Investigating the Impact of Proactive Palliative Care

Memorial Sloan Kettering Cancer Center (MSK)

Status: Active, not recruiting

Conditions: Locally Advanced Solid Tumor Cancers; Metastatic Solid Tumor Cancers

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

Study type: Observational

Funder types: Other

Identifiers

NCT03667378

18-363

Details and patient eligibility

About

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.

Enrollment: 83 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

83 participants in 2 patient groups

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

Treatment:

Behavioral: NCCN Distress Thermometer

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

Behavioral: Hospital Anxiety and Depression Scale (HADS)

Behavioral: Expectations Survey (CanCORS)

Behavioral: Quality of Communication (QOC)

Behavioral: visits with a supportive care clinician

Behavioral: Values Survey (Serious Illness Care Program)

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.

Treatment:

Behavioral: NCCN Distress Thermometer

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

Behavioral: Hospital Anxiety and Depression Scale (HADS)

Behavioral: Expectations Survey (CanCORS)

Behavioral: Quality of Communication (QOC)

Behavioral: Values Survey (Serious Illness Care Program)