Neoplasms

Symptoms and General Pathology

All Conditions

Neoplasm Metastasis

Neoplastic Processes

4 sessions completed with an IU Health chaplain using a framework of questions called the Spiritual Care Assessment And Intervention tool. The weekly sessions will focus on one of the 4 areas of spiritual experience (meaning and purpose, relationships, transcendence and peace, self-worth and identity)

SCAI (Spiritual Care Assessment and Intervention)

Alexia Torke, MD

The purpose of this study is to test a spiritual care intervention for adults with advanced cancer and their caregivers. This intervention will assess 4 areas of spiritual experience: meaning and purpose, relationships, transcendence and peace, self-worth and identity. Participants will be asked to complete questionnaires and participate in 4 sessions with research chaplains.

Several studies have shown that cancer affects multiple dimensions of a patient's life as well as the lives of caregivers and others close to the patient who, when faced with life crises, may use religion and spirituality (R/S) to cope. This study is the first of its kind to incorporate a semi-structured spiritual care and intervention (SCAI) framework into the spiritual care of advanced cancer patients while maintaining proper controls in order to investigate its feasibility, acceptability and potential effects on the emotional and spiritual outcomes of advanced cancer patients and their caregivers. This framework will assess 4 areas of spiritual experience: meaning and purpose, relationships, transcendence and peace, self-worth and identity. Additionally, not only will this study assess acceptability and feasibility of the intervention, it will also track and document coping, satisfaction, anxiety, depression, quality of life outcomes and follow-up with both patient and caregivers following Spiritual Care Assessment and Intervention (SCAI).

Specific Aim 1: To evaluate the feasibility and acceptability of the SCAI intervention for adults with advanced cancer and their caregivers.

Specific Aim 2: To establish our ability to collect outcome data to support a future efficacy trial for patients and their caregivers in the outpatient clinic and home setting.

Specific Aim 3: To test the preliminary impact of the SCAI intervention on patient and caregiver spiritual wellbeing (primary outcome) and quality of life, religious coping, depression, and anxiety (secondary outcomes)

Feasibility, Acceptability and Preliminary Effects of the Spiritual Care Assessment and Intervention

Feasibility, Acceptability and Preliminary Effects of the Spiritual Care Assessment and Intervention (SCAI) Framework for Adults With Advanced Cancer and Their Caregivers (FCGs): A Clinical Pilot Trial

number of eligible patients that are consented and enrolled in the trial

proportion of participants who attend all four intervention sessions

satisfaction score among participants on the satisfaction survey

Total score at baseline will be compared to score at to the score at 1 week, 6 weeks, and 3 months

percentage of completed baseline surveys in enrolled patients

Measure of patient quality of life through total score at baseline compared to score at 1 week, 6 weeks, and 3 months

Measure of caregiver quality of life through total score at baseline compared to score at 1 week, 6 weeks, and 3 months

Measure of Anxiety through total score at baseline compared to score at 1 week, 6 weeks, and 3 months

Measure of depression through total score at baseline compared to score at 1 week, 6 weeks, and 3 months

Measure of coping through total score at baseline compared to score at 1 week, 6 weeks, and 3 months

Indiana University Health

Indiana University

Associate Professor of Medicine and Associate Division Chief of General Internal Medicine and Geriatrics

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Behaviors and Mental Disorders

Rare Diseases

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Carcinoma

Fallopian Tube Neoplasms

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Endocrine System Diseases

Gonadal Disorders

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Fallopian Tube Diseases

Quality of Life

Ovarian Cancer

Ovarian Epithelial Cancer

Fallopian Tube Cancer

Patients with newly diagnosed ovarian, primary peritoneal, or fallopian tube cancer.

Questionnaires that ask questions about religion, spirituality, and decisions about treatment at three points (at time of diagnosis, end of primary chemotherapy, and one year later).

Questionnaire

Lois M. Ramondetta, MD

The goal of this psychosocial research study is to examine and explain the influence of spirituality on patients with ovarian, primary peritoneal or fallopian tube cancer.

Little is known about the role a patient's spirituality plays in their quality of life. This study consists of a series of questionnaires that ask questions about religion, spirituality, and decisions about treatment.

All patients with newly diagnosed ovarian, primary peritoneal or fallopian tube cancer who come to the Department of Gynecologic Oncology at M. D. Anderson and affiliated clinics for care will be offered study participation.

Patients will be asked to complete a series of questionnaires at specific times: at the time of diagnosis (before their second cycle of therapy begins), at the end of primary chemotherapy, and one year later. The questionnaires should take a total of about 65 minutes to complete, and patients can choose not to answer any question they do not want to answer.

Patients who agree to participate but do not have time to fill out the questionnaires during their visits may return the questionnaire by mail in a pre-stamped envelope.

