Nutritional and Metabolic Diseases

Gland and Hormone Related Diseases

All Conditions

Neoplasms

Skin and Connective Tissue Diseases

Diabetes Mellitus

Breast Neoplasms

Metabolic Diseases

Glucose Metabolism Disorders

Endocrine System Diseases

Breast Diseases

Skin Diseases

4 intervention sessions over 6 months using an educational and counseling intervention developed by the study team.

Attention Control group - Supportive counseling for DM management

All pilot participants will be required to have a SMB target to be included in this study. A SMB target will be chosen by the participant after reviewing their 18mo follow-up responses with the Care Coach. Participants may endorse a maladaptive belief or emotional response; however, this is not required to participate in this intervention. At each follow-up session, the Care Coach will review the participant's SMB goal and progress, address participant's challenges and suggest alternatives, and correct further misinformation on the disease(s). Additionally, the Care Coach will reinforce or introduce techniques that could help overcome barriers to reaching SMB goal and recommend participants to continue improving on the same goal or begin action planning towards a new SMB goal.

1. Just SMB concern
2. SMB + maladaptive belief + emotional response
3. SMB + maladaptive belief
4. SMB + emotional response

Integrated Intervention for Breast Cancer Survivors with Diabetes

Participants in the control arm will receive a brochure to discuss healthy lifestyle behaviors to improve DM management. To control for the potentially confounding effect of personalized attention from the care coach on the relationship between the intervention and outcomes, participants also receive 4 calls to discuss study progress, thoughts and feelings about study/illness/behaviors, remind them about returning their pill bottles, and about scheduling for their upcoming 24mo follow-up study interview.

Attention Control

Jenny J. Lin, MD, MPH

The purpose of this research study is to learn how therapy for breast cancer or DCIS/LCIS affects cognitive function and beliefs about cancer/DCIS/LCIS and diabetes (DM). For this portion of the study, the study team will integrate the information collected at previous follow-ups to create educational modules to change disease and medication beliefs and improve DM self-management behaviors (SMB). The educational counseling modules the study team plans to pilot test are rooted in the Common Sense Self-Regulation Model, a theory that posits that health behaviors are influenced by two parallel processes: cognitive (i.e., disease beliefs and expectations) and affective (i.e., emotional responses).

The study team will develop and pilot an educational and counseling intervention to improve SMB among breast cancer survivors with comorbid DM. Development of Counseling Modules to Promote SMB: The study team will use triangulation analysis to integrate, compare, and contrast the quantitative and qualitative data in order to identify modifiable beliefs and emotional reactions that are associated with DM SMB and which could be the target of tailored education and counseling interventions. The study team will develop modules that address survivors' modifiable beliefs, provide coping skills for emotional reactions to illness, and suggest self-management strategies that have been found to be successful among peers. Triangulation analyses will be conducted following the methods outlined by Farmer beginning with sorting findings from qualitative and quantitative interviews, convergence coding and then convergence assessment, completeness assessment, researcher comparison and feedback.

Developing the Counseling and Education Approach: The CSM has been used to develop behavioral interventions for patients with low adherence to chronic disease SMB. It is similar to DiMatteo's evidence-based 3-factor model of strategies (provide correct information, ensure appropriate beliefs, and eliminate tangible barriers) that has been successfully used to improve medication adherence. The study team will develop 3 basic modules addressing determinants of SMB identified in the study team's quantitative and qualitative analyses and that could be integrated into a future comprehensive self-management support intervention: 1) Addressing DM and Breast Cancer Beliefs: The study team will use cognitive restructuring techniques to address misconceptions about breast cancer and DM and medication adherence. For example, some may believe that DM self-management is not important because breast cancer will likely recur and progress quickly. These views can be "reconstructed" by teaching survivors about timeline and consequences of breast cancer vs. DM allowing them to understand the disease timelines relative to each other. Moreover, the study team will clarify the potential impact of poor DM control on breast cancer outcomes. 2) Addressing Emotional Responses: Anxiety and worries will be addressed with normalizing statements (e.g., "Many patients feel that way..." "It is natural to be worried about side-effects..."). For those who report elevated levels of cancer (or DM) worry and distress, the study team will offer relaxation exercises, such as a deep breathing exercise coupled with stress reducing visualizations. 3) Practical Strategies to Instill Routine SMB: Qualitative interviews will elucidate various strategies that survivors have devised to support their SMB. These patient-identified approaches will be collated and explored with participants as potential strategies the participants might employ as well. Particularly for those with cognitive issues, strategies might include using external aids (i.e., texted phone reminders, alarms, pill box organizers, medication schedules, etc.), linking SMB to routine daily tasks, providing family support, etc. The study team will also use strategies to enhance information comprehension and retention by breast cancer survivors with cognitive dysfunction including teach-to-goal, multi-modal communication, and optimized formatting of print materials.

Pilot Overview phase and intervention phase

The participant, the outcomes assessor, and the Principal Investigator (Jenny J. Lin) are blinded to study randomization and treatment arm for each participant.

Integrated Intervention for Breast Cancer Survivors With Diabetes

Disease Beliefs and Cognition: Effect on Diabetes Management in Older Breast Cancer Survivors

This behavioral coaching intervention plans to enroll a small pilot study of 60 participants. The sample size will be small and the data will be mostly qualitative in nature. The data will be release in the aggregate to protect the participants.

It is a widely used multi-factorial pencil-and-paper questionnaire which assesses the five cognitive illness representations on a five-point Likert scale. The IPQ is an 80-item instrument, total scale from 0-10, with higher score indicating higher perception of effects on illness.

To assess beliefs about diabetes medication adherence, the MARS, a validated measure, will be administered after the pilot study, at 6 months. MARS is a 10-item self-reported instrument. Total scores range from 0 (low likelihood of medication adherence) to 10 (high likelihood), with higher score indicating higher likelihood of medication adherence.

The SDSCA measure is a brief self-report questionnaire of diabetes self-management that includes items assessing the following aspects of the diabetes regimen: general diet, specific diet, exercise, blood-glucose testing, foot care, and smoking.

SDSCA is a validated, self-reported measure assessing the number of days the recommended diabetes self-care activities are performed over the past 7 days in the areas of general diet, specific diet, exercise, blood-glucose testing, and foot care. Possible scores range from 0 to 7 days.

The purpose of the questionnaires is to provide common instruments that can be used to obtain internationally comparable data on health-related physical activity, a validated measure, will be administered at the end of the pilot study, at 6 months. The IPAQ results can be reported in categories (low activity levels, moderate activity levels or high activity levels) or as a continuous variable (MET minutes a week). MET minutes represent the amount of energy expended carrying out physical activity.

The Center for Epidemiological Studies-Depression (CES-D) is a 20-item measure that asks participants to rate how often over the past week they experienced symptoms associated with depression, such as restless sleep, poor appetite, and feeling lonely. The CES-D also provides cutoff scores (e.g., 16 or greater) that aid in identifying individuals at risk for clinical depression. Full score from 0- 20, with higher score indicating more symptomology.

The eCAP™ ECM has the regular pharmacy bottle look and feel patients are used to. The important difference is that eCap™ records real-time adherence data, tracking each opening with the date and time.

To assess beliefs about medications, the BMQ, a validated measure, will be administered after the pilot study, at 6 months. The BMQ has two components: beliefs about overuse (score range from 3-15) and perceived risk of medicines (score range from 5-25), total scale 8-40, higher score indicates stronger beliefs in the concepts of the scale.

Northwestern University Feinberg School of Medicine

Feinstein Institute for Medical Research

National Cancer Institute (NCI)

Icahn School of Medicine at Mount Sinai

Professor, General Internal Medicine

Symptoms and General Pathology

Recurrence

Disease Attributes

Participants were exposed to the following conditions: general health for week 1, diet-general information for week 2, and diet-BCSS information (breast cancer survivor-specific) for week 3. Telephone coaching was given.

Participants were exposed to the one of the following usual care conditions: general health for week 1, diet-general information for week 2, and diet-BCSS information (breast cancer survivor-specific) for week 3.

Participants were exposed to the following conditions: cognitive restructuring for week 1, general health for week 2, and diet-general information and diet-BCSS information (breast cancer survivor-specific) for week 3. Telephone coaching was given.

Participants were exposed to the following conditions: cognitive restructuring for week 1, general health for week 2, and diet-general information and diet-BCSS information (breast cancer survivor-specific) for week 3.

Participants were exposed to the following conditions: scheduled worry practice for week 1, general health for week 2, and diet-general information and diet-BCSS information (breast cancer survivor-specific) for week 3. Telephone coaching was given.

Participants were exposed to the following conditions: scheduled worry practice for week 1, general health for week 2, and diet-general information and diet-BCSS information (breast cancer survivor-specific) for week 3.

Participants were exposed to the following conditions: cognitive restructuring for week 1, worry practice for week 2, and General Health and Diet (General and BCSS) for week 3. Telephone coaching was given.

Participants were exposed to the following conditions: cognitive restructuring for week 1, scheduled worry practice for week 2, and General Health and Diet (General and BCSS) for week 3.

Participants were exposed to the following conditions: Diaphragmatic breathing and relaxation for week 1, general health for week 2, and Diet - General and BCSS for week 3. Telephone coaching was given.

Participants were exposed to the following conditions: Diaphragmatic breathing and relaxation for week 1, general health for week 2, and Diet - General and BCSS for week 3.

Participants were exposed to the following conditions: Diaphragmatic breathing and relaxation for week 1, cognitive restructuring for week 2, and General health and Diet (General and BCSS) for week 3. Telephone coaching was given.

