Investigating the Impact of Proactive Palliative Care

NCT03667378 | Active Not Recruiting

• 1 other identifier: 18-363
• Study Type: observational
• Target: 83
• Locations: 1 country
• Sites: 1

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.

Conditions

Metastatic Solid Tumor Cancers; Locally Advanced Solid Tumor Cancers

Keywords

Quality of Life; Supportive Care; 18-363

Outcome Measures

Primary Outcomes (1)

• 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 Arms (2)

supportive care visits

A concurrent supportive care intervention (intervention arm) 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).intervention arm will have at least monthly visits with a supportive care clinician

Behavioral: Expectations Survey (CanCORS); Behavioral: Values Survey (Serious Illness Care Program); Behavioral: Functional Assessment of Cancer Therapy-General (FACT-G); Behavioral: NCCN Distress Thermometer; Behavioral: Hospital Anxiety and Depression Scale (HADS); Behavioral: Quality of Communication (QOC); Behavioral: visits with a supportive care clinician

without supportive care visits

A concurrent supportive care intervention (intervention arm) 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).intervention arm will have at least monthly visits with a supportive care clinicianTo receive the investigational cancer treatment alone (control arm) no monthly visit with a supportive care clinician.

Behavioral: Expectations Survey (CanCORS); Behavioral: Values Survey (Serious Illness Care Program); Behavioral: Functional Assessment of Cancer Therapy-General (FACT-G); Behavioral: NCCN Distress Thermometer; Behavioral: Hospital Anxiety and Depression Scale (HADS); Behavioral: Quality of Communication (QOC)

Interventions

Expectations Survey (CanCORS) BEHAVIORAL

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).

supportive care visits; without supportive care visits

Values Survey (Serious Illness Care Program) BEHAVIORAL

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).

supportive care visits; without supportive care visits

Functional Assessment of Cancer Therapy-General (FACT-G) BEHAVIORAL

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).

supportive care visits; without supportive care visits

NCCN Distress Thermometer BEHAVIORAL

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).

supportive care visits; without supportive care visits

Hospital Anxiety and Depression Scale (HADS) BEHAVIORAL

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).

supportive care visits; without supportive care visits

Quality of Communication (QOC) BEHAVIORAL

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).

supportive care visits; without supportive care visits

visits with a supportive care clinician BEHAVIORAL

Monthly visits with a supportive care clinician

supportive care visits

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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
• years of age and older
• Has a progressive or metastatic solid tumor cancer with MSK pathology confirmation at the primary or metastatic anatomic site

You may not qualify if:

• 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)

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead

Study Sites (1)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Interventions

4-amino-4'-hydroxylaminodiphenylsulfone

Study Officials

• Andrew Epstein, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2018
• First Posted: September 12, 2018
• Study Start: September 7, 2018
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: October 28, 2025

Record last verified: 2025-10

Locations

US (1)