Nutritional and Metabolic Diseases

Symptoms and General Pathology

All Conditions

Neoplasms

Skin and Connective Tissue Diseases

Overweight

Breast Neoplasms

Obesity

Body Weight

Neoplasm Metastasis

Weight Loss

Breast Diseases

Skin Diseases

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.

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.

Bi-weekly phone counseling sessions from 6 - 18 months

Group phone counseling

Bi-weekly newsletter mailings from 6 - 18 months

Newsletter

Christie Befort, Ph.D.

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)

* 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

Rural Women Connecting for Better Health

Group Phone-Based Weight Control for Rural Breast Cancer Survivors

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.

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.

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.

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).

National Cancer Institute (NCI)

University of Kansas Medical Center

Nervous System Diseases

Cancer Pain

Pain

Neurologic Manifestations

Group acupuncture sessions take place in a multipurpose room, with 3-6 participants, each session lasts 30-45 minutes, occurring twice-weekly, over the course of six weeks, for a total of twelve treatments. The acupuncture was administered by a Naturopathic Doctor.

Individual acupuncture sessions take place in a multipurpose room, privately each session lasts 30-45 minutes, occurring twice-weekly, over the course of six weeks, for a total of twelve treatments. The acupuncture was administered by a Naturopathic Doctor.

Traditional Chinese Medicine (TCM) Acupuncture

Acupuncture

Linda E Carlson, PhD

Typically, in North America, acupuncture is performed on an individual basis. However, community acupuncture, also known as group acupuncture, is an emerging method of treating patients. Cancer patients, post-treatments were given acupuncture treatments to help alleviate pain, in a two-arm randomized trial.

Typically, in North America, acupuncture is performed on an individual basis. However, community acupuncture, also known as group acupuncture, is an emerging method of treating patients. Although the practice can vary, community acupuncture is performed in a group setting, typically with reclining chairs dispersed around a large room, and one practitioner treating up to six people per session.

The outcomes of this this randomized controlled trial will allow the researchers to assess whether group acupuncture is a viable treatment option for people with cancer who are suffering from pain, especially those who are either resistant to or looking to avoid the side effects of opioids.

Objectives Examine the efficacy of community acupuncture for alleviating cancer pain, fatigue, sleep disturbances and distress when compared to individual acupuncture.

Evaluate the cost-effectiveness of community acupuncture compared to individual acupuncture.

Group Versus Individual Acupuncture for Cancer Pain

A Non-Inferiority Randomized Controlled Trial Comparing Community (Group) Acupuncture to Individual Acupuncture to Alleviate Cancer Pain

The Brief Pain Inventory-Short Form (BPISF) is a widely used self-report measure, originally developed for cancer pain, which measures both pain severity and pain interference

The Profile of Mood States-Short Form (POMS-SF) is a validated measure of psychological distress, which calculates Total Mood Disturbance (TMD) using six subscales: fatigue, vigor, tension, depression, anger and confusion (Shacham, 1983). The 37-item questionnaire asks patients to rate how various adjectives relate to how they have felt in the past week, on a Likert scale from zero (not at all) to four (extremely).

The Pittsburg Sleep Quality Index (PSQI) is 19-item questionnaire that measures quality of sleep and sleep disturbances

The Functional Assessment of Cancer Therapy-General (FACT-G) is a 20-item questionnaire that measures health-related quality of life (HRQOL) within the cancer population. The questionnaire contains four subscales: physical, social/family, emotional and functional well-being.

The Functional Assessment of Cancer Therapy-Fatigue (FACT-F) comprised of the FACT-G, plus an additional 13 questions related to fatigue

The Inventory of Socially Supportive Behaviours (ISSB) Short Form is an 18-item questionnaire designed to measure social support, which asks participants to indicate the number of times they have experienced particular behaviours in the past month

The Edmonton Symptom Assessment Scale (ESAS) is a simple screening measure that can be used to assess various physical and psychological symptoms, originally designed for palliative care patients

The pain visual analog scale (VAS) consists of a 10 centimetre line on a slip of white paper, with the indicators "no pain at all" on the far-left end, and "worst pain imaginable" on the far-right end

This utility scoring instrument is intended to provide an overall quality of life evaluation with a scale from 1 (perfect health) to 0 (death) and allows for the calculation of quality adjusted life years (QALYs)

University of Calgary

Professor, Department of Oncology

Nuevo Amanecer is the peer support program. Participants receive the peer support program as soon as possible after randomization.

Waits six months, and at the end of the six months is offered the option of participating in the peer support program.

* Work with a trained counselor who is a breast cancer survivor
* Meet 8 times in-person over the 8 week program with the counselor
* Counselor helps participant develop a personalized support program to help her improve her quality of life
* Receives information on breast cancer, its treatments, and stress management

Peer Support Program

Steven Gregorich, PhD

The purpose of this study is to test whether a new program Nuevo Amanecer (A New Dawn), improves the quality of life of Latinas diagnosed with breast cancer. Trained Latina counselors who have had breast cancer provide support to recently diagnosed women. The investigators call these counselors peer support counselors.

This study will assess the effectiveness of a cognitive-behavioral stress management (CBSM) intervention for newly diagnosed Latina breast cancer patients. In our prior work, the investigators established the appropriate content of the intervention, the need for early intervention, and the value of culturally competent peer support. In this study the investigators will adapt an evidence-based CBSM intervention designed to meet these needs. This study will use a randomized controlled trial (RCT) design with a wait-listed usual care control group to adapt the intervention and test its effectiveness in improving breast cancer specific quality-of-life, and decreasing anxiety and breast cancer specific distress. The new, adapted intervention will be called "Nuevo Amanecer" (A New Dawn).

Nuevo Amanecer: Promoting the Psychosocial Health of Latinas

FACT-B was used as the breast cancer-specific quality-of-life measure. FACT-B consists of 5 subscale scores pertaining to 4 well-being dimensions (physical, social-family, emotional, functional) and additional breast cancer concerns. A total overall score is the sum of all subscales. Response options were 0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, and 4=very much.

Psychometric analysis in our Spanish-speaking Latina sample resulted in modifications to FACT-B: physical well-being subscale. Of 7 items, 1 was dropped because it was conceptually different from other items on that scale. Modified subscale was scored by summing items. Possible score ranges for physical well-being were 0-24. Higher scores indicated greater well-being.

FACT-B was used as the breast cancer-specific quality-of-life measure. FACT-B consists of 5 subscale scores pertaining to 4 well-being dimensions (physical, social-family, emotional, functional) and additional breast cancer concerns. A total overall score is the sum of all subscales. Response options were 0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, and 4=very much.

Psychometric analysis in our Spanish-speaking Latina sample resulted in modifications to FACT-B: social/family well-being subscale. Of 7 items, 2 were dropped because the items were conditional on having a partner (resulting in lots of missing data). Modified subscale was scored by summing items. Possible score ranges for social/family well-being were 0-20. Higher scores indicated greater well-being.

FACT-B was used as the breast cancer-specific quality-of-life measure. FACT-B consists of 5 subscale scores pertaining to 4 well-being dimensions (physical, social-family, emotional, functional) and additional breast cancer concerns. A total overall score is the sum of all subscales. Response options were 0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, and 4=very much.

Psychometric analysis in our Spanish-speaking Latina sample resulted in modifications to FACT-B: emotional well-being subscale. Of 6 items, 1 was dropped because of low item-scale correlations and it was conceptually different from the other items on that scale (only positively worded item on the scale). Modified subscale was scored by summing items. Possible score ranges for emotional well-being were 0-20. Higher scores indicated greater well-being.

FACT-B was used as the breast cancer-specific quality-of-life measure. FACT-B consists of 5 subscale scores pertaining to 4 well-being dimensions (physical, social-family, emotional, functional) and additional breast cancer concerns. A total overall score is the sum of all subscales. Response options were 0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, and 4=very much.

Psychometric analysis in our Spanish-speaking Latina sample resulted in modifications to FACT-B: breast cancer concerns subscale. Of 7 items, 2 were dropped because of low item-scale correlations and were conceptually different from the other items on that scale. Modified subscale was scored by summing items. Possible score ranges for emotional well-being were 0-28. Higher scores indicated greater well-being.

FACT-B was used as the breast cancer-specific quality-of-life measure. FACT-B consists of 5 subscale scores pertaining to 4 well-being dimensions (physical, social-family, emotional, functional) and additional breast cancer concerns. A total overall score is the sum of all subscales. Response options were 0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, and 4=very much.

Psychometric analysis in our Spanish-speaking Latina sample resulted in modifications to FACT-B: functional well-being subscale. Of 7 items, 3 were dropped because items were conceptually different and did not converge psychometrically with the other items on that scale; the remaining 4 items were specific to enjoyment of life, thus we renamed the subscale to "Enjoyment of Life". Modified subscale was scored by summing items. Possible score ranges for enjoyment of life were 0-16. Higher scores indicated greater well-being.

