Early Palliative Care With Standard Care or Standard Care Alone in Improving Quality of Life of Patients With Incurable Lung or Non-colorectal Gastrointestinal Cancer and Their Family Caregivers
Overview
Tab Title Description
Study type
InterventionalDescribes 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: 15-001099
NCT ID: NCT02349412
Sponsor Protocol Number: A221303
About this study
This randomized phase III trial studies how well early palliative care integrated with standard care works compared with standard care alone in improving the quality of life of patients and their family caregivers. Palliative care focuses on improving the quality of life for patients with advanced diseases and their family members by providing support for relief of physical symptoms, emotional and psychological support, and counseling. Patients who receive palliative care along with their regular care at an earlier time in their disease may experience fewer emotional and physical issues from their cancer. This may also improve the quality of life of family caregivers.
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.
Study Patient Participant Eligibility Requirements:
- Documentation of Disease: Confirmed advanced lung cancer (NSCLC, small cell lung cancer, or mesothelioma) or non-colorectal GI cancer (esophageal, gastric, hepatic, biliary, or pancreatic) not being treated with curative intent.
- Diagnosed with incurable disease within the previous 8 weeks.
- Age ≥ 18 years
- ECOG Performance Status 0-2
- Ability to read and respond to questions in English or able to complete questions with minimal assistance required from an interpreter or family member.
- Planning to receive all medical care for cancer at the enrolling institution.
- Participants must be under the care of an oncologist, but their current plan may or may not include chemotherapy or other forms of tumor-directed therapies.
Study Family Caregiver Participant Eligibility Requirements:
- Relative or friend who is identified by the patient participant who plans to regularly accompany the patient to the majority of their clinic visits.
- Family caregiver must live with the patient or have in-person contact with him or her at least twice per week.
- Ability to read and respond to questions in English or able to complete questions with minimal assistance required from an interpreter or family member.
- Age ≥ 18 years
Note: An eligible patient may participate in this trial without an eligible family caregiver being registered.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
Contact |
Rochester, Minn.
Mayo Clinic principal investigator Kathryn Ruddy, M.D. |
Closed for enrollment |
Contact information:
Cancer Center Clinical Trials Referral Office
855-776-0015
|
More information
Publications
Publications are currently not available