Trial Outcomes & Findings for TOPS for African American Breast Cancer Survivors (NCT NCT04741802)

NCT ID: NCT04741802

Last Updated: 2024-02-28

Results Overview

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 26 participants
• Primary outcome timeframe: One-time invitation
• Results posted on: 2024-02-28

Participant Flow

Participants were recruited from the local chapter of a national African American breast cancer support group (Sisters Network Triangle North Carolina, SNTNC), which has a roster of 160 members.

Participant milestones

Measure	TOPS Weight loss program (Take Off Pounds Sensibly, TOPS) for overweight and obese African American breast cancer survivors TOPS: 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).
Overall Study STARTED	26
Overall Study COMPLETED	14
Overall Study NOT COMPLETED	12

Reasons for withdrawal

Measure	TOPS Weight loss program (Take Off Pounds Sensibly, TOPS) for overweight and obese African American breast cancer survivors TOPS: 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).
Overall Study Death	1
Overall Study Lost to Follow-up	11

Baseline Characteristics

TOPS for African American Breast Cancer Survivors

Baseline characteristics by cohort

Measure	TOPS n=26 Participants Weight loss program (Take Off Pounds Sensibly, TOPS) for overweight and obese African American breast cancer survivors TOPS: 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).
Age, Continuous	59.7 years STANDARD_DEVIATION 7.6 • n=5 Participants
Sex: Female, Male Female	26 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	26 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	26 Participants n=5 Participants

PRIMARY outcome

Timeframe: One-time invitation

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

Outcome measures

Measure	TOPS n=160 Participants Weight loss program (Take Off Pounds Sensibly, TOPS) for overweight and obese African American breast cancer survivors TOPS: 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).
Number of Invited Women Who Attended the TOPS (Take Off Pounds Sensibly) Information Session	45 Participants

PRIMARY outcome

Timeframe: One-time information session

Population: Number of women who attended the information session.

Outcome measures

Measure	TOPS n=45 Participants Weight loss program (Take Off Pounds Sensibly, TOPS) for overweight and obese African American breast cancer survivors TOPS: 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).
Number of Women Who Attended the Information Session and Joined the TOPS Program	26 Participants

PRIMARY outcome

Timeframe: up to 12 weeks

Measured by the number of women who reported to the 12-week weigh in.

Outcome measures

Measure	TOPS n=26 Participants Weight loss program (Take Off Pounds Sensibly, TOPS) for overweight and obese African American breast cancer survivors TOPS: 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).
Number of Women Who Remained in the Program for 12 Weeks	23 Participants

PRIMARY outcome

Timeframe: up to 24 weeks

Measured by the number of women who reported to the 24-week weigh in.

Outcome measures

Measure	TOPS n=26 Participants Weight loss program (Take Off Pounds Sensibly, TOPS) for overweight and obese African American breast cancer survivors TOPS: 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).
Number of Women Who Remained in the Program for 24 Weeks	18 Participants

SECONDARY outcome

Timeframe: baseline, 3 months, 6 months, 12 months

Population: Completers at each time point.

Outcome measures

Measure	TOPS n=23 Participants Weight loss program (Take Off Pounds Sensibly, TOPS) for overweight and obese African American breast cancer survivors TOPS: 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).
Percent Change in Participants' Weight as Measured by Scale Reading Baseline to 12 months	-6.4 percentage of change Standard Deviation 5.5
Percent Change in Participants' Weight as Measured by Scale Reading Baseline to 3 months	-2.6 percentage of change Standard Deviation 3.5
Percent Change in Participants' Weight as Measured by Scale Reading Baseline to 6 months	-3.5 percentage of change Standard Deviation 4.5

Adverse Events

TOPS

Serious events: 0 serious events

Other events: 0 other events

Deaths: 1 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Nia S. Mitchell, MD, MPH

Duke University

Phone: 919-668-7202

Email: nia.s.mitchell@duke.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place