Breast CancerNCT02574507
Behavioral Weight and Symptom Management for Breast Cancer Survivors and Partners
A study testing Couples-Based Behavioral Weight and Symptom Management in people with Breast Cancer, run by Duke University at 1 site in United States.
Trial summary
The objective of the study is to develop and test the feasibility, acceptability, and initial efficacy of a novel couples-based behavioral weight and symptom management intervention for obese breast cancer survivors and their partners. The proposed project consists of two phases. Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Couples-Based Behavioral Weight and Symptom Management
- 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
- Oct 2015to Dec 2018
- 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 21 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients:
- Female,
- obese (BMI >30)
- partnered
- diagnosis of non-metastatic breast cancer (stages I-III)
- completed adjuvant chemotherapy and/or radiation treatment in the last 5 years
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- healthy enough to participate in a home-based walking program (if participating in intervention refinement),
- able to speak English
- able and willing to give informed consent.
- Partners:
- Overweight/obese (BMI >25)
- cohabiting partner of a woman with non-metastatic breast cancer completing adjuvant chemotherapy and/or radiation in the last 5 years
- healthy enough to participate in a home-based walking program (if participating in intervention refinement)
- able to speak English
- able and willing to give informed consent.
- Patients:
- Female, obese (BMI >30)
- partnered
- diagnosis of non-metastatic breast cancer (stages I-III)
- completed adjuvant chemotherapy and/or radiation treatment in the last 3 years
- healthy enough to participate in a home-based walking program
- able to speak English
- able and willing to give informed consent.
- Partners:
- Overweight/obese (BMI >25)
- cohabiting partner of a woman with non-metastatic breast cancer completing adjuvant chemotherapy and/or radiation in the three years
- healthy enough to participate in a home-based walking program
- able to speak English
- able and willing to give informed consent.
Who cannot join
- male breast cancer survivors
- non-ambulatory
- unable to provide informed consent
- have a major mental illness (i.e., schizophrenia);
- have a mental illness that is not being treated/controlled (i.e., bipolar disorder)
- reside > 100 miles from the research site.
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- Phase II: Feasibility, Acceptability, and Efficacy of the Intervention
- male breast cancer survivors
- non-ambulatory
- unable to provide informed consent
- have a major mental illness (i.e., schizophrenia)
- have a mental illness that is not being treated/controlled (i.e., bipolar disorder)
- reside > 100 miles from the research site.
- Pregnant women will also be excluded from the study.
Trial locations and contacts
1 site in 1 country.
About this study
The objective of the study is to develop and test the feasibility, acceptability, and initial efficacy of a novel couples-based behavioral weight and symptom management intervention for obese breast cancer survivors and their partners. The proposed project consists of two phases. Phase I will include intervention development and refinement. Intervention development will be guided by the research team's prior work, the interdependence model of communal coping and behavior change, and information obtained from couples participating in focus groups. The intervention protocol will then be tested with 5 couples to assist with refinement of intervention content. During phase II, the feasibility, acceptability and initial efficacy of the intervention will be examined. Obese breast cancer survivors in the three years following treatment and their overweight or obese partners will receive 6 weekly and 6 biweekly sessions for a total of 12 sessions spaced across approximately 5 months. The intervention will be provided in a couples-based format where each couple will meet separately with the therapist. Couples will be assessed at pre-, post-, and 3-months post-treatment. Study outcomes will be weight, symptoms (i.e., pain, fatigue, distress), eating behavior, and physical activity. Exploratory outcomes examine biomarkers (i.e., insulin, IL-6, IL-8, TNF-alpha, adiponectin) associated with health outcomes for cancer survivors and their partners. It is hypothesized that the intervention will be feasible (i.e., completed sessions), and participants will find the intervention acceptable as assessed by a measure of treatment acceptability. It is also hypothesized that participants will evidence decreased weight and improvements in symptoms (i.e., pain, fatigue, distress), eating behavior, and physical activity, and their change in weight will covary with change in symptoms, eating behavior, and daily physical activity. Finally, it is hypothesized that participants with greater weight loss will evidence improved functioning in insulin, IL-6, IL-8, TNF-α, adiponectin, and heart rate.
- Conditions
- Breast Cancer
- Being tested
- Couples-Based Behavioral Weight and Symptom Management
- Keywords
- breast cancer, weight management, couples, symptom management
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Couples-Based Behavioral Weight and Symptom ManagementBehavioural
Investigators anticipate that the intervention developed in phase I will consist of a total of 12 sessions 90 minutes in length (18 therapy hours) spaced across approximately 5 months. Sessions are spaced to provide participants sufficient time to complete home practice exercises and adequately examine change in weight and maintenance of weight loss. Sessions will be conducted individually for each day. The first 6 sessions will occur weekly and the final 6 sessions will occur biweekly.
| Study group | Role | What they receive |
|---|---|---|
| Couples-Based Behavioral Weight and Symptom Management | Experimental | Participants will receive 12 session (6 weekly and 6 biweekly) of a behavioral weight and symptom management intervention. Receives: Behavioral: Couples-Based Behavioral Weight and Symptom Management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Weight
Participants will be weighed at each assessment and each session.
Measured: baseline, week 1, week 2, week 3, week 4, week 5, week 6, week 8, week 10, week 12, week 14, week 16, week 18, post-treatment (approximately 18-20 weeks), 3 months post-treatment (approximately 30-32 weeks)
Change in steps per day
Participants will wear wireless activity trackers (Fitbits) to measure daily activity (e.g., steps taken). Participants will be provided with the activity trackers by study staff and begin to use the trackers following the pre-treatment assessment. Participants will continue to use the trackers throughout treatment. Participants will return the Fitbits to the study staff upon completion of the study.
Measured: Through study completion (an average of 31 weeks)
Change in 6 minute walk ability score
The 6-minute walk test is a self-paced, timed test of the total distance in meters that a patient is able to walk over a six-minute period and assesses the ability to exert effort during activity.
Measured: baseline, post-treatment (approximately 18-20 weeks), 3 months post-treatment (approximately 30-32 weeks)
Change in 6 minute walk pain score
The degree of pain experienced during the 6-minute walk test will also be assessed.
Measured: baseline, post-treatment (approximately 18-20 weeks), 3 months post-treatment (approximately 30-32 weeks)
Change in Stanford Leisure-Time Activity Categorical Item (L-Cat)
The L-Cat is a measure of physical activity. Individuals identify which descriptive category best describes their level of activity during leisure time in the last month. Descriptive categories range from inactive to very active.
Measured: baseline , post-treatment (approximately 18-20 weeks), 3 months post-treatment (approximately 30-32 weeks)
Change in Eating Behavior
Participants will also be asked to complete the Dietary Instrument for Nutrition Education (DINE). The DINE is a brief assessment of the amount of fat and dietary fiber in an individual's usual diet. Participants are provided with a list of food items and asked about the frequency with which they have eaten the items per week when considering the last month.
Measured: baseline , post-treatment (approximately 18-20 weeks), 3 months post-treatment (approximately 30-32 weeks)
Change in The Brief Pain Inventory (BPI)
The BPI is a 9-item self-report measure assessing pain severity. Participants rate their pain on a scale from 0 to 10 where 0 represents "no pain" and 10 represents "pain as bad as you can imagine." Participants also rate their level of interference from pain.
Measured: baseline , post-treatment (approximately 18-20 weeks), 3 months post-treatment (approximately 30-32 weeks)
Change in Promis Fatigue Scale
The Promis Fatigue Scale is a 6-item self-report measure of fatigue in the last week
Measured: pre-treatment, post-treatment (approximately 18-20 weeks), 3 months post-treatment (approximately 30-32 weeks)
Change in Profile of Mood States (POMS)
The POMS will be used to assess psychological distress. Each item is rated on a scale from 0 (not at all) to 4 (extremely) as being self-descriptive for the last seven days.
Measured: baseline , post-treatment (approximately 18-20 weeks), 3 months post-treatment (approximately 30-32 weeks)
Change in Physical Activity based on the International Physical Activity Questionnaire
Participants will also complete the International Physical Activity Questionnaire (IPAQ). This seven-item questionnaire assesses the amount of time participants have spent doing moderate and vigorous physical activities in the last seven days.
Measured: pre-treatment, post-treatment (approximately 18-20 weeks), 3 months post-treatment (approximately 30-32 weeks)
Change in eating behavior using the Three Factor Eating Questionnaire
Eating behaviors will be assessed using the Three Factor Eating Questionnaire (TFEQ). The 21-item short-form will be used for the present study. The TFEQ measures three domains of eating behavior: 1) cognitive restraint, 2) uncontrolled eating, and 3) emotional eating.
Measured: pre-treatment, post-treatment (approximately 18-20 weeks), 3 months post-treatment (approximately 30-32 weeks)
Secondary outcomes (12)
Change in Fasting insulin
Fasting insulin will be examined by taking a sample of peripheral blood from participants at the baseline and post-treatment assessments.
