Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

* Stride is delivered as a Five weekly one-hour virtual (videophone) or in-person sessions in small groups with a trained clinician
* Two 15-minute check-in phone calls later in the study
* Participants will store hormonal therapy medication in a bottle provided by the study team.
* Participants will complete questionnaires at enrollment and 3-months post- enrollment

* Stride is delivered as six weekly one-hour virtual (videophone) sessions in small groups with a trained clinician (or individually, in the rare instance in which scheduling doesn't allow for groups and the participant is approaching the 12-week assessment window)
* Two 15-minute check-in phone calls later in the study
* Participants will store hormonal therapy medication in a bottle provided by the study team.
* Participants will complete questionnaires at enrollment, 12-weeks, and 24-weeks post-enrollment

* Medication monitoring plus standard care
* Participants will store hormonal therapy medication in a bottle provided by the study team.
* Participants will complete questionnaires at enrollment, 12-weeks and 24-weeks post-enrollment

STRIDE is a brief, group-based, virtual (videoconference) cognitive-behavioral intervention. The intervention incorporates adherence problem-solving, cognitive restructuring, relaxation training, symptom management, coping skills training, and mindfulness techniques.

STRIDE

Care provided as standard by the hospital and medication monitoring

Medication Monitoring Control

Jamie M. Jacobs, MD

The purpose of this study is to explore the feasibility and acceptability of a brief, virtual, group-based cognitive-behavioral intervention for breast cancer survivors taking hormonal therapy. The intervention (STRIDE) aims to alleviate symptoms related to hormonal therapy or breast cancer, optimize medication-taking (i.e., adherence), and reduce distress.

Background: The majority of breast cancer is hormone sensitive and treated with 10 years of adjuvant endocrine therapy (AET) (i.e., tamoxifen, aromatase inhibitors) to reduce risk of recurrence and improve survival; however, adherence to AET among breast cancer survivors (BCS) is a challenge, with half of women becoming non-adherent within five years. Difficulty coping with symptoms (e.g., sleep problems, hot flashes, weight gain, fatigue) and psychosocial distress (i.e., depression or anxiety symptoms), and other emotional and logistical factors are major barriers to adherence. There is a dearth of efficacious interventions targeting the needs and adherence challenges of BCS prescribed AET.

Objective: To address this gap, the proposed study, funded by the National Cancer Institute, employs a mixed-methods design to develop and test an evidence-based intervention (STRIDE) to enhance adherence to AET, improve symptom management, and reduce distress in breast cancer survivors.

Specific Aims: The primary aims of this study are: 1) to examine the feasibility and acceptability of a tailored, small-group, virtual intervention (STRIDE) compared to a medication monitoring control for survivors of breast cancer taking AET, and 2) to explore the effects of the STRIDE intervention on adherence to AET, symptom distress, and satisfaction with AET.

Study Design: Phase 1 included (1) semi-structured interviews with BCS on AET (n=30) and intervention development with psychologists and oncology clinicians. The intervention is a a brief, virtual, small-group, cognitive-behavioral intervention that aims to alleviate symptoms and side effects related to hormonal therapy or breast cancer, optimize medication-taking, and reduce emotional distress for breast cancer survivors taking hormonal therapy. Phase 2 will entail a run-in phase (n=5) to evaluate acceptability and further refine the intervention, followed by a randomized controlled pilot trial (n=100) to assess the feasibility of comparing the STRIDE intervention to a medication monitoring control with assessments and adherence monitoring over the course of six months. Participants will be recruited at Massachusetts General Hospital Cancer Center and three community satellite sites. Eligible participants will be hormone-receptor positive breast cancer survivors prescribed AET who are experiencing distress related to AET (e.g., adherence difficulties, side effects, etc.). This research study involves completing 3 questionnaire batteries at the time of enrollment, 12 weeks, and 24 weeks. The participant will also be asked to store their hormonal therapy pills in a medication bottle provided by the study team throughout the 24 week study period. If the participants are randomized to receive the STRIDE intervention, the participant will have six weekly one-hour virtual (videoconferencing) sessions in small groups with a trained clinician followed by two 15-minute check-in phone calls later in the study.

The outcomes assessor will be blinded to the participant's study condition

Small-group, Virtual Program for Improving Symptoms and Distress Related to Hormonal Therapy for Breast Cancer Survivors

Symptom-Targeted Randomized Intervention for Distress and Adherence to Adjuvant Endocrine Therapy (STRIDE) Among Breast Cancer Survivors: A Pilot Feasibility Trial

The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research

The investigators will evaluate program feasibility by examining rates of recruitment (enrollment rate \> 50%), retention (follow-up assessment completion rate \> 70% of all participants who complete baseline) and attendance of program sessions (attendance rate of at least 70% of participants completing at least 4 of 6 sessions \[67%\]).

The investigators will evaluate program acceptability by examining satisfaction scores on the Client Satisfaction Questionnaire (CSQ). The program will be deemed acceptable if \>75% of participants report average satisfaction scores greater than the CSQ's mid-point. The CSQ is scored on a four-point Likert scale with higher scores indicating higher satisfaction.

Medication Event Monitoring System (MEMS Caps): Participants will store medication in the MEMS bottles to electronically monitor adjuvant endocrine therapy daily dose and timing of dose administration. Prescribed medication, dose, and timing will be identified in the Electronic Health Record and verified by the patient. Adherence will be calculated as the percentage of medication taken of the total prescribed. A mean medication adherence rate will be calculated in each group to examine differences in adherence rates and changes across the 24-week study period between groups.

Medication Adherence Report Scale (MARS-5): Changes in self-reported adherence to adjuvant endocrine therapy between groups will be explored using the MARS-5 at 3-months post-baseline. The MARS-5 assesses adherence to treatment and has been used specifically in the context of AET adherence. The scale consists of five items that ask about suboptimal adherence behaviors, such as "I stop taking my adjuvant endocrine therapy medicine for a while." Each item is answered on a scale of 1 (Always) to 5 (Never). Scores range from 5 to 25 points with scores less than 25 defined as low adherence to the medication.

Cancer Therapy Satisfaction Questionnaire (CTSQ): Changes in self-reported satisfaction with AET will be explored between groups at 12 weeks post-baseline with the Cancer Therapy Satisfaction Questionnaire (CTSQ). The CTSQ is a previously published 21-item measure that evaluates patients' beliefs about the following aspects of medical care: expectations of the effectiveness of cancer therapy, feelings about side effects, oral cancer therapy adherence, satisfaction with cancer therapy, stopping cancer therapy, and reasons for non-adherence. We used the satisfaction with cancer therapy subscale. Each item is scored on a scale of 1 ("Never" or "Very inconvenient") to 5 ("Always" or Very Convenient"). A greater score on this measure indicates greater patient cancer therapy satisfaction. Scores can range from a minimum of 0 to a maximum of 100.

Breast Cancer Prevention Trial Symptom Scale (BCPT): The investigators will examine changes in self-reported symptom distress on the BCPT between groups at 12 weeks post-baseline. The BCPT is a symptom checklist used to document physical and psychological symptoms associated with ET use. The measure includes several clinically-relevant symptom subscales and has been used broadly in previous studies on symptom distress in breast cancer patients. The BCPT asks participants to rate how much they have been bothered by several symptoms over the past week on a scale of 0 (Not at all bothered) to 4 (Extremely bothered). There are 8 subscales: hot flashes, nausea, bladder control, vaginal problems, musculoskeletal pain, cognitive problems, weight problems, and arm problems. For this study, we summed the 8 subscale scores for a total score ranging from 0-72, with higher scores representing greater symptom distress.

National Cancer Institute (NCI)

Massachusetts General Hospital

Principal Investigator

* Stride is delivered as six weekly one-hour virtual (videophone) sessions in small groups with a trained clinician (or individually, in the rare instance in which scheduling doesn't allow for groups and the participant is approaching the 12-week assessment window)
* Two 15-minute check-in phone calls later in the study
* Participants will store hormonal therapy medication in a bottle provided by the study team.
* Participants will complete questionnaires at enrollment, 12-weeks, and 24-weeks post-enrollment

STRIDE: STRIDE is a brief, group-based, virtual (videoconference) cognitive-behavioral intervention. The intervention incorporates adherence problem-solving, cognitive restructuring, relaxation training, symptom management, coping skills training, and mindfulness techniques.

* Medication monitoring plus standard care
* Participants will store hormonal therapy medication in a bottle provided by the study team.
* Participants will complete questionnaires at enrollment, 12-weeks and 24-weeks post-enrollment

Medication Monitoring Control: Care provided as standard by the hospital and medication monitoring

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

American Indian or Alaskan Native

Asian

African American or Black

Native Hawaiian or other Pacific Islander

White

Other

Not Reported

Race/Ethnicity, Customized

United States

Region of Enrollment

Aromatase Inhibitor

Tamoxifen

Type of Adjuvant Endocrine Therapy

Stage 0

Stage I

Stage II

Stage III

Breast Cancer Stage per the AJCC Cancer Staging Manual and as determined by the treating oncologist. As the stage of breast cancer increases from zero to three, the degree of severity increases, and the patient's prognosis worsens. Stage four breast cancer indicates that breast cancer has traveled outside of the breast and regional lymph nodes to a distant organ and is considered advanced breast cancer. Patients with stage four, advanced breast cancer were not eligible for this study.

Breast Cancer Stage

Receiving Ovarian Suppression

Not Receiving Ovarian Suppression

Ovarian suppression is the medical suppression of ovarian function often utilized in pre-menopausal patients with estrogen-receptor-positive breast cancer in combination with other anti-cancer therapies to lower estrogen levels. In this study, study staff determined if patients underwent ovarian suppression via chart review of the electronic medical record.

Ovarian Suppression

Study recruitment paused due to the COVID-19 pandemic from mid-March 2020 through May of 2020.

Jamie Jacobs, PhD

Feasibility - Retention at Week 12

Feasibility - Session Attendance

Acceptability

The analysis populations are as follows.

Feasibility:

Enrollment - 141 eligible participants were approached and 100 participants enrolled (70.9%).

For the remainder of the feasibility analyses, the analysis population will utilize a denominator of 100 participants enrolled to the STRIDE study.

For the acceptability analysis, the analysis population will utilize a denominator of the 43 participants who completed at least four out of the six STRIDE sessions.

Feasibility and Acceptability

Analysis comparing the change in monthly adherence to adjuvant endocrine therapy across the study period adjusting for distress and receipt of ovarian suppression.

Analysis comparing the change in weekly adherence rates to adjuvant endocrine therapy across the study period adjusting for distress and receipt of ovarian suppression.

Analysis Population includes the participants in both arms using the MEMs caps throughout the study period.

Group Differences in Mean Medication Adherence Rates to Adjuvant Endocrine Therapy Across the 24-week Study Period

Analysis comparing the change in self-reported endocrine therapy adherence between groups on the MARS-5 scale from baseline to 12-weeks post-baseline adjusting for distress, receipt of ovarian suppression, and baseline values of criterion outcome.

Analysis Population includes the participants in both arms that completed the MARS-5 measure at 12 weeks

Changes in Self-Reported Adjuvant Endocrine Therapy Adherence Between Groups on the Medication Adherence Report Scale (MARS-5) From Baseline to 12-weeks Post-baseline

Analysis comparing the change in satisfaction with adjuvant endocrine therapy between groups on the CTSQ from baseline to 12 weeks post-baseline adjusting for distress, receipt of ovarian suppression, and baseline values of criterion outcome.

The analysis population includes the 92 participants in the STRIDE study who completed the CTSQ at 12 weeks.

Changes in Satisfaction With Adjuvant Endocrine Therapy (AET) Between Groups on the Cancer Therapy Satisfaction Questionnaire (CTSQ) From Baseline to 12-weeks Post-baseline.

Analysis comparing the change in symptom distress between groups on the BCPT scale from baseline to 12-weeks post-baseline adjusting for distress, receipt of ovarian suppression, and baseline values of criterion outcome.

The analysis population includes the 92 participants in the STRIDE study who completed the BCPT at 12 weeks.

Changes in Symptom Distress Between Groups on the Breast Cancer Prevention Trial Symptom Scale (BCPT) From Baseline to 12-weeks Post-baseline

Overall Study

Digestive System Diseases

Carcinoma

Carcinoma, Hepatocellular

Liver Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Liver Diseases

All Drugs and Chemicals

Antineoplastic Agents

Hematinics

Antibodies

Durvalumab

Immunoglobulins

Immunoglobulin G

Liver Extracts

Immunoglobulins, Intravenous

Tremelimumab

Antineoplastic Agents, Immunological

Participants will receive a single priming dose of Tremelimumab plus Durvalumab at Day 1 (Week 0), followed by Durvalumab monotherapy starting at Week 4 and continuing until clinical progression, confirmed RECIST 1.1-defined radiological progression, unacceptable toxicity, withdrawal of consent, or any intervention discontinuation criteria.

Participants will receive 1500 mg at Day 1 and later receive as monotherapy starting at Week 4 for every 4 weeks through IV infusion

Participants will receive single dose of 300 mg through IV infusion at Day 1

AstraZeneca Clinical Study Information Center

Stephen Chan, MD

Lorenza Rimassa, MD

This study will assess the safety and efficacy of Single Tremelimumab Regular Interval Durvalumab (STRIDE) as first-line therapy in participants with advanced unresectable HCC.

This is a Phase IIIb, open-label, single arm, multicentre study to assess the safety and efficacy of STRIDE as first-line therapy in participants with advanced unresectable HCC who have one of the following:

1. Child-Pugh score B7 or B8 with a World Health Organisation Eastern Cooperative Oncology Group Performance Status (WHO/ECOG PS) of 0-1 at enrolment, or
2. Child-Pugh class A with a WHO/ECOG PS of 2 at enrolment, or
3. Child-Pugh class A with a WHO/ECOG PS of 0-1 and with evidence of chronic main trunk portal vein thrombosis at enrolment

Participants must not have received any prior systemic therapy for HCC. Participants may have previously received locoregional therapy (LRT) but must no longer be suitable for additional LRT. Any local treatment needs to have been completed at least 4 weeks prior to initiation of treatment. The study consists of 4 periods: screening (Day-28 to Day -1), Treatment period, safety follow-up and survival follow-up.

Phase IIIb Non-randomised and non-blinded single arm study

Durvalumab and Tremelimumab as First Line Treatment in Participants With Advanced Hepatocellular Carcinoma (HCC)

A Phase IIIb Single Arm, Open-label, Multicentre Study of Durvalumab and Tremelimumab as First Line Treatment in Participants With Advanced Hepatocellular Carcinoma (SIERRA)

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All requests will be evaluated as per the AZ disclosure commitment:

https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

PRAE is defined as an AE which has been assessed by the investigator to be possibly related to IMP.

ORR is defined as the number (%) of participants with a confirmed objective tumour response (complete response \[CR\] or partial response \[PR\]) as determined by the investigator per Response Evaluation Criteria in Solid Tumours, Version 1.1 (RECIST 1.1).

To assess the safety and tolerability of STRIDE in participants with advanced unresectable HCC

OS is defined as the time from the date of the first dose of IMP until death due to any cause.

PFS is defined as the time from the first dose of IMP until the date of objective PD (per RECIST 1.1 as assessed by the investigator) or death (by any cause in the absence of progression)

DCR-16w is defined as the percentage of participants who have a best objective response of complete response or partial response (by Week 16 + 7 days) or who have stable disease for at least 16 weeks (-7 days), following the start of study intervention as determined by the investigator per RECIST 1.1

DCR-24w is defined as the percentage of participants who have a best objective response of complete response or partial response (by Week 24 + 7 days) or who have stable disease for at least 24 weeks (-7 days), following the start of study intervention per RECIST 1.1

DOR is defined as the time from the date of first documented response until the date of documented progression per RECIST 1.1, as assessed by the investigator or death in the absence of disease progression.

DOT is defined as time on study intervention.

Time to deterioration is defined as time from date of first dose of study intervention to the date of the first clinically meaningful deterioration (defined as a a decrease from baseline of at least 10 points for EORTC QLQ-C30 global HRQoL and functional scales, and an increase from baseline of at least 10 points for the EORTC QLQ-C30 symptom scales) that is confirmed at a subsequent visit or death (by any cause) in the absence of a clinically meaningful deterioration. The domains/scales of the EORTC QLQ-C30 prioritized include global health status/QoL, functioning (physical), multi-term symptom (fatigue) and single item symptoms (appetite loss and nausea). Final scores range from 0 to 100, where higher scores on the global measure of health status and functional scales indicate better health status/function, but higher scores on symptom scales represent greater symptom severity.

Clinically meaningful change from baseline in global health status/QoL, symptoms and function score (categorized as improvement, no change or deterioration) is defined as an absolute change in the score from baseline of ≥ 10 for scales from the EORTC QLQ-C30 to assess disease and treatment related symptoms and HRQoL.The domains/scales of the EORTC QLQ-C30 prioritized include global health status/QoL, functioning (physical), multi-term symptom (fatigue) and single item symptoms (appetite loss and nausea). Final scores range from 0 to 100, where higher scores on the global measure of health status and functional scales indicate better health status/function, but higher scores on symptom scales represent greater symptom severity.