Participants were exposed to the following conditions: Diaphragmatic breathing and relaxation for week 1, cognitive restructuring for week 2, and General health and Diet (General and BCSS) for week 3.

Participants were exposed to the following conditions: Diaphragmatic breathing and relaxation for week 1, worry practice for week 2, and General health and Diet (General and BCSS) for week 3. Telephone coaching was given.

Participants were exposed to the following conditions: Diaphragmatic breathing and relaxation for week 1, scheduled worry practice for week 2, and General health and Diet (General and BCSS) for week 3.

Participants were exposed to the following conditions: Diaphragmatic breathing and relaxation for week 1, worry practice for week 2, and cognitive restructuring for week 3. Telephone coaching was given.

Participants were exposed to the following conditions: Diaphragmatic breathing and relaxation for week 1, scheduled worry practice for week 2, and cognitive restructuring for week 3.

Education on physiological effects of anxiety, instructions in diaphragmatic breathing and relaxation techniques, and audio-recordings 5-15 minutes in length that provide guided relaxation exercises (autogenic, imagery-based and progressive muscle relaxation).

Diaphragmatic breathing and relaxation

Education on the thought-emotion connection and exercises designed to better understand cognitions associated with increased anxiety and tools to evaluate and replace anxiety-generating cognitions. Includes an interactive tool (thought record) participants complete to facilitate this process.

Cognitive restructuring

Education on the association between avoidance and increased anxiety, and instructions on actively thinking about feared events to reduce avoidance and engage healthy coping strategies. Interactive tool includes a video-based guided worry practice session and an interactive worksheet and timer.

Scheduled worry practice

BCS will receive 5 TeleCoaching calls over a period of 4 weeks, to include one introductory phone call, followed by 4 calls focused each week on the current CSM; if the participant is not randomized to a CSM, TeleCoaching will provide reflective listening and encouragement.

Telephone coaching

Includes general health, diet-general information and diet-BCSS (breast cancer survivor-specific) information.

Usual care

Lynne Wagner, Ph.D.

The FoRtitude trial aims to evaluate an eHealth intervention designed to teach breast cancer survivors strategies to manage anxiety about cancer recurrence. The eHealth intervention includes educational content and interactive tools, designed to teach coping strategies and/or inert content, depending on the study participant's randomization assignment. The FoRtitude study will examine whether three coping strategies (relaxation training, cognitive restructuring, worry practice) are more effective than general health-related content in reducing fear of cancer recurrence.

The purpose of the FoRtitude trial is to develop and evaluate a targeted eHealth intervention designed to teach breast cancer survivors (BCS) coping strategies to manage fear about cancer recurrence (FoR). FoRtitude, a web-based program with interactive text messaging capabilities, was created to deliver a targeted intervention for BCS with moderate to severe FoR. FoRtitude consists of didactic content presented in written and video-based formats and interactive tools, designed to teach coping strategies. Commonly used cognitive behavior therapy (CBT) techniques were tailored to the management of FoR and included diaphragmatic breathing and relaxation, cognitive restructuring, and scheduled worry practice. Participants are encouraged to use the FoRtitude site several times per week over a period of 4 weeks. The investigators employed principles of user-centered design to create the FoRtitude website and incorporated feedback from 17 BCS to refine site content and improve FoRtitude usability.

After refining the FoRtitude site, the investigators will conduct a randomized controlled trial using the Multiphase Optimization Strategy (MOST) to individually evaluate three coping strategies; each coping strategy will be compared to health management content. Inert content includes general health information and managing comorbid illnesses, information on general nutrition, and information on nutritional topics of interest to BCS. Half of the participants will be randomized to receive telecoaching, which included 3-4 telephone-based brief sessions with a motivational interviewer, aimed at improving adherence to use of the FoRtitude site. Participants will complete questionnaires at baseline, 4 weeks (immediately after completing the FoRtitude site) and at 8 weeks.

Study hypotheses:

1. BCS randomized to Relaxation training will report a greater reduction in fear of cancer recurrence from pre-post intervention than BCS randomized to inert (health management) content
2. BCS randomized to Cognitive restructuring will report a greater reduction in fear of cancer recurrence from pre-post intervention than BCS randomized to inert (health management) content
3. BCS randomized to Scheduled Worry practice will report a greater reduction in fear of cancer recurrence from pre-post intervention than BCS randomized to inert (health management) content
4. BCS randomized to receive Telecoaching will demonstrate higher adherence to using the FoRtitude site and will report a greater reduction in fear of cancer recurrence from pre-post intervention compared to BCS randomized to no Telecoaching
5. BCS randomized to a higher number of coping strategies will report a greater reduction in fear of cancer recurrence from pre-post intervention than BCS randomized to receive all inert content or fewer coping strategies (dose-response effect)

