Breast Cancer
Conditions
Brief summary
Using a pilot 1-arm pre-post design, investigators will implement an intervention that is personalized, low burden (the majority of interactions are telephone coaching sessions), and delivered during the initial survivorship transition. To determine the feasibility of the intervention 48 community-dwelling rural breast cancer survivors (BCS) (ages 40 and older) will receive the intervention. The 12-week intervention consists of three home-based face-to-face consultations with the therapist, 9 weekly habit tele phone coaching sessions, and the use of implementation intentions, environmental modifications, and tailored text messages to support physical activity and dietary habit formation and address unmet needs.
Detailed description
The objective of the present study is to determine the feasibility of a manual, theory based, occupational therapist delivered, preventative intervention to increase habit development (HD) of healthy dietary and physical activity behaviors, and reduce metabolic syndrome (MetS) among high-risk, rural breast cancer survivors (BCS). Using a pilot 1-arm pre-post design, investigators will implement an intervention that is personalized, low burden (the majority of interactions are telephone coaching sessions), and delivered during the initial survivorship transition. To determine the feasibility of the intervention 48 community-dwelling rural BCS (ages 40 and older) will receive the intervention. The 12-week intervention consists of three home-based face-to-face consultations with the therapist, 9 weekly habit telephone coaching sessions, and the use of implementation intentions, environmental modifications, and tailored text messages to support physical activity and dietary habit formation and address unmet needs. Feasibility metrics will be collected throughout the intervention. The one specific aim is: Aim 1. To determine the feasibility and acceptability of the intervention for rural BCS. Investigators will evaluate recruitment, trial engagement and retention rates, treatment satisfaction, and the feasibility of the data collection processes for the primary behavioral measures of HD.
Interventions
BEHAVIORALHabit development intervention
Lifestyle behavior change intervention targeting physical activity and dietary habit development as well as improving physical and social functioning
Sponsors
Barbara Ann Karmanos Cancer Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* English speaking * Diagnosis of stage 1-3 histologically confirmed first cancer of the breast * Reside in a zip code designated as rural by the United States Department of Agriculture Economic Research Service * Be within the initial 12 months following the end of primary treatment and meet 3 of the following 5 criteria for MetS confirmed via point-of-care testing or documentation in their medical record: A large waistline \> 35 inches Blood pressure \> 130/85; HbA1c of 5.7%-6.4%; Triglyceride levels \> 150 mg/dL; HDL cholesterol levels \< 50 mg/dL
Exclusion criteria
* Will not exclude participants based on hormone receptivity, one exception is that we will exclude HER2 positive BCS * Pregnant patients * Resistant Hypertension * Steroid-dependent asthma or Chronic obstructive pulmonary disease * Cirrhosis or hepatic failure * A major cardiovascular event (e.g., stroke, myocardial infarction) within the previous 90 days * Chronic kidney disease on renal replacement therapy * Type one or two diabetes * Stage 4 cancer; those with a secondary cancer (except for nonmelanomatous skin cancers and carcinoma of the cervix in situ) * Taking weight loss medications * Current involvement in a behavioral program * Neuropsychiatric disorder or dementia
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Self Reported Behavioral Automaticity Index | From week 0-2 | Measures changes in habit strength, scores range from 1-7 with higher scores indicating a stronger habit |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Habit Development Intervention Treatment includes occupational therapy evaluation and consultation to address any deficits in physical function, safety, social participation and/or life roles. After the occupational therapy evaluation, the therapist delivers education on physical activity and dietary recommendations and habit development techniques, and uses behavioral skills training to develop habit plans, as well as prompts/cues, environmental modifications, and reminder text messages to reinforce engagement in the plan. The intervention is delivered through 3 face to face sessions, 9 tele coaching calls, and text messages.
Habit development intervention: Lifestyle behavior change intervention targeting physical activity and dietary habit development as well as improving physical and social functioning | 7 |
| Total | 7 |
Baseline characteristics
| Characteristic | Habit Development Intervention |
|---|---|
| Age, Continuous | 56.5 years STANDARD_DEVIATION 10.8 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 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 | 5 Participants |
| Region of Enrollment United States | 7 participants |
| Sex: Female, Male Female | 7 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 7 |
| other Total, other adverse events | 0 / 7 |
| serious Total, serious adverse events | 0 / 7 |
Outcome results
Primary
Self Reported Behavioral Automaticity Index
Measures changes in habit strength, scores range from 1-7 with higher scores indicating a stronger habit
Time frame: From week 0-2
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Habit Development Intervention | Self Reported Behavioral Automaticity Index | Baseline | 1.6 score on a scale | Standard Deviation 1.3 |
| Habit Development Intervention | Self Reported Behavioral Automaticity Index | Post test | 4.8 score on a scale | Standard Deviation 2.1 |