Weight Loss Program After Cancer DiagnosisNCT01978899
Healthy Living After Cancer: Weight Management Pilot Study
A study testing Immediate Weight Loss Program Group and Delayed Weight Loss Program Group in people with Weight Loss Program After Cancer Diagnosis, run by Dana-Farber Cancer Institute at 1 site in United States.
Trial summary
Studies have shown that patients who weigh more at the time of cancer diagnosis may be at increased risk of complications from surgery, fatigue, poor body image and other problems. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Weight Loss Program After Cancer Diagnosis
- What is being tested?
- Immediate Weight Loss Program Group and Delayed Weight Loss Program Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2013to Feb 2016
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent prior to any study-related procedures
- History of any malignancy
- Completed with all adjuvant surgery, chemotherapy and/or radiation at least one month prior to study enrollment (patients receiving ongoing hormonal or biologic therapy are eligible to participate)
- BMI >25kg/m2
- ECOG performance status of 0 or 1
- At least 18 years old
Show all 9Show fewer
- Physically able to exercise and physician consent to start a weight loss program
- Willingness to be randomized
- English speaking and able to read English
Who cannot join
- Self-reported inability to walk 2 blocks (at any pace)
- Serious digestive and/or absorptive problems, including inflammatory bowel disease and chronic diarrhea that preclude adherence to the study diet.
- Bariatric surgery within the last year
- Cardiovascular, respiratory or musculoskeletal disease or joint problems that preclude moderate physical activity. Examples would include unstable angina, recent myocardial infarction, oxygen-dependent pulmonary disease, and osteoarthritis requiring imminent joint replacement. Moderate arthritis that does not preclude physical activity is not a reason for ineligibility.
- Psychiatric disorders or conditions that would preclude participation in the study intervention (e.g. untreated major depression or psychosis, substance abuse, severe personality disorder).
Trial locations and contacts
1 site in 1 country.
United States1 site
Dana Farber Cancer Institute
Boston, Massachusetts, 02115
About this study
Studies have shown that patients who weigh more at the time of cancer diagnosis may be at increased risk of complications from surgery, fatigue, poor body image and other problems. Some research suggests that losing weight after cancer diagnosis can lead to improvements in these problems, as well as having other potential benefits for cancer survivors. Programs that reduce calories and increase exercise have been shown to help cancer survivors lose weight, but more research is needed to develop and test weight loss programs in cancer survivors.
This study is designed to look at the ability of a 15-week diet and exercise program to help cancer survivors lose weight. The investigator will look at changes in weight, body composition, quality of life, fatigue, body image as well as diet and exercise patterns, to see if this program can help men and women feel better and live healthier lives after cancer diagnosis.
Read the detailed description
Before the research starts
- After signing this consent form, the participant will be asked to answer some questions about their health and ability to exercise to find out if the participant can be in the research study.
- If these tests show that the participant is eligible to participate in the research study, the participant will be able to participate in the research study. If the participant does not meet the eligibility criteria, the participant will not be able to participate in this research study.
- After the screening procedures confirm that the participant are eligible to participate in the research study.
- The participant will be scheduled to come to Dana-Farber to complete a number of study measures at baseline and at 16 and 32-weeks after the participant enrolls in the study.
- We will ask the participant to complete a number of study questionnaires that will include questions about: diet and exercise habits, medical history and quality of life (social support, thoughts and feelings).
It should take the participant about 30 minutes to complete the questionnaires. Some of the questions on these questionnaires are personal - the participant can refuse to answer these if the participant wishes. The information the participant provides is for research purposes only and will remain strictly confidential. The individuals (e.g. doctors, nurses, etc.) directly involved in the participant's care will not usually see their responses to these questions-if the participant wishes them to know this information please bring it to their attention.
Study staff will also record the participant's height and weight and will also ask the participant to undergo a walking test to measure how far the participant can comfortably walk in 6 minutes.
The participant will have an X-ray examination, called a dual energy x-ray absorptiometry (DEXA) scan that measures your body fat and bone mass at baseline and 16-weeks after enrollment. The DEXA scan involves lying still for about 10 minutes on a padded table. The scanner will not touch the participant and the participant will not feel any discomfort. The test does not require the participant to undress. If the participant wishes, we will provide your doctor with a copy of your DEXA scan.