Best overall response for global health status/QoL, function and symptom (fatigue) will be derived as the best response the participant achieved, based on evaluable electronic patient-reported outcome (ePRO) data collected during the study period to assess disease and treatment related symptoms and HRQoL. The domains/scales of the EORTC QLQ-C30 prioritized include global health status/QoL, functioning(physical), multi-term symptom (fatigue) and single item symptoms (appetite loss and nausea). Final scores range from 0 to 100, where higher scores on the global measure of health status and functional scales indicate better health status/function, but higher scores on symptom scales represent greater symptom severity.

Change from baseline of global health status/QoL, symptom and functioning scores to assess disease and treatment related symptoms and HRQoL. The domains/scales of the EORTC QLQ-C30 prioritized include global health status/QoL, functioning(physical), multi-term symptom (fatigue) and single item symptoms(appetite loss and nausea). Final scores range from 0 to 100, where higher scores on the global measure of health status and functional scales indicate better health status/function, but higher scores on symptom scales represent greater symptom severity.

Time to deterioration is defined as time from date of first dose of study intervention to the date of the first clinically meaningful deterioration (defined as an increase from baseline of at least 10 points for EORTC QLQ-HCC18) that is confirmed at a subsequent visit or death (by any cause) in the absence of a clinically meaningful deterioration. The QLQ-HCC18 is an HCC-specific module from the EORTC comprising 18 questions to assess HCC symptoms. The module includes 6 multi-item domain scales and 2 single-item scales. Final scores range from 0 to 100 where higher scores indicate a greater level of symptom severity and a poorer HRQoL. The items prioritized are single items shoulder pain, abdominal pain and abdominal swelling.

Clinically meaningful change from baseline (categorized as improvement, no change or deterioration) is defined as an absolute change in the score from baseline of ≥ 10 for scales/items from QLQ-HCC18 to assess disease-related symptoms. The single items prioritized are shoulder pain, abdominal pain and abdominal swelling. The EORTC QLQ-HCC18 module is an 18-item questionnaire. All questions have a 4-point scale: "Not at all," "A little," "Quite a bit," and "Very much." For each of the 8 domains (6 multiple-item scales and 2 single-item scales), final scores are transformed such that they range from 0 to 100, where higher scores indicate greater level of symptoms and worse symptom or a poorer HRQoL.

Best overall response in single-item symptoms (shoulder pain, abdominal pain, abdominal swelling) will be derived as the best response the participant achieved, based on evaluable ePRO data collected during the study period to assess disease-related symptoms. The single items prioritized are shoulder pain, abdominal pain and abdominal swelling. The EORTC QLQ-HCC18 module is an 18-item questionnaire. All questions have a 4-point scale: "Not at all," "A little," "Quite a bit," and "Very much." For each of the 8 domains (6 multiple-item scales and 2 single-item scales), final scores are transformed such that they range from 0 to 100, where higher scores indicate greater level of symptoms and worse symptom or a poorer HRQoL.

Change from baseline assessment in EORTC QLQ-HCC18 scale/item score at each post baseline assessment. The prioritized single items scores are shoulder pain, abdominal pain and abdominal swelling. The EORTC QLQ-HCC18 module is an 18-item questionnaire. All questions have a 4-point scale: "Not at all," "A little," "Quite a bit," and "Very much." For each of the 8 domains (6 multiple-item scales and 2 single-item scales), final scores are transformed such that they range from 0 to 100, where higher scores indicate greater level of symptoms and worse symptom or a poorer HRQoL.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Small-group, Virtual Program for Improving Symptoms and Distress Related to Hormonal Therapy for Breast Cancer Survivors	NCT03837496	Breast Cancer Adherence, Medi...	STRIDE Medication Moni...	21 Months -	Massachusetts General Hospital
Durvalumab and Tremelimumab as First Line Treatment in Participants With Advanced Hepatocellular Carcinoma (HCC)	NCT05883644	Advanced Hepato...	Durvalumab Tremelimumab	18 Years - 130 Years	AstraZeneca
Durvalumab and Tremelimumab as First Line Treatment in Participants With Advanced Hepatocellular Carcinoma (HCC)	NCT05883644	Advanced Hepato...	Durvalumab Tremelimumab	18 Years - 130 Years	AstraZeneca

Spots Global Cancer Trial Database for stride

Every month we try and update this database with for stride cancer trials from around the world to help patients and their families find trials that might be right for them.
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Spots Global Cancer Trial Database for stride

Every month we try and update this database with for stride 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 stride 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.