Telephone Support for Advanced Gastrointestinal Cancer Patients and Caregivers
Study Details
Study Description
Brief Summary
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 were randomly assigned in equal numbers to either the ACT intervention or an education/support condition. Dyads in both conditions participated in six weekly 50-minute telephone sessions. Outcomes were 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Detailed Description
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 recruited advanced GI cancer patients receiving care at the Indiana University Simon Cancer Center or Eskenazi Health hospital. Potentially eligible patients were mailed an introductory letter signed by their oncologist and the PI along with a consent form. The letter had a number to call if they did not wish to be contacted further. A research assistant (RA) called all prospective participants who did not opt out approximately 1 to 2 weeks after the letter was mailed. The RA described the study as outlined in the consent form and answered any questions. Then the RA administered an eligibility screening to those who consented to participate. Eligible and consenting patients identified a potentially eligible family caregiver. If the family caregiver was eligible and consented to participate, then the patient and caregiver each completed a baseline phone assessment. Following baseline assessments, patient-caregiver dyads (N = 42 dyads) were 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 completed 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 was 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 assessed outcomes during follow-up phone assessments at 2 weeks and 3 months post-intervention.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Acceptance and Commitment Therapy Patients and caregivers in the ACT arm learn new and more adaptive ways to respond to difficult internal experiences (e.g., fatigue, thoughts, and feelings). |
Behavioral: Acceptance and Commitment Therapy
Across six weekly 50-minute sessions, advanced GI cancer patients and caregivers practice various mindfulness exercises, clarify their values, and set specific goals in alignment with their values. Through in-session and home practice of skills, participants learn new and more adaptive ways to respond to unwanted internal experiences (e.g., fatigue, distress). Participants receive handouts on session topics and a CD that we developed to guide mindfulness practices.
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| Active Comparator: Education/Support Patients and caregivers in the education/support arm discuss their cancer-related concerns and receive education on services available in their medical center and community. |
Behavioral: Education/Support
Across six weekly 50-minