Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

Participants are free to use any psychosocial care available to cancer patients. No restrictions to participation in other groups or services.

ten 90 minute group sessions by teleconference. Lead by social workers. Sessions focus on information, story sharing and coping.

Therapeutic Group by Teleconference

Sue P. Heiney, PhD

African American women with breast cancer have decreased quality of life (and mood when compared to European American. Research has not examined the effectiveness of therapeutic group for African American women with breast cancer even though positive effects are well established for Caucasians. The aims of the randomized clinical trial are to determine the effectiveness of TG by teleconference for African American women with breast cancer and what factors may impact on the intervention. The primary hypothesis is that participants in the intervention group will have significantly greater cancer knowledge, less fear, less isolation, better social connection, better mood, and better QOL when compared to a control group receiving usual psychosocial care. Two hundred forty African American women with breast cancer will be recruited. Intervention participants attend eight weekly 90 minute sessions by teleconference and two follow-up boosters. Each culturally appropriate session contains the story, information and group processes of connection, commonality and catharsis. Information focuses on increasing self care and stress management knowledge while countering myths and taboos. Story capitalizes on African American oral traditions by discussing coping parables. Group processes provide an alternative source of social support and opportunities to express feelings. Control group subjects receive standard psychosocial care (the use of any support programs or services locally or nationally. Testing will occur at baseline, after 10 group sessions and 16 weeks post baseline. The study findings are expected to inform about the effectiveness of therapeutic groups in African American women with breast cancer and lay the groundwork for exploring if reducing disparities in psychosocial care have a health benefit.

A. Specific Aims Aim One The major aim of the proposed study is to compare the effects of a TG by conference call for AAWBC with usual psychosocial care. We hypothesize that AAWBC who receive the TG by teleconference will have significantly greater cancer knowledge, less fear, less isolation, better social connection, better mood, and better QOL than a control group receiving usual psychosocial care.

Aim One A: Substantiate intervention integrity (purity, dosage, specificity and interventionist competency) of first 14 waves of study.

Aim One B: Establish reliability and validity of measures (Profile of Mood States and Functional Assessment of Cancer Therapy - Breast Cancer Version, Social Support Questionnaire) Aim Two To have a strong intervention, it is essential to identify the processes of change that lead to beneficial outcomes.29, 30 Therefore, the second aim of the proposed study is to identify the mediators of the intervention that predict successful treatment outcomes.

Aim Three Since it is particularly important to identify AA women's characteristics and sociocultural factors which may affect their responses to the intervention,30, 31 the third aim of the study is to identify the effects of demographic, health and socio-cultural variables as moderators of treatment effects on social connection, and QOL.

Aim Three A: Examine baseline moderators and concept of social connection to establish associations.

C. EXPERIMENTAL DESIGN \& METHODS Design The proposed study will be conducted as a multiple-group randomized trial to compare the TG intervention with a control group receiving usual psychosocial care. A maximum of 10 subjects will be assigned randomly to each of two groups during a common time period, with one group receiving the TG intervention and the other receiving usual care. The randomization will be stratified by treatment type (chemo therapy only or radiation therapy only or chemotherapy and radiation therapy combined). Multiple time periods will be used to achieve the required number of subjects for the entire trial. Subjects will be evaluated at three time points in a repeated measures fashion: (1) at baseline before the intervention begins, (2) at the end of the intervention period, and (3) 16 weeks from baseline. Mediating, moderating and outcome variable data will be collected at all three time periods.

These measurement times have been chosen for several reasons. The intervention will be delivered during the stressful time after diagnosis when the patient is facing fears, side effects (especially body image changes), and negative community attitudes. During this time, patients are challenged to learn about the disease and its treatment and are emotionally open to using positive coping strategies.133-136 The T-2 measurement will provide information on the immediate effects of the treatment and T-3 will provide information on the sustainability of the intervention effects.

Setting South Carolina is an ideal setting within which to test the proposed intervention, TG by teleconference. AA represent about 31 % of the population. Unlike other parts of the US, SC is mostly rural (and 46 % of its AA are rural) and the AA population has experienced very little in-migration over the past several centuries.137 Furthermore, religious affiliation is largely fundamentalist Christian (African Methodist Episcopal, Baptist and Pentecostal Churches),138 and a spiritual focus permeates the community, which is known as the "Buckle" of the Bible Belt.

Major statewide initiatives to decrease health disparities are in progress and these efforts have resulted in multiple networks for communication with key SC community leaders and health providers. We will use the Cancer Research Network, SC Cancer Alliance, Women's Cancer Coalition and the Best Chance Network to enhance recruitment efforts.

Palmetto Health and the University of South Carolina are exceptional bases from which to conduct this research. Palmetto Health is South Carolina's most comprehensive health resource, a locally owned, not-for-profit healthcare system with Palmetto Health Baptist Easley in upstate SC and two Columbia hospitals, Palmetto Health Baptist and Palmetto Health Richland. Palmetto Health's Comprehensive Breast Center (PHCBC) was established to improve treatment using national guidelines and decrease mortality. Over the past several years, major strides have been made in attaining these goals through detection of smaller tumors and use of sentinel node biopsy. Two multi-disciplinary and multi-specialty breast cancer tumor conferences are held weekly. Additionally, Palmetto Health has made a strong commitment to decrease health disparities in the communities it serves through its Cancer Community Health Initiative. The 6 year-old initiative has targeted AAs and is working to improve individual and community health by providing services to underserved and uninsured populations especially cancer screening.

One of the oldest and most comprehensive public universities in the United States, USC has been designated a research institution of "very high research activity," the only university in South Carolina to have this designation, granted to 62 public and 32 private research institutions. University libraries in Columbia house over 7,000,000 processed items including 2,639,171 volumes and approximately 4,075,413 units in microform. Some 17,405 current periodicals are received. Thomas Cooper Library. Included in the seating are more than 900 private locked facilities for faculty and graduate students involved in research. Special areas in the library include the Student Computer Labs, the Science Library, Special Collections, and the Map Library. Access to the collection is obtained through the USCAN/NOTIS Online Card Catalog with terminals located throughout the building. CD ROM stations are available for user searching of multiple databases. The Thomas Cooper Library offers access to literature from international sources through the on-line computer-assisted reference department. The computerized reference service provides bibliographic citations, statistics, and international news from recent literature on a wide range of subjects. This service is particularly strong in the natural and social sciences. Also included are government activities, publications, and grant sources. Data bases in nursing include Medline, Nursing and Allied Health, and Health Planning and Administration. Data bases related to nursing include Psychological Abstracts and Mental Health Abstracts. New data bases are added regularly, and information on them is available in the Reference Department.

The majority of participants in the proposed study will be recruited from the two cancer treatment sites within Palmetto Health, which treats about 600 breast cancer patients annually. Of those, more than 225 are AAWBC. Other recruitment will be statewide.

Teleconference Group: Breast Cancer in African Americans (STORY)

Teleconference Group: Breast Cancer in African Americans

Measured using the social well-being scale from the FACT-B

University of South Carolina

Research Professor

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

For 180 days participants in this arm will be exposed to the intervention and 180 days afterwards they will be exposed to the standard of care.

For 180 days participants in this arm will be exposed to the standard of care and 180 days afterwards they will be exposed to the intervention.

The 6 months "at home" program focuses on aerobic and strength training, pelvic floor muscle exercises, meditation, social connection, and overall healthy lifestyle practices supported with daily text message/email reminders. The aerobic (5 times/week) and strength (2 times/week) program will comprise of a single 30-minute session daily and will be individualized to each participant. Pelvic floor muscle training will include three, 10-minute sessions and mediation for 10 minutes daily. Intimacy and Connection component of PC-PEP consists of engaging in at least one form of intimacy practice prescribed, per day. Social connection will be fostered by pairing participants up with peers from the study. To encourage program compliance, study participants will receive 3 daily reminders to do their pelvic floor muscle exercises per day plus an additional motivational email daily containing helpful tips.

PC-PEP

Gabriela Ilie, PhD

Rob Rutledge, MD, FRCPC

Each year over 20,000 men are diagnosed with prostate cancer in Canada with the majority undergoing some form of treatment option. Radical prostatectomy and/or radiation therapy are common procedures that are effective in the treatment of prostate cancer. However, they typically incur both short- and long-term side effects (e.g. urinary incontinence, sexual dysfunction, reduced physical function, etc) that can negatively impact one's quality of life. This study aims to educate and teach pre- (as opposed to most common post-) habilitation - preventive life habits aimed to empower men and address many of the issues faced by men undergoing radical prostatectomy or other active forms of prostate cancer treatments. The investigators hypothesize that daily text and email reminders, in addition to connecting men with other men undergoing similar challenges, will improve participant adherence to the pre-habilitation program. Secondary objectives will assess change in mental health, physical fitness, urological symptoms, state of relaxation, and quality of life parameters before and after the program.

In a survey study of almost 400 survivors of prostate cancer (PC), we found that 17% of them suffered currently from mental health issues, and most were not on medication to address this issue. Compounding issues included urinary and sexual disfunction, poor attendance to support groups, intimacy, problems sleeping and other health problems. To address these many issues directly, with the endorsement of physicians and patients attending our regional PC integrative care conference (April 2018) and expanding on pre-habitation (pre-surgery) science, we created a Patient Empowerment Program (PEP) to be delivered from day one of diagnosis, to educate and teach the men and partners life skills/habits which are aimed to improve their fitness levels and quality of life, and to decrease treatment related side effects. This program is in line with the Auditor General of Nova Scotia's 2017 report endorsing the use of bottom-up evidence-based interventions, created from actively engaging patients in development and process. We aim to trial PC-PEP for men undergoing curative treatment for PC versus a control group receiving standard care. The PC-PEP program includes in-person and multimedia informational, physical activity, pelvic floor, stress reduction, and relationship/connection training. The men are connected with other participants to increase social support and maximize compliance. We use technology to deliver daily alerts to patients to remind them to engage in the program. A PC-PEP feasibility study of 30 men, over 28 days, showed that the program is feasible, leads to positive outcomes in patients and is highly (9.79/10) endorsed by patients. We propose a Randomized Clinical Trial assessing PC-PEP over 6 months from day one of diagnosis. We predict that PC-PEP will improve mental health (primary outcome) and other quality of life outcomes of patients compared with 'usual care'.

This is a randomized, wait-list controlled clinical trial for men newly diagnosed with PC and undergoing curative surgery and/or radiotherapy. The PEP group will receive the intervention for six months (early intervention) while the wait-list group will start the same program at the end of this intervention (late intervention; for six months). Outcomes will be assessed at baseline, six and twelve months. The primary outcome is mental health measured by the Kessler Psychological Distress Scale (K10 questionnaire) at the end of the intervention period. Multiple secondary endpoints include urinary, bowel and sexual function, fitness levels, fatigue, sleep, intimacy/sexuality concerns, relationship satisfaction, social support and surrogates of medical costs (e.g., number of visits to medical professionals).

Introducing a comprehensive empowerment program from day 1 of diagnosis may mitigate against the high levels of mental distress short and long-term suffered by hundreds of Nova Scotian men undergoing curative PC treatment every year, and the burden treatment related side effects will place on our health care system. Given that the study has the endorsement of patients, clinicians and administrators at NSHA, if proven successful it will have the evidence base needed to change the current standard of care.

Participants receive one of two (or more) alternative interventions during the initial phase of the study and receive the other intervention during the second phase of the study

Prostate Cancer - Patient Empowerment Program

Randomized Clinical Trial of an Early vs Late Patient Empowerment Program for Men Undergoing Curative Treatment for Prostate Cancer

Kessler 10 - assessment of psychological distress pre (day 0) and post (6 months) intervention and end of study (12 months). Measured through on-line survey.

The Short Form (SF-12) Health Survey will be used to assess views about general health (physical and mental) quality of life. Change score will be calculated by taking the difference between measures taken at baseline (day 0) and post intervention (day 180).Assessment of these measures will also be completed at the end of the study (day 360). Assessed via on-line survey.

The Functional Assessment of Cancer Therapy-Prostate (FACT-P) will be used to measure psychosocial factors. Changes will be calculated by taking the difference between measures taken at baseline (day 0) and post intervention (day 180).Assessment of these measures will also be completed at the end of the study (day 360). Assessed via on-line survey.

The Expanded Prostate Index Composite (EPIC) (urinary, bowel, hormonal and sexual) and I-PSS (urinary) will be used to measure urinary function pre and post intervention. Change score will be calculated by taking the difference between measures taken at baseline (day 0) and post intervention (day 180). This will be assessed via on-line survey. Assessment of these measures will also be completed at the end of the study (day 360).