FoRtitude includes three CSMs: (1) diaphragmatic breathing and relaxation, (2) cognitive restructuring, and (3) scheduled worry practice. The fourth intervention component is (4) telephone coaching. We assigned two levels (yes, no) to each component. Evaluating individual and combined intervention components, each with two levels, results in a classic full factorial design with 16 (2 x 2 x 2 x 2) experimental conditions

Targeted eHealth Intervention to Reduce Fear of Recurrence Among Breast Cancer Survivors

Targeted eHealth Intervention to Reduce Fear of Recurrence Among Breast Cancer Survivors: The FoRtitude Trial

Questionnaire aims to better understand the experience of worries about cancer recurrence. Scaled from 1-4 with 4 being "all the time" and 1 being "never". The FCRI is the only FoR measure validated using interview to define 'caseness' and has demonstrated reliability and validity with English speaking survivors. FCRI total score to be calculated without including the Coping and Reassurance subscales defined a priori and determined by FoR theoretical model.

Questionnaire to assess illness-related distress and post-truamatic type anxiety

Questionnaire to assess concerns about recurrence among BCS

Questions administered using a computer adaptive test-based algorithm to assess overall anxiety

Questions administered using a computer adaptive test-based algorithm to assess depression

Questions administered using a computer adaptive test-based algorithm to assess sleep disturbances

Questions administered using a computer adaptive test-based algorithm to assess fatigue

Questionnaire to assess overall health and health-related quality of life

Questions administered using a computer adaptive test-based algorithm to assess patient-reported cognitive impairments

Questionnaire to assess confidence in one's ability to manage breast cancer

Wake Forest University Health Sciences

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

Standard weekly treatments with radiation oncologist and nurse. All control patients offered intervention at end of 8-week course of radiotherapy.

Weekly relaxation therapy with PhD psychologist and home cognitive restructering practice

Weekly Reiki therapy with a Reiki therapist, involves laying of the therapist's hands on the patient to rechannel energy, considered pleasant and calming

Relaxation Therapy: Practice of focus on breathing or repeated word while ignoring random thoughts without bias. Designed to lower heart rate, blood pressure and stress.

Reiki: Practice of laying on hands by a Reiki therapist in order to channel patient's energy, considered calming and pleasant.

Reiki & Relaxation Response Therapy with Cognitive Restructuring

Clair Beard, MD

Randomized clinical study of two CAM therapies, 1) Reiki and 2) Relaxation Response Therapy with Cognitive Restructuring counseling (RRT with CR), compared to an education-only control arm in patients about to begin an eight-week course of external beam radiotherapy (EBRx) for prostate cancer.

Generally, we would like to examine the feasibility of studying Reiki and RRT with CR in patients with prostate cancer, and to obtain preliminary results on the effectiveness of these treatments compared to controls.

Specific objectives:

1. Determine the proportion of eligible patients who agree to participate in the study
2. Measure compliance with CAM therapy interventions
3. Measure compliance with physiologic and psychological outcome measurement assessments
4. Assess differences between experimental and control groups on measures on depression, anxiety, quality of life, salivary cortisol levels and an immunomarkers

Part of the mission of the Dana-Farber/Brigham and Women's Cancer Center is to enhance the quality of life for cancer patients and their families. Treatments and therapies specifically designed to address changes in the cognitive, emotional and spiritual realm experienced by patients as they attempt to cope with cancer are now routinely offered in addition to standard and experimental medical therapies and fall into the realm of complementary and alternative medicine (CAM) and support. Our patients may participate in support groups; work with a social worker, psychologist or psychiatrist privately; learn about diet in seminars or meet with a dietician; participate in art or music therapy; or participate in the many programs offered by the Leonard P. Zakim Center, which include Reiki therapy, acupuncture, acupressure, massage and therapeutic touch. All of these services are provided with the hope that the participants derive some benefit, however intangible. That cancer patients experience significant short- and long-term psychological distress associated with their cancer diagnosis and treatment is well documented.1-4 Most feel a strong sense of lost self-control and experience disturbances in appetite, sleep, concentration, and stamina.5-9 Anxiety and depression appear to be almost ubiquitous with a cancer diagnosis, including those men diagnosed with prostate cancer.8,10-12 This may explain the prevalence of prostate cancer support groups, internet sites and self-help books. However, we have little precise information on our own prostate cancer population with regards to the choices they make regarding CAM and no information on how CAM therapies affect them.

