Stage IA Breast CancerNCT01941784
Health Education Intervention in Reducing Weight Gain in Patients With Newly Diagnosed Stage I-IV Breast Cancer Undergoing Chemotherapy
A study testing educational intervention, counseling intervention and telephone-based intervention in people with Stage IA Breast Cancer and Stage IB Breast Cancer, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
This pilot clinical trial studies a health education intervention in reducing weight gain in patients with newly diagnosed stage I-IV breast cancer undergoing chemotherapy. A health education program may reduce weight gain and improve quality of life in patients undergoing chemotherapy for breast cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Stage IA Breast Cancer, Stage IB Breast Cancer, Stage II Breast Cancer
- What is being tested?
- educational intervention, counseling intervention and telephone-based intervention
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Nov 2013to 12 Apr 2017
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women with newly-diagnosed breast cancer, stage I-IV who are within first two rounds of chemotherapy
- 3.1.2 Women who are receiving, or scheduled to receive, one of the following classes of therapy in the adjuvant or neo-adjuvant setting: anthracyclines, taxanes, cyclophosphamide, or trastuzumab. Participants must be within their first two rounds of chemotherapy - Body mass index (BMI) > 20
- Treating physician approval to participate in study
- Ability to understand and the willingness to sign an Institutional Review Board (IRB)-approved informed consent document
Who cannot join
- Diagnosis of recurrent breast cancer
- Women who are already participating in a formal or medically prescribed weight management program
- Women who have already completed more than two rounds of chemotherapy
- Women who are pregnant or nursing
Trial locations and contacts
1 site in 1 country.
United States1 site
Comprehensive Cancer Center of Wake Forest University
Winston-Salem, North Carolina, 27157
About this study
Official title: Taking Health Realization Into Valued Eating and Exercise (THRIVE): A Feasibility Study of an Intervention to Prevent Weight Gain for Breast Cancer Survivors During Chemotherapy
This pilot clinical trial studies a health education intervention in reducing weight gain in patients with newly diagnosed stage I-IV breast cancer undergoing chemotherapy. A health education program may reduce weight gain and improve quality of life in patients undergoing chemotherapy for breast cancer.
Read the detailed description
PRIMARY OBJECTIVES:
- To determine the feasibility of conducting a weight maintenance intervention, in terms of recruiting and retaining participants.
II. To obtain preliminary data on the effectiveness of an intervention to prevent weight gain on body composition, self-efficacy, perceived stress, fatigue, depression, exercise capacity, and health-related quality of life (HRQL). Changes in physical activity and dietary intake will also be monitored.
III. To determine if the weight control protocol requires refinement for use in a randomized controlled trial.
IV. To determine how many participants opt to enroll in a short-term healthy lifestyle program at completion of the final testing visit.
OUTLINE:
Participants undergo four 30-60 minute health education sessions and 3 follow-up phone sessions with an interventionist trained in behavioral science, physical activity and nutrition, and positive psychology over 12 months.
EDUCATION SESSION I: Participants receive information from the interventionist concerning healthy diet choices and exercise and begin to keep a food log.
EDUCATION SESSION II: Interventionists review information from session I and patient food logs. Participants receive recommendations for exercise and set activity goals.
EDUCATION SESSION III: Participants receive information on how to determine portion sizes and the importance of strength training and building lean muscle mass.
EDUCATION SESSION IV: Interventionists review information from the previous 3 sessions and discuss the importance of planning and goal setting with participants. The interventionist also discusses physical and mental barriers to exercise.
After completion of the education sessions, patients receive 3 phone calls at times convenient to the patient to answer questions about information learned in previous educational sessions.
After completion of study, participants are followed up for 12 months.
- Conditions
- Stage IA Breast Cancer, Stage IB Breast Cancer, Stage II Breast Cancer, Stage IIIA Breast Cancer, Stage IIIB Breast Cancer, Stage IIIC Breast Cancer
- Being tested
- educational intervention, counseling intervention, telephone-based intervention, questionnaire administration, quality-of-life assessment
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
educational interventionOther
Also called intervention, educational
Undergo health education program
counseling interventionOther
Also called counseling and communications studies
Undergo health education program
telephone-based interventionBehavioural
Receive follow-up phone calls
questionnaire administrationOther
Ancillary studies
quality-of-life assessmentProcedure or surgery
Also called quality of life assessment
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Supportive care (health education program) | Experimental | See Detailed Description. Receives: Other: educational intervention; Other: counseling intervention; Behavioral: telephone-based intervention; Other: questionnaire administration; Procedure: quality-of-life assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of conducting the weight gain prevention intervention, measured as the percent of screened participants that are eligible and agree to participate
Reasons why participants are not eligible will be reported and inclusion/exclusion criteria will be reevaluated. The proportion of participants who completed all sessions and testing visits will be estimated and compared. Barriers to recruitment (e.g., timing of intervention, inconvenience, time constraints, participant feeling too sick) will be recorded to assist in designing the larger trial.
Measured: Baseline
Secondary outcomes (9)
Effect of the intervention on body composition
Descriptive statistics consisting of frequency tables and percents for categorical variables and means, medians, standard deviations, and ranges for continuous variables will be tabulated. Repeated-measure analysis of covariance (ANCOVAs) to test for change in our primary variables over the 3 timepoints will be conducted, controlling for baseline differences. Additionally, effect sizes will be calculated as they account for sample size and are useful when a lack of power leads to nonsignificant findings. These estimates of variability will be used when designing a future trial.
Measured: Up to 52 weeks
Effect of the intervention on self-efficacy
Descriptive statistics consisting of frequency tables and percents for categorical variables and means, medians, standard deviations, and ranges for continuous variables will be tabulated. Repeated-measure ANCOVAs to test for change in our primary variables over the 3 timepoints will be conducted, controlling for baseline differences. Additionally, effect sizes will be calculated as they account for sample size and are useful when a lack of power leads to nonsignificant findings. These estimates of variability will be used when designing a future trial.
Measured: Up to 52 weeks
Effect of the intervention on perceived stress
Descriptive statistics consisting of frequency tables and percents for categorical variables and means, medians, standard deviations, and ranges for continuous variables will be tabulated. Repeated-measure ANCOVAs to test for change in our primary variables over the 3 timepoints will be conducted, controlling for baseline differences. Additionally, effect sizes will be calculated as they account for sample size and are useful when a lack of power leads to nonsignificant findings. These estimates of variability will be used when designing a future trial.
Measured: Up to 52 weeks
Effect of the intervention on fatigue
Descriptive statistics consisting of frequency tables and percents for categorical variables and means, medians, standard deviations, and ranges for continuous variables will be tabulated. Repeated-measure ANCOVAs to test for change in our primary variables over the 3 timepoints will be conducted, controlling for baseline differences. Additionally, effect sizes will be calculated as they account for sample size and are useful when a lack of power leads to nonsignificant findings. These estimates of variability will be used when designing a future trial.
Measured: Up to 52 weeks
Effect of the intervention on 6 minute walk distance
Descriptive statistics consisting of frequency tables and percents for categorical variables and means, medians, standard deviations, and ranges for continuous variables will be tabulated. Repeated-measure ANCOVAs to test for change in our primary variables over the 3 timepoints will be conducted, controlling for baseline differences. Additionally, effect sizes will be calculated as they account for sample size and are useful when a lack of power leads to nonsignificant findings. These estimates of variability will be used when designing a future trial.
Measured: Up to 52 weeks
Effect of the intervention on fruit, vegetable, and fat intake
Descriptive statistics consisting of frequency tables and percents for categorical variables and means, medians, standard deviations, and ranges for continuous variables will be tabulated. Repeated-measure ANCOVAs to test for change in our primary variables over the 3 timepoints will be conducted, controlling for baseline differences. Additionally, effect sizes will be calculated as they account for sample size and are useful when a lack of power leads to nonsignificant findings. These estimates of variability will be used when designing a future trial.
Measured: Up to 52 weeks
Effect of the intervention on physical activity participation
Descriptive statistics consisting of frequency tables and percents for categorical variables and means, medians, standard deviations, and ranges for continuous variables will be tabulated. Repeated-measure ANCOVAs to test for change in our primary variables over the 3 timepoints will be conducted, controlling for baseline differences. Additionally, effect sizes will be calculated as they account for sample size and are useful when a lack of power leads to nonsignificant findings. These estimates of variability will be used when designing a future trial.
Measured: Up to 52 weeks
Effect of the intervention on health-related quality of life
Descriptive statistics consisting of frequency tables and percents for categorical variables and means, medians, standard deviations, and ranges for continuous variables will be tabulated. Repeated-measure ANCOVAs to test for change in our primary variables over the 3 timepoints will be conducted, controlling for baseline differences. Additionally, effect sizes will be calculated as they account for sample size and are useful when a lack of power leads to nonsignificant findings. These estimates of variability will be used when designing a future trial.
Measured: Up to 52 weeks
Sample size for future larger trials
Data from outcomes 1 and 2 along with qualitative data, will allow researchers to refine the protocol accordingly.
Measured: Up to 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2013 (estimated)
- Study start25 Nov 2013
- Primary completion1 Mar 2017
- Study completion12 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stage IA Breast CancerStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Shannon Mihalko, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01941784
- Sponsor's protocol ID
- IRB00025131
- Other IDs
- NCI-2013-01742, CCCWFU 97513, P30CA012197
- Status last verified
- Jul 2018
- First submitted
- 10 Sep 2013
- Last updated
- 25 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Taking Health Realization Into Valued Eating and Exercise (THRIVE): A Feasibility Study of an Intervention to Prevent Weight Gain for Breast Cancer Survivors During Chemotherapy
- ClinicalTrials.gov ID
- NCT01941784
- Acronym / sponsor ID
- IRB00025131
- Conditions
- Stage IA Breast Cancer, Stage IB Breast Cancer, Stage II Breast Cancer, Stage IIIA Breast Cancer, Stage IIIB Breast Cancer, Stage IIIC Breast Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 25 Nov 2013 (actual)
- Primary completion
- 1 Mar 2017 (actual)
- Study completion
- 12 Apr 2017 (actual)
- First posted
- 13 Sep 2013 (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.
This pilot clinical trial studies a health education intervention in reducing weight gain in patients with newly diagnosed stage I-IV breast cancer undergoing chemotherapy. A health education program may reduce weight gain and improve quality of life in patients undergoing chemotherapy for breast cancer.
Detailed description
PRIMARY OBJECTIVES:
- To determine the feasibility of conducting a weight maintenance intervention, in terms of recruiting and retaining participants.
II. To obtain preliminary data on the effectiveness of an intervention to prevent weight gain on body composition, self-efficacy, perceived stress, fatigue, depression, exercise capacity, and health-related quality of life (HRQL). Changes in physical activity and dietary intake will also be monitored.
III. To determine if the weight control protocol requires refinement for use in a randomized controlled trial.
IV. To determine how many participants opt to enroll in a short-term healthy lifestyle program at completion of the final testing visit.
OUTLINE:
Participants undergo four 30-60 minute health education sessions and 3 follow-up phone sessions with an interventionist trained in behavioral science, physical activity and nutrition, and positive psychology over 12 months.
EDUCATION SESSION I: Participants receive information from the interventionist concerning healthy diet choices and exercise and begin to keep a food log.
EDUCATION SESSION II: Interventionists review information from session I and patient food logs. Participants receive recommendations for exercise and set activity goals.
EDUCATION SESSION III: Participants receive information on how to determine portion sizes and the importance of strength training and building lean muscle mass.
EDUCATION SESSION IV: Interventionists review information from the previous 3 sessions and discuss the importance of planning and goal setting with participants. The interventionist also discusses physical and mental barriers to exercise.
After completion of the education sessions, patients receive 3 phone calls at times convenient to the patient to answer questions about information learned in previous educational sessions.
After completion of study, participants are followed up for 12 months.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Supportive care (health education program) | Experimental | Other: educational intervention, Other: counseling intervention, Behavioral: telephone-based intervention, Other: questionnaire administration, Procedure: quality-of-life assessmentSee Detailed Description. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Women with newly-diagnosed breast cancer, stage I-IV who are within first two rounds of chemotherapy
- 3.1.2 Women who are receiving, or scheduled to receive, one of the following classes of therapy in the adjuvant or neo-adjuvant setting: anthracyclines, taxanes, cyclophosphamide, or trastuzumab. Participants must be within their first two rounds of chemotherapy - Body mass index (BMI) > 20
- Treating physician approval to participate in study
- Ability to understand and the willingness to sign an Institutional Review Board (IRB)-approved informed consent document
Key exclusion criteria (4 listed)
- Diagnosis of recurrent breast cancer
- Women who are already participating in a formal or medically prescribed weight management program
- Women who have already completed more than two rounds of chemotherapy
- Women who are pregnant or nursing
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 interventionAlso: intervention, educationalUndergo health education program | Other | Supportive care (health education program) |
| counseling interventionAlso: counseling and communications studiesUndergo health education program | Other | Supportive care (health education program) |
| telephone-based interventionReceive follow-up phone calls | Behavioural | Supportive care (health education program) |
| questionnaire administrationAncillary studies | Other | Supportive care (health education program) |
| quality-of-life assessmentAlso: quality of life assessmentAncillary studies | Procedure or surgery | Supportive care (health education program) |
Primary outcome
Feasibility of conducting the weight gain prevention intervention, measured as the percent of screened participants that are eligible and agree to participate
Time frame: Baseline
Reasons why participants are not eligible will be reported and inclusion/exclusion criteria will be reevaluated. The proportion of participants who completed all sessions and testing visits will be estimated and compared. Barriers to recruitment (e.g., timing of intervention, inconvenience, time constraints, participant feeling too sick) will be recorded to assist in designing the larger trial.
9 secondary outcomes
Effect of the intervention on body composition
Time frame: Up to 52 weeks
Effect of the intervention on self-efficacy
Time frame: Up to 52 weeks
Effect of the intervention on perceived stress
Time frame: Up to 52 weeks
Effect of the intervention on fatigue
Time frame: Up to 52 weeks
Effect of the intervention on 6 minute walk distance
Time frame: Up to 52 weeks
Effect of the intervention on fruit, vegetable, and fat intake
Time frame: Up to 52 weeks
Effect of the intervention on physical activity participation
Time frame: Up to 52 weeks
Effect of the intervention on health-related quality of life
Time frame: Up to 52 weeks
Sample size for future larger trials
Time frame: Up to 52 weeks
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 25 Jan 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.
Shannon Mihalko principal investigator
Wake Forest University Health Sciences
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, counseling intervention and telephone-based intervention in people with Stage IA Breast Cancer and Stage IB Breast Cancer, run by Wake Forest University Health Sciences 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 4 inclusion and 4 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 25 Jan 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.
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?
Feasibility of conducting the weight gain prevention intervention, measured as the percent of screened participants that are eligible and agree to participate (time frame: Baseline). 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 Jan 2019.