Breast Cancer, Feasibility and Acceptability of the TOPS Program, Obesity, Weight Loss
Conditions
Brief summary
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).
Interventions
BEHAVIORALTOPS
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).
Sponsors
National Institutes of Health (NIH)
Duke University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
55 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Women diagnosed with breast cancer with BMI ≥ 25 kg/m after completion of primary 2 therapy (surgery, radiation, adjuvant or neo-adjuvant chemotherapy).
Exclusion criteria
* Women whose oncology providers do not agree with their participation in a weight loss program or those participating in another weight loss program.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Invited Women Who Attended the TOPS (Take Off Pounds Sensibly) Information Session | One-time invitation | — |
| Number of Women Who Attended the Information Session and Joined the TOPS Program | One-time information session | — |
| Number of Women Who Remained in the Program for 12 Weeks | 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 | up to 24 weeks | Measured by the number of women who reported to the 24-week weigh in. |
Secondary
| Measure | Time frame |
|---|---|
| Percent Change in Participants' Weight as Measured by Scale Reading | baseline, 3 months, 6 months, 12 months |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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). | 26 |
| Total | 26 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 1 |
| Overall Study | Lost to Follow-up | 11 |
Baseline characteristics
| Characteristic | TOPS |
|---|---|
| Age, Continuous | 59.7 years STANDARD_DEVIATION 7.6 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 26 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Region of Enrollment United States | 26 Participants |
| Sex: Female, Male Female | 26 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 26 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
Number of Invited Women Who Attended the TOPS (Take Off Pounds Sensibly) Information Session
Time frame: One-time invitation
Population: Women who were invited to attend the information session (all members of the Sisters Network Triangle North Carolina).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| TOPS | Number of Invited Women Who Attended the TOPS (Take Off Pounds Sensibly) Information Session | 45 Participants |
Primary
Number of Women Who Attended the Information Session and Joined the TOPS Program
Time frame: One-time information session
Population: Number of women who attended the information session.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| TOPS | Number of Women Who Attended the Information Session and Joined the TOPS Program | 26 Participants |
Primary
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.
Time frame: up to 12 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| TOPS | Number of Women Who Remained in the Program for 12 Weeks | 23 Participants |
Primary
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.
Time frame: up to 24 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| TOPS | Number of Women Who Remained in the Program for 24 Weeks | 18 Participants |
Secondary
Percent Change in Participants' Weight as Measured by Scale Reading
Time frame: baseline, 3 months, 6 months, 12 months
Population: Completers at each time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TOPS | Percent Change in Participants' Weight as Measured by Scale Reading | Baseline to 3 months | -2.6 percentage of change | Standard Deviation 3.5 |
| TOPS | Percent Change in Participants' Weight as Measured by Scale Reading | Baseline to 6 months | -3.5 percentage of change | Standard Deviation 4.5 |
| TOPS | Percent Change in Participants' Weight as Measured by Scale Reading | Baseline to 12 months | -6.4 percentage of change | Standard Deviation 5.5 |