No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Study type
Interventional
Purpose
Supportive Care
Participants needed
400 (estimated)
Sponsor
M.D. Anderson Cancer Center · Other
Who this trial is looking for
This trial is looking for patients with certain types of advanced cancer and their family caregivers. Participants will take part in programs aimed at improving emotional wellbeing and overall quality of life.
Are You a Good Fit for This Trial?
You may be able to join if
I have metastatic (stage IV) cancer
I have not had disease progression for at least 3 months
I have a performance status of 2 or lower
I have a family caregiver who wants to participate
I am 18 years old or older
I can read and speak English or Spanish
I can provide informed consent
I have a distress score of 4 or higher
You may not be able to join if
I have cognitive issues that would make it hard to fill out forms
I am under 18 years old
I am a pregnant patient
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
The goal of this behavioral research study is to learn about the effects of two different supportive care programs on patients' and their family caregivers' psychological wellbeing and overall quality of life.
Trial Locations
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Status
Eligibility Criteria
Inclusion Criteria:
* Be diagnosed with a metastatic (stage IV) breast, thoracic, gastrointestinal, gynecological, or genitourinary cancer
* Be without disease progression for at least 3 months based on surveillance CT imaging
* Have an ECOG performance status of ≤2
* Have a family caregiver willin…
Inclusion Criteria:
* Be diagnosed with a metastatic (stage IV) breast, thoracic, gastrointestinal, gynecological, or genitourinary cancer
* Be without disease progression for at least 3 months based on surveillance CT imaging
* Have an ECOG performance status of ≤2
* Have a family caregiver willing to participate
Both patient and caregiver must meet all the following criteria:
* Be ≥18 years old
* Be able to read and speak English or Spanish.
* Be able to provide informed consent
Additionally, either the patient and/or caregiver must:
• Have a NCCN Distress Thermometer score of ≥4
Exclusion Criteria:
A patient who meets the following criteria will be excluded from participation in this study:
• Have cognitive deficits that would impede the completion of self-report instruments as deemed by their attending oncologist
3.3 Vulnerable Populations This study is designed for individuals who are at least 18 years of age, and there is no upper age limit. Children under the age of 18 will not be included. First and foremost, it is unlikely that a minor is diagnosed with a metastatic solid tumor. It is also unlikely that a minor serves as the primary family caregiver of a patient with cancer. Additionally, the intervention is designed for adults, and the assessment tools are not validated for minors. While pregnant caregivers (self-identified) are study eligible, we will also exclude pregnant patients (medical notes).
3.4 Recruitment/Screening Process Eligible study participants (i.e. cancer patients) will be identified using the electronic clinic appointment systems on their tumor characteristics (i.e. cancer type and stage) and date of birth (i.e. minimum 18 years old). Potential patients and caregivers will be approached during patients' appointment at an outpatient oncology appointment, screened for eligibility, and consented. Since this is a family-based intervention, it is possible that caregivers will not be present during the patients' clinic visits. If so, patients will be asked for permission to contact the caregiver via phone to obtain consent.
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