Randomization (assignment to a group):
Because no one knows which of the study options is best, the participant will be "randomized" into one of the study groups: Immediate Weight Loss Program Group or Delayed Weight Loss Program Group. Randomization means that the participants are put into a group by chance. It is like flipping a coin. The central office that is coordinating the study will assign the participants to one of the two treatment groups. Neither the participant nor your doctor can choose what group the participant will be in. The participant will have an equal chance of being placed in either group.
Immediate Weight Loss Program Group If the participant is placed in the Immediate Weight Loss Program group, the participant will participate in the weight loss program soon after signing up for the study. The program consists of 15 sessions focused on reducing calories and increasing exercise. Sample goals of the program include reducing weight by 1-2 pounds per week and increasing exercise to at least 150 minutes of moderate exercise (such as walking) per week. Weight loss sessions will take place once per week for 15-weeks at Dana-Farber. The participant will meet with a dietician and exercise specialist weekly during the sessions to set diet and exercise goals for the week. Each session will consist of discussion of a diet and/or exercise topic for 30 minutes and 30 minutes of group exercise, such as moderate-paced walking or step aerobics. The participant will also be given the opportunity to be weighed, either as part of the group or in private with one of the weight loss study staff members, at each session in order to track their progress.
As part of participating in the weight loss program, the participant will be provided with a weight loss workbook with materials to supplement the weekly sessions. The participant will also be given a pedometer to help keep track of their exercise and a journal to keep track of their exercise and the food eaten each day. The participant will bring the journal to each weight loss session to review with study staff.
Delayed Weight Loss Program Group If the participant is placed in the Delayed Weight Loss Program group, he/or she will be offered the opportunity to participate in the weight loss program after an initial 15-week waiting period. During this waiting period, the participant is welcome to work on weight loss on your own, but the investigators will not provide the participant with the weight loss program materials or counseling until after the initial 15-week waiting period is over.
- Being tested
- Immediate Weight Loss Program Group, Delayed Weight Loss Program Group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immediate Weight Loss Program GroupBehavioural
Participation in 15-week Healthy Living Program.
Delayed Weight Loss Program GroupBehavioural
Participation in 15-week Healthy Living Program following 15-week wait period.
| Study group | Role | What they receive |
|---|---|---|
| Immediate Weight Loss Program Group | Active comparator | Immediate Weight Loss Program Group
* The weight loss Program Group will include weekly in-person sessions comprised of dietary counseling and increased physical activity. Patients will also be provided with exercise and dietary goals each week to implement at home.
* Assessments will occur at baseline (pre-randomization), at the end of the 16-week intervention or control period and at 32 weeks. Receives: Behavioral: Immediate Weight Loss Program Group |
| Delayed Weight Loss Program Group | Active comparator | The Delayed Weight Loss Program Group will take part in the weight loss intervention after the 16-week control period. Assessments will occur at baseline (pre-randomization), at the end of the 16-week intervention or control period and at 32 weeks Receives: Behavioral: Delayed Weight Loss Program Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the impact of a 15-week, group-based weight loss intervention upon body weight in a group of cancer survivors.
Change in weight (post-pre)weight loss intervention
Measured: 2 Years
Secondary outcomes (1)
To evaluate the impact of a 15-week weight loss intervention upon the following in a group of cancer survivors.
Correlate the effect of the intervention with anthropometric outcomes of percentage change or differences, changes in QOL, physical activity, or body image relative to baseline.
Measured: 2 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2013 (estimated)
- Study startNov 2013
- Primary completionDec 2015
- Study completionFeb 2016
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 Weight Loss Program After Cancer DiagnosisStudies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe 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
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jennifer A. Ligibel, MD, Dana-Farber Cancer Institute
- Investigators
- Jennifer Ligibel, MD, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01978899
- Sponsor's protocol ID
- 13-336
- Status last verified
- Jun 2016
- First submitted
- 9 Oct 2013
- Last updated
- 3 Jun 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: There are no plans to release individual participant data.
Publications
Brown JC, Giobbie-Hurder A, Yung RL, Mayer EL, Tolaney SM, Partridge AH, Ligibel JA. The effects of a clinic-based weight loss program on health-related quality of life and weight maintenance in cancer survivors: A randomized controlled trial. Psychooncology. 2022 Feb;31(2):326-333. doi: 10.1002/pon.5817. Epub 2021 Sep 12.
PubMed 34510643
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Healthy Living After Cancer: Weight Management Pilot Study
- ClinicalTrials.gov ID
- NCT01978899
- Acronym / sponsor ID
- 13-336
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Dec 2015 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 8 Nov 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.
Studies have shown that patients who weigh more at the time of cancer diagnosis may be at increased risk of complications from surgery, fatigue, poor body image and other problems. Some research suggests that losing weight after cancer diagnosis can lead to improvements in these problems, as well as having other potential benefits for cancer survivors. Programs that reduce calories and increase exercise have been shown to help cancer survivors lose weight, but more research is needed to develop and test weight loss programs in cancer survivors.
This study is designed to look at the ability of a 15-week diet and exercise program to help cancer survivors lose weight. The investigator will look at changes in weight, body composition, quality of life, fatigue, body image as well as diet and exercise patterns, to see if this program can help men and women feel better and live healthier lives after cancer diagnosis.
Detailed description
Before the research starts
- After signing this consent form, the participant will be asked to answer some questions about their health and ability to exercise to find out if the participant can be in the research study.
- If these tests show that the participant is eligible to participate in the research study, the participant will be able to participate in the research study. If the participant does not meet the eligibility criteria, the participant will not be able to participate in this research study.
- After the screening procedures confirm that the participant are eligible to participate in the research study.
- The participant will be scheduled to come to Dana-Farber to complete a number of study measures at baseline and at 16 and 32-weeks after the participant enrolls in the study.
- We will ask the participant to complete a number of study questionnaires that will include questions about: diet and exercise habits, medical history and quality of life (social support, thoughts and feelings).
It should take the participant about 30 minutes to complete the questionnaires. Some of the questions on these questionnaires are personal - the participant can refuse to answer these if the participant wishes. The information the participant provides is for research purposes only and will remain strictly confidential. The individuals (e.g. doctors, nurses, etc.) directly involved in the participant's care will not usually see their responses to these questions-if the participant wishes them to know this information please bring it to their attention.
Study staff will also record the participant's height and weight and will also ask the participant to undergo a walking test to measure how far the participant can comfortably walk in 6 minutes.
The participant will have an X-ray examination, called a dual energy x-ray absorptiometry (DEXA) scan that measures your body fat and bone mass at baseline and 16-weeks after enrollment. The DEXA scan involves lying still for about 10 minutes on a padded table. The scanner will not touch the participant and the participant will not feel any discomfort. The test does not require the participant to undress. If the participant wishes, we will provide your doctor with a copy of your DEXA scan.
Randomization (assignment to a group):
Because no one knows which of the study options is best, the participant will be "randomized" into one of the study groups: Immediate Weight Loss Program Group or Delayed Weight Loss Program Group. Randomization means that the participants are put into a group by chance. It is like flipping a coin. The central office that is coordinating the study will assign the participants to one of the two treatment groups. Neither the participant nor your doctor can choose what group the participant will be in. The participant will have an equal chance of being placed in either group.
Immediate Weight Loss Program Group If the participant is placed in the Immediate Weight Loss Program group, the participant will participate in the weight loss program soon after signing up for the study. The program consists of 15 sessions focused on reducing calories and increasing exercise. Sample goals of the program include reducing weight by 1-2 pounds per week and increasing exercise to at least 150 minutes of moderate exercise (such as walking) per week. Weight loss sessions will take place once per week for 15-weeks at Dana-Farber. The participant will meet with a dietician and exercise specialist weekly during the sessions to set diet and exercise goals for the week. Each session will consist of discussion of a diet and/or exercise topic for 30 minutes and 30 minutes of group exercise, such as moderate-paced walking or step aerobics. The participant will also be given the opportunity to be weighed, either as part of the group or in private with one of the weight loss study staff members, at each session in order to track their progress.
