Breast Cancer
Conditions
Keywords
Breast cancer, Exercise, Physical activity, Community volunteers, Peer mentors, Peer coaches, Social support, Exercise maintenance
Brief summary
Exercise adoption enhances well-being and recovery from breast cancer. Researchers trained American Cancer Society volunteers to provide exercise counseling to breast cancer survivors and the survivors increased their exercise in the short-term. This RCT examines the effects of three maintenance conditions on survivors' exercise participation at longer follow-ups. The cost-effectiveness of the three groups will be examined to guide implementation of this peer mentoring approach in community-based organizations.
Detailed description
The current study, a randomized controlled trial (RCT), represents the next step of the efforts to to extend the research on physical activity to the community setting; community volunteers will deliver the intervention, thereby making physical activity interventions much more accessible to survivors. In partnership with the National American Cancer Society office (Atlanta, GA) and Reach To Recovery (RTR) programs in North Carolina, South Carolina, and Georgia, researchers at the University of South Carolina's College of Nursing will share skills, experience and resources to examine the effects of RTR coaches offering a theoretically-based 3-month exercise program among 150 breast cancer survivors to increase moderate-to-vigorous physical activity (MVPA) followed by self-monitoring (i.e. exercise logs) and feedback reports in Months 4-9 (Reach Plus), monthly phone calls from RTR coaches, self monitoring and feedback reports in Months 4-9 (Reach Plus Message) or weekly email/text messages, self-monitoring and feedback reports in Months 4-9 (Reach Plus Message). In this three group study, researchers will assess survivors' exercise, fatigue, mood, quality of life, and self-reported physical functioning at baseline, 3, 9 and 12 months. The costs of the methods vary and data on costs will be collected to guide the selection of maintenance strategies for dissemination. If the results are promising, researchers will proceed with a dissemination trial wherein the large network of RTR volunteers can expand the scope of their services to benefit breast cancer survivors.
Interventions
BEHAVIORALReach Plus
In Months 1-3, participants in this group will receive the previously tested telephone counseling for exercise. RTR volunteers or coaches will be asked to contact participants by telephone weekly over 3 months (12 calls). In months 4-9, participants will no longer receive calls from RTR coaches and will be encouraged to use the heart rate monitors and pedometers during exercise. Participants will continue to complete their exercise logs and receive feedback reports from study staff.
BEHAVIORALReach Plus Phone
In Months 1-3, participants in this group will receive the previously tested telephone counseling for exercise. RTR volunteers or coaches will be asked to contact participants by telephone weekly over 3 months (12 calls). In months 4-9, these participants will have the opportunity to continue to receive support calls from their coach. Participants will also continue to complete their exercise logs and receive feedback reports from study staff.
BEHAVIORALReach Plus Message
In Months 1-3, participants in this group will receive the previously tested telephone counseling for exercise. RTR volunteers or coaches will be asked to contact participants by telephone weekly over 3 months (12 calls). In months 4-9, participants will receive messages by email or text to motivate, prompt and reinforce continued exercise. Participants will also continue to complete their exercise logs and receive feedback reports from study staff.
Sponsors
National Cancer Institute (NCI)
American Cancer Society, Inc.
University of South Carolina
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
21 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Women aged 21 years or over will be eligible if they: * Have been diagnosed in the past 5 years with Stage 0-3 breast cancer. * Are able to read and speak English. * Are ambulatory. * Are sedentary (i.e., do not meet recommendations for moderate-intensity PA \[30 minutes/ day or more for at least 5 days/ week\] or vigorous-intensity PA \[20 minutes/day or more for at least 3 days/week\] * Are able to walk unassisted. * Have access to a telephone.
Exclusion criteria
Women with: * More advanced disease (Stage 4). * Medical or psychiatric problems (e.g., substance abuse, coronary artery disease, peripheral vascular disease, diabetes, and orthopedic problems) that may interfere with protocol adherence will not be included. * Participants will be asked to provide consent for medical chart review to extract disease and treatment variables. Eligible participants will obtain medical clearance from their physicians.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Physical Activity | 9 and 12 months | Through interviewer - administered Seven Day Activity Recall |
| Min/Week Objectively Measured Moderate-to-vigorous Physical Activity | 9 and 12 months | Minutes per week of at least moderate intensity activity as measured by accelerometer (GT3X) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Breast Cancer Quality of Life | Change at 9 and 12 months | Assessed via the Functional Assessment of Cancer Therapy Scale - Breast (FACT-B) Sub-scales scored: Physical well-being, social/family well-being, emotional well-being, functional well-being and other breast cancer related statements. Scale ranges from 0-148 with higher scores indicating higher quality of life. |
| Fatigue | Score at 9 and 12 months | Assessed via the Functional Assessment of Cancer Therapy Scale - Fatigue (FACT-F). This scale ranges from 0-52. Higher values indicate better functioning (or lower fatigue). |
| Mood | Score at 9 and 12 months | Assessed via the Profile of Mood States (POMS). Higher scores indicated a greater mood disturbance. Scale ranges from 0-28. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Reach Plus In Months 1-3, participants in this group will receive the previously tested telephone counseling for exercise. RTR volunteers or coaches will be asked to contact participants by telephone weekly over 3 months (12 calls). In months 4-9, participants will no longer receive calls from RTR coaches and will be encouraged to use the heart rate monitors and pedometers during exercise. Participants will continue to complete their exercise logs and receive feedback reports from study staff.
Reach Plus: In Months 1-3, participants in this group will receive the previously tested telephone counseling for exercise. RTR volunteers or coaches will be asked to contact participants by telephone weekly over 3 months (12 calls). In months 4-9, participants will no longer receive calls from RTR coaches and will be encouraged to use the heart rate monitors and pedometers during exercise. Participants will continue to complete their exercise logs and receive feedback reports from study staff. | 55 |
| Reach Plus Phone In Months 1-3, participants in this group will receive the previously tested telephone counseling for exercise. RTR volunteers or coaches will be asked to contact participants by telephone weekly over 3 months (12 calls). In months 4-9, these participants will have the opportunity to continue to receive support calls from their coach. Participants will also continue to complete their exercise logs and receive feedback reports from study staff.
Reach Plus Phone: In Months 1-3, participants in this group will receive the previously tested telephone counseling for exercise. RTR volunteers or coaches will be asked to contact participants by telephone weekly over 3 months (12 calls). In months 4-9, these participants will have the opportunity to continue to receive support calls from their coach. Participants will also continue to complete their exercise logs and receive feedback reports from study staff. | 53 |
| Reach Plus Message In Months 1-3, participants in this group will receive the previously tested telephone counseling for exercise. RTR volunteers or coaches will be asked to contact participants by telephone weekly over 3 months (12 calls). In months 4-9, participants will receive messages by email or text to motivate, prompt and reinforce continued exercise. Participants will also continue to complete their exercise logs and receive feedback reports from study staff.
Reach Plus Message: In Months 1-3, participants in this group will receive the previously tested telephone counseling for exercise. RTR volunteers or coaches will be asked to contact participants by telephone weekly over 3 months (12 calls). In months 4-9, participants will receive messages by email or text to motivate, prompt and reinforce continued exercise. Participants will also continue to complete their exercise logs and receive feedback reports from study staff. | 53 |
| Total | 161 |
Baseline characteristics
| Characteristic | Reach Plus | Reach Plus Phone | Reach Plus Message | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 11 Participants | 18 Participants | 16 Participants | 45 Participants |
| Age, Categorical Between 18 and 65 years | 44 Participants | 35 Participants | 37 Participants | 116 Participants |
| Age, Continuous | 57.09 years STANDARD_DEVIATION 9.12 | 58.62 years STANDARD_DEVIATION 11.01 | 56.17 years STANDARD_DEVIATION 12.31 | 57.33 years STANDARD_DEVIATION 10.85 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 0 Participants | 1 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 52 Participants | 53 Participants | 52 Participants | 157 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 15 Participants | 3 Participants | 9 Participants | 27 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) White | 40 Participants | 49 Participants | 42 Participants | 131 Participants |
| Region of Enrollment United States | 55 participants | 53 participants | 53 participants | 161 participants |
| Sex: Female, Male Female | 55 Participants | 53 Participants | 53 Participants | 161 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 55 | 0 / 53 | 0 / 53 |
| other Total, other adverse events | 2 / 55 | 0 / 53 | 2 / 53 |
| serious Total, serious adverse events | 0 / 55 | 0 / 53 | 0 / 53 |
Outcome results
Primary
Min/Week Objectively Measured Moderate-to-vigorous Physical Activity
Minutes per week of at least moderate intensity activity as measured by accelerometer (GT3X)
Time frame: 9 and 12 months
Population: All analysis was conducted on the intent to treat sample with all randomized participants included in the analysis
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Reach Plus | Min/Week Objectively Measured Moderate-to-vigorous Physical Activity | 9 months | 46.43 min/week | Standard Deviation 73.28 |
| Reach Plus | Min/Week Objectively Measured Moderate-to-vigorous Physical Activity | 12 months | 61.90 min/week | Standard Deviation 82.11 |
| Reach Plus Phone | Min/Week Objectively Measured Moderate-to-vigorous Physical Activity | 12 months | 68.75 min/week | Standard Deviation 177.43 |
