Behaviors and Mental Disorders

All Conditions

Neoplasms

Skin and Connective Tissue Diseases

Symptoms and General Pathology

Anxiety Disorders

Carcinoma

Breast Neoplasms

Recurrence

Mammary Neoplasms, Animal

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Breast Diseases

Skin Diseases

Disease Attributes

All Drugs and Chemicals

Nicotine

The EUC group will meet for a single 90-minute coaching session via Zoom Health.

The ACT group will meet for 90-minute sessions via Zoom Health weekly for 6 weeks.

The CBT group will meet for 90-minute sessions via Zoom Health weekly for 6 weeks.

Interventionists will provide a brief explanation of the intervention and coaching to the group on how to utilize the resources provided. Prior to the single session group, EUC participants will have received a workbook with the National Cancer Institute's "Facing Forward: Life After Cancer Treatment" booklet on maximizing quality of life during cancer survivorship and the American Society of Clinical Oncology's "Guide to Cancer Survivorship."

Enhanced Usual Care

Interventionists will support participants in adopting a psychologically flexible posture toward FCR through six interdependent processes of change - acceptance, cognitive defusion, mindfulness, perspective taking, values, and committed action. During ACT sessions, participants will learn to respond adaptively to FCR by being more fully aware of thoughts, feelings, and bodily sensations without judging or attempting to control or avoid them. Participants will also clarify their deeply-held values and set action goals in alignment with their values.

Acceptance Commitment Therapy

Interventionists will provide psycho-education on the cognitive behavioral model of FCR and assist participants in changing unhelpful thinking patterns and maladaptive behaviors linked to FCR. Session topics will include FCR triggers, behavioral experiments to reduce FCR-perpetuating safety behaviors, and pleasant events scheduling. Interventionists will also provide evidence-based information on behaviors that may reduce recurrence risk (e.g., achieving a healthy weight, physical activity, cancer surveillance).

Cognitive Behavioral Therapy

Shelley A Johns, PsyD

Fear of cancer recurrence (FCR) is a highly prevalent, disruptive, and under-treated problem for breast cancer survivors. This randomized controlled trial will test the efficacy of group-based Acceptance and Commitment Therapy compared to Cognitive Behavioral Therapy and enhanced usual care for breast cancer survivors suffering from FCR while examining its cost-effectiveness and the mechanisms by which the intervention may work. Study findings will guide the future care of breast cancer survivors with FCR.

The primary objective of this 3-arm randomized control trial (RCT) is to build on the investigators' pilot work by testing the impact of Acceptance Commitment Therapy (ACT) on FCR. The investigators will randomly assign up to 375 early-stage Breast Cancer Survivors (BCS; for at least 300 study completers after attrition) who have finished primary cancer treatment and who report clinically significant FCR to: (1) group-based ACT (6 weekly 1.5-hour videoconference sessions), (2) group-based Cognitive Behavioral Therapy (CBT; 6 weekly 1.5-hour videoconference sessions), or (3) Enhanced Usual Care (EUC; a single 90-minute videoconference coaching session with self-administered readings). Outcomes will be assessed at baseline and at 2, 6, and 12 months; additionally, potential theory-driven mediators of the ACT intervention's effects on key outcomes will be analyzed at these time points and at intervention midpoint. Cost-effectiveness of each intervention will be assessed.

Specific Aims are to: (1) test the efficacy of group-based ACT compared to CBT and EUC on FCR (primary outcome) and anxiety, depressive symptoms, post-traumatic stress, avoidant coping, fatigue, sleep disturbance, and quality of life (secondary outcomes) in BCS with clinical FCR; (2) to examine changes in psychological flexibility as a mediator of ACT's effect on FCR; and (3) to perform comparative assessments of ACT, CBT, and EUC to determine the cost-effective intervention.

An external statistician will create the randomization sequence. An unblinded research manager will maintain the randomization sequence and randomization assignment for each participant in password-protected databases not accessible by the study team. All study personnel, including the study's principal investigator (PI), biostatistician, data manager, research coordinator (RC), and research assistants (RAs), will be blind to the randomization sequence. The PI, research manager, interventionists, and intervention supervisors will be the only individuals privy to participants' randomization assignments. The study RC, RAs (including outcome assessors), and the study biostatistician and data manager will remain blind to participants' random assignments for the trial's duration to enhance rigor and reduce the risk of outcome expectancy and other biases. Participants will be blind to study hypotheses, yet will be aware of their assignment to a 6-session versus single-session intervention.

