Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Fatigue Reduction Diet in Breast Cancer Survivors
Brief Summary: There are over 2 million breast cancer survivors today. Persistent cancer-related fatigue (PCRF), a state of being tired or weary, is one of the most common and distressing symptoms experienced by breast cancer (BC) survivors. PCRF is associated with decreased quality of life, decreased sleep quality, depression, chronic pain and impaired cognition. Currently, there are few treatment options for PCRF and existing treatment options are associated with significant costs, are a considerable burden on the part of the patient, or have unacceptable side-effects. As such, there is a clear need to conduct studies evaluating the impact of safe, easy to implement and inexpensive treatments for PCRF in BC survivors.

Individualized nutritional counseling has been found to be beneficial for decreasing fatigue and improving quality of life in cancer patients receiving treatment.However, there is a dearth of research examining the use of diet for treating fatigue in cancer survivors. Our preliminary data in 40 adult cancer survivors found that fatigue severity was associated with decreased intake of key food groups, e.g., green leafy vegetables, and nutrients, e.g., omega-3 fatty acids, as reported in diet records. However, diet records are often not highly correlated with actual nutrient concentrations in the body and tend to capture short-term dietary habits not long-term patterns. The main objective of this research is to expand upon and confirm our cross-sectional preliminary data and to take advantage of a pilot clinical dietary study we are conducting by examining key nutrient differences in biological samples in the breast cancer survivors. By examining differences in biological samples we will be able to explore three key questions, which will directly influence our future interventional studies: (1) to determine if there are actual differences in concentrations of key nutrients in body tissue and which nutrients these are; (2) to assess if a dietary intervention focused on improving fatigue in BC survivors changes baseline levels of key nutrients; and (3) what is the effect size and variability of change in key nutrients in body tissue both at baseline and after a dietary intervention.


Options:
A: Arm Label: Web-based, Stage-matched Exercise and Diet Planning program; Type: EXPERIMENTAL; Interventions: Behavioral: Web-based Health Planner on diet and exercise | Arm Label: Non-tailored booklet on exercise and diet; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Non-tailored booklet on exercise and diet | Intervention Type: BEHAVIORAL; Name: Web-based Health Planner on diet and exercise; Assigned to Arm(s): Web-based, Stage-matched Exercise and Diet Planning program | Intervention Type: BEHAVIORAL; Name: Non-tailored booklet on exercise and diet; Assigned to Arm(s): Non-tailored booklet on exercise and diet
B: Arm Label: Lifestyle counseling; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: behavioral dietary intervention, Other: counseling intervention, Other: educational intervention, Other: preventative dietary intervention, Procedure: quality-of-life assessment | Arm Label: Without Counseling; Type: ACTIVE_COMPARATOR; Interventions: Procedure: quality-of-life assessment | Intervention Type: BEHAVIORAL; Name: behavioral dietary intervention; Assigned to Arm(s): Lifestyle counseling | Intervention Type: OTHER; Name: counseling intervention; Assigned to Arm(s): Lifestyle counseling | Intervention Type: OTHER; Name: educational intervention; Assigned to Arm(s): Lifestyle counseling | Intervention Type: OTHER; Name: preventative dietary intervention; Assigned to Arm(s): Lifestyle counseling | Intervention Type: PROCEDURE; Name: quality-of-life assessment; Assigned to Arm(s): Lifestyle counseling, Without Counseling
C: Arm Label: Fatigue Reduction Diet; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Social Cognitive Theory | Arm Label: General Health Curriculum; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Social Cognitive Theory | Intervention Type: BEHAVIORAL; Name: Social Cognitive Theory; Assigned to Arm(s): Fatigue Reduction Diet, General Health Curriculum
D: Arm Label: Nutritional counseling; Type: EXPERIMENTAL; Interventions: Procedure: Nutritional counseling | Arm Label: No intervention; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: PROCEDURE; Name: Nutritional counseling; Assigned to Arm(s): Nutritional counseling

Answer: C