Feasibility and Acceptability of the TOPS ProgramNCT04741802

TOPS for African American Breast Cancer Survivors

A study testing TOPS in people with Feasibility and Acceptability of the TOPS Program and Obesity, run by Duke University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 55 years and older, women only
Conditions the study is for: Feasibility and Acceptability of the TOPS Program, Obesity, Breast Cancer
What is being tested?: TOPS
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 26 participants
Where: 1 siteUnited States
Study dates: 11 Jun 2021to 30 Aug 2022
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 55 years and older
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

Women diagnosed with breast cancer with BMI ≥ 25 kg/m after completion of primary 2 therapy (surgery, radiation, adjuvant or neo-adjuvant chemotherapy).

Who cannot join

Women whose oncology providers do not agree with their participation in a weight loss program or those participating in another weight loss program.

Trial locations and contacts

1 site in 1 country.

United States1 site

Duke University Health System
Durham, North Carolina, 27710

Other trials in United States

About this study

Official title: Feasibility and Acceptability of a Community-based Weight Loss Program Among African American Breast Cancer Survivors

For women diagnosed with breast cancer, dietary, weight loss, and physical activity have been linked with clinically significant weight loss; decreased risk of death; reduced risk of breast cancer recurrence; fewer cardiovascular events; and improved physical function. The objectives of these aims are to a) determine if the TOPS materials and format are possible and accepted by overweight and obese African American breast cancer survivors; b) gather data for sample size calculations for a larger future study.

To meet these aims, we will collect data to see if participants enjoyed the TOPS program and suggestions for changes to the program to make it fit their needs. Other methods will measure recruitment, retention, and weight change.

Aim 1: Examine the feasibility and acceptability of a national, low-cost, community-based, peer-led, weight loss program (Take Off Pounds Sensibly, TOPS) for overweight and obese African American breast cancer survivors in the local chapter of a national African American breast cancer support group (Sisters Network Triangle North Carolina, SNTNC).

Aim 2: Assess the weight change of overweight and obese African American breast cancer survivors after 6 months in the TOPS program to gather data for sample size calculations for a future RCT (randomized controlled trial).

Conditions: Feasibility and Acceptability of the TOPS Program, Obesity, Breast Cancer, Weight Loss
Being tested: TOPS
Medical subject headings: Obesity, Breast Neoplasms, Weight Loss

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

TOPSBehavioural
weight loss program (Take Off Pounds Sensibly, TOPS) for overweight and obese African American breast cancer survivors in the local chapter of a national African American breast cancer support group (Sisters Network Triangle North Carolina, SNTNC).

Study groups in NCT04741802
Study group	Role	What they receive
TOPS	Experimental	weight loss program (Take Off Pounds Sensibly, TOPS) for overweight and obese African American breast cancer survivors Receives: Behavioral: TOPS

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Invited Women Who Attended the TOPS (Take Off Pounds Sensibly) Information Session
Measured: One-time invitation
Number of Women Who Attended the Information Session and Joined the TOPS Program
Measured: One-time information session
Number of Women Who Remained in the Program for 12 Weeks
Measured by the number of women who reported to the 12-week weigh in.
Measured: up to 12 weeks
Number of Women Who Remained in the Program for 24 Weeks
Measured by the number of women who reported to the 24-week weigh in.
Measured: up to 24 weeks

Secondary outcomes (1)

Percent Change in Participants' Weight as Measured by Scale Reading
Measured: baseline, 3 months, 6 months, 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

11 Jun 202130 Aug 2022

First posted5 Feb 2021
Study start11 Jun 2021
Primary completion16 Mar 2022
Study completion30 Aug 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Feasibility and Acceptability of the TOPS ProgramStudies 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: Supportive care
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 26 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04741802
Sponsor's protocol ID: Pro00107615
Status last verified: Feb 2024
First submitted: 2 Feb 2021
Last updated: 28 Feb 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Study at a glance

From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Feasibility and Acceptability of a Community-based Weight Loss Program Among African American Breast Cancer Survivors
ClinicalTrials.gov ID: NCT04741802
Acronym / sponsor ID: Pro00107615
Conditions: Feasibility and Acceptability of the TOPS Program, Obesity, Breast Cancer, Weight Loss
Study type: Interventional
Recruitment status: Completed
Enrolment: 26 participants (actual)
Lead sponsor: Duke UniversityUniversity, hospital or other
Collaborators: National Institutes of Health (NIH)
Study start: 11 Jun 2021 (actual)
Primary completion: 16 Mar 2022 (actual)
Study completion: 30 Aug 2022 (actual)
First posted: 5 Feb 2021 (actual)
Results: Posted 28 Feb 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Supportive care
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
TOPS	Experimental	Behavioral: TOPSweight loss program (Take Off Pounds Sensibly, TOPS) for overweight and obese African American breast cancer survivors

Who may qualify

Ages: 55 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Women diagnosed with breast cancer with BMI ≥ 25 kg/m after completion of primary 2 therapy (surgery, radiation, adjuvant or neo-adjuvant chemotherapy).

Key exclusion criteria (1 listed)

Women whose oncology providers do not agree with their participation in a weight loss program or those participating in another weight loss program.

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
TOPSweight loss program (Take Off Pounds Sensibly, TOPS) for overweight and obese African American breast cancer survivors in the local chapter of a national African American breast cancer support group (Sisters Network Triangle North Carolina, SNTNC).	Behavioural	TOPS

Primary outcome

Number of Invited Women Who Attended the TOPS (Take Off Pounds Sensibly) Information Session
Time frame: One-time invitation
Number of Women Who Attended the Information Session and Joined the TOPS Program
Time frame: One-time information session
Number of Women Who Remained in the Program for 12 Weeks
Time frame: up to 12 weeks
Measured by the number of women who reported to the 12-week weigh in.
Number of Women Who Remained in the Program for 24 Weeks
Time frame: up to 24 weeks
Measured by the number of women who reported to the 24-week weigh in.

1 secondary outcome

Percent Change in Participants' Weight as Measured by Scale Reading
Time frame: baseline, 3 months, 6 months, 12 months

Results and safety

Results posted to the registry on 28 Feb 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
TOPS	26	14

Primary outcome: Number of Invited Women Who Attended the TOPS (Take Off Pounds Sensibly) Information Session

Time frame: One-time invitation. Count of participants. Unit: Participants

Measure	TOPS n = 160
Value	45

Population analysed: Women who were invited to attend the information session (all members of the Sisters Network Triangle North Carolina).

Primary outcome: Number of Women Who Attended the Information Session and Joined the TOPS Program

Time frame: One-time information session. Count of participants. Unit: Participants

Measure	TOPS n = 45
Value	26

Population analysed: Number of women who attended the information session.

Primary outcome: Number of Women Who Remained in the Program for 12 Weeks

Time frame: up to 12 weeks. Count of participants. Unit: Participants

Measure	TOPS n = 26
Value	23

Primary outcome: Number of Women Who Remained in the Program for 24 Weeks

Time frame: up to 24 weeks. Count of participants. Unit: Participants

Measure	TOPS n = 26
Value	18

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Up to 12 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
TOPS	0 of 0	0 of 0	1 of 26

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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.

Nia Mitchell, MD 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 TOPS in people with Feasibility and Acceptability of the TOPS Program and Obesity, 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 1 inclusion and 1 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 28 Feb 2024. 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?

Yes. Results are posted in the registry (first posted 28 Feb 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Invited Women Who Attended the TOPS (Take Off Pounds Sensibly) Information Session (time frame: One-time invitation). The study lists 4 primary outcomes in all. 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 NCT04741802.

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 28 Feb 2024.