FACT-B was used as the breast cancer-specific quality-of-life measure. FACT-B consists of 5 subscale scores pertaining to 4 well-being dimensions (physical, social-family, emotional, functional) and additional breast cancer concerns. A total overall score is the sum of all subscales. Response options were 0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, and 4=very much.

Psychometric analysis in our Spanish-speaking Latina sample resulted in modifications to each of the FACT-B subscale. The total overall score is based on the sum of modified subscales (see above primary outcomes for modifications to subscales). Possible score ranges for the total overall score were 0-108. Higher scores indicated greater well-being.

BSI was used to measure general symptoms of distress. BSI consists of 3 scale scores pertaining to general symptoms of distress (anxiety, depression, somatization). Response options were 0=not at all, 1=a little bit, 2=moderately, 3=quite a bit, and 4=extremely. Scores were the mean of nonmissing items. Possible score ranges for anxiety were 0-4. Higher scores indicated more distress.

BSI was used to measure general symptoms of distress. BSI consists of 3 scale scores pertaining to general symptoms of distress (anxiety, depression, somatization). Response options were 0=not at all, 1=a little bit, 2=moderately, 3=quite a bit, and 4=extremely. Scores were the mean of nonmissing items. Possible score ranges for depression were 0-4. Higher scores indicated more distress.

BSI was used to measure general symptoms of distress. BSI consists of 3 scale scores pertaining to general symptoms of distress (anxiety, depression, somatization). Response options were 0=not at all, 1=a little bit, 2=moderately, 3=quite a bit, and 4=extremely. Scores were the mean of nonmissing items. Possible score ranges for somatization were 0-4. Higher scores indicated more distress.

Breast cancer-specific distress was measured with the 7 item Intrusive Thoughts Scale (anchored to the breast cancer experience), a subscale of the revised Impact of Event Scale (RIES). Response options were 0=not at all, 1=rarely, 2=sometimes, and 3=often. Using the published scoring algorithm, items were summed after recoding responses to 0, 1, 3, and 5. Possible score ranges were 0-35. Higher scores indicate greater distress.

California Breast Cancer Research Program

Circulo de Vida Cancer Support and Resource Center

University of California, San Francisco

Nuevo Amanecer is a cognitive-behavioral stress management program delivered by peers (Spanish-speaking Latinas who have had breast cancer) designed to address the first year of survivorship.

Peer Support Program:

* Work with a trained counselor who is a breast cancer survivor
* Meet 8 times in-person over the 8 week program with the counselor
* Counselor helps participant develop a personalized support program to help her improve her quality of life
* Receives information on breast cancer, its treatments, stress management, and cognitive refraining.

Nuevo Amanecer Peer Support Program

Wait-list Control

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Less than 6th grade

6th grade to less than high school

High school graduate

Educational attainment

Any private

Public insurance only

None

Missing data

Health insurance

Ductal Carcinoma In Situ (DCIS)

Invasive

Breast cancer

0 (in situ)

I (1)

II (2)

III (3)

Stage 0-Carcinoma in situ;

Stage I, Stage II, and Stage III-Higher numbers indicate more extensive disease: Larger tumor size and/or spread of the cancer beyond the organ in which it first developed to nearby lymph nodes and/or tissues or organs adjacent to the location of the primary tumor

Stage

Breast conserving

Mastectomy

Surgery

Both chemotherapy and radiation

Only radiation

Only chemotherapy

No treatment

Adjuvant treatment

Dr. Anna Maria Napoles

Baseline

6 month

Using intention-to-treat analyses, used repeated-measures linear regression models to estimate the intervention effects on outcomes. Likelihood-based model estimation assumed outcome responses were missing at random.

Physical Well-being a Subcale of the Functional Assessment of Cancer Therapy-Breast Quality of Life Instrument (FACT-B)

Anxiety a Subscale of the Brief Symptom Inventory (BSI)

Social/Family Well-being a Subcale of the Functional Assessment of Cancer Therapy-Breast Quality of Life Instrument (FACT-B)

Emotional Well-being a Subscale of the Functional Assessment of Cancer Therapy-Breast Quality of Life Instrument (FACT-B)

Breast Cancer Concerns a Subscale of the Functional Assessment of Cancer Therapy-Breast Quality of Life Instrument (FACT-B)

Enjoyment of Life a Subscale of the Functional Assessment of Cancer Therapy-Breast Quality of Life Instrument (FACT-B)

Total Score of the Functional Assessment of Cancer Therapy-Breast Quality of Life Instrument (FACT-B)

Depression a Subscale of the Brief Symptom Inventory (BSI)

Somatization a Subscale of the Brief Symptom Inventory (BSI)

Breast Cancer-Specific Distress of the Intrusive Thoughts Scale

Baseline Assessment

3 Month Assessment

6 Month Assessment

Nuevo Amanecer-II (NA-II) is a 10-week peer-delivered cognitive-behavioral stress management program. Participants receive the stress management program as soon as possible after randomization.

