Development and Pilot Trial of Focused ACT (FACT) for Patients With Advanced Cancer
ConditionAdvanced Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorM.D. Anderson Cancer Center
About this trial
To learn about the effects of an intervention program called Focused Acceptance and Commitment Therapy (FACT) on the level of anxiety patients diagnosed with cancer feel about death.
To learn if an intervention program called Focused Acceptance and Commitment Therapy (FACT), designed to help reduce death-related anxiety, is effective and acceptable to patients diagnosed with advanced cancer.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult cancer patients diagnosed with advanced cancer (solid tumor and hematologic)
Progressed past at least one line of palliative systemic cancer therapy
Patient followed by Supportive Care Outpatient Service
English speaking
Disqualifiers
ECOG performance status >=3 "capable of only limited selfcare; confined to bed or chair more than 50% of waking hours"
Currently participating in regular psychotherapy (patient defined)
Documented out of hospital DNR (do not resuscitate) orders
Presence of active suicidal ideation or need for a higher level of care (as determined by Supportive Care physician or licensed mental health clinician).
Trial design
Design model
Single group
Treatments tested in this trial
FACT Session
BehavioralParticipants will participate in 4 weekly, 35-45 minute sessions
Enhanced Usual Care and Assessments
BehavioralParticipants will complete a symptoms questionnaire
Treatment groups
70 Participants
are divided into 2 treatment groupsGroup A: Examine Initial Acceptability and Efficacy Signal of FACTExperimental treatment 1 intervention
Group B: Controlled Trial (RCT) to Examine Feasibility, Acceptability and Initially Efficacy of FACTExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
1. Safety and Adverse Events (AEs)
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Time frame
Through study completion; an average of 1 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov