Breast Cancer SurvivorsCASTLENCT01217216
Cancer Survival Through Weight Loss and Exercise
A study testing Group-based Intervention and Telephone-based Intervention in people with Breast Cancer Survivors, run by Pennington Biomedical Research Center at 1 site in United States.
Trial summary
To test the effectiveness and feasibility of intensive motivational, behavior modifying intervention aimed at improving physical activity and dietary habits to produce at least 7% weight loss in women with a history of breast cancer in a community health setting. Read more about this study
- Who is it for?
- Ages 30 to 75 years, women only
- Conditions the study is for
- Breast Cancer Survivors
- What is being tested?
- Group-based Intervention and Telephone-based Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- May 2009to Oct 2010
- 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 30 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women between the ages of 30 and 75.
- Positive history of breast cancer treatment completed at least 2 months but no longer than 36 months prior to randomization.
- BMI ≥ 25 kg/m2 and ≤ 45 kg/m2
- Not involved in regular physical activity or weight loss management programs.
- Stage I, II or IIIa breast cancer with good prognosis.
Who cannot join
- Presence of any co-morbidities including cardiovascular disease or diabetes
- Fasting triglycerides > 500 mg/dl.
- Consume more than 14 alcoholic beverages per week.
- A history of drug abuse, or excess alcohol consumption (40g/day)6.
- Currently dieting or engaging in any activity with the goal of losing weight.
- Significant intentional weight loss in the past year (> 50 lbs in the past year) or current use of weight loss medications.
Show all 16Show fewer
- History of gastrointestinal bypass or other bariatric surgery in the last 3 years.
- Pregnant or plan on becoming pregnant in the next 12 months.
- Factors that may limit adherence to intervention or affect conduct of the trial.
- Unable or unwilling to communicate with staff, to provide written informed consent, or accept the randomized assignment.
- Failure to complete run-in and baseline testing.
- Lack support from health care provider or family members.
- Other temporary intervening event, such as sick spouse, bereavement, or recent move.
- Any other medical condition or disease that is life threatening or that can interfere with or be aggravated by exercise.
- Current diagnosis of schizophrenia, other psychotic disorders, or bipolar disorder.
- Any other condition, which, in the opinion of the investigators would impede competence or compliance or possibly hinder completion of the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70808
About this study
Official title: Cancer Survival Through Weight Loss and Exercise (CASTLE)
To test the effectiveness and feasibility of intensive motivational, behavior modifying intervention aimed at improving physical activity and dietary habits to produce at least 7% weight loss in women with a history of breast cancer in a community health setting.
Read the detailed description
This study will be divided into two phases (Phase I and II) that will differ by the intensity of motivational intervention. In Phase I, participants will receive 6 months of intensive weekly group-based or telephone-based motivational, behavior modifying intervention aimed at improving physical activity levels and dietary habits. Phase II will be an additional 6 months of monthly individualized motivational intervention in order to attain and maintain at least 7% body weight loss. All participants will attend an orientation, 2 run-in sessions, and a baseline assessment prior to the intervention. Participants will then be assigned to either the group based intervention or telephone intervention. The first 30 participants will enter into the group-based intervention and the second 30 will enter into the telephone-based intervention. Follow-up visits will be completed at the end of Phase I (week 25) and Phase II (week 50). Up to 60 women with a previous history of breast cancer will participate in this study.
- Conditions
- Breast Cancer Survivors
- Being tested
- Group-based Intervention, Telephone-based Intervention
- Keywords
- Breast Cancer, Weight loss, Group Intervention, Telephone Intervention
- Medical subject headings
- Breast Neoplasms, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group-based InterventionBehavioural
compared effects of a group-based intervention on weight loss and physical activity.
Telephone-based InterventionBehavioural
compared telephone-based intervention to weight loss and physical activity.
| Study group | Role | What they receive |
|---|---|---|
| Group-based Intervention | Active comparator | We randomly assigned 30 individuals to a group-based intervention to promote weight loss through dietary restriction and physical activity. Receives: Behavioral: Group-based Intervention |
| Telephone-based Intervention | Active comparator | We randomly assigned 22 individuals to the telephone-based intervention to promote weight loss through dietary restriction and physical activity. Receives: Behavioral: Telephone-based Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight loss
To examine the effectiveness of using motivational, behavioral interventions aimed at improving physical activity levels and dietary habits to produce weight loss in women with a history of breast cancer.
Measured: 1 year
Secondary outcomes (2)
Feasibility of recruiting breast cancer survivors
To examine the feasibility of recruiting, administering, and maintaining interventions in a small sample of women with a history of breast cancer in a community health setting for pilot data.
Measured: 1 year
Examination of health outcomes, breast cancer reoccurrence, and mortality.
To examine health outcomes, cancer reoccurrence, and mortality in women with a history of breast cancer within the 12 month period via adverse events. Additional procedures include resting ECG, waist circumference, weight, and blood work.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2010 (estimated)
- Study startMay 2009
- Primary completionOct 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast Cancer SurvivorsStudies 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pennington Biomedical Research Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Timothy S Church, MD, MPH, PhD, Principal investigator, Pennington Biomedica Research CenterDonna H Ryan, MD, Study director, Pennington Biomedical Research CenterConrad P Earnest, PhD, Study director, Pennington Biomedical Research CenterValerie H Myers, PhD, Study director, Pennington Biomedical Research CenterCatherine M Champagne, PhD, Study director, Pennington Biomedical Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01217216
- Sponsor's protocol ID
- PBRC 28036
- Acronym
- CASTLE
- Status last verified
- Sep 2022
- First submitted
- 5 Oct 2010
- Last updated
- 15 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Harris MN, Swift DL, Myers VH, Earnest CP, Johannsen NM, Champagne CM, Parker BD, Levy E, Cash KC, Church TS. Cancer survival through lifestyle change (CASTLE): a pilot study of weight loss. Int J Behav Med. 2013 Sep;20(3):403-12. doi: 10.1007/s12529-012-9234-5.