Facilitating Adaptive Coping With Fear of Recurrence Among Breast Cancer Survivors

Acceptance and Commitment Therapy for Fear of Recurrence in Breast Cancer Survivors

EuroQoL Five Dimensions Questionnaire (EQ-5D-5L) is a standardized non-disease specific instrument used to estimate 'utilities' for cost-effectiveness analyses. Consists of 5 items assessing mobility, self-care, usual activities, pain/discomfort, and anxiety/depression on a 1-5 scale. An additional item asks respondents to assess overall health on a 0 (worst health imaginable) to 100 (best health imaginable) scale. This measure will be used in cost effectiveness analysis.

Medical and non-medical costs are measure over the past 4 weeks using the validated Treatment Inventory of Costs in Patients with Psychiatric Disorders (TiC-P). The first part of the TiC-P assesses frequency of use of various types of health care resources. The second part is an adaptation of the Short Form of the Health and Labor Questionnaire. This measure will be used in cost effectiveness analysis.

The 18-item Cancer Acceptance and Action Questionnaire is a validated measure of cancer-related psychological flexibility, with items rated on a 1 (never true) to 7 (always true) scale. Lower scores indicate greater psychological flexibility. This measure will be used in mediator analysis.

The 10-item Cognitive and Affective Mindfulness Scale-Revised (CAMS-R) comprehensively assesses mindfulness processes including attention, present-focused awareness, and acceptance/non-judgment. Items are rated on a 1 (rarely or not at all) to 4 (almost always) scale, with higher scores indicating greater mindfulness. This measure will be used in mediator analysis.

The 5-item Value Progress subscale of the Valuing Questionnaire assesses progress in living consistently with personal values. Items are rated on a 0 (not at all true) to 6 (completely true) scale, with higher scores indicating greater values-consistent living. This measure will be used in mediator analysis.

The 43-item Fear of Cancer Recurrence Inventory (FCRI) includes triggers, psychological distress, coping strategies, reassurance seeking, insight, severity, and functional impairments subscales. Each item is rated on a scale from 0 (never, not at all, or I don't think about it) to 4 (all the time or a great deal), participants indicate the extent to which they are fearful, with higher scores indicating greater FCR.

The 7-item FCR-7 assesses anxiety, worry, and strong feelings associated with cancer recurrence, coupled with items assessing cognitive and behavioral responses to FCR. The first six items are on a scale from 1 (not at all) to 5 (all the time). The seventh item assesses the extent to which worry about getting cancer again intrudes on thoughts and activities on a 0 (not at all) to 10 (great deal) scale. Higher scores indicate greater FCR.

The 4-item Concerns About Recurrence Scale includes frequency, potential for upset, consistency, and intensity of fears on a 1-4 scale. Higher scores indicate greater FCR.

Participants will be asked "Overall, since starting your assigned study program, is your fear of cancer recurrence worse, about the same, or better?" Those rating their fear of cancer recurrence as "better" are then asked if their fear is "a little better," "somewhat better," "moderately better," "a lot better," or "completely better".

The 7-item Generalized Anxiety Disorder Scale (GAD-7) assesses how often in the past two weeks participants have been bothered by symptoms of anxiety on a 0 (not at all) to 3 (nearly everyday) scale, with higher scores indicating greater anxiety.

The 4-item Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety measure assesses how often participants felt various symptoms of anxiety in the past 7 days on a 1 (never) to 5 (always) scale, with higher scores indicating greater anxiety.

The 22-item Impact of Events Scale-Revised (IES-R) assesses post-traumatic distress on a 0 (not at all) to 4 (extremely) scale, with higher scores indicating greater post traumatic distress.

The 8-item Patient Health Questionnaire (PHQ-8) depression scale assesses how often participants have been bothered with symptoms of depression over the past two weeks on a 0 (not at all) to 3 (nearly everyday) scale, with higher scores indicating greater depressive symptomatology.