There are some data on the use of CAM in other prostate cancer populations.13-16 In a study of 1,099 men, the prostate cancer diagnosis prompted 23.5% of the sample to start using some form of CAM for health, and 67% of the group reported having used some form of CAM for prostate health before being diagnosed.17 The study included 14 herbal or dietary therapies and 16 mind-body therapies. There were demographic differences between patients who opted for CAM use and those who did not. Patients choosing CAM were more likely to be white versus not, and more likely to be college-educated versus not. The latter variable was particularly significant in this analysis. A second study of patients living in and around San Francisco reported on 543 prostate cancer patients who completed a 30-minute telephone interview regarding complementary and alternative medicines.14 Overall, 30% of the participants used at least one type of complementary or alternative medicine. CAM users were younger than non-users and likely to be college graduates. In this group, herbal remedies and mental health approaches were the most commonly utilized, followed by dietary changes. Twelve percent of the population used two or more CAM approaches.11

For our own study, we chose to look at two forms of CAM, Reiki and relaxation response therapy (RRT). These two were chosen as we had some evidence of utilization within our own cancer population. Reiki treatment is given at the Zakim Center. In the four years since the Zakim Center opened, there have been approximately 300 patient visits for Reiki therapy. Reiki is an energy healing method discovered in the late 1800s in Japan. The word Reiki is made up of two Japanese words: Rei, an unlimited universal power of force that acts in all created matter; and Ki, a living spirit energy that applies to the physical principle of life. Licensed Reiki Masters perform Reiki. All of the Reiki Masters at the Zakim Center are also registered nurses. Subjects often express an enhanced sense of well-being and relaxation after a Reiki session, according to the Reiki practitioners, and most return for at least one more session. Led by Susan DeCristofaro, the Reiki experience at the Zakim Center has been standardized. Here, Reiki is given for acute and chronic pain, headache, depression, anxiety, nausea, vomiting and insomnia. The fee for a Reiki session is $55.00. However, the effects of receiving Reiki have not been subjected to rigorous scientific study. In a review of energy healing, eleven studies looking at Reiki were reviewed. Of these, seven showed a beneficial effect,18-22 three showed no effect21,23,24 and one had a negative effect.25 We believe, after review of this data, that there are many unanswered questions about this treatment.

The second CAM of interest to us was relaxation response therapy (RRT), described and pioneered at the Mind/Body Medical Institute, directed by Herbert Benson, MD. The Mind/Body Medical Institute is an independent, nonprofit organization dedicated to the study of mind/body interactions, including RRT. Three to four hundred cancer patients per year participate in programs at the Mind/Body Medical Institute. Interventions using RRT in combination with cognitive restructuring (CR) counseling are commonly employed and are felt to be 'successful' in cancer patients by the practitioners who deliver them.

The term "relaxation response" was first coined in 1974.26,27 This technique has two characteristics: repetition of a word or phrase and a disregard of everyday thoughts. The elicitation of the RR down-regulates the sympathetic nervous system. It is characterized by reductions in oxygen consumption, respiratory rate, blood pressure, heart rate and arterial blood lactate. The mind/body state achieved with RR is consistent with a wakeful, hypometabolic physiological state.28 EEG studies clearly differentiate the RR from sleep.29 PET30 and fMRI31 studies have correlated specific regional changes in brain activity with the elicitation of the RR. When the patient is in a relaxed state, the therapist focuses on helping him to identify emotions, negative thoughts or anxieties and assisting him to deal with these thoughts in a more constructive way. This is called "cognitive restructuring" and it is an integral part of RT.

RRT is believed to be a useful therapeutic intervention in numerous conditions including: headache;32-34 premature ventricular contractions in stable ischemic heart disease or hypertension;35-38 anxiety;39,40 stress symptoms;41 cardiac surgery;37 pain relief and anxiety reduction in femoral arteriography;42 premenstrual syndrome;43 infertility;44 psychosomatic complaints;45 chronic pain;46-48 and insomnia.29 Other investigators have also found that RRT techniques were effective in the treatment of rheumatoid arthritis. The fee for RT with cognitive restructuring is $100.00 per hour, paid for privately or through insurance.

Thus, we identified two reasonably mature CAM therapies offered and apparently utilized by our own patients, paid for by the patients and their insurance providers, believed by the practitioners to be beneficial to patients but without much solid evidence to support their use. We also know that prostate cancer patients have a high level of interest in CAM. With this in mind, we applied for and received a grant from the Advanced Medical Research Foundation and submitted a protocol to the Dana-Farber/ Harvard Cancer Center Internal Review Board with the primary aim of assessing the feasibility of recruiting and maintaining enrollment in CAM therapy during an 8-week course of RT and a 2-month follow-up period. Our protocol was accepted, #05-005, and is now accruing patients.

Study of Complementary Therapies in Men Receiving Radiation Therapy for Prostate Cancer: A Feasibility Trial

QOL testing performed at four time points

Brigham and Women's Hospital

Attending Physician, Vice-Chair, Genitourinary Radiaton Oncology

Behaviors and Mental Disorders

Anxiety Disorders

Depression

Depressive Disorder

Uterine Cervical Neoplasms

Uterine Neoplasms

Genital Neoplasms, Female

Uterine Cervical Diseases

Uterine Diseases

Genital Diseases, Female

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Quality of Life

Pharmaceutical Solutions

All Drugs and Chemicals

Psychoeducation, Relaxation, Cognitive Reestructuring and Problem Solving

Delivering systematic information about cancer, oncological treatment and efficient coping strategies.