All participants will be asked to provide the following information: their age, religious preference, race, marital status, date of diagnosis, stage of disease, and their current treatment. This information will be on a data sheet and should take about 5 minutes to complete.

Any collected information will be confidential. Each participant will be given a specific identification number so that confidentiality can be maintained.

This study is partially funded by a research grant from the Blanton Davis Ovarian Cancer Research Program, in Department of Gynecologic Oncology at M. D. Anderson.

This is an investigational study. About 115 participants will be enrolled in this multicenter study.

About 60 participants will be enrolled at MD Anderson. Up to 31 will be enrolled at the Harris Health System.

Role of Spirituality in Coping and Surviving With Ovarian Cancer, Primary Peritoneal or Fallopian Tube Cancer

Evaluation of the Role of Spirituality in Coping With and Surviving Ovarian, Primary Peritoneal or Fallopian Tube Cancer

The Blanton Davis Ovarian Cancer Research Program

M.D. Anderson Cancer Center

Facies

Death

Adolescent/family dyads randomized to the experimental condition receive Family Centered Advance Care Planning for Teens with Cancer (FACE-TC) intervention - 3 sessions scheduled one week apart of approximately 60 minutes duration each. Session 1 - Lyon Advance Care Planning Survey-Adolescent \& Surrogate versions. Session 2 - Respecting Choices Interview facilitated by trained/certified facilitator with adolescent and family. Focuses on patient's understanding of their illness, possible complications, goals of care and treatment preferences in 3 bad outcome situations; and the Session 3 - Five Wishes an advance directive.

Adolescent/family dyads randomized to the treatment as usual (TAU) condition receive written information on advance care planning, but no active intervention.

3 session weekly intervention: 1) survey completed by adolescent and family (surrogate decision maker) separately with facilitator; 2) Respecting Choices structured interview about patient's representation of illness, goals of care, hopes, treatment preferences; 3) completion of an advance directive.

FAmily CEntered Advance Care Planning for Teens with Cancer

Maureen E Lyon, PhD

To test the efficacy of FACE-TC on key outcomes, the investigators propose using an intent-to-treat, longitudinal, prospective, multi-site, randomized controlled trial (RCT) design. Adolescents with cancer, aged 14 up to 20 years, and their families (N=130 dyads; N=260 participants) will be recruited and randomized to FACE-TC or Treatment as Usual (TAU) control. Participants will complete standardized questionnaires at baseline and 3, 6, 12, and 18 months post-intervention. Our goal is to assess the extent to which FACE-TC helps adolescents and young adults with cancer and their families: (1) reach and maintain better congruence in treatment preferences over time; (2) improve their quality of life; and (3) document goals of care and advance directives earlier in the course of their potentially life limiting illness.

The investigators propose a prospective, longitudinal, 2-arm RCT to test the efficacy of FACE-TC on key measurable outcomes through 18 months post-intervention. Dyads composed of adolescents with cancer and their families (N=130 dyads; 260 subjects) will be enrolled and randomized to either the FACE-TC intervention or Treatment as Usual (TAU) Control group at a ratio of 2:1 \[N=87 FACE-TC dyads and N=43 TAU Control dyads\]. The investigators estimate 30% attrition by the 18 month post-intervention assessment (20%-25% due to death/complications and 10% due to dropout). Of the original sample of 130 randomized dyads (N=260 subjects), the investigators estimate the investigators will have full longitudinal data at 18 months post-intervention for 91 dyads (N=182 subjects). Participants will be recruited from Akron Children's Hospital, St. Jude Children's Research Hospital and University of Minnesota Masonic Children's Hospital pediatric oncology programs. Participants will undergo written informed consent/assent. Eligible participants will be enrolled and complete the baseline assessment followed by randomization. Randomization will be at the level of the dyad. Allocation will be concealed from the RA-Assessor to prevent bias. Block randomization by study site will control for site differences. Intervention and Control Conditions: The curriculum based FACE-TC consists of: The Session 1 ACP Survey; Session 2 Respecting Choices Interview; and the Session 3 Five Wishes advance directive. To minimize the burden to ill adolescents, the investigators have chosen a Treatment as Usual comparison condition. This group will be provided with an advance care planning booklet/information only. Assessments occur at baseline, and 3, 6, 12, and 18 months post-intervention. At each site the assessments and intervention will be administered by a research team comprised of the site Co-Investigator and two Research Assistants (RA) (RA-Assessor \& RA-Interventionist).Visit protocol: Screening Visit: The RA-Assessor presents the adolescent with cancer and family with an Information Sheet describing the study and conduct an initial assessment about whether they are eligible for enrollment. After consent/assent, further screening for inclusion/exclusion criteria is conducted. Baseline Visit: At enrollment and prior to randomization, baseline measures will be obtained. Entry of baseline data by the RA-Assessor will trigger computerized randomization of patient/family dyads to either FACE-TC intervention or TAU Control using a randomly permuted block design and a 2:1 ratio by study site. The Children's National clinical coordinator will then notify the RA-Interventionist who will schedule the next study visit. The adolescent and family will learn their assignment when the RA-Interventionist calls to schedule study sessions. Attendance will be recorded to assess effects of full vs. partial participation in FACE-TC. Follow-up Visits: RA-Assessor will obtain follow-up measures from the adolescent and family at 3, 6, 12 and 18 month post intervention.

