Brief Summary
The purpose of this study is to evaluate feasibility and acceptability of completing PROs among AYAs randomized to Choice PRO vs Fixed PRO.
Brief Title
Improving Adolescent and Young Adult Self-Reported Data in ECOG-ACRIN Trials
Detailed Description
Primary Aim: Conduct a pilot randomized controlled trial with AYAs to determine the feasibility and acceptability of completing PROs informed by AYAs' priorities. AYAs will be consented and randomized to select five HRQOL domains from a dashboard (Choice PRO) at each assessment period or to five standard HRQOL domains (Fixed PRO; physical function, pain, cognitive function, social support, finances) at each assessment period. AYAs will complete baseline, 1-, 3-, 6-, and 12-month assessments which will include a combination of CATs and static short forms. Feasibility will be operationalized as ≥ 75% completed PROs and ≥ 75% acceptability. Feasibility and acceptability will be compared between AYAs randomized to Choice PRO vs Fixed PRO. Adherence boosters (reminder calls, text messages) will be used to minimize missing data and evaluated as moderators.
Exploratory Aim: Solicit AYA preferences for how their PRO data should be shared with them and/or their providers. To inform future research, AYAs will be asked if and how participants want their PRO data to be used by their medical teams as well as if and how participants want their PRO data to be shared with them and their families.
The investigators anticipate PROMIS CATs will increase capacity for PRO data capture, AYAs randomized to Choice PRO, who are given the opportunity to choose which PRO domains to complete, will have less missing data. The investigators expect the majority of AYAs will want PRO feedback for themselves, their families, and their providers. Findings will promote and sustain the inclusion of PROs in clinical and supportive care trials, providing AYA's a voice and informing future patient-centered care tailored to the diverse needs of AYAs. By offering AYAs the opportunity to choose which PRO domains to complete based on relevance to their health-related quality of life, as opposed to completing domains pre-determined by the research team, the investigators raise the patient-centeredness of investigators assessment approach.
Exploratory Aim: Solicit AYA preferences for how their PRO data should be shared with them and/or their providers. To inform future research, AYAs will be asked if and how participants want their PRO data to be used by their medical teams as well as if and how participants want their PRO data to be shared with them and their families.
The investigators anticipate PROMIS CATs will increase capacity for PRO data capture, AYAs randomized to Choice PRO, who are given the opportunity to choose which PRO domains to complete, will have less missing data. The investigators expect the majority of AYAs will want PRO feedback for themselves, their families, and their providers. Findings will promote and sustain the inclusion of PROs in clinical and supportive care trials, providing AYA's a voice and informing future patient-centered care tailored to the diverse needs of AYAs. By offering AYAs the opportunity to choose which PRO domains to complete based on relevance to their health-related quality of life, as opposed to completing domains pre-determined by the research team, the investigators raise the patient-centeredness of investigators assessment approach.
Categories
Completion Date
Completion Date Type
Estimated
Conditions
Breast Cancer, NOS
CNS Primary Tumor, NOS
Cervical Cancer, NOS
Colorectal Cancer, NOS
Leukemia, NOS
Lymphoma, NOS
Miscellaneous Neoplasm, NOS
Non-Rhabdomyosarcoma Soft Tissue Sarcoma, NOS
Testicular Nonseminomatous Germ Cell Tumor, NOS
Thyroid Cancer, NOS
Melanoma
Bone Cancer, NOS
Eligibility Criteria
Inclusion Criteria:
Patient must be ≥ 18 years and ≤ 39 years of age at registration. Patient must have a histologically confirmed diagnosis of primary cancer of any stage within 12 weeks (84 days) at registration.
Patient must have received, be currently receiving or planning to receive treatment for cancer, including surgery and/or chemotherapy and/or radiation therapy.
Patient must have an ECOG performance status 0-3. Patient must have a life expectancy \>24 months. Patient must be able to complete questionnaires in English. Patient must have internet access through computer, tablet, or smartphone. Patient must have an email address. Patient must have a mobile phone able with text messaging capabilities. Patient must be able to accurately provide self-report data (e.g. per clinical judgment, cognitive function is intact).
Patient must be able to provide informed consent.
Exclusion Criteria:
Patient must not have a recurrence or second primary cancer. Patients must not have basal cell skin carcinoma.
Patient must be ≥ 18 years and ≤ 39 years of age at registration. Patient must have a histologically confirmed diagnosis of primary cancer of any stage within 12 weeks (84 days) at registration.
Patient must have received, be currently receiving or planning to receive treatment for cancer, including surgery and/or chemotherapy and/or radiation therapy.
Patient must have an ECOG performance status 0-3. Patient must have a life expectancy \>24 months. Patient must be able to complete questionnaires in English. Patient must have internet access through computer, tablet, or smartphone. Patient must have an email address. Patient must have a mobile phone able with text messaging capabilities. Patient must be able to accurately provide self-report data (e.g. per clinical judgment, cognitive function is intact).
