The In4M Study: Integrating 4 Measures to Assess Physical Function in Cancer Patients
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 21-010404
NCT ID: NCT05214144
Sponsor Protocol Number: 2000031319
About this study
The purpose of this study is to evaluate the measurement characteristics of these different sources of physical function data in a cancer population undergoing cytotoxic chemotherapy.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Age 18 and over;
- English- or Spanish speaking;
- Eligible cancer type and planned intravenous multi-agent chemotherapy regimen:
- Breast cancer patients:
- Patients with stage 1-3 breast cancer diagnosed within previous 9 months;;
- Planned to receive multi-agent intravenous adjuvant and/or neoadjuvant chemotherapy during their treatment course;
- Patients should be enrolled prior to receipt of cytotoxic chemotherapy for breast cancer.
- Patients with concurrent/prior/future immunotherapy/radiotherapy, targeted therapy and endocrine therapy for breast cancer can be included.
- Eligible regimens include:
- Taxotere-Cytoxan (TC);
- Adriamycin-Cytoxan followed by Taxol +/- carboplatin (AC-T +/- carbo);
- Taxol +/- carbo followed by Adriamycin-Cytoxan (T +/- carbo-AC);
- Taxotere-Carboplatin-Herceptin (TCH);
- Taxotere-Carboplatin-Herceptin-Perjeta (TCH-P);
- AC-T-Herceptin (AC-TH);
- AC-T-Herceptin-Perjeta (AC-THP);
- Other.
- Similar multi-agent frontline chemotherapy depending on the state of the field and with approval from the study PI or co-investigators. Ado-trastuzumab (TDM1), capecitabine and immunotherapy are allowed in addition to or following a multi-agent regimen.
- ymphoma patients a) Newly diagnosed high grade/aggressive lymphoma patients of any stage, including:
- High grade/aggressive B cell lymphoma per the 2016 revision of the World Health Organization (WHO) classification of lymphoid neoplasms (including composite, discordant or transformed disease, if applicable);
- High grade/aggressive T cell lymphoma per the 2016 revision of the WHO classification of lymphoid neoplasms (including composite, discordant or transformed disease, if applicable);
- Hodgkin lymphoma (including composite, discordant or transformed disease, if applicable);
- Planned to receive multi-agent chemotherapeutic regimens for a fixed period (4-6 months) on an outpatient basis;
- Patients should be enrolled prior to receipt of cytotoxic chemotherapy for lymphoma;
- Patients with pre-existing low-grade lymphoma who transform to higher grade histology are eligible if the transformation is newly diagnosed and the patient has not previously received cytotoxic chemotherapy.
- Eligible regimens include:
- Cyclophosphamide, doxorubicin, vincristine and prednisone (CHOP);
- Rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone (R-CHOP);
- Brentuximab vedotin, cyclophosphamide, doxorubicin, prednisone (BV-CHP);
- Rituximab, etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin (Outpatient R-EPOCH);
- Doxorubicin, bleomycin, vinblastine, dacarbazine (ABVD);
- Brentuximab vedotin, doxorubicin, vinblastine, dacarbazine (BV+AVD);
- Cyclophosphamide, doxorubicin, vincristine, etoposide, prednisone (CHOEP);
- Cyclophosphamide, etoposide, vincristine, prednisone (CEOP);
- Rituximab with cytarabine alternating with rituximab with maxi-CHOP (Nordic regimen);
- Other similar multi-agent frontline chemotherapy depending on the state of the field and with approval from the study PI or co-investigators. Patient planned to receive radiation, maintenance chemotherapy or consolidation stem cell transplant may also be included.
- If patients are receiving the above standard therapies as part of a frontline clinical trial which may include a novel agent or combination, they are also eligible for the present study if the therapeutic protocol permits enrollment in both studies.
- Receiving chemotherapy on a primarily outpatient basis.
- Willing and able to give consent and participate in study.
- Able to access a mobile device (smartphone or tablet) or computer with web access every day to complete study surveys; able to connect Fitbit to a device that can regularly link to Hugo for data transfer.
- Willing and able to perform an in-clinic 6-minute walk test (gait aides are permitted if regularly used by the patient).
- Willing to use the health data sharing platform. Potential subjects who do not meet all of the enrollment criteria will not be enrolled. Any deviations from these criteria must be reported in accordance with Institutional Review Board (IRB) Policies and Procedures.
Exclusion Criteria:
- Lack of access to a mobile device (smartphone or tablet) or computer with web access.
- Unable or unwilling to connect Fitbit to device.
- Unable or unwilling to use the health data sharing platform.
- Unable to give consent and be enrolled in person.
- Prior receipt of cytotoxic chemotherapy within 12 months of study start date.
Note: Other protocol defined Inclusion/Exclusion Criteria may apply.
Eligibility last updated 8/16/22. Questions regarding updates should be directed to the study team contact
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
More information
Publications
Publications are currently not available