Site Co-Is will oversee site activities and provide weekly, face-to-face supervision of the RAs. They are responsible for recruitment, retention, safety, fidelity to protocol, and supervision and support of RAs. The RAs will assist with recruitment, screening, enrollment and baseline screening measure collection, as well as the day-to-day functioning. RAs will be blind to random assignment. RA-Interventionists will be trained to implement the protocol. Only the RA-Assessor will be permitted to administer post-randomization assessments. Children's National will serve as the data coordinating center and will be responsible for database design and maintenance and the statistical analyses. Sites will be overseen by a Safety Monitoring Committee (SMC). A 2-day Investigator Meeting will be held in Washington, District of Columbia (DC) and will include all site Co-Is, RA-Assessors and consultants. The protocol, its scientific rationale, underlying ethics issues, implementation including recruitment and retention, will be reviewed with the entire team. In month 9 of Year 1 there will be a 3-day training meeting of the RA-Interventionists and RA-Assessors on the intervention, which site-Co-Is will also attend. RA-Assessors will attend only one day of this training in order to maintain blindness. Site Initiation. To begin screening/enrollment (1) the protocol must be approved at each site's Institutional Review Board (IRB) and all personnel must be certified in Human Subjects Research training, (2) personnel are recruited and trained for RA roles, and (3) each RA-Interventionist must complete certification as a Next Steps-ACP Facilitator. Dr. Lyon and the Research Coordinator will verify that the site has all components in place for the logistics of screening, enrolling, scheduling, performing assessments, administering interventions, and collecting the data. To assure continuous quality for the intervention and its evaluation, monitoring will be ongoing. Dr. Lyon and Ms. Briggs will review the first 5 DVD/audio recordings of intervention sessions from each site to ensure fidelity with the protocol. Thereafter, they will randomly review 1 DVD per week, rotating sites. Dr. Lyon and Ms. Briggs will use a competency checklist. Dr. Lyon and Research Coordinator will monitor ongoing site IRB approval documentation and assist sites in annual continuing reviews. The Research Coordinator will keep copies of all regulatory forms, including consent-stamped templates from each site and staff members' Human Subjects Research Training approval certificates. Dr. Lyon and the Research Coordinator will perform twice yearly site monitoring visits while the intervention is being implemented to assure standardization of procedures and resolve any problems that are identified. They will review and confirm that all consents have occurred properly at the sites and that the sites are maintaining all participant and regulatory data. The REDCap database from the FACE-TC pilot will be updated and expanded for this study, and the systems for data entry will be revised to address multi-site implementation. A data dictionary will be created. An external Safety Monitoring Committee (SMC) will be assembled by Dr. Lyon with the responsibility of reviewing safety information, study progress, and other relevant data. The SMC will meet a minimum of once a year. Prior to parametric testing, scale reliabilities for multi-item measures (e.g., pain/fatigue, child and parent psychological, spiritual/religious measures) will be assessed using Cronbach's alpha and their composite scores will be used for data analyses. Analytical Plan for AIM 1. To evaluate the efficacy of FACE-TC on adolescent-family congruence in treatment preferences. Congruence in decision-making for medical treatment will be tested based on agreement (i.e., both patient and his/her family choose the same option) on the Statement of Treatment Preferences in four different cancer-related situations. Kappa coefficients will be applied to assess chance-adjusted agreement between patient and family responses. Change in Kappa coefficient (congruence improvement) from baseline to each follow-up time point during the study period will be tested using bootstrapping technique. The latent growth model (LGM) with categorical outcome will be used to test Hypotheses H1a, i.e., FACE-TC participants will have a higher congruence rate over time. In the LGM, the investigators will set time scores, except those for identification purpose, as free parameters to let the shape of growth trajectory be determined by data. As such, the congruence development trajectory would have an empirically based nonlinear shape, instead of assuming a linear or nonlinear polynomial function. The investigators will apply the growth mixture model (GMM) to test heterogeneity of congruence development trajectories and identify possible patterns of congruence in development trajectories in the full sample. The latent class variable estimated from the GMM captures the pattern of congruence development trajectories. Time-invariant covariates will be used to predict the memberships of the latent trajectory groups; and time-varying covariates will be included to predict the level of congruence at different time points. To test Hypotheses H1b, the investigators will regress the latent growth slope factor and the latent class variable on FACE-TC intervention, controlling for covariates in the GMM to assess 1) how FACE-TC would affect the membership of the latent classes of congruence development; and 2) how the effect of FACE-TC on congruence change over time varies across the latent trajectory classes. Analytical Plan for AIM 2. To evaluate efficacy of FACE-TC on AYA quality of life and family QOL. The LGM and GMM models proposed for evaluating Aim 1 can be readily applied to evaluate Aim 2 and test Hypotheses H2 where the outcome measures are continuous variables. When examining the effects of FACE-TC on QOL for AYAs with cancer and their families, socio-demographics will be controlled as time-invariant covariates, while time-varying covariates will be included in the model to predict measures of QOL at different time points. In addition, family caregiver appraisal/depression measured at the end of the study period will be included as a distal outcome in the GMM models, and how this distal outcome is associated with the patterns of the developmental trajectories of AYA QOL will be assessed. As the same model will be used to evaluate multiple outcomes, Bonferroni correction will be applied to exert a stringent control over false discovery. As attrition is inevitable in longitudinal studies, robust model estimator (e.g., MLR) using the full information maximum likelihood will be used for model estimation. Importantly, missing at random (MAR), instead of missing completely at random, can be assumed in MLR. MAR is a plausible assumption that allows missingness to be dependent on observed measures like intervention assignment. Analytical Plan for AIM 3. To evaluate the efficacy of FACE-TC on early completion of pACP goals of care and advance directives. First, the investigators will use the two-proportion z-test to test the differences in proportions of completion of pACP goals of care and advance directives between FACE-TC and control groups. Then logistic regressions will be used to test the Hypothesis H3, controlling for socio-demographics. Interaction between intervention and ethnicity will be included in the models to test ethnic disparity in regard to intervention efficacy. The investigators will also explore if FACE-TC improves the match between patients' goals of care and the medical care received at the EOL among the adolescents who may die. Descriptive statistics will be used to estimate the frequencies of the study variables. Chi-square statistics with Fisher Exact tests will be used to assess the difference in the match between FACE-TC and controls; and exact logistic regression will be applied to examine the effect of FACE-TC on such a match, controlling for covariates. For continuous outcomes with a modest observation autocorrelation (p=0.20) and moderate effect size (delta=0.35), the estimated sample size to achieve a power of 0.80 at =0.05 level and detect a moderate effect size (delta=0.35) is about N=76 individuals at each of the 5 observation time points. For binary outcomes, a sample size of N=70 can achieve a power of 0.80 to detect a moderate response probability difference of d=0.17 given p=0.20. Our proposed sample of N=130 dyads will ensure a large enough statistical power for our proposed longitudinal analyses on patient data and parent data, respectively. For the cross-sectional logistic regression model proposed to evaluate Aim 3, a sample size of N=100 would achieve a power of 0.83 at alpha=0.05 level to detect an odds ratio of 4.