Measured: baseline and 3 months post-treatment (approximately 30-32 weeks)
Change in IL-6
The pro-inflammatory cytokine IL-6 will be examined by taking a sample of peripheral blood from participants at the baseline and post-treatment assessments.
Measured: baseline and 3 months post-treatment (approximately 30-32 weeks)
Change in IL-8
The pro-inflammatory cytokine IL-8 will be examined by taking a sample of peripheral blood from participants at the baseline and post-treatment assessments.
Measured: baseline and 3 months post-treatment (approximately 30-32 weeks)
Change in TNF-alpha
The pro-inflammatory cytokine TNF-alpha will be examined by taking a sample of peripheral blood from participants at the baseline and post-treatment assessments.
Measured: baseline and 3 months post-treatment (approximately 30-32 weeks)
Change in Adiponectin
The anti-inflammatory cytokine adiponectin will be examined by taking a sample of peripheral blood from participants at the baseline and post-treatment assessments.
Measured: baseline and 3 months post-treatment (approximately 30-32 weeks)
Change in Heart Rate
Heart rate will be assessed via the wireless activity trackers (Fitbit) worn by participants throughout the study.
Measured: Through study completion (an average of 31 weeks)
Treatment Acceptability Questionnaire (TAQ)
The Treatment Acceptability Questionnaire (TAQ) is a six-item scale assessing whether participants view an intervention as acceptable, ethical, and effective. Items are rated on a 7-point Likert scale (e.g., 1 "very unacceptable" to 7 "very acceptable).
Measured: post-treatment (approximately 30-32 weeks)
Change in Session attendance rate
Treatment feasibility will be assessed by measuring the session attendance rate for each participant and each day.
Measured: week 1, week 2, week 3, week 4, week 5, week 6, week 8, week 10, week 12, week 14, week 16, week 18
Change in Use of intervention strategies
Participants' use of intervention strategies will be assessed using a measure developed for components of the present study. Participants will be asked about how frequently treatment strategies discussed in session have been used outside of session in the past week or past month depending on the timing of the questionnaire. A scale ranging from 0 "not at all" to 5 "2 or more times a day" will be used.
Measured: week 1, week 2, week 3, week 4, week 5, week 6, week 8, week 10, week 12, week 14, week 16, week 18
Change in partner support for eating and exercise
Partner support for eating and exercise will be assessed using a modified version of the Social Support for Diet and Exercise questionnaires. Participants will be asked to provide information about the amount of encouragement and discouragement they have received from their partner over the last three months regarding healthy eating and exercise. Items are rated on a 5 point scale from 1 "none" to 5 "very often."
Measured: pre-treatment, post-treatment (approximately 18-20 weeks), 3 months post-treatment (approximately 30-32 weeks)
Change in Self-Efficacy for Weight
The Weight Efficacy Lifestyle Questionnaire is an 8-item measure of eating self-efficacy. Participants are asked to provide information about how certain they are that they can resist overeating in difficult situation (e.g., over the weekend, when tired, etc.). Response choices range from 0= "not at all confident" to 10= "very confident."
Measured: pre-treatment, post-treatment (approximately 18-20 weeks), 3 months post-treatment (approximately 30-32 weeks); at each intervention session (week 1, week 2, week 3, week 4, week 5, week 6, week 8, week 10, week 12, week 14, week 16, week 18)
Change in self-efficacy for managing chronic disease
The Self-Efficacy for Managing Chronic Disease Scale is a 6-item scale that asks participants to rate their confidence in doing certain activities (e.g., keep emotional distress from interfering with the things you want to do) on a scale from 1= "not at all confident" to 10= "totally confident." The wording of items was slightly altered to better match the sample intended for the present study.
Measured: pre-treatment, post-treatment (approximately 18-20 weeks), 3 months post-treatment (approximately 30-32 weeks); at each intervention session (week 1, week 2, week 3, week 4, week 5, week 6, week 8, week 10, week 12, week 14, week 16, week 18)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2015 (estimated)
- Study startOct 2015
- Primary completionDec 2018
- Study completionDec 2018
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.