The 4-item PROMIS Depression measure assesses how often participants felt various symptoms of depression in the past 7 days on a 1 (never) to 5 (always) scale, with higher scores indicating greater depression severity.

The 4-item PROMIS Fatigue measure assesses how often participants felt various symptoms of fatigue in the past 7 days on a 1 (not at all) to 5 (very much) scale, with higher scores indicating greater fatigue severity.

The 4-item PROMIS Sleep Disturbance measure assesses how often participants experienced aspects of sleep disturbance in the past 7 days on a 1 (not at all) to 5 (very much) scale, with higher scores indicating greater sleep disturbance.

The 28-item Brief COPE assesses how often participants have been utilizing a series of coping strategies since their cancer diagnosis on a 1 (I haven't been doing this at all) to 4 (I have been doing this a lot) scale, with higher scores indicating greater use of the coping strategy.

The 10-item PROMIS Global Health measure assesses mental and physical health. The first nine items are on a 1 (poor or not at all) to 5 (excellent or completely) scale. The tenth item assesses average pain on a 0 (no pain) to 10 (worst pain imaginable) scale and is reverse scored. Higher scores are indicative of better global health.

National Cancer Institute (NCI)

Indiana University Health

Eskenazi Health

Indiana University

Associate Professor of Medicine, Research Scientist

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Digestive System Diseases

Gland and Hormone Related Diseases

Nervous System Diseases

Rare Diseases

Prostatic Neoplasms

Colonic Neoplasms

Cholangiocarcinoma

Melanoma

Thyroid Neoplasms

Thyroid Diseases

Glioblastoma

Glioma

Central Nervous System Neoplasms

Chondrosarcoma

Adenocarcinoma

Neoplasms, Connective Tissue

Neoplasms, Connective and Soft Tissue

Sarcoma

Bile Duct Cancer

Soft Tissue Sarcoma

Antineoplastic Agents

Herbal and Botanical

Gemcitabine

Cisplatin

Durvalumab

Antimetabolites

Antineoplastic Agents, Immunological

Cola

Phase 1 dose escalation - Multiple doses of LY3410738

Phase 1 dose expansion - The maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of LY3410738 alone or in combination with gemcitabine plus cisplatin or in combination with durvalumab

LY3410738

Hui Liu

This is an open-label, multicenter Phase 1 study to evaluate safety, tolerability and preliminary efficacy of oral LY3410738 in patients with isocitrate dehydrogenase 1 (IDH1) arginine 132 (R132)-mutant advanced solid tumors, including but not limited to cholangiocarcinoma, chondrosarcoma, and glioma or isocitrate dehydrogenase 2 (IDH2) arginine 140 (R140) or arginine 172 (R172) mutant cholangiocarcinoma.

This is an open-label, multicenter Phase 1 study to evaluate safety, tolerability and preliminary efficacy of oral LY3410738 in patients with IDH1 R132-mutant advanced solid tumors, including but not limited to cholangiocarcinoma, chondrosarcoma, and glioma or IDH2 R140 or R172 mutant cholangiocarcinoma.

This study includes 2 parts: Phase 1 dose escalation and Phase 1 dose expansion. The Phase 1 dose escalation monotherapy cohort will enroll any eligible patient with IDH1 R132-mutant advanced solid tumor or IDH1 or IDH2 mutant cholangiocarcinoma. The Phase 1 dose expansion will include 5 cohorts to further evaluate safety and clinical activity. Three cohorts will be administered LY3410738 monotherapy. The fourth cohort will administer LY3410738 at or below the monotherapy RP2D in combination with gemcitabine and cisplatin. The fifth cohort (US only) will administer LY3410738 at or below the monotherapy RP2D in combination with durvalumab.

IDH1 R132, IDH2 R140, or IDH2 R172 mutations will be identified through genomic testing utilizing material collected prior to patient consent. Molecular assays utilized for enrollment are required to be performed in CLIA, ISO/IEC, CAP, or other similarly certified laboratory. Enrollment of patients with cholangiocarcinoma, chondrosarcoma or glioma may be made based on molecular tests performed in either tumor or blood. Enrollment of patients with other tumor types is limited to testing performed in tumor tissue.