Psychoeducation

Teaching the patient in diaphragmatic breathing retraining and passive relaxation with guided imagination.

Relaxation

Teaching the patient to identify dysfunctional cognitions about cancer and oncological treatment that trigger maladaptive emotions and behavior. Then, focus in generating alternative thoughts through contrast with empirical reality based on the Beck Model.

Cognitive Restructuring

To generate alternative solutions to practical problems based on the model described by Nezu.

Solving Problems

Jessica Salazar, MSc

Cancer represents the second cause of death in general population worldwide and according to statistics, it is expected to increase in the next 20 years. Cervical cancer is the fourth cause of morbidity and mortality among women around the world. Late diagnosis and treatment indices several emotional reactions in patients leading to psychological disorders with an impact in quality of life. Anxiety and depression are the most frequent emotional reactions in cancer patients, which may vary depending on psychosocial factors such as coping and family support, mostly provided by the primary caregiver. Despite the high psychological morbidity in cancer patients, it is estimated that, among those patients needing psychological support, only 10% receive such interventions. A growing interest on psychological interventions in oncology has increased in the last 40 years, however, scarce investigations have been performed, especially in cervical cancer patients. The Cognitive-Behavioral Therapy has proven to be beneficial in general cancer population decreasing the psychological symptoms and improving the quality of life. Thus, the aim of this study is to evaluate the effect of two Cognitive-Behavioral psychological interventions on anxiety, depression, coping, therapeutic adherence, sexual satisfaction and quality of life of cervical cancer patients with locally-advanced and advanced disease attended at the National Cancer Institute from Mexico. Psychological intervention will be provided during ten weekly sessions including psychoeducation, relaxation, cognitive restructuring and problem solving with a pretest, posttest performed one week after intervention, and finally a follow up after three months after finishing the psychological intervention.

Cervical cancer is the fourth cause of morbidity and mortality worldwide, being one of the most important threats to women's health. More than 83,000 women were diagnosed with cervical cancer and 36,000 died in the Region of the Americas in 2012. This phenomenon will increase by 45% for 2030.

During the natural history of Cervical cancer, and as a consequence of therapeutic approaches, a certain proportion of the patients may have emotional reactions leading to psychological disorders, as severe as those disease complications, which also deteriorate their quality of life. The most frequent reactions are anxiety and depression. These may vary depending on different psychosocial factors, including coping and social support, mostly provided by the Primary Caregiver, who has a fundamental role in hospital and home care, helping on therapeutic adherence.

Therapeutic adherence is essential in order to obtain optimal results of the given oncological treatment, representing a mediating variable with important implications for survival, disease progression and in the improving of quality of life.

Response to treatment has been widely evaluated by tumor size, OS and DFS. Nevertheless, in the past tree decades the evaluation of Quality of Life has risen as an indicator of therapeutic response. Quality of life is an indicator that measures the general well-being of the patients according to the overall effects of the oncological treatments. Scientific evidence reports that cervical cancer survivors may have a worst quality of life as well as other physical and emotional symptoms than those observed in other cancer populations. Hence, it is necessary to focus on psychological interventions aimed to improve the quality of life and to decrease the psychological morbidity in cervical cancer patients.

During the last four decades a special interest in psychosocial interventions in oncology population has risen, establishing that Cognitive-Behavioral Therapy is beneficial in the reduction of physical and emotional symptoms of patients, promoting the adaptive coping and improving the quality of life.

Few evidences exist about psycho-social factors prevalence on gynecological cancer patients. The current available studies have grouped different types of gynecological cancer including breast, ovary, endometrium and vulva, but cervical cancer has been included only in a small proportion of those studies producing a certain degree of bias at the time of interpreting the results. Moreover, most of the studies has focused in breast and ovarian cancer patients. However, it has been proposed the existence of differences in psychological morbidity in women with cervical cancer, therefore is essential to focus our efforts in this particular population due to its high morbidity and mortality.

Hypothesis Patients with locally advanced and advanced cervical cancer receiving "A" psychological intervention will have a greater decrease in anxiety, depression, better coping responses, sexual satisfaction, therapeutic adherence and quality of life compared with the "B" psychological intervention.

The general aim of this study is to evaluate the effect of two cognitive-behavioral interventions on psycho-social factors and quality of life of cervical cancer patients with locally advanced and advanced disease.

Specific objectives:

1. To identify and to compare the degree of the psychosocial variables: anxiety, depression, coping responses, therapeutic adherence and sexual satisfaction at different evaluation phases (pre-intervention, post-intervention and follow-up) in cervical cancer patients.
2. To evaluate and to compare the health-related quality of life perceived at different evaluation phases (pre-intervention, post-intervention and follow-up) in cervical cancer patients.

Exploratory objectives:

1. To evaluate the degree of anxiety, depression, quality of life and the presence of Caregiver Burden Syndrome in primary caregivers before the psychological treatment given to cervical cancer patients.
2. To evaluate the association between psychological variables of the primary caregiver and the emotional distress and quality of life of their locally advanced and advanced cervical cancer patients.

METHODS

Study Design: This a prospective, experimental, longitudinal, open and randomized study

Study population: patients will be divided into two treatment groups ("A" and "B") for pre-intervention, post-intervention and a three months follow-up evaluation treated at the National Cancer Institute from Mexico.

Sample size:

According to the criteria of two proportions, a sample of 92 cervical cancer patients (two intervention groups) and their matched primary caregivers (92) was obtained.

Statistical analysis:

The processing and analysis of the database will be carried out with the SPSS version 22.0® package for Microsoft.

* Univariate analysis will be carried out to describe the study population. Descriptive statistics will be used to obtain measures of central tendency and dispersion, for continuous variables depending on their distribution, mean and standard deviation (parametric) or median and interquartile range (non-parametric) may be reported. For qualitative variables, the distribution of absolute and relative frequencies will be reported.
* Group homogeneity analysis: the general characteristics of the patients in both intervention groups will be evaluated to asses the balance and homogeneity. For quantitative variables t-Student of independent samples or U of Mann-Whitney will be used. For qualitative variables Chi-Square or Chi-Square trends will be used.
* To estimate the change in the variables of interest throughout the measurements in both intervention groups, ANOVA analysis of repeated measures or Friedmand will be carried out.
* To determine the clinical intra-subject changes, an analysis of individual replicates will be performed analyzing the pre-intervention, post-intervention and after three-month follow-up evaluation.

Procedure:

Patients affiliated to the MICAELA Program referred to the Psychooncology service will be considered as candidates for the study.

Informed consent obtention: after reading the Informed Consent, patients will be informed that their participation will consist on answering questionnaires for psychological assessment and psychological attention, if required. If the patient agree to participate, she will sign the Informed Consent document. A semi-structured interview will be applied to obtain socio-demographic and familiar psycho-pathological disorders history. Then, psychometric instruments will be applied.

Patients who are detected with distress or maladaptive coping will be randomized to one of the two interventions groups.

There will be scheduled ten weekly sessions of one hour approximately in with "A" Intervention or "B" Intervention will be applied according the group assigned by randomization. Then, patients will be scheduled for psychological treatment appointments and for evaluation after finishing treatment.

Ethical considerations:

Participants will be informed about details regarding the study, through the Informed Consent process. Patients that desire to participate will express their willingness with the sign of the Informed Consent document. Patients could leave the study at any time when desire.

The study will be conducted according to the ethical principles established in the documents adopted by the international community as declared at the Good Clinical Practices, the Nuremberg Code, the Declaration of Helsinki as well as the Guide of Good Clinical Practices of the Conference Harmonization International and anyone who represents the greatest protection for the individual.

According to the regulations of the General Health Law on Health Research, the second title on the Ethical Aspects of Research in Human Beings, Chapter I, Article 17, paragraph III, the proposed interventions on this study are considered as risk-free.

Protocol and Informed Consent have been approved by Institutional Research and the Ethics Committees.

Effect of Two Cognitive-Behavioral Interventions on Cervical Cancer Patients

Effect of Two Cognitive-Behavioral Interventions on Psychosocial Factors and Quality of Life of Cervical Cancer Patients With Locally-advanced and Advanced Disease

Change in Hospital Anxiety and Depression Scale total score and in the two Subescales

The Hospital Anxiety and Depression Scale (HADS-M) for Mexican patients. HADS was especially designed to detect anxiety and depression states of patients with chronic diseases. HADS-M is a HADS-modified version that has been validated in an oncological sample of patients in Mexican population. HADS-M comprises 12 items measured in a 0-3-point Likert scale, divided into two subescales, one for depression and one for anxiety. The validated version in Mexico has an internal consistency of alpha= 0.86 for global scale, and 0.79 for depression and 0.80 for anxiety subscales. Compared to other instruments, it has sensitivity to detect therapeutic changes associated to psychological interventions. The subscales score is categorized in without (0-5), low (6-8), moderate (9-11), and severe (12 or more) anxiety or depression.

Change in the Brief COPE-17 Inventory subescales scores

The Brief COPE Inventory (COPE-17). Is a brief version of the COPE Inventory (Carver, et al., 1989). It has 17 items measured in a 0-3 point Likert scale, to evaluate coping strategies, that are grouped in seven subescales (planning, self-distraction, humor, seeking for social support, substance use, emotional-religious-spiritual support and self-blame). COPE-17 determines two primary coping styles either as approach coping or avoidant coping. It was adapted and validated in Mexico on a breast cancer population (Ornelas, et al., 2013), obtaining an internal alpha consistency of 0.70 either for the general scale and for each subescale. Avoidant Coping is characterized by the subscales of self-distraction, substance use and self-blame. Approach Coping is characterized by the subscales of planning and seeking for social support. Humor and Emotional-Religious-spiritual are neither Approach nor Avoidance coping.

