Telephone Support for Advanced Gastrointestinal Cancer Patients and Caregivers
Telephone Support for Advanced Gastrointestinal Cancer Patients and Caregivers
This trial tests telephone-based Acceptance and Commitment Therapy (ACT), a type of
 psychotherapy, to reduce fatigue interference with activities, mood, and cognition in
 advanced gastrointestinal (GI) cancer patients and family caregiver burden. ACT includes
 mindfulness exercises (e.g., meditations, performing activities with greater awareness),
 identifying personal values (e.g., family, spirituality), and engaging in activities
 consistent with these values. A total of 42 patient-caregiver dyads will be randomly assigned
 in equal numbers to either the ACT intervention or an education/support condition. Dyads in
 both conditions will participate in six weekly 50-minute telephone sessions. Outcomes will be
 assessed at baseline, 2 weeks post-intervention, and 3 months post-intervention. The
 investigators hypothesize that ACT will lead to improved primary and secondary outcomes as
 compared to education/support. Study findings will inform a large-scale trial of intervention
 efficacy.
This trial evaluates the feasibility, acceptability, and preliminary efficacy of
 telephone-based Acceptance and Commitment Therapy (ACT) on fatigue interference in advanced
 gastrointestinal (GI) cancer patients and family caregiver burden as well as secondary
 outcomes. The study team will recruit advanced GI cancer patients receiving care at the
 Indiana University Simon Cancer Center or Eskenazi Health hospital. Potentially eligible
 patients will be mailed an introductory letter signed by their oncologist and the PI along
 with a consent form. The letter will have a number to call if they do not wish to be
 contacted further. A research assistant (RA) will call all prospective participants who do
 not opt out approximately 1 to 2 weeks after the letter is mailed. The RA will describe the
 study as outlined in the consent form and answer any questions. Then the RA will administer
 an eligibility screening to those who consent to participate. Eligible and consenting
 patients will identify a potentially eligible family caregiver. If the family caregiver is
 eligible and consents to participate, then the patient and caregiver will each complete a
 baseline phone assessment. Following baseline assessments, patient-caregiver dyads (N = 42
 dyads) will be randomly assigned in equal numbers to ACT or education/support using a
 stratified block randomization scheme to balance the groups by patient performance status
 (patient-reported Eastern Cooperative Oncology Group [ECOG] scores 0 or 1 vs. 2). Dyads in
 both study conditions will complete six weekly 50-minute telephone sessions with the first
 session occurring one week after baseline. For ACT participants, adherence to home practice
 during the past week will be assessed and recorded during each session. Feasibility will be
 examined via accrual, attrition, and adherence rates, and acceptability will be evaluated
 using a mixed methods approach (qualitative and quantitative). Blind interviewers will assess
 outcomes during follow-up phone assessments at 2 weeks and 3 months post-intervention.
Patient Inclusion Criteria:

 -  Patient is at least 3 weeks post-diagnosis of stage IV gastrointestinal cancer (i.e.,
 anal, colon, esophageal, gallbladder, liver, pancreatic, rectal, small intestine, or
 stomach cancer) and is receiving care at the Indiana University Simon Cancer Center or
 Eskenazi Health.

 -  Patient is at least 18 years of age.

 -  Patient can speak and read English.

 -  Patient has an eligible, consenting family caregiver (see criteria below).

 -  Patient has moderate to severe fatigue interference with functioning.

 Patient Exclusion Criteria:

 -  Patient shows significant psychiatric or cognitive impairment that would preclude
 providing informed consent and study participation.

 -  Patient reports being able to do little activity on a functional status measure.

 -  Patient is receiving hospice care at screening.

 -  Patient does not have working phone service.

 -  Patient has hearing impairment that precludes participation.

 Caregiver Inclusion Criteria:

 -  Family caregiver identified by a stage IV gastrointestinal cancer patient who meets
 the eligibility criteria.

 -  Caregiver has significant caregiving burden or distress

 -  Caregiver lives with the patient or has visited the patient in-person at least twice a
 week for the past month.

 -  Caregiver is at least 18 years of age.

 -  Caregiver can speak and read English.

 Caregiver Exclusion Criteria:

 -  Caregiver shows significant psychiatric or cognitive impairment that would preclude
 providing informed consent and study participation.

 -  Caregiver does not have working phone service.

 -  Caregiver has hearing impairment that precludes participation.

 -  Patient declines study participation.