Electroencephalography (EEG) assessment of stress state will be measured using the Muse (IntraXon, Inc. Toronto, Ontario, Canada) neurofeedback device. Averages in relaxation brainwaves activity measurements (e.g. alpha, beta, delta, theta, and gamma) will be taken over listening to 10 minutes of relaxation music and instructions. The difference between scores at baseline (day 0) and post intervention (day 180) will be assessed. Assessment of these measures will also be completed at the end of the study (day 360). Assessment will be performed during study visits.

Heart rate variability (HRV) will be assessed through a HRV monitor produced by HeartMath institute. participants will be given home the device for biofeedback purposes with regards to practicing the meditation training received. The device produces scores of HRV and those at pre- (day 0) will be compared to scores at post intervention (day 180), and also at the end of the study (day 360). This will be assessed via on-line survey.

Dyadic Assessment Scale will be used to assess relationship satisfaction at pre- (day 0) will be compared to scores at post intervention (day 180), and also at the end of the study (day 360).

Starting the conversation diet questionnaire will be used (developed by CHPDP). It will be assessed on-line via a survey (day 0, day 180 and day 360)

This will be assessed online through two questions assessing number of visits to see a health care practitioner, and hospital admissions one year prior to the study and then during the year when the study was conducted.

Pre and post intervention assessment of physical fitness assessed to see how many meters the p\[participant can walk during a timed six-minute walk test. Pre and Post scores will be taken at baseline (day 0 - pre) and post intervention (day 180 post). Assessment of these measures will also be completed at the end of the study (day 360) during study visits. Differences between the assessments will be assessed to see if the intervention had an effect.

The length of time (in seconds) of static postural and balance control will be assessed at pre and post intervention, measured in minutes. Change score will be calculated by taking the difference between each of the pre and post measures taken at baseline (day 0) and post intervention (day 180). Assessment of these measures will also be completed at the end of the study (day 360) during study visits. Differences between the assessments will be assessed to see if the intervention had an effect.

Pre and post intervention participants will be timed for 30 seconds to measure the amount of time they can go from sitting to standing in the allocated 30 seconds. The test will be used to test for lower limb strength. Change score will be calculated by taking the difference between each of the measures taken at baseline (day 0) and post intervention (day 180). Assessment of these measures will also be completed at the end of the study (day 360) during study visits.Differences between the assessments will be assessed to see if the intervention had an effect.

Flexibility of shoulder and hamstring will be assessed recording the distance (in cm) rather than the degrees of the reach. Change score will be calculated by taking the difference between each of the measures taken at baseline (day 0) and post intervention (day 180). Assessment of these measures will also be completed at the end of the study (day 360) during study visits.Differences between the assessments will be assessed to see if the intervention had an effect.

Pre and Post measurements of grip strength using a dynamometer will be used to test the strength of the arm and and hand forearm muscles. Change score will be calculated by taking the difference between each of the measures taken at baseline (day 0) and post intervention (day 180). Assessment of these measures will also be completed at the end of the study (day 360) during study visits.Differences between the assessments will be assessed to see if the intervention had an effect.

The height of the individual will be measured in cm at the start of the program.

The weight of the individual participants will be measured in kg using a manual scale, in kg, at pre and post intervention. Change score will be calculated by taking the difference between each of the measures taken at baseline (day 0) and post intervention (day 180). Assessment of these measures will also be completed at the end of the study (day 360) during study visits.Differences between the assessments will be assessed to see if the intervention had an effect.

Body mass index will be calculated at pre and post intervention using the height and weight scores obtained. The BMI formula we will use is: Kg/m2 where kg is a person's weight in kilograms and m2 is their height in metres squared. Change score will be calculated by taking the difference between each of the measures taken at baseline (day 0) and post intervention (day 180). Assessment of these measures will also be completed at the end of the study (day 360) during study visits. Differences between the assessments will be assessed to see if the intervention had an effect.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Teleconference Group: Breast Cancer in African Americans (STORY)	NCT01339351	Breast Cancer	Therapeutic Gro...	21 Years -	University of South Carolina
Teleconference Group: Breast Cancer in African Americans (STORY)	NCT01339351	Breast Cancer	Therapeutic Gro...	21 Years -	University of South Carolina
Prostate Cancer - Patient Empowerment Program	NCT03660085	Prostate Cancer	PC-PEP	18 Years - 80 Years	Nova Scotia Health Authority

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