Have you or your loved ones been diagnosed with metastatic solid tumor cancers?

You may be eligible to participate in a metastatic solid tumor cancers clinical trial.

Have you or your loved ones been diagnosed with metastatic solid tumor cancers? You may be eligible to participate in a metastatic solid tumor cancers clinical trial.

What is a clinical trial? Is participating in a clinical trial right for you? Learn more

Metastatic Solid Tumor Cancers Clinical Trial in New York NY

NCT03667378 | Observational

Have you or your loved ones been diagnosed with metastatic solid tumor cancers?

You may be eligible to participate in a metastatic solid tumor cancers clinical trial.

Have you or your loved ones been diagnosed with metastatic solid tumor cancers? You may be eligible to participate in a metastatic solid tumor cancers clinical trial.

Active not recruiting

Male & Female

18 Years +

This study has recruited 83 Participants

This study will test whether adding personalized supportive care to medical treatment on a clinical trial affects the study participants' ability and desire to discuss their symptoms, their concerns about the future, and their approach to coping with cancer. The effects of supportive care on participants' responses to questions about these topics will be compared with those of other study participants who are being treated for cancer in a clinical trial, but are not receiving personalized supportive care.

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Details for the study

Population

The study population will be patients with metastatic or locally advanced solid tumor cancers who progress beyond standard treatment and are deemed eligible to receive treatment with investigational targeted or immune-based therapeutics with Phase I, Phase I/Ib, and Phase I/II trials at MSK.

Brief Title

Investigating the Impact of Proactive Palliative Care

Official Title

Evaluating the Impact of Proactive Palliative Care in Patients Initiating Phase I Targeted or Immune-Based Cancer Therapeutics: A Randomized Controlled Trial

Brief Summary

This study will test whether adding personalized supportive care to medical treatment on a clinical trial affects the study participants' ability and desire to discuss their symptoms, their concerns about the future, and their approach to coping with cancer. The effects of supportive care on participants' responses to questions about these topics will be compared with those of other study participants who are being treated for cancer in a clinical trial, but are not receiving personalized supportive care.

Treatments and/or Procedures

Expectations survey can CORS

Study assessments will be conducted at baseline (t0); at 3-6 weeks +/- 1 week from Day 1 of receiving investigational therapy, prior to sharing information on treatment response and before the first planned scan to evaluate extent of disease (t1); and at 8-12 weeks (the end of the 3 month total study time period) (t2).

Values survey serious illness care program

Hospital anxiety and depression scale HADS

Quality of communication QOC

Visits with a supportive care clinician

Monthly visits with a supportive care clinician

Functional Assessment of Cancer Therapy General (FACT G)

NCCN distress thermometer

Outcome Measures

Outcome measures are the tests that investigators perform to prove whether or not a treatment being tested in a clinical trial is having any effect.

Primary

patients' expectations for therapeutic benefit

using the CanCORS Expectations Survey, which will assess, on a 4-point Likert-type scale, patients' expectations for therapeutic benefit after talking with their doctors about their experimental drug

3 months

Study Criteria

Inclusion Criteria:

  -  Patients with disease progression on at least one standard chemotherapy regimen, and
     now eligible and consented to begin Phase I, Phase I/Ib, Phase I/II and non-randomized
     Phase II (including basket studies) investigational targeted and immune-based
     therapeutics in MSK medical oncology, EDD, or ITC clinics

  -  Able to speak, read, and understand English well enough to complete study assessments
     in the judgment of the consenting professional

  -  18 years of age and older

  -  Has a progressive or metastatic solid tumor cancer with MSK pathology confirmation at
     the primary or metastatic anatomic site

Exclusion Criteria:

  -  Patients who already are receiving specialty supportive care (already referred for a
     supportive care consultation) prior to enrollment in a Phase I protocol.

  -  Patients will be excluded if the Phase I, Phase I/Ib, Phase I/II or Phase II trial
     involves known active drugs in combination with experimental drugs, in which the
     patient has not previously received the known active drug or active drugs of the same
     class. For example, a patient with metastatic pancreatic cancer who has not received
     gemcitabine/nab-paclitaxel, but enrolls on a study that tests an experimental drug in
     addition to gemcitabine/nab-paclitaxel, will be excluded.

  -  Significant psychiatric or cognitive disturbance in the primary clinician"s or
     investigator"s judgment, to preclude providing informed consent or participating in
     the interventions (i.e. acute psychiatric symptoms which require individual treatment)