Change in quality of life summary score of The European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30).

The EORTC QLQ-C30 questionnaire evaluates the quality of life in oncological population, is composed of both multi-item and single-item measures. It has 30 items, including nine scales: five functional scales (physical, role, emotional, cognitive and social functioning), three symptom scales (fatigue, pain and nausea / vomiting) and one global health status/QoL scale. Six single items are also included (Dyspnea, Insomnia, Appetite loss, Constipation, Diarrhea and Financial difficulties). A high score for all functional and global health/QoL scales represents a high/healthy level of functioning/high QoL, whereas a high score for a symptom scale/item represents a high level of symptoms/problems. The QLQ-C30 was validated in mexican population, obtaining a Crombach's coefficient of 0.7 (Oñate-Ocaña, et al, 2009).

Change in quality of life summary score and subescales using The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Cervical Cancer Module (EORTC QLQ-CX24).

The EORTC QLQ-CX24 is the supplementary module of the QLQ-C30 aimed to evaluate quality of life of cervical cancer patients. It consists of 24 items divided in three multi-item scales to assess symptoms experience (gastrointestinal and genitourinary), body image and sexual/vaginal functioning, and six single items to assess lymphedema, peripheral neuropathy, menopausal symptoms, sexual worry, sexual activity and sexual enjoyment. The last five questions are answered only by patients with an active sex life. Higher scores are equivalent to worse or more symptoms, except for items 49 and 54 (higher score indicates better quality of life). The responses are in a 4-point Likert scale. There is a Spanish version used in Mexican population that was provided by EORTC to use in this study.

Changes in Screening Questionnaire aimed to identify sexual satisfaction in women treated for cervical cancer Screening questionnaire aimed at identifying sexual satisfaction in women treated for cervical cancer. To explore sexual activity and cognitive distortions about sexuality during and after oncological treatment, with 20 questions in a dichotomous yes/no response. It was developed for this study as part of the semi-structured screening interview in order to determine the cognitions that generate emotional distress and affectation in the quality of life.

Changes in the Factors related to therapeutic adherence in cancer patients Scale subscales scores Scale to assess factors related to therapeutic adherence in cancer patients (Urzúa et al., 2012). This scale consists in 20 items measured in a 1-4 point likert scale, it evaluates three factors that may affect the therapeutic adherence of patients to oncological treatment. It has three subescales: a) Expectations and personal tools to face the disease, b) Beliefs about the treatment and c) Perceived effects of the treatment. It was developed especially for oncological population with an internal consistency of alpha=0.96 in the global scale and 0.9, 0.93 and 0.91 for the three subscales.

Quantitative Changes in the records of physiological measures in which blood pressure (mmHg) are recorded before and after performing the training relaxation exercises.

Quantitative Changes in the records of physiological measures in which temperature (Celsius degrees) are recorded before and after performing the training relaxation exercises.

Quantitative Changes in the records of physiological measures in which heart rate (beats/min) are recorded before and after performing the training relaxation exercises.

Quantitative Changes in the records of physiological measures in which breathing rate (breaths/minute) are recorded before and after performing the training relaxation exercises.

Qualitative Changes of automatic thoughts during Cognitive Restructuring Technique will be recorded in order to promote "alternative thoughts" according to the Beck Theory for Cognitive Restructuring.

Correlation of the total scores of anxiety, depression, caregiver burden syndrome and quality of life evaluated in the primary Caregiver with the variables of anxiety, depression, coping adherence and quality of life of cervical cancer patients

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Integrated Intervention for Breast Cancer Survivors With Diabetes	NCT05092477	Diabetes Breast Cancer	Integrated Inte... Attention Contr...	55 Years -	Icahn School of Medicine at Mount Sinai
Targeted eHealth Intervention to Reduce Fear of Recurrence Among Breast Cancer Survivors	NCT03384992	Breast Cancer Fear of Cancer	Diaphragmatic b... Cognitive restr... Scheduled worry... Telephone coach... Usual care	18 Years -	Wake Forest University Health Sciences
Targeted eHealth Intervention to Reduce Fear of Recurrence Among Breast Cancer Survivors	NCT03384992	Breast Cancer Fear of Cancer	Diaphragmatic b... Cognitive restr... Scheduled worry... Telephone coach... Usual care	18 Years -	Wake Forest University Health Sciences
Study of Complementary Therapies in Men Receiving Radiation Therapy for Prostate Cancer: A Feasibility Trial	NCT00207259	Prostate Cancer	Reiki & Relaxat...	30 Years -	Brigham and Women's Hospital
Effect of Two Cognitive-Behavioral Interventions on Cervical Cancer Patients	NCT04165460	Cervical Cancer Psychological D... Coping Skills	Psychoeducation Relaxation Cognitive Restr... Solving Problem...	18 Years -	National Institute of Cancerología

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