- More trials run by Duke UniversityThe 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Caroline S Dorfman, PhD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02574507
- Sponsor's protocol ID
- Pro00063328
- Other IDs
- 1F32CA200091-01
- Status last verified
- May 2020
- First submitted
- 5 Oct 2015
- Last updated
- 6 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Behavioral Weight and Symptom Management for Breast Cancer Survivors and Partners
- ClinicalTrials.gov ID
- NCT02574507
- Acronym / sponsor ID
- Pro00063328
- Conditions
- Breast Cancer
- Keywords
- breast cancer, weight management, couples, symptom management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Oct 2015
- Primary completion
- Dec 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 14 Oct 2015 (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 objective of the study is to develop and test the feasibility, acceptability, and initial efficacy of a novel couples-based behavioral weight and symptom management intervention for obese breast cancer survivors and their partners. The proposed project consists of two phases. Phase I will include intervention development and refinement. Intervention development will be guided by the research team's prior work, the interdependence model of communal coping and behavior change, and information obtained from couples participating in focus groups. The intervention protocol will then be tested with 5 couples to assist with refinement of intervention content. During phase II, the feasibility, acceptability and initial efficacy of the intervention will be examined. Obese breast cancer survivors in the three years following treatment and their overweight or obese partners will receive 6 weekly and 6 biweekly sessions for a total of 12 sessions spaced across approximately 5 months. The intervention will be provided in a couples-based format where each couple will meet separately with the therapist. Couples will be assessed at pre-, post-, and 3-months post-treatment. Study outcomes will be weight, symptoms (i.e., pain, fatigue, distress), eating behavior, and physical activity. Exploratory outcomes examine biomarkers (i.e., insulin, IL-6, IL-8, TNF-alpha, adiponectin) associated with health outcomes for cancer survivors and their partners. It is hypothesized that the intervention will be feasible (i.e., completed sessions), and participants will find the intervention acceptable as assessed by a measure of treatment acceptability. It is also hypothesized that participants will evidence decreased weight and improvements in symptoms (i.e., pain, fatigue, distress), eating behavior, and physical activity, and their change in weight will covary with change in symptoms, eating behavior, and daily physical activity. Finally, it is hypothesized that participants with greater weight loss will evidence improved functioning in insulin, IL-6, IL-8, TNF-α, adiponectin, and heart rate.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Couples-Based Behavioral Weight and Symptom Management | Experimental | Behavioral: Couples-Based Behavioral Weight and Symptom ManagementParticipants will receive 12 session (6 weekly and 6 biweekly) of a behavioral weight and symptom management intervention. |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (29 listed)
- Patients:
- Partners:
- Patients:
- Partners:
Key exclusion criteria (14 listed)
- male breast cancer survivors
- non-ambulatory
- unable to provide informed consent
- have a major mental illness (i.e., schizophrenia);
- have a mental illness that is not being treated/controlled (i.e., bipolar disorder)
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 |
|---|---|---|
| Couples-Based Behavioral Weight and Symptom ManagementInvestigators anticipate that the intervention developed in phase I will consist of a total of 12 sessions 90 minutes in length (18 therapy hours) spaced across approximately 5 months. Sessions are spaced to provide participants sufficient time to complete home practice exercises and adequately examine change in weight and maintenance of weight loss. Sessions will be conducted individually for each day. The first 6 sessions will occur weekly and the final 6 sessions will occur biweekly. | Behavioural | Couples-Based Behavioral Weight and Symptom Management |
Primary outcome
Change in Weight
Time frame: baseline, week 1, week 2, week 3, week 4, week 5, week 6, week 8, week 10, week 12, week 14, week 16, week 18, post-treatment (approximately 18-20 weeks), 3 months post-treatment (approximately 30-32 weeks)
Participants will be weighed at each assessment and each session.
Change in steps per day
Time frame: Through study completion (an average of 31 weeks)
Participants will wear wireless activity trackers (Fitbits) to measure daily activity (e.g., steps taken). Participants will be provided with the activity trackers by study staff and begin to use the trackers following the pre-treatment assessment. Participants will continue to use the trackers throughout treatment. Participants will return the Fitbits to the study staff upon completion of the study.
Change in 6 minute walk ability score
Time frame: baseline, post-treatment (approximately 18-20 weeks), 3 months post-treatment (approximately 30-32 weeks)
The 6-minute walk test is a self-paced, timed test of the total distance in meters that a patient is able to walk over a six-minute period and assesses the ability to exert effort during activity.
Change in 6 minute walk pain score
Time frame: baseline, post-treatment (approximately 18-20 weeks), 3 months post-treatment (approximately 30-32 weeks)
The degree of pain experienced during the 6-minute walk test will also be assessed.
Change in Stanford Leisure-Time Activity Categorical Item (L-Cat)
Time frame: baseline , post-treatment (approximately 18-20 weeks), 3 months post-treatment (approximately 30-32 weeks)
The L-Cat is a measure of physical activity. Individuals identify which descriptive category best describes their level of activity during leisure time in the last month. Descriptive categories range from inactive to very active.
