Clinical trial NCT06532877: Telephone Support in Advanced Gastrointestinal Cancer
Official title: Telephone Support Program for Patients with Advanced Gastrointestinal Cancer and Their Family Caregivers
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Gastrointestinal Neoplasm Malignant
Caregiver Burden
Keywords: Gastrointestinal Neoplasms
Family Caregivers
Acceptance and Commitment Therapy
Fatigue
Psychotherapy
Caregiver Burden
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: Northwestern University
name: M.D. Anderson Cancer Center
name: Eskenazi Health
First posted: 2024-08-01
Enrollment: 488
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Advanced gastrointestinal cancer patient-family caregiver dyads (N = 244) will be randomly assigned in equal numbers to Acceptance and Commitment Therapy (ACT) or education/support using a stratified block randomization scheme to balance the groups by patient age (\<65 vs. \>=65 years) and performance status (patient-reported Eastern Cooperative Oncology Group \[ECOG\] scores 0 or 1 vs. 2).
Primary purpose: SUPPORTIVE_CARE

Brief summary: The goal of this clinical trial is to see if telephone support programs help patients and their family caregivers adjust to advanced gastrointestinal cancer. A new telephone counseling program that involves practicing strategies for managing stress and symptoms will be compared to a telephone program involving education on quality-of-life issues and psychosocial support. The main questions it aims to answer are:

Does our telephone counseling program lower the negative impact of patients' fatigue on their activities, emotions, and thinking abilities compared to a telephone program involving education and support? Does our telephone counseling program lower family caregivers' feelings of burden compared to a telephone program involving education and support?

Participants in both study conditions will:

Complete 6 weekly telephone sessions of counseling or education/support Complete a telephone booster session Complete 3 telephone interviews over about 5 months

Detailed description: This trial tests the effects of telephone-delivered acceptance and commitment therapy (ACT) on patient fatigue interference with functioning and family caregiver burden in advanced gastrointestinal (GI) cancer (Aim 1) as well as secondary outcomes (Aim 2). This trial also examines increases in psychological flexibility as a hypothesized mediator of ACT's effects on patient fatigue interference and caregiver burden (Aim 3). Finally, two core aspects of psychological flexibility (i.e., mindfulness/acceptance and commitment/behavior change processes) are examined as exploratory mediators of ACT's effects on patient fatigue interference and caregiver burden (Aim 4). The investigators will recruit advanced GI cancer patients and caregivers from Indiana University Health, Eskenazi Health, MD Anderson Cancer Center, and Northwestern University hospitals. Potentially eligible patients will be mailed a study introductory letter 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 will call all prospective participants who do not opt out approximately 1 to 2 weeks after the letter is mailed. The research assistant will describe the study as outlined in the consent form and answer any questions. Then the research assistant will administer an eligibility screening to those who consent to participate. With the patient's permission, the primary family caregiver will also be mailed a consent form and contacted via phone to screen for eligibility and obtain consent. Consenting patients and caregivers will complete a 35-minute individual phone assessment at baseline.

Following baseline assessments, patient-caregiver dyads (N = 244) will be randomly assigned in equal numbers to ACT or education/support using a stratified block randomization scheme to balance the groups by patient age (\<65 vs. \>=65 years) and performance status (patient-reported Eastern Cooperative Oncology Group \[ECOG\] scores 0 or 1 vs. 2). Dyads in both groups will complete six weekly 50-minute telephone sessions with the first session occurring one week after baseline. Blind interviewers will assess outcomes during 30-minute individual phone assessments at 2 weeks and 3 months post-intervention. Dyads in both conditions will also complete a 30-minute booster phone session one month after the 2-week follow-up. During the booster session, ACT therapists will reinforce and address any barriers to skill practice, and education/support therapists will review key medical center and community resources.

Eligibility criteria: Patient Inclusion Criteria:

* Patient is at least 3 weeks post-diagnosis of unresectable stage III or stage IV gastrointestinal cancer (i.e., anal, colon, esophageal, gallbladder, liver, pancreatic, rectal, small intestine, or stomach cancer) and is receiving cancer care at one of the study sites.
* 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.
* Patient participated in the pilot trial testing the same intervention.

Caregiver Inclusion Criteria:

* Family caregiver identified by a gastrointestinal cancer patient who meets the eligibility criteria.
* Caregiver has significant caregiving burden.
* 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.

Primary outcomes:
measure: Fatigue Interference Subscale of Fatigue Symptom Inventory
timeFrame: 2 weeks and 3 months post-intervention
measure: Short-form of Zarit Burden Interview
timeFrame: 2 weeks and 3 months post-intervention
Secondary outcomes:
measure: Patient-Reported Outcome Measurement Information System (PROMIS) Sleep-Related Impairment
timeFrame: 2 weeks and 3 months post-intervention
measure: PROMIS Ability to Participate in Social Roles and Activities
timeFrame: 2 weeks and 3 months post-intervention
measure: PROMIS Global Health measure
timeFrame: 2 weeks and 3 months post-intervention
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern Medicine
state: Illinois
city: Indianapolis
country: United States
facility: Eskenazi Health
state: Indiana
city: Indianapolis
country: United States
facility: Indiana University Health
state: Indiana
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: Indiana University Indianapolis
name: Catherine E Mosher, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: