Symptom Control Disease Site

Symptom Control

ID Sort	Study Title	Status Sort
SC31 (SC.31)	Using SMART to optimize the stepped care delivery of TEMPO – a Tailored, dyadic, wEb-based physical activity and self-Management PrOgram for men with prostate cancer and their caregivers (TEMPO) Complexity Level: 3 NCI US Affiliation: No Clinical Trials Application (Canada): No Coordination: Intergroup Led Trial Status: Planned Chair: (Canada) Dr. Sylvie Lambert, St. Mary's Hospital, (514) 761-6131	Planned
SC30 (TRU-RLS-21)	Role of Antibiotic Therapy or Immunoglobulin On iNfections in hAematoLogy Platform Trial - RATIONAL-PT Complexity Level: 3 NCI US Affiliation: No Clinical Trials Application (Canada): No Coordination: Intergroup Led Trial Status: Planned Chair: (Canada) Dr. Alfonso Rivera Duarte, Regional Health Authority B, Zone 2, (506) 648-7109	Planned
SC29	A Randomized Phase III Study Comparing Stereotactic Body Radiotherapy (SBRT) versus Conventional Palliative Radiotherapy (CRT) for Participants with Painful Non-Spine Bone Metastases To detemine if staeotactic body radiation therapy is better at reducing bone metastses pain compared to conventional radiation therapy. Complexity Level: 2 Eligibility: Histologic confirmation of cancer Patient with a dominant painful non-spine bone metastasis and a worst minimum pain score of 2 using the ESAS attributed to the dominant site. Suitable for protocol defined SBRT and EBRT Objectives: The primary objective is to compare conventional EBRT to SBRT for 3-month complete pain response (CPR) administered to the dominant site of pain using the pain score question from the ESAS instrument and analgesic intake as recommended by the ICPRE NCT Registration ID (from clinicaltrials.gov): NCT06391242 Participation: Open to member centres NCI US Affiliation: No Clinical Trials Application (Canada): No Coordination: CCTG Led Trial Status: Open to Accrual Activation Date: June 26, 2024 Chair: (Canada) Dr. Arjun Sahgal, Odette Cancer Centre, (416) 480-4834, (Canada) Dr. Timothy Nguyen, London Regional Cancer Program, (519) 685-8600	Open to Accrual
SC28	The SEAMLESS Study: A Pragmatic Multi-Site Randomized Waitlist-Controlled Trial of a Smartphone App-Based Mindfulness Intervention for French and English Speaker Cancer Survivors This study is being done to answer the following question: Can a mindfulness program (Mindfulness Based Cancer Survivorship (MBCS) Journey) delivered through a mobile smartphone application (app) (Am Mindfulness) reduce symptoms such as stress, anxiety, depression, and fatigue. These symptoms fall into the category of psychosocial symptoms and are often experienced by cancer survivors. Complexity Level: 3 Eligibility: • Adult ≥ 18 years • Diagnosed with any type of cancer (stages I-IV) • Completed primary treatment (i.e. surgery, chemotherapy, radiation therapy) at least 2 weeks (14days) prior. Note: ongoing maintenance therapy, hormone-blocking therapies, intermittent bone-modifying agents, herceptin and targeted therapy with trastuzumab are not exclusionary Objectives: • Evaluate the effectiveness of the 4-week MBCS Journey intervention in decreasing total symptoms of stress in adult PLWC at 3 months from randomization • • Determine the impact of the 4-week MBCS Journey intervention on anxiety, depression, fatigue, and overall physical functioning and quality of life in adult PLWC post-treatment, immediately after the therapeutic intervention NCT Registration ID (from clinicaltrials.gov): NCT05470010 Participation: Open to member centres NCI US Affiliation: No Clinical Trials Application (Canada): No Coordination: CCTG Led Trial Status: Open to Accrual Activation Date: August 29, 2023 Chair: (Canada) Dr. Linda Carlson, Tom Baker Cancer Centre - Cancer Control Alberta, (403) 355-3207	Open to Accrual
SC27	Living with Cancer in the Time of COVID-19: A Cohort Study of the Impact of the COVID-19 Pandemic on Cancer Patients During Treatment and Survivors Complexity Level: 3 Eligibility: >=18 years of age: any cancer diagnosis in the last 10 years, any stage; must be able to read/ write english or french Objectives: Primary objectives 1. Describe the pattern of psychosocial and physical symptom severity, and QOL over time and differences by sub-groups (e.g., age, gender, cancer stage) 2. Assess participants' perceptions of their experience and satisfaction of cancer care over time 3. Identify the coping strategies, and health and safety actions used by patients and survivors during cancer diagnosis, treatment, and recovery in the context of COVID-19 Secondary objectives 4. Examine factors associated with psychosocial and physical symptom severity, poor QOL and other clinical outcomes (e.g., COVID-19 status, hospitalization, and mortality). 4a. Explore effect modification by selected subgroups (e.g., age, sex, gender, cancer stage) NCT Registration ID (from clinicaltrials.gov): no NCT Participation: Limited to invited centres NCI US Affiliation: No Clinical Trials Application (Canada): No Coordination: CCTG Led Trial Status: Closed to Accrual Activation Date: June 30, 2020 Closing Date: August 16, 2022 Chair: (Canada) Dr. Linda Carlson, Tom Baker Cancer Centre - Cancer Control Alberta, (403) 355-3207	Closed to Accrual
SC26	Emotion and Symptom-focused Engagement (EASE): A Multi-Site Randomized Controlled Trial of an Intervention for Individuals with Acute Leukemia Leukemia is the 6th most common cause of cancer death in Canada, with adult acute leukemia (AL) being the most fatal form. Despite the rapid onset and life-threatening nature of AL and its treatment, little research on its psychological and physical effects and the interventions to reduce them have been done. Preliminary evidence has showed that an integrated psychosocial and early palliative intervention (e.g. EASE) reduces physical and psychological distress as compared to usual care (UC).This large, unblended phase 3 randomized controlled trial of EASE vs. UC will tests its effectiveness in reducing and preventing psychological and physical distress in adults with newly-diagnosed or relapsed AL. Complexity Level: 2 Eligibility: Patients with newly-diagnosed acute leukemia (AL) within 2 weeks of admission who will be receiving induction chemotherapy with curative intent. Patients must be fluent in English and must pass the cognitive screening test. Objectives: PRIMARY OBJECTIVE: To determine the effectiveness of EASE vs. usual care (UC) to reduce psychological distress and physical symptom severity in adults with newly diagnosed acute leukemia after 8 weeks of implementation. SECONDARY OBJECTIVE: (1) To determine the effectiveness of EASE vs. UC to reduce psychological distress and physical symptom severity after 4 and 12 weeks, 6 months, and 1 year; (2) to determine the effects of EASE vs UC on other domains of health-related quality of life; and (3) to conduct post-trial, an economic analysis of EASE to determine the cost-effectiveness of EASE delivery in relation to its effect on reduction of distress in individuals with AL compared to UC. NCT Registration ID (from clinicaltrials.gov): NCT04224974 Participation: Limited to invited centres NCI US Affiliation: No Clinical Trials Application (Canada): No Coordination: CCTG Led Trial Status: Open to Accrual Activation Date: December 23, 2019 Chair: (Canada) Dr. Gary Rodin, University Health Network, (416) 946-4504, (Canada) Dr. Camilla Zimmermann, University Health Network, (416) 946-2135	Open to Accrual
ICC1 (NCICOVID)	NCI COVID-19 in Cancer Patients Study (N-CCaPS): A Longitudinal Natural History Study Complexity Level: 3 Eligibility: Patients must have a prior or current cancer diagnosis, that fits into one of the following categories: - Patient is receiving active treatment (current or within the last 6 weeks) for metastatic cancer - Patient is receiving adjuvant treatment + had IV chemotherapy, immuno or targeted therapy, endocrine therapy, or RT in the last 6 weeks - Patient received ASCT, CAR-T or modified cell therapy at any time - Patient is receiving treatment or prophylaxis or host disease, or received bone marrow transplant within the past 2 years. Patients must have had a positive COVID-19 test within the last 14 days using any specimen source. Patients with brain mets or HIV are eligible. Co-enrollment on other clinical trials is allowed. Objectives: 1. Characterize patient factors, such as pre-existing comorbidities, cancer type and treatment, and demographic factors, associated with short- and long-term outcomes of COVID-19, including severity and fatality, in cancer patients undergoing treatment. 2. Describe cancer treatment modifications made in response to COVID-19, including dose adjustments, changes in symptom management, or temporary or permanent cessation. 3. Evaluate the association of COVID-19 with cancer outcomes in patient subgroups defined by clinico-pathologic characteristics. 4. Correlative study objectives by collection, storage, and research of blood specimens and radiological images. NCT Registration ID (from clinicaltrials.gov): NCT04387656 Participation: Open to member centres NCI US Affiliation: Yes Clinical Trials Application (Canada): No Coordination: Intergroup Led Trial Status: Closed to Accrual Activation Date: June 18, 2020 Closing Date: February 01, 2022 Chair: (Canada) Dr. Nathalie Daaboul, Hopital Charles LeMoyne, (450) 466-5000	Closed to Accrual
IC8	COV-IMMUNO - A Randomized, Phase III Trial of Immunization with IMM-101 versus Observation for the Prevention of Severe Respiratory and COVID-19 Related Infections in Cancer Patients at Increased Risk of Exposure Complexity Level: 2 Eligibility: Patients must be: -undergoing (or be planned to undergo) active treatment for one or more solid malignancy, lymphoma or myeloma, requiring them to present to the hospital or cancer clinic at least twice/month for assessments and/or treatments, anticipated for at least 3 months. - have one or more of the following risk factors for a severe COVID-19 infection: Age > 65 years old; Hypertension (on medications); Type 1 or 2 Diabetes (on medication); A relevant chronic condition as per the investigator based on the medical record including heart, lung, liver and/or serious kidney disease; receiving systemic therapy; Body Mass Index > 40; Living in a nursing home or long term care facility. - Age 18 or greater and an ECOG PS of 0-2 Objectives: Primary objective: to investigate the effectiveness of IMM 101 at preventing "influenza-like illnesses" (ILI), as defined by the WHO, OR a confirmed viral/bacterial respiratory infection (via microbiology or radiography), AND that results in a change or delay in a priori planned cancer treatment or requirement for an unscheduled medical assessment (i.e. emergency room visit, family physician assessment, etc.), hospitalization, or death compared to control subjects. Numerous Secondary and Tertiary/Exploratory Objectives planned. NCT Registration ID (from clinicaltrials.gov): NCT04442048 Participation: Limited to invited centres NCI US Affiliation: No Clinical Trials Application (Canada): Yes Coordination: CCTG Led Trial Status: Closed to Accrual Activation Date: June 25, 2020 Closing Date: May 14, 2021 Chair: (Canada) Dr. Rebecca Ann Auer, Ottawa Hospital Research Institute, (613) 737-7700 Ext. 72791	Closed to Accrual

CANADIAN CANCER TRIALS GROUP

Sinclair Cancer Research Institute
Queen's University

10 Stuart Street
Kingston, Ontario
Canada K7L 3N6

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Cancer Research Institute