5 years
- Any condition that, in the opinion of the investigator might interfere with the subject's participation in the study, pose an added risk for the subject or confound the assessment of the subject
Trial locations and contacts
1 site in 1 country.
United States1 site
Trinitas Comprehensive Cancer Center
Elizabeth, New Jersey, 07207
About this study
The primary objectives of this study are to determine if the use of Guided Relaxation Training (GRT) during cancer treatment in individuals with newly diagnosed breast cancer increases their ability to cope as measured by the Coping Self-Efficacy Scale (CSES) and reduces their perceived stress as measured by the Perceived Stress Scale (PSS).
Read the detailed description
This is a study of self-reported stress in individuals with newly diagnosed breast cancer. Subjects will be randomized to either the standard of care (SOC) arm or the intervention arm. The principle investigators will be blinded to the arm assignment. The intervention utilized will be six weekly on-site GRT sessions. In addition, subjects will be provided with a CD utilizing a standardized GRT script and music for home use twice daily during the study period. During the intervention period, they will also be provided with a diary and required to keep a record of date and time of CD utilization at home. The subjects will also be required to record their stress level before and after each of the two home sessions. The sessions must be at least 4 hours apart.
The SOC arm will consist of an education session with the nurse or nurse practitioner and supportive care / symptom management as needed. This group will also be required to keep a daily diary in which they record their stress levels twice daily, at intervals separated by at least 4 hours.
- Conditions
- Breast Cancer
- Being tested
- GRT (Guided Relaxation Training)
- Keywords
- Complementary Medicine, Alternative Medicine, 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.
GRT (Guided Relaxation Training)Other
Weekly on-site GRT sessions at the center in combination with twice daily independent GRT sessions at home.
| Study group | Role | What they receive |
|---|---|---|
| Guided Relaxation Training | Experimental | Eligible subjects who have been randomized to the intervention arm will be scheduled for GRT introduction and training with a research staff member. The GRT sessions will consist of six weekly on-site sessions in which the subject is provided instructions and then allowed to listen to the GRT CD. Subjects will be instructed to conduct independent GRT sessions at home, twice daily, at least four hours apart, for the duration of the study. Subjects will also be instructed that on the days of one-on-one sessions with a research staff member at TCCC, that they will only be required to perform the independent session once at home.
Subjects will be provided with a diary to record the date and time of each independent GRT session performed at home. Subjects will be instructed to bring their completed diary with them at each subsequent visit. Receives: Other: GRT (Guided Relaxation Training) |
| Standard of Care(SOC) | No intervention | Eligible subjects who are randomized to the SOC arm will not receive the GRT sessions. During the six week treatment phase, these subjects will only receive SOC provided to all subjects newly diagnosed with breast cancer at TCCC. This consists of an education session with the nurse or nurse practitioner. In addition, they will also be provided with supportive care and symptom management as needed. This arm will also be provided with a diary to record their stress level at least twice daily. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determining if the use of GRT during treatment in individuals newly diagnosed with breast cancer reduces their perceived stress.
Measured: Endpoint
Determining if the use of GRT during treatment in individuals newly diagnosed with breast cancer increases their coping ability.
Measured: Endpoint
Secondary outcomes (2)
Determining the effects of GRT on vital signs and self-reported levels of fatigue.
Measured: End Point
Determining differences of perceived levels of stress among various racial and ethnic groups.
Measured: End Point
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2009 (estimated)
- Study startJul 2009
- Primary completionJul 2013 (estimated)
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
- Early Phase 1
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Trinitas Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Aptium Oncology Research Network
- Investigators
- Carol S Blecher, RN, MS, AOCN, APNC, Principal investigator, Trinitas Comprehensive Cancer CenterSharon Kurtz, RN, BSN, C.Ht., Principal investigator, Trinitas Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00945607
- Sponsor's protocol ID
- 09-IM-01
- Acronym
- 09-IM-01
- Status last verified
- Jul 2011
- First submitted
- 22 Jul 2009
- Last updated
- 25 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Guided Relaxation Training for the Reduction of Self-Reported Stress in Individuals With Newly Diagnosed Breast Cancer
- ClinicalTrials.gov ID
- NCT00945607
- Acronym / sponsor ID
- 09-IM-01 / 09-IM-01
- Conditions
- Breast Cancer
- Keywords
- Complementary Medicine, Alternative Medicine, Breast Cancer
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Trinitas Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- Aptium Oncology Research Network
- Study start
- Jul 2009
- Primary completion
- Jul 2013 (estimated)
- First posted
- 24 Jul 2009 (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.