Building Evidence for Effective Palliative/End of Life Care for Teens With Cancer

Assess documentation of goals of care, advance directives and care received last week to last month of life.

To monitor quality of communication with dyads

To assess adolescent and family satisfaction with participating in the study

Congruence in treatment preferences between adolescent and their family

Assess adolescent Physical Function Mobility; Physical Function Upper Extremity; Emotional distress-Anxiety; Emotional Distress-Depressive Symptoms; Fatigue; and Pain Interference. 8 items each.

Assess the construct of spiritual functioning and religious practices, e.g. religious preferences and practices, feeling God's presence. Nonreligious participants can pass on these items. 38 items.

Assess construct of peace and spiritual well-being

Assess caregiver strain, positive caregiving appraisals, caregiver distress, and family well-being.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Feasibility, Acceptability and Preliminary Effects of the Spiritual Care Assessment and Intervention	NCT03823313	Advanced Cancer Metastatic Canc...	SCAI (Spiritual...	18 Years -	Indiana University
Feasibility, Acceptability and Preliminary Effects of the Spiritual Care Assessment and Intervention	NCT03823313	Advanced Cancer Metastatic Canc...	SCAI (Spiritual...	18 Years -	Indiana University
Role of Spirituality in Coping and Surviving With Ovarian Cancer, Primary Peritoneal or Fallopian Tube Cancer	NCT00499512	Ovarian Cancer Peritoneal Canc... Fallopian Tube ...	Questionnaire	-	M.D. Anderson Cancer Center
Building Evidence for Effective Palliative/End of Life Care for Teens With Cancer	NCT02693665	Cancer	FAmily CEntered...	14 Years - 99 Years	Children's National Research Institute

Spots Global Cancer Trial Database for religion

Every month we try and update this database with for religion cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for religion

Every month we try and update this database with for religion cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for religion cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.