Waits six months and at the end of the six months is offered the option of receiving the NA-II program.

Participant meets weekly with a trained interventionist called a Compañera (a peer who has had breast cancer) to complete a structured 10-week program designed to develop cognitive and behavioral skills to manage stress and distress, improve communication with family and clinicians, and increase knowledge of self-management after breast cancer.

Nuevo Amancer-II Stress Management Program

The primary aim is to assess the effectiveness of the Nuevo Amanecer-II (NA-II) cognitive-behavioral stress management program through a 6-month RCT with 150 Spanish-speaking Latinas with breast cancer in three rural settings in terms of improving quality of life (QoL) and reducing distress, compared to a usual care control group (that is offered the program at the end of the 6 months). The investigators will also test the effects of the program on biomarkers of stress (hair and saliva cortisol) and aging (telomere length from saliva). Trained Latinas, called Compañeras (Companions), who have had breast cancer deliver the stress management program in-person to Spanish-speaking Latinas with breast cancer.

The purpose of this study is to adapt Nuevo Amanecer (NA-I) for use in rural populations and test the effects of the new adapted program, NA-II, in a 6-month RCT among 150 rural, low literacy Latinas with non-metastatic breast cancer. Primary outcomes will consist of quality of life and distress. In an ancillary study, the investigators will compare the intervention and wait-list control groups on biomarkers of stress (hair and saliva cortisol) and aging (telomere length from saliva). Finally, to facilitate statewide dissemination of Nuevo Amanecer-II (NA-II), the investigators will develop a guide to implementation for community-based organizations.

The investigators will adapt NA-I to be appropriate for rural and low-literacy Latinas with breast cancer. Needed program adaptations will be identified through a formative evaluation consisting of semi-structured interviews with key informants (e.g., rural Latina breast cancer survivors, advocates, health care providers) and iterative consultations with community representatives in three rural areas with large Latino populations. Results will be applied by the study team and community advisors to adapt NA-I to create NA-II and create the implementation guide.

The investigators will identify key individual, organizational, and community factors that facilitate implementation and support scalability and statewide dissemination through a process evaluation where the investigators will track key implementation activities and debrief program participants, interventionists, and advocates. Products will include NA-II interventionist and participant manuals and a guide to implementation for organizations seeking to replicate the program.

Nuevo Amanecer II: Translating a Stress Management Program for Latinas

Translating a Stress Management Program for Latinas

Study staff will collect hair sample pre-intervention (baseline) and at the 6-month follow-up. All hair samples will then be picked up by San Francisco State University Health Equity Research Laboratory (HER) staff for cortisol characterization.

Study staff will collect a saliva sample pre-intervention (baseline) and at the 6-month follow-up. All saliva samples will then be picked up by San Francisco State University Health Equity Research Laboratory (HER) staff to process to extract DNA and measure telomeres.

Participants will collect nine saliva samples pre-invention (baseline) and at the 6-month follow-up. The first two samples will be taken within the first half hour of waking (first upon awakening and 30 minutes after waking). Participants will collect the last sample right before they go to bed. All saliva samples will then be picked up by San Francisco State University Health Equity Research Laboratory (HER) staff for cortisol characterization.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Rural Women Connecting for Better Health	NCT01441011	Breast Cancer Obesity	Group phone cou... Newsletter	- 75 Years	University of Kansas Medical Center
Group Versus Individual Acupuncture for Cancer Pain	NCT03641222	Cancer Pain	Acupuncture	18 Years -	University of Calgary
Group Versus Individual Acupuncture for Cancer Pain	NCT03641222	Cancer Pain	Acupuncture	18 Years -	University of Calgary
Group Versus Individual Acupuncture for Cancer Pain	NCT03641222	Cancer Pain	Acupuncture	18 Years -	University of Calgary
Rural Women Connecting for Better Health	NCT01441011	Breast Cancer Obesity	Group phone cou... Newsletter	- 75 Years	University of Kansas Medical Center
Nuevo Amanecer: Promoting the Psychosocial Health of Latinas	NCT01383174	Breast Neoplasm... Psychology, Soc...	Peer Support Pr...	18 Years -	University of California, San Francisco
Nuevo Amanecer II: Translating a Stress Management Program for Latinas	NCT02931552	Breast Neoplasm... Psychology, Soc...	Nuevo Amancer-I...	18 Years -	University of California, San Francisco

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