The primary objectives of this study are to determine if the use of Guided Relaxation Training (GRT) during cancer treatment in individuals with newly diagnosed breast cancer increases their ability to cope as measured by the Coping Self-Efficacy Scale (CSES) and reduces their perceived stress as measured by the Perceived Stress Scale (PSS).
Detailed description
This is a study of self-reported stress in individuals with newly diagnosed breast cancer. Subjects will be randomized to either the standard of care (SOC) arm or the intervention arm. The principle investigators will be blinded to the arm assignment. The intervention utilized will be six weekly on-site GRT sessions. In addition, subjects will be provided with a CD utilizing a standardized GRT script and music for home use twice daily during the study period. During the intervention period, they will also be provided with a diary and required to keep a record of date and time of CD utilization at home. The subjects will also be required to record their stress level before and after each of the two home sessions. The sessions must be at least 4 hours apart.
The SOC arm will consist of an education session with the nurse or nurse practitioner and supportive care / symptom management as needed. This group will also be required to keep a daily diary in which they record their stress levels twice daily, at intervals separated by at least 4 hours.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Guided Relaxation Training | Experimental | Other: GRT (Guided Relaxation Training)Eligible subjects who have been randomized to the intervention arm will be scheduled for GRT introduction and training with a research staff member. The GRT sessions will consist of six weekly on-site sessions in which the subject is provided instructions and then allowed to listen to the GRT CD. Subjects will be instructed to conduct independent GRT sessions at home, twice daily, at least four hours apart, for the duration of the study. Subjects will also be instructed that on the days of one-on-one sessions with a research staff member at TCCC, that they will only be required to perform the independent session once at home. Subjects will be provided with a diary to record the date and time of each independent GRT session performed at home. Subjects will be instructed to bring their completed diary with them at each subsequent visit. |
| Standard of Care(SOC) | No intervention | –Eligible subjects who are randomized to the SOC arm will not receive the GRT sessions. During the six week treatment phase, these subjects will only receive SOC provided to all subjects newly diagnosed with breast cancer at TCCC. This consists of an education session with the nurse or nurse practitioner. In addition, they will also be provided with supportive care and symptom management as needed. This arm will also be provided with a diary to record their stress level at least twice daily. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Able to speak and understand English
- At or between the ages of 18 and 75
- Newly diagnosed with breast cancer (within 12 weeks of study entry)
- Expected to receive chemotherapy and/or radiation
- Willingness to complete CSES, PSS-14 and FACIT-F scales
Key exclusion criteria (5 listed)
- Cognitive or mental status affecting ability to follow directions
- Previous or current use of complementary therapies for their cancer diagnosis, except herbal supplements
- Brain metastasis
- Treatment for any other diagnosis of cancer within the previous 5 years
- Any condition that, in the opinion of the investigator might interfere with the subject's participation in the study, pose an added risk for the subject or confound the assessment of the subject
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 |
|---|---|---|
| GRT (Guided Relaxation Training)Weekly on-site GRT sessions at the center in combination with twice daily independent GRT sessions at home. | Other | Guided Relaxation Training |
Primary outcome
Determining if the use of GRT during treatment in individuals newly diagnosed with breast cancer reduces their perceived stress.
Time frame: Endpoint
Determining if the use of GRT during treatment in individuals newly diagnosed with breast cancer increases their coping ability.
Time frame: Endpoint
2 secondary outcomes
Determining the effects of GRT on vital signs and self-reported levels of fatigue.
Time frame: End Point
Determining differences of perceived levels of stress among various racial and ethnic groups.
Time frame: End Point
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2011.
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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.
Carol S Blecher, RN, MS, AOCN, APNC principal investigator
Trinitas Comprehensive Cancer Center
Sharon Kurtz, RN, BSN, C.Ht. principal investigator
Trinitas Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing GRT (Guided Relaxation Training) in people with Breast Cancer, run by Trinitas Comprehensive 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?
The sponsor lists 9 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 25 Jul 2011. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Determining if the use of GRT during treatment in individuals newly diagnosed with breast cancer reduces their perceived stress. (time frame: Endpoint). 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?
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 25 Jul 2011.