PubMed 22535636
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cancer Survival Through Weight Loss and Exercise (CASTLE)
- ClinicalTrials.gov ID
- NCT01217216
- Acronym / sponsor ID
- CASTLE / PBRC 28036
- Conditions
- Breast Cancer Survivors
- Keywords
- Breast Cancer, Weight loss, Group Intervention, Telephone Intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Pennington Biomedical Research CenterUniversity, hospital or other
- Study start
- May 2009
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 8 Oct 2010 (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.
To test the effectiveness and feasibility of intensive motivational, behavior modifying intervention aimed at improving physical activity and dietary habits to produce at least 7% weight loss in women with a history of breast cancer in a community health setting.
Detailed description
This study will be divided into two phases (Phase I and II) that will differ by the intensity of motivational intervention. In Phase I, participants will receive 6 months of intensive weekly group-based or telephone-based motivational, behavior modifying intervention aimed at improving physical activity levels and dietary habits. Phase II will be an additional 6 months of monthly individualized motivational intervention in order to attain and maintain at least 7% body weight loss. All participants will attend an orientation, 2 run-in sessions, and a baseline assessment prior to the intervention. Participants will then be assigned to either the group based intervention or telephone intervention. The first 30 participants will enter into the group-based intervention and the second 30 will enter into the telephone-based intervention. Follow-up visits will be completed at the end of Phase I (week 25) and Phase II (week 50). Up to 60 women with a previous history of breast cancer will participate in this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group-based Intervention | Active comparator | Behavioral: Group-based InterventionWe randomly assigned 30 individuals to a group-based intervention to promote weight loss through dietary restriction and physical activity. |
| Telephone-based Intervention | Active comparator | Behavioral: Telephone-based InterventionWe randomly assigned 22 individuals to the telephone-based intervention to promote weight loss through dietary restriction and physical activity. |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Women between the ages of 30 and 75.
- Positive history of breast cancer treatment completed at least 2 months but no longer than 36 months prior to randomization.
- BMI ≥ 25 kg/m2 and ≤ 45 kg/m2
- Not involved in regular physical activity or weight loss management programs.
- Stage I, II or IIIa breast cancer with good prognosis.
Key exclusion criteria (16 listed)
- Presence of any co-morbidities including cardiovascular disease or diabetes
- Fasting triglycerides > 500 mg/dl.
- Consume more than 14 alcoholic beverages per week.
- A history of drug abuse, or excess alcohol consumption (40g/day)6.
- Currently dieting or engaging in any activity with the goal of losing weight.
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 Interventioncompared effects of a group-based intervention on weight loss and physical activity. | Behavioural | Group-based Intervention |
| Telephone-based Interventioncompared telephone-based intervention to weight loss and physical activity. | Behavioural | Telephone-based Intervention |
Primary outcome
Weight loss
Time frame: 1 year
To examine the effectiveness of using motivational, behavioral interventions aimed at improving physical activity levels and dietary habits to produce weight loss in women with a history of breast cancer.
2 secondary outcomes
Feasibility of recruiting breast cancer survivors
Time frame: 1 year
Examination of health outcomes, breast cancer reoccurrence, and mortality.
Time frame: 1 year
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 15 Sep 2022.
- Results publication: PubMed 22535636Harris MN, Swift DL, Myers VH, Earnest CP, Johannsen NM, Champagne CM, Parker BD, Levy E, Cash KC, Church TS. Cancer survival through lifestyle change (CASTLE): a pilot study of weight loss. Int J Behav Med. 2013 Sep;20(3):403-12. doi: 10.1007/s12529-012-9234-5.
Related trials for Breast Cancer Survivors
Not yet recruiting
Evaluation of Massage Therapy for Cancer Related Fatigue in Breast Cancer Survivors
Breast Cancer, Fatigue in Cancer Survivors
Not yet recruiting
Mind-Body Interventions for the Improvement of Quality of Life, Stress, and Sleep Quality Among Survivors of Breast, Prostate, Endometrial, or Colorectal Cancer
Breast Cancer Stage I, Colorectal Cancer
RecruitingObservational study
Improved Facial Skin Quality and Quality of Life After VYC-12L Treatment in Breast Cancer Survivors
Quality of Life, Breast Neoplasms
Active, not recruitingPhase 2
A Study of Flibanserin in Breast Cancer Survivors on Tamoxifen or Aromatase Inhibitors
Breast Cancer, Hyposexual Desire Disorder
Active, not recruitingObservational study
A Study of Attention and Memory Processes in Breast Cancer Survivors
Breast Cancer Survivors
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.
Timothy S Church, MD, MPH, PhD principal investigator
Pennington Biomedica Research Center
Donna H Ryan, MD study director
Pennington Biomedical Research Center
Conrad P Earnest, PhD study director
Pennington Biomedical Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group-based Intervention and Telephone-based Intervention in people with Breast Cancer Survivors, run by Pennington Biomedical Research 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 16 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 15 Sep 2022. 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?
Weight loss (time frame: 1 year). 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 NCT01217216, which also lists 1 linked publication.
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 15 Sep 2022.