As part of participating in the weight loss program, the participant will be provided with a weight loss workbook with materials to supplement the weekly sessions. The participant will also be given a pedometer to help keep track of their exercise and a journal to keep track of their exercise and the food eaten each day. The participant will bring the journal to each weight loss session to review with study staff.
Delayed Weight Loss Program Group If the participant is placed in the Delayed Weight Loss Program group, he/or she will be offered the opportunity to participate in the weight loss program after an initial 15-week waiting period. During this waiting period, the participant is welcome to work on weight loss on your own, but the investigators will not provide the participant with the weight loss program materials or counseling until after the initial 15-week waiting period is over.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediate Weight Loss Program Group | Active comparator | Behavioral: Immediate Weight Loss Program GroupImmediate Weight Loss Program Group * The weight loss Program Group will include weekly in-person sessions comprised of dietary counseling and increased physical activity. Patients will also be provided with exercise and dietary goals each week to implement at home. * Assessments will occur at baseline (pre-randomization), at the end of the 16-week intervention or control period and at 32 weeks. |
| Delayed Weight Loss Program Group | Active comparator | Behavioral: Delayed Weight Loss Program GroupThe Delayed Weight Loss Program Group will take part in the weight loss intervention after the 16-week control period. Assessments will occur at baseline (pre-randomization), at the end of the 16-week intervention or control period and at 32 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Written informed consent prior to any study-related procedures
- History of any malignancy
- Completed with all adjuvant surgery, chemotherapy and/or radiation at least one month prior to study enrollment (patients receiving ongoing hormonal or biologic therapy are eligible to participate)
- BMI >25kg/m2
- ECOG performance status of 0 or 1
Key exclusion criteria (5 listed)
- Self-reported inability to walk 2 blocks (at any pace)
- Serious digestive and/or absorptive problems, including inflammatory bowel disease and chronic diarrhea that preclude adherence to the study diet.
- Bariatric surgery within the last year
- Cardiovascular, respiratory or musculoskeletal disease or joint problems that preclude moderate physical activity. Examples would include unstable angina, recent myocardial infarction, oxygen-dependent pulmonary disease, and osteoarthritis requiring imminent joint replacement. Moderate arthritis that does not preclude physical activity is not a reason for ineligibility.
- Psychiatric disorders or conditions that would preclude participation in the study intervention (e.g. untreated major depression or psychosis, substance abuse, severe personality 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 |
|---|---|---|
| Immediate Weight Loss Program GroupParticipation in 15-week Healthy Living Program. | Behavioural | Immediate Weight Loss Program Group |
| Delayed Weight Loss Program GroupParticipation in 15-week Healthy Living Program following 15-week wait period. | Behavioural | Delayed Weight Loss Program Group |
Primary outcome
To evaluate the impact of a 15-week, group-based weight loss intervention upon body weight in a group of cancer survivors.
Time frame: 2 Years
Change in weight (post-pre)weight loss intervention
1 secondary outcome
To evaluate the impact of a 15-week weight loss intervention upon the following in a group of cancer survivors.
Time frame: 2 Years
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 3 Jun 2016.
- Derived from this study: PubMed 34510643Brown JC, Giobbie-Hurder A, Yung RL, Mayer EL, Tolaney SM, Partridge AH, Ligibel JA. The effects of a clinic-based weight loss program on health-related quality of life and weight maintenance in cancer survivors: A randomized controlled trial. Psychooncology. 2022 Feb;31(2):326-333. doi: 10.1002/pon.5817. Epub 2021 Sep 12.
- Individual participant dataSharing planned: No. There are no plans to release individual participant data.
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.
Jennifer Ligibel, MD principal investigator
Dana-Farber Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Immediate Weight Loss Program Group and Delayed Weight Loss Program Group in people with Weight Loss Program After Cancer Diagnosis, run by Dana-Farber Cancer Institute 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: finished, as of the sponsor's last update on 3 Jun 2016. 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?
To evaluate the impact of a 15-week, group-based weight loss intervention upon body weight in a group of cancer survivors. (time frame: 2 Years). 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 NCT01978899, 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 3 Jun 2016.