| Reach Plus Phone | Min/Week Objectively Measured Moderate-to-vigorous Physical Activity | 9 months | 82.17 min/week | Standard Deviation 161.47 |
| Reach Plus Message | Min/Week Objectively Measured Moderate-to-vigorous Physical Activity | 9 months | 54.62 min/week | Standard Deviation 88.13 |
| Reach Plus Message | Min/Week Objectively Measured Moderate-to-vigorous Physical Activity | 12 months | 49.95 min/week | Standard Deviation 67.62 |
p-value: <0.05Regression, Linear
Primary
Physical Activity
Through interviewer - administered Seven Day Activity Recall
Time frame: 9 and 12 months
Population: All analyses were run on the intent to treat sample with all randomized participants included in the analysis
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Reach Plus | Physical Activity | 9 Months | 145.83 min/week | Standard Deviation 153.89 |
| Reach Plus | Physical Activity | 12 Months | 120.81 min/week | Standard Deviation 111.58 |
| Reach Plus Phone | Physical Activity | 9 Months | 159.86 min/week | Standard Deviation 155.19 |
| Reach Plus Phone | Physical Activity | 12 Months | 137.16 min/week | Standard Deviation 139.31 |
| Reach Plus Message | Physical Activity | 9 Months | 172.94 min/week | Standard Deviation 110.83 |
| Reach Plus Message | Physical Activity | 12 Months | 135.00 min/week | Standard Deviation 105.27 |
Comparison: A series of longitudinal mixed effects models with subject-specific intercepts were used to examine between-group differences in mean min/week of self reported moderate-to-vigorous physical activity (MVPA).p-value: <0.05Regression, Linear
Secondary
Breast Cancer Quality of Life
Assessed via the Functional Assessment of Cancer Therapy Scale - Breast (FACT-B) Sub-scales scored: Physical well-being, social/family well-being, emotional well-being, functional well-being and other breast cancer related statements. Scale ranges from 0-148 with higher scores indicating higher quality of life.
Time frame: Change at 9 and 12 months
Population: Analysis was conducted on the intent to treat sample with all randomized participants included in the analysis
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Reach Plus | Breast Cancer Quality of Life | 9 months | 24.72 score on a scale | Standard Deviation 3.47 |
| Reach Plus | Breast Cancer Quality of Life | 12 months | 24.66 score on a scale | Standard Deviation 3.19 |
| Reach Plus Phone | Breast Cancer Quality of Life | 9 months | 24.86 score on a scale | Standard Deviation 3.63 |
| Reach Plus Phone | Breast Cancer Quality of Life | 12 months | 24.88 score on a scale | Standard Deviation 3.36 |
| Reach Plus Message | Breast Cancer Quality of Life | 9 months | 24.76 score on a scale | Standard Deviation 2.93 |
| Reach Plus Message | Breast Cancer Quality of Life | 12 months | 25.12 score on a scale | Standard Deviation 2.29 |
Secondary
Fatigue
Assessed via the Functional Assessment of Cancer Therapy Scale - Fatigue (FACT-F). This scale ranges from 0-52. Higher values indicate better functioning (or lower fatigue).
Time frame: Score at 9 and 12 months
Population: Analysis was conducted on the intent to treat sample with all randomized participants included in the analysis
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Reach Plus | Fatigue | 9 months | 40.91 score on a scale | Standard Deviation 8.64 |
| Reach Plus | Fatigue | 12 months | 41.33 score on a scale | Standard Deviation 8.78 |
| Reach Plus Phone | Fatigue | 9 months | 42.02 score on a scale | Standard Deviation 9.52 |
| Reach Plus Phone | Fatigue | 12 months | 41.66 score on a scale | Standard Deviation 7.79 |
| Reach Plus Message | Fatigue | 9 months | 41.79 score on a scale | Standard Deviation 7.31 |
| Reach Plus Message | Fatigue | 12 months | 41.35 score on a scale | Standard Deviation 7.6 |
Secondary
Mood
Assessed via the Profile of Mood States (POMS). Higher scores indicated a greater mood disturbance. Scale ranges from 0-28.
Time frame: Score at 9 and 12 months
Population: Analysis was conducted on the intent to treat sample with all randomized participants included in the analysis
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Reach Plus | Mood | 9 months | 8.52 score on a scale | Standard Deviation 23.38 |
| Reach Plus | Mood | 12 months | 7.73 score on a scale | Standard Deviation 23.91 |
| Reach Plus Phone | Mood | 9 months | 8.82 score on a scale | Standard Deviation 33.89 |
| Reach Plus Phone | Mood | 12 months | 5.12 score on a scale | Standard Deviation 20.93 |
| Reach Plus Message | Mood | 9 months | 7.71 score on a scale | Standard Deviation 17.2 |
| Reach Plus Message | Mood | 12 months | 7.59 score on a scale | Standard Deviation 18.48 |