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

Investigating the Impact of Proactive Palliative Care

Sponsors

Lead sponsor: Memorial Sloan Kettering Cancer Center

Source Memorial Sloan Kettering Cancer Center
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.

Overall Status Recruiting
Start Date September 7, 2018
Completion Date September 2021
Primary Completion Date September 2021
Study Type Observational
Primary Outcome
Measure Time Frame
patients' expectations for therapeutic benefit 3 months
Enrollment 80
Condition
Intervention

Intervention type: Behavioral

Intervention name: Expectations Survey (CanCORS)

Description: 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 type: Behavioral

Intervention name: Values Survey (Serious Illness Care Program)

Description: 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 type: Behavioral

Intervention name: Functional Assessment of Cancer Therapy-General (FACT-G)

Description: 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 type: Behavioral

Intervention name: NCCN Distress Thermometer

Description: 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 type: Behavioral

Intervention name: Hospital Anxiety and Depression Scale (HADS)

Description: 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 type: Behavioral

Intervention name: Quality of Communication (QOC)

Description: 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 type: Behavioral

Intervention name: visits with a supportive care clinician

Description: Monthly visits with a supportive care clinician

Arm group label: supportive care visits

Eligibility

Sampling method: Probability Sample

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)

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Andrew Epstein, MD Principal Investigator Memorial Sloan Kettering Cancer Center
Overall Contact

Last name: Andrew Epstein, MD

Phone: 646 888-4313

Email: [email protected]

Location
facility status contact contact_backup investigator Memorial Sloan Kettering Cancer Center Andrew Epstein, MD 646-888-4313 Andrew Epstein, MD Principal Investigator
Location Countries

United States

Verification Date

November 2019

Responsible Party

Responsible party type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Arm Group

Arm group label: supportive care visits

Description: 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

Arm group label: without supportive care visits

Description: 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.

Study Design Info

Observational model: Case-Control

Time perspective: Prospective

Source: ClinicalTrials.gov