Patient must be able to provide informed consent.
Exclusion Criteria:
Patient must not have a recurrence or second primary cancer. Patients must not have basal cell skin carcinoma.
Inclusion Criteria
Inclusion Criteria:
Patient must be ≥ 18 years and ≤ 39 years of age at registration. Patient must have a histologically confirmed diagnosis of primary cancer of any stage within 12 weeks (84 days) at registration.
Patient must have received, be currently receiving or planning to receive treatment for cancer, including surgery and/or chemotherapy and/or radiation therapy.
Patient must have an ECOG performance status 0-3. Patient must have a life expectancy \>24 months. Patient must be able to complete questionnaires in English. Patient must have internet access through computer, tablet, or smartphone. Patient must have an email address. Patient must have a mobile phone able with text messaging capabilities. Patient must be able to accurately provide self-report data (e.g. per clinical judgment, cognitive function is intact).
Patient must be able to provide informed consent.
Patient must be ≥ 18 years and ≤ 39 years of age at registration. Patient must have a histologically confirmed diagnosis of primary cancer of any stage within 12 weeks (84 days) at registration.
Patient must have received, be currently receiving or planning to receive treatment for cancer, including surgery and/or chemotherapy and/or radiation therapy.
Patient must have an ECOG performance status 0-3. Patient must have a life expectancy \>24 months. Patient must be able to complete questionnaires in English. Patient must have internet access through computer, tablet, or smartphone. Patient must have an email address. Patient must have a mobile phone able with text messaging capabilities. Patient must be able to accurately provide self-report data (e.g. per clinical judgment, cognitive function is intact).
Patient must be able to provide informed consent.
Gender
All
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Maximum Age
39 Years
Minimum Age
18 Years
NCT Id
NCT05108298
Org Class
Network
Org Full Name
Eastern Cooperative Oncology Group
Org Study Id
EAQ202
Overall Status
Recruiting
Phases
Not Applicable
Primary Completion Date
Primary Completion Date Type
Estimated
Official Title
Improving Adolescent and Young Adult Self-Reported Data in ECOG-ACRIN Trials
Primary Outcomes
Outcome Description
Evaluate feasibility and acceptability of completing PROs among AYAs randomized to Choice PRO vs Fixed PRO.
Outcome Measure
Evaluate completion of PROs among AYAs randomized to Choice PRO vs Fixed PRO.
Outcome Time Frame
Feasibility at 1 month and acceptability at baseline
Secondary Ids
Secondary Id
NCI-2021-07529
Secondary Id
EAQ202
Secondary Id
ECOG-ACRIN-EAQ202
Secondary Id
EAQ202
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Adult
Maximum Age Number (converted to Years and rounded down)
39
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Balazs Halmos
Investigator Email
bahalmos@montefiore.org
Investigator Department
Medicine
Investigator Division
Oncology
Investigator Sponsor Organization
External
Study Department
Oncology (Medical/Hematologic)
Study Division
Medical and Hematologic Oncology
Categories Mesh Debug
Brain, Spine & Nerve Cancers --- CENTRAL NERVOUS SYSTEM NEOPLASMS
Gastrointestinal (GI) Cancers --- COLORECTAL NEOPLASMS
Cancer --- LEUKEMIA
Blood & Bone Marrow Cancers --- LEUKEMIA
Cancer --- SARCOMA
Sarcomas --- SARCOMA
Endocrine System Cancers --- THYROID NEOPLASMS
Skin Cancer --- MELANOMA
Sarcomas --- OSTEOSARCOMA
Cancer --- NEOPLASMS BY SITE
Prostate Cancer --- NEOPLASMS BY SITE
Cancer --- NEOPLASMS
Endocrine System Cancers --- NEOPLASMS
Gastrointestinal (GI) Cancers --- NEOPLASMS
Gynecologic Cancers --- NEOPLASMS
Lung & Chest Cancers --- NEOPLASMS
Prostate Cancer --- NEOPLASMS
Brain, Spine & Nerve Cancers --- NERVOUS SYSTEM NEOPLASMS
Brain, Spinal Cord & Nervous System --- NERVOUS SYSTEM DISEASES
Brain, Spine & Nerve Cancers --- NERVOUS SYSTEM DISEASES
Prostate Cancer --- UROGENITAL NEOPLASMS
Gynecologic Cancers --- UTERINE CERVICAL DISEASES
Gynecologic Cancers --- UTERINE DISEASES
Gastrointestinal (GI) Cancers --- INTESTINAL NEOPLASMS
Gastrointestinal (GI) Cancers --- GASTROINTESTINAL NEOPLASMS
Gastrointestinal (GI) Cancers --- DIGESTIVE SYSTEM NEOPLASMS
Gastrointestinal (GI) Cancers --- DIGESTIVE SYSTEM DISEASES
Digestive System --- DIGESTIVE SYSTEM DISEASES
Liver --- DIGESTIVE SYSTEM DISEASES
Gastrointestinal (GI) Cancers --- GASTROINTESTINAL DISEASES
Digestive System --- GASTROINTESTINAL DISEASES
Gastrointestinal (GI) Cancers --- COLONIC DISEASES
Digestive System --- COLONIC DISEASES
Gastrointestinal (GI) Cancers --- INTESTINAL DISEASES
Digestive System --- INTESTINAL DISEASES
Blood & Bone Marrow Cancers --- NEOPLASMS BY HISTOLOGIC TYPE
Blood Disorders --- HEMATOLOGIC DISEASES
Blood & Bone Marrow Cancers --- HEMATOLOGIC DISEASES
Blood & Bone Marrow Cancers --- LYMPHOPROLIFERATIVE DISORDERS
Blood & Bone Marrow Cancers --- LYMPHATIC DISEASES
Blood & Bone Marrow Cancers --- IMMUNOPROLIFERATIVE DISORDERS
Infectious Disease --- IMMUNE SYSTEM DISEASES
Lung --- IMMUNE SYSTEM DISEASES
Gastrointestinal (GI) Cancers --- STOMACH DISEASES
Brain, Spine & Nerve Cancers --- NEOPLASMS, CONNECTIVE AND SOFT TISSUE
Endocrine System Cancers --- ENDOCRINE GLAND NEOPLASMS
Endocrine System Cancers --- HEAD AND NECK NEOPLASMS
Endocrine System Cancers --- ENDOCRINE SYSTEM DISEASES
Diabetes --- ENDOCRINE SYSTEM DISEASES
Diabetes & Endocrine System --- ENDOCRINE SYSTEM DISEASES
Endocrine System Cancers --- THYROID DISEASES
Skin Cancer --- NEUROECTODERMAL TUMORS
Skin Cancer --- SKIN NEOPLASMS
MeSH Terms
MAMMARY NEOPLASMS, ANIMAL
CENTRAL NERVOUS SYSTEM NEOPLASMS
UTERINE CERVICAL NEOPLASMS
COLORECTAL NEOPLASMS
LEUKEMIA
LYMPHOMA
PYLORIC STENOSIS, HYPERTROPHIC
SARCOMA
THYROID NEOPLASMS
MELANOMA
OSTEOSARCOMA
NEOPLASMS BY SITE
NEOPLASMS
ANIMAL DISEASES
NERVOUS SYSTEM NEOPLASMS
NERVOUS SYSTEM DISEASES
UTERINE NEOPLASMS
GENITAL NEOPLASMS, FEMALE
UROGENITAL NEOPLASMS
UTERINE CERVICAL DISEASES
UTERINE DISEASES
GENITAL DISEASES, FEMALE
FEMALE UROGENITAL DISEASES
FEMALE UROGENITAL DISEASES AND PREGNANCY COMPLICATIONS
UROGENITAL DISEASES
GENITAL DISEASES
INTESTINAL NEOPLASMS
GASTROINTESTINAL NEOPLASMS
DIGESTIVE SYSTEM NEOPLASMS
DIGESTIVE SYSTEM DISEASES
GASTROINTESTINAL DISEASES
COLONIC DISEASES
INTESTINAL DISEASES
RECTAL DISEASES
NEOPLASMS BY HISTOLOGIC TYPE
HEMATOLOGIC DISEASES
HEMIC AND LYMPHATIC DISEASES
LYMPHOPROLIFERATIVE DISORDERS
LYMPHATIC DISEASES
IMMUNOPROLIFERATIVE DISORDERS
IMMUNE SYSTEM DISEASES
PYLORIC STENOSIS
GASTRIC OUTLET OBSTRUCTION
STOMACH DISEASES
NEOPLASMS, CONNECTIVE AND SOFT TISSUE
ENDOCRINE GLAND NEOPLASMS
HEAD AND NECK NEOPLASMS
ENDOCRINE SYSTEM DISEASES
THYROID DISEASES
NEUROENDOCRINE TUMORS
NEUROECTODERMAL TUMORS
NEOPLASMS, GERM CELL AND EMBRYONAL
NEOPLASMS, NERVE TISSUE
NEVI AND MELANOMAS
SKIN NEOPLASMS
SKIN DISEASES
SKIN AND CONNECTIVE TISSUE DISEASES
NEOPLASMS, BONE TISSUE
NEOPLASMS, CONNECTIVE TISSUE
SURVEYS AND QUESTIONNAIRES
DATA COLLECTION
EPIDEMIOLOGIC METHODS
INVESTIGATIVE TECHNIQUES
HEALTH CARE EVALUATION MECHANISMS
QUALITY OF HEALTH CARE
HEALTH CARE QUALITY, ACCESS, AND EVALUATION
PUBLIC HEALTH
ENVIRONMENT AND PUBLIC HEALTH