Investigating the Impact of Proactive Palliative Care

Locally Advanced Solid Tumor Cancers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03667378
• Other study ID #: 18-363
• Status: Active, not recruiting
• Start date: September 7, 2018
• Est. completion date: September 2025

Study information

• Verified date: October 2023
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 83
• Est. completion date: September 2025
• Est. primary completion date: September 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Locally Advanced Solid Tumor Cancers
• Metastatic Solid Tumor Cancers
• Neoplasms

Intervention

Behavioral:
• Expectations Survey (CanCORS)
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)
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).
• Functional Assessment of Cancer Therapy-General (FACT-G)
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).
• NCCN Distress Thermometer
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).
• Hospital Anxiety and Depression Scale (HADS)
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).
• Quality of Communication (QOC)
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).
• visits with a supportive care clinician
Monthly visits with a supportive care clinician

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Cancer Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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

External Links

•   Memorial Sloan Kettering Cancer Center