Breast Cancer
Conditions
Keywords
breast cancer survivors, lifestyle intervention, health behaviors
Brief summary
1. The purpose of the study is to test the effectiveness of a new mail-based intervention for breast cancer survivors compared with standard lifestyle management and no-treatment. 2. This intervention addresses both lifestyle factors such as dietary and physical activities and psychological issues specific to breast cancer survivors to improve healthy behaviors.
Detailed description
Participants will be assigned randomly to one of three groups: 1) newly developed mail-based intervention (Targeting the Teachable Moment Intervention; TTMI), 2) standard Lifestyle Intervention (SLM), and 3) usual care. Both TTMI and SLM focus on health behaviors, however TTMI additionally addresses psychosocial issues specific to breast cancer survivors. All participants will complete questionnaires at the time they start the study, the end of the 4 months, and 3 months later for a follow-up. If participants are assigned to any of the intervention group, they will receive materials every other week for 4 months. If participants are assigned to the usual care group, they will receive the same materials as the standard lifestyle intervention et the end of the 7 months.
Interventions
BEHAVIORALTargeting the Teachable Moment
TTMI material (every other week for 4 months)
BEHAVIORALStandardized Lifestyle Management
SLM material (every other week for 4 months)
Sponsors
National Cancer Institute (NCI)
Hartford Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* First diagnosed with breast cancer in the past 1.5 years * stage 0\ 2 breast cancer * no prior adjuvant treatment for another cancer * Can read and write English * Are not participating in other health behavior research right now
Exclusion criteria
* apparent serious mental disturbance * male breast cancer survivors
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in physical activity measured by the Paffenbarger physical activity questionnaire | Meaured at baseline, 4 months, and 7 months | Frequency and amount of time for physical exercise will be measured at 3 times: at baseline, at the end of 4 months, and at the end of 7 months. |
| Changes in eating habits measured by the National Cancer Institute Quick Food Scan | Meaured at baseline, 4 months, and 7 months | Diet habits (amount of fat and fruit/vegetable uptake) will be assessed at 3 times: at baseline, at the end of the 4 months, and at the end of 7 months. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Self-efficacy measured by the General Self-Efficacy Scale | Measured at baseline, 4 months, and 7 months | A general sense of perceived self-efficacy will be measured at 3 times: at the baseline, at the end of 4 months, and at the end of 7 months |
| Changes in life meaning measured by the Meaning in Life Questionnaire (MLQ) | Measured at baseline, 4 months, and 7 months | Presence of Meaning and Search for Meaning will be measured at 3 times: at baseline, at the end of 4 months, and at the end of 7 months. |
| Changes in social support measured by the Interpersonal Support Evaluation List (ISEL) | Measured at baseline, 4 months, and 7 months | Social support will be measured at 3 times: at baseline, at the end of 4 months, and at the end of 7 months |
| Changes in coping strategies measured by the Brief COPE | Measured at baseline, 4 months, and 7 months | Coping strategies (e.g., problem-focused coping, emotional approach coping) will be assessed at 3 times: at baseline, at the end of the 4 months, and at the end of 7 months. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Feedback of each module | up to 4 months | usefulness of each module (e.g., whether each intervention is helpful or not) will be assessed at each mailing (for eight times) for 4 months. |
Countries
United States
Outcome results
None listed