Rural Women Connecting for Better Health
| Status: | Completed |
|---|---|
| Conditions: | Breast Cancer, Cancer, Obesity Weight Loss |
| Therapuetic Areas: | Endocrinology, Oncology |
| Healthy: | No |
| Age Range: | Any - 75 |
| Updated: | 11/24/2016 |
| Start Date: | August 2011 |
| End Date: | October 2015 |
Group Phone-Based Weight Control for Rural Breast Cancer Survivors
Women who are obese at breast cancer diagnosis have a 1.5 to 2.5 increased risk of
recurrence and death compared to their normal weight counterparts. Moreover, weight gain and
decreased physical activity are common after diagnosis and also increase the likelihood of
breast cancer recurrence and death. Rural women suffer from health disparities in breast
cancer diagnosis and treatment. Women of the most rural counties also have the highest
prevalence of obesity compared to urban women. To address these disparities, the overarching
objective of this proposal is to develop a clinically effective and cost efficient strategy
for delivering a weight control intervention to rural breast cancer survivors. Group
phone-based treatment via conference call is a novel treatment delivery approach that the
investigators have shown to be effective for initial weight loss among rural breast cancer
survivors and more effective than the standard individual phone-based approach among rural
women. This innovative method of providing group treatment addresses access barriers in
rural areas and may be especially ideal for rural breast cancer survivors because it
provides social support in conjunction with a level of anonymity. However, the impact of
group phone counseling during extended care for weight loss maintenance beyond 6 months
remains unknown. Weight loss maintenance is the more challenging phase of treatment when
weight regain is common, and this regain presents a potential risk for breast cancer
recurrence. This randomized controlled trial will evaluate the effects of group phone-based
treatment for weight loss maintenance among rural breast cancer survivors, compared to an
established mail-based education comparison condition, subsequent to a 6 month group
phone-based weight loss phase for both conditions. In addition to the intervention impact on
weight loss maintenance, the study will provide estimates of incremental cost-effectiveness
per kg loss between the two conditions and the impact on secondary outcomes including
quality of life, breast cancer risk biomarkers, dietary intake, and physical activity.
recurrence and death compared to their normal weight counterparts. Moreover, weight gain and
decreased physical activity are common after diagnosis and also increase the likelihood of
breast cancer recurrence and death. Rural women suffer from health disparities in breast
cancer diagnosis and treatment. Women of the most rural counties also have the highest
prevalence of obesity compared to urban women. To address these disparities, the overarching
objective of this proposal is to develop a clinically effective and cost efficient strategy
for delivering a weight control intervention to rural breast cancer survivors. Group
phone-based treatment via conference call is a novel treatment delivery approach that the
investigators have shown to be effective for initial weight loss among rural breast cancer
survivors and more effective than the standard individual phone-based approach among rural
women. This innovative method of providing group treatment addresses access barriers in
rural areas and may be especially ideal for rural breast cancer survivors because it
provides social support in conjunction with a level of anonymity. However, the impact of
group phone counseling during extended care for weight loss maintenance beyond 6 months
remains unknown. Weight loss maintenance is the more challenging phase of treatment when
weight regain is common, and this regain presents a potential risk for breast cancer
recurrence. This randomized controlled trial will evaluate the effects of group phone-based
treatment for weight loss maintenance among rural breast cancer survivors, compared to an
established mail-based education comparison condition, subsequent to a 6 month group
phone-based weight loss phase for both conditions. In addition to the intervention impact on
weight loss maintenance, the study will provide estimates of incremental cost-effectiveness
per kg loss between the two conditions and the impact on secondary outcomes including
quality of life, breast cancer risk biomarkers, dietary intake, and physical activity.
Phase 1 - Weight Loss (0-6 months)
- Weekly group phone counseling sessions for all participants (12-14 women per group) via
conference call for 26 consecutive weeks
- Low-calorie, low-fat diet recommended, including 2 pre-packaged entrees, five one-cup
servings of fruits and vegetables and meal replacement shakes (provided free of charge)
- Physical activity program program recommended, beginning with 15 minutes per day, 3
days a week, working toward a goal of 225 minutes a week
- Experienced group counselor facilitates all sessions
Phase 2 - Weight Loss Maintenance (6-18 months)
- Participants randomized to either group phone counseling or mail-based comparison with
no phone counseling
- Weight loss maintenance group condition includes 26 bi-weekly phone sessions, while
mail-based comparison includes 26 bi-weekly newsletters in the mail
- Focus is on problem-solving
Phase 3 - Transition to Self-Reliance (18-24 months)
- Lasts from 18-24 months
- No sessions or newsletter mailings
- Participants are encouraged to continue to self-monitor throughout this period
- Weekly group phone counseling sessions for all participants (12-14 women per group) via
conference call for 26 consecutive weeks
- Low-calorie, low-fat diet recommended, including 2 pre-packaged entrees, five one-cup
servings of fruits and vegetables and meal replacement shakes (provided free of charge)
- Physical activity program program recommended, beginning with 15 minutes per day, 3
days a week, working toward a goal of 225 minutes a week
- Experienced group counselor facilitates all sessions
Phase 2 - Weight Loss Maintenance (6-18 months)
- Participants randomized to either group phone counseling or mail-based comparison with
no phone counseling
- Weight loss maintenance group condition includes 26 bi-weekly phone sessions, while
mail-based comparison includes 26 bi-weekly newsletters in the mail
- Focus is on problem-solving
Phase 3 - Transition to Self-Reliance (18-24 months)
- Lasts from 18-24 months
- No sessions or newsletter mailings
- Participants are encouraged to continue to self-monitor throughout this period
Inclusion Criteria:
- Breast cancer patients with a BMI 27-45 kg/m2
- Diagnosis of Stage 0-IIIc disease within the past 10 years (except Stage 0, treated
with mastectomy only)
- Have completed all local and systemic therapy at least 3 months prior to entry
- Have clearance from their oncologist or current medical provider to participate in a
weight control study
- Must be ≤ 75 years old
- Post-menopausal
- Participants must live in a rural area
- Have access to a phone
- Able to participate in the physical activity component of the intervention, i.e., be
able to walk briskly unassisted and without serious medical risk
- Weight stable within ten pounds three months prior to entry
Exclusion Criteria:
- Women with insulin-dependent diabetes
- Ongoing participation in a formal weight loss program
- Ongoing use of pharmacotherapy for weight loss
- Ongoing use of medications that seriously affect weight and metabolism (e.g.,
steroids, phentermine)
- Positive screen for current substance abuse, major depression, or binge eating
disorder
- Any cardiac or pulmonary disease preventing participation
- Treatment for any other cancers within the past year
- Previous bariatric surgery
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