Change in Eating Behavior
Time frame: baseline , post-treatment (approximately 18-20 weeks), 3 months post-treatment (approximately 30-32 weeks)
Participants will also be asked to complete the Dietary Instrument for Nutrition Education (DINE). The DINE is a brief assessment of the amount of fat and dietary fiber in an individual's usual diet. Participants are provided with a list of food items and asked about the frequency with which they have eaten the items per week when considering the last month.
Change in The Brief Pain Inventory (BPI)
Time frame: baseline , post-treatment (approximately 18-20 weeks), 3 months post-treatment (approximately 30-32 weeks)
The BPI is a 9-item self-report measure assessing pain severity. Participants rate their pain on a scale from 0 to 10 where 0 represents "no pain" and 10 represents "pain as bad as you can imagine." Participants also rate their level of interference from pain.
Change in Promis Fatigue Scale
Time frame: pre-treatment, post-treatment (approximately 18-20 weeks), 3 months post-treatment (approximately 30-32 weeks)
The Promis Fatigue Scale is a 6-item self-report measure of fatigue in the last week
Change in Profile of Mood States (POMS)
Time frame: baseline , post-treatment (approximately 18-20 weeks), 3 months post-treatment (approximately 30-32 weeks)
The POMS will be used to assess psychological distress. Each item is rated on a scale from 0 (not at all) to 4 (extremely) as being self-descriptive for the last seven days.
Change in Physical Activity based on the International Physical Activity Questionnaire
Time frame: pre-treatment, post-treatment (approximately 18-20 weeks), 3 months post-treatment (approximately 30-32 weeks)
Participants will also complete the International Physical Activity Questionnaire (IPAQ). This seven-item questionnaire assesses the amount of time participants have spent doing moderate and vigorous physical activities in the last seven days.
Change in eating behavior using the Three Factor Eating Questionnaire
Time frame: pre-treatment, post-treatment (approximately 18-20 weeks), 3 months post-treatment (approximately 30-32 weeks)
Eating behaviors will be assessed using the Three Factor Eating Questionnaire (TFEQ). The 21-item short-form will be used for the present study. The TFEQ measures three domains of eating behavior: 1) cognitive restraint, 2) uncontrolled eating, and 3) emotional eating.
12 secondary outcomes
Change in Fasting insulin
Time frame: baseline and 3 months post-treatment (approximately 30-32 weeks)
Change in IL-6
Time frame: baseline and 3 months post-treatment (approximately 30-32 weeks)
Change in IL-8
Time frame: baseline and 3 months post-treatment (approximately 30-32 weeks)
Change in TNF-alpha
Time frame: baseline and 3 months post-treatment (approximately 30-32 weeks)
Change in Adiponectin
Time frame: baseline and 3 months post-treatment (approximately 30-32 weeks)
Change in Heart Rate
Time frame: Through study completion (an average of 31 weeks)
Treatment Acceptability Questionnaire (TAQ)
Time frame: post-treatment (approximately 30-32 weeks)
Change in Session attendance rate
Time frame: week 1, week 2, week 3, week 4, week 5, week 6, week 8, week 10, week 12, week 14, week 16, week 18
Change in Use of intervention strategies
Time frame: week 1, week 2, week 3, week 4, week 5, week 6, week 8, week 10, week 12, week 14, week 16, week 18
Change in partner support for eating and exercise
Time frame: pre-treatment, post-treatment (approximately 18-20 weeks), 3 months post-treatment (approximately 30-32 weeks)
Change in Self-Efficacy for Weight
Time frame: pre-treatment, post-treatment (approximately 18-20 weeks), 3 months post-treatment (approximately 30-32 weeks); at each intervention session (week 1, week 2, week 3, week 4, week 5, week 6, week 8, week 10, week 12, week 14, week 16, week 18)
Change in self-efficacy for managing chronic disease
Time frame: pre-treatment, post-treatment (approximately 18-20 weeks), 3 months post-treatment (approximately 30-32 weeks); at each intervention session (week 1, week 2, week 3, week 4, week 5, week 6, week 8, week 10, week 12, week 14, week 16, week 18)
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 6 May 2020.
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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.
Caroline S Dorfman, PhD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Couples-Based Behavioral Weight and Symptom Management in people with Breast Cancer, run by Duke University 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 29 inclusion and 14 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 6 May 2020. 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?
Change in Weight (time frame: baseline, week 1, week 2, week 3, week 4, week 5, week 6, week 8, week 10, week 12, week 14, week 16, week 18, post-treatment (approximately 18-20 weeks), 3 months post-treatment (approximately 30-32 weeks)). The study lists 11 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 6 May 2020.