Participants receive education about both cancer and CVD risk factors and their relationship to dietary and physical activity health behaviors.

Participants receive education about CVD risk factors and their relationship to dietary and physical activity health behaviors.

Integrated group receives education about risk factors for both cancer and CVD whereas the non-integrated group receives information about CVD only to assess differences in health behavior outcomes.

Integrated vs Non-integrated Risk Education

Chanita H Halbert, PhD

The investigators will evaluate the effects of an integrated risk counseling program on behavioral and psychological outcomes in African American men and women in a randomized trial that is implemented and evaluated collaboratively through the West Philadelphia Consortium to Address Disparities. The specific aims of this research are as follows:

1. To evaluate the effects of integrated versus disease specific counseling on risk exposure behaviors. The investigators predict that compared to individuals who receive disease specific counseling, those who receive integrated counseling will report greater intake of fruits and vegetables and increased rates of physical activity.
2. To evaluate effects of integrated versus disease specific counseling on psychological outcomes. The investigators predict that compared to individuals who receive disease specific counseling, those who receive integrated counseling will report greater risk comprehension related to cancer and cardiovascular disease and will be more motivated to make behavioral changes.
3. To identify the mechanisms through which integrated risk counseling leads to behavioral change. The investigators predict that changes in risk exposure behaviors (e.g., diet and physical activity) will be mediated by increased risk comprehension and self-efficacy for diet and physical activity.

West Philadelphia Consortium Randomized Control Trial

West Philadelphia Consortium to Address Disparities

University of Pennsylvania

Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

Study participants randomized to the Integrative Medicine intervention will attend 14 sessions with an Integrative Medicine clinician over the course of 6 months potentially followed by a 6 month maintenance phase. The treatment modalities employed in the study will include nutrition and lifestyle recommendations.

Study participants randomized to the Health Education intervention will attend 14 sessions with a Health Educator over the course of 6 months. The emphasis in the sessions will be to provide engaging educational information on common survivorship issues.

Study participants will attend 14 sessions with an Integrative Medicine clinician over the course of 6 months, potentially followed by a 6 month maintenance phase.

Integrative Medicine Intervention

Study participants will attend 14 sessions with a Health Educator over the course of 6 months.

Health Education Intervention

Anand Dhruva, MD

The purpose of this study is to conduct a randomized controlled trial or RCT of the following 2 supportive care interventions in recent breast cancer survivors: an Integrative Medicine intervention based on Ayurvedic medicine and a Health Education intervention.

Post-treatment cancer survivorship is often associated with a void in care given the drop-off in support provided to survivors from the medical team as well as family and friends. In addition, cancer associated symptoms and impaired quality of life remain significant problems for patients despite advances in cancer treatment. Few effective treatment options exist for these symptoms. Integrative medicine is rising in popularity in the United States; however, few integrative medicine modalities have been rigorously studied. Ayurveda, a whole system of medicine that originated in the Indian subcontinent, has its own system of diagnostics and therapeutics, and among its strengths are wellness and prevention. In the Integrative Medicine intervention, Ayurvedic nutrition and lifestyle guidance will be presented, along with instruction in Yoga. In the Health Education intervention, informative content on issues relevant to breast cancer survivors will be presented including the physical, social and emotional impacts of survivorship. The investigators aim to perform a pilot RCT in breast cancer survivors with impaired quality of life. Specifically, the investigators aim to assess feasibility of randomization, adherence and retention to the Integrative Medicine and Health Education interventions.

Integrative Approaches to Cancer Survivorship: Project 3

Developing an Integrative Intervention for Breast Cancer Survivorship

The investigators will use the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ C30) in conjunction with a breast cancer-specific subscale, BR23, to collect data on qualify of life and cancer-related symptoms.

The scales range in score from 0 to 100. A high scale score represents a higher response level. Thus a high score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / QoL represents a high QoL, but a high score for a symptom scale / item represents a high level of symptomatology / problems.

The principle for scoring these scales is the same in all cases:

1. Estimate the average of the items that contribute to the scale; this is the raw score.
2. Use a linear transformation to standardise the raw score, so that scores range from 0 to 100; a higher score represents a higher ("better") level of functioning, or a higher ("worse") level of symptoms.

The investigators will use the Lee Fatigue Scale (LFS) to collect data on fatigue.

The scale ranges from 0 - 10. Scoring Instructions: To interpret it clinically, it is good to think about the lower 1/3 scores (0-3.2) being none or minimal fatigue, the middle 1/3 (3.3 to 6.6) being moderate fatigue, and the top 1/3 (6.7 to 10) being high fatigue.

* Energy Item Score: Mean of items 6-10
* Fatigue Item Score: Mean of 1-5 and 11-18

The investigators will use the General Sleep Disturbance Scale (GSDS) to collect data on sleep disturbance.

The scale ranges from 0 (never) - 7 (Every Day) Reverse score items: 4, 10, 11, 12 (e.g., 0=7, 1=6, 2=5, 3=4, 4=3, 5=2, 6=1, 7=0).

Scoring Instructions:

* Total Sum Score (gstot): Mean of all items \* 21 (must have at least 16 items scored)
* Medications for Sleep Sum Score (gsmed): Mean of items 16-21 \* 16 (must have at least 4)
* Quality of Sleep Sum Score (gsqal): Mean of items 4, 5, 10 \* 3 (must have at least 2)
* Quantity of Sleep Sum Score (gsqnt): Mean of items 12, 13 \* 2 (must have at least 2)
* Sleep Onset Latency (gsol): Item 1
* Mid Sleep Wakes (gsmid): Item 2
* Early Awakenings (gsend): Item 3
* Excessive Daytime Sleepiness Sum Score (gseds): Mean of 6, 7, 8, 9, 11, 14, 15 \* 7 (must have at least 5)

The investigators will use the Spielberger State Anxiety Inventory (STAI-S) to collect data on anxiety.

The scale ranges from 1 (Not at all) - 4 (Very much so) Reverse Scoring Items: 1, 2, 5, 8, 10, 11, 15, 16, 19, 20 Outcome Variables: Scores range between 20-80

* Total Sum Score (no missing values): Sum all questions
* Total Sum Score (few items missing): Average of the non-missing items and multiply by 20.

The investigators will use the Center for Epidemiological Studies - Depression Scale (CES-D) to collect data on depressive symptoms.

The scale ranges from 0 (Rarely) - 3 (Most Days) Reverse Scoring Items: 4, 8, 12, 16 Outcome Variables: Scores range between 0-60. If participant scores higher than 16, refer to guidelines for CES-D

• Total Sum Score: Sum of 20 questions. Do not score if more than 4 missing answers.

The investigators will use the Brief Pain Inventory (BPI) to collect data on pain intensity and interference with function.

The investigators will use the Automated Self-Administered 24-hour Recall (ASA24) to assess dietary recall over a 24 hour period.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
West Philadelphia Consortium Randomized Control Trial	NCT01299883	Cancer Cardiovascular ...	Integrated vs N...	18 Years - 75 Years	University of Pennsylvania
West Philadelphia Consortium Randomized Control Trial	NCT01299883	Cancer Cardiovascular ...	Integrated vs N...	18 Years - 75 Years	University of Pennsylvania
Integrative Approaches to Cancer Survivorship: Project 3	NCT03479385	Breast Cancer	Integrative Med... Health Educatio...	18 Years -	University of California, San Francisco

Spots Global Cancer Trial Database for health education intervention