Study of LY3410738 Administered to Patients With Advanced Solid Tumors With IDH1 or IDH2 Mutations

A Phase 1 Study of LY3410738 Administered to Patients With Advanced Solid Tumors With IDH1 or IDH2 Mutations

Loxo Oncology, Inc.

Eli Lilly and Company

Respiratory Tract (Lung and Bronchial) Diseases

Nutritional and Metabolic Diseases

Carcinoma, Non-Small-Cell Lung

Thyroid Cancer, Papillary

Head and Neck Neoplasms

Lung Neoplasms

Lung Diseases

Endocrine Gland Neoplasms

Protein-Energy Malnutrition

Respiratory Tract Diseases

Thoracic Neoplasms

Respiratory Tract Neoplasms

Bronchial Neoplasms

Carcinoma, Bronchogenic

Endocrine System Diseases

Carcinoma, Neuroendocrine

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms, Nerve Tissue

Papillary Thyroid Carcinoma

Thyroid Cancer, Medullary

Neuroendocrine Tumor

Neuroepithelioma

Phase 1 - Multiple doses of LOXO-292 (selpercatinib) Phase 2 - The maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Facilitating Adaptive Coping With Fear of Recurrence Among Breast Cancer Survivors	NCT05364450	Breast Neoplasm Breast Cancer Breast Carcinom... Malignant Neopl... Cancer of Breas... Mammary Neoplas... Human Mammary C... Malignant Tumor... Mammary Cancer Mammary Carcino... Anxiety Fear	Enhanced Usual ... Acceptance Comm... Cognitive Behav...	18 Years - 99 Years	Indiana University
Study of LY3410738 Administered to Patients With Advanced Solid Tumors With IDH1 or IDH2 Mutations	NCT04521686	Cholangiocarcin... Chondrosarcoma Glioma Any Solid Tumor	LY3410738 Gemcitabine Cisplatin Durvalumab	18 Years -	Eli Lilly and Company
A Study of Selpercatinib (LOXO-292) in Participants With Advanced Solid Tumors, RET Fusion-Positive Solid Tumors, and Medullary Thyroid Cancer (LIBRETTO-001)	NCT03157128	Non-Small Cell ... Medullary Thyro... Colon Cancer Any Solid Tumor	LOXO-292	12 Years -	Eli Lilly and Company
Facilitating Adaptive Coping With Fear of Recurrence Among Breast Cancer Survivors	NCT05364450	Breast Neoplasm Breast Cancer Breast Carcinom... Malignant Neopl... Cancer of Breas... Mammary Neoplas... Human Mammary C... Malignant Tumor... Mammary Cancer Mammary Carcino... Anxiety Fear	Enhanced Usual ... Acceptance Comm... Cognitive Behav...	18 Years - 99 Years	Indiana University
Study of LY3410738 Administered to Patients With Advanced Solid Tumors With IDH1 or IDH2 Mutations	NCT04521686	Cholangiocarcin... Chondrosarcoma Glioma Any Solid Tumor	LY3410738 Gemcitabine Cisplatin Durvalumab	18 Years -	Eli Lilly and Company
A Study of Oral LOXO-292 (Selpercatinib) in Pediatric Participants With Advanced Solid or Primary Central Nervous System (CNS) Tumors	NCT03899792	Medullary Thyro... Infantile Myofi... Infantile Fibro... Papillary Thyro... Soft Tissue Sar...	LOXO-292	6 Months - 21 Years	Eli Lilly and Company
Facilitating Adaptive Coping With Fear of Recurrence Among Breast Cancer Survivors	NCT05364450	Breast Neoplasm Breast Cancer Breast Carcinom... Malignant Neopl... Cancer of Breas... Mammary Neoplas... Human Mammary C... Malignant Tumor... Mammary Cancer Mammary Carcino... Anxiety Fear	Enhanced Usual ... Acceptance Comm... Cognitive Behav...	18 Years - 99 Years	Indiana University
A Study of Oral LOXO-292 (Selpercatinib) in Pediatric Participants With Advanced Solid or Primary Central Nervous System (CNS) Tumors	NCT03899792	Medullary Thyro... Infantile Myofi... Infantile Fibro... Papillary Thyro... Soft Tissue Sar...	LOXO-292	6 Months - 21 Years	Eli Lilly and Company

Spots Global Cancer Trial Database for mammary carcinoma, human