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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01CA155014-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
Phase 1 - Weight Loss (0-6 months)
Phase 2 - Weight Loss Maintenance (6-18 months)
Phase 3 - Transition to Self-Reliance (18-24 months)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group (GRP) phone counseling | Experimental | The group phone counseling includes 26 bi-weekly phone sessions from 6 to 18 months and focuses on group problem-solving. Women continue in the same group as in weight loss intervention phase. |
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| Mail-based Comparison Condition | Active Comparator | Participants in this group will receive a newsletter by mail every other week for 12 months starting after the initial 6 month weight loss period. The newsletters will provide problem-solving tips and will review nutrition and physical activity information. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Group phone counseling | Behavioral | Bi-weekly phone counseling sessions from 6 - 18 months |
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| Measure | Description | Time Frame |
|---|---|---|
| Weight loss maintenance | Examine the impact of group phone-based treatment on weight loss maintenance from 6 to 18 months, compared to a mail-based education COMPARISON condition, following a 6-month weight loss phase among obese rural breast cancer survivors. | 6 - 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life | Compare the effects of treatment conditions on aspects of quality of life important for breast cancer survivorship, including general physical, social, and emotional well-being, fatigue, arthralgia, lymphedema symptoms, menopausal symptoms, and depressive symptoms. | Baseline and 6, 12, 18, and 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christie Befort, Ph.D. | University of Kansas Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29086523 | Derived | Fazzino TL, Fabian C, Befort CA. Change in Physical Activity During a Weight Management Intervention for Breast Cancer Survivors: Association with Weight Outcomes. Obesity (Silver Spring). 2017 Nov;25 Suppl 2(Suppl 2):S109-S115. doi: 10.1002/oby.22007. | |
| 28410181 | Derived | Fazzino TL, Fleming K, Befort C. Alcohol Intake Among Breast Cancer Survivors: Change in Alcohol Use During a Weight Management Intervention. JMIR Cancer. 2016 Nov 9;2(2):e15. doi: 10.2196/cancer.6295. |
| Label | URL |
|---|---|
| National Cancer Institute: Cancer Survivorship Research | View source |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D009765 | Obesity |
| D015431 | Weight Loss |
| D050177 | Overweight |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| Newsletter | Behavioral | Bi-weekly newsletter mailings from 6 - 18 months |
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| Breast cancer risk biomarkers |
Examine the association of weight change with changes in selected breast cancer risk biomarkers, including bioavailable estradiol, testosterone, and fasting insulin. Examine whether modulation of biomarkers is sustained during weight loss maintenance. |
| Baseline and 6 and 18 months |
| Cost effectiveness | Compare the incremental cost-effectiveness of weight loss maintenance (kg below baseline) between group and control conditions. Costs include fixed and variable provider costs (facility, time, phone charges, supplies) and fixed and variable participant costs (time, out-of-pocket expenses). | 18 months |
| 26932848 | Derived | Fazzino TL, Sporn NJ, Befort CA. A qualitative evaluation of a group phone-based weight loss intervention for rural breast cancer survivors: Themes and mechanisms of success. Support Care Cancer. 2016 Jul;24(7):3165-73. doi: 10.1007/s00520-016-3149-7. Epub 2016 Mar 2. |
| 24486636 | Derived | Befort CA, Klemp JR, Fabian C, Perri MG, Sullivan DK, Schmitz KH, Diaz FJ, Shireman T. Protocol and recruitment results from a randomized controlled trial comparing group phone-based versus newsletter interventions for weight loss maintenance among rural breast cancer survivors. Contemp Clin Trials. 2014 Mar;37(2):261-71. doi: 10.1016/j.cct.2014.01.010. Epub 2014 Jan 31. |
| D017437 |
| Skin and Connective Tissue Diseases |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001836 | Body Weight Changes |