Improving Care for Rural Patients With Solid Tumors

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-99
SponsorUniversity of Colorado, Denver

About this trial

This study will assess if the CARES (Cancer Advocacy, Resources, Education and Support) intervention improves time to start of treatment after diagnosis and time to treatment completion for solid tumors (ex: lung, head, neck, thyroid, cervical, breast, bladder, colon, and rectal cancers) in rural patients.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Provision to sign and date the consent form.

Stated willingness to comply with all study procedures and be available for the duration of the study.

Male and female adults over 18 years old

English or Spanish speaking

Disqualifiers

Children under 18 years old

Individuals who do not speak English or Spanish

Individuals not receiving cancer treatment at UCH (Aurora, Highlands Ranch, UCHealth North, UCHealth Memorial Hospital), San Juan Cancer Center, RMCC-Pueblo, St. Mary's or Parkview Medical Center.

Diagnosed with primary cancer other than breast, bladder, cervix, colon, rectum, lung, and/or head-and-neck cancer or other type of cancer not listed in the inclusion criteria.

Trial design

Design model

Parallel

Treatments tested in this trial

  • CARES Intervention

    Behavioral

    Nurse navigators and masters levels counselors will meet with participants up to 10 times each (10 navigation and 10 counseling) over a 6 month period. The number of sessions will be determined by the length of the patient's treatment. The timing of each session will be guided by a regular assessment to reduce the time from diagnosis to initiation of treatment and the time between subsequent treatments. Sessions will occur at key transition points during treatment to target the factors associated with treatment delays, reduced Quality of Care and poor Patient Reported Outcomes

Treatment groups

320 Participants
are divided into 2 treatment groups
Group A: CARES InterventionActive comparator 1 intervention
Group B: Usual CareNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Time to care

Number of days from diagnosis to treatment initiation and number of days from treatment initiation to treatment completion

Time frame
From study start to study end (6 months)

Secondary outcomes

1

Quality of Care

Use Quality of Care (QOC) questionnaire to determine if CARES intervention results in favorable QOC experience

Time frame
From study start to study end (6 months)
2

Patient Reported Outcomes

Use Patient Reported Outcomes (PRO) questionnaire to determine if CARES intervention results in improvements in distress, adaptive coping, and tobacco use

Time frame
From study start to study end (6 months)

Other outcomes

Sponsors and contacts

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University of Colorado, Denver

Lead sponsor

National Cancer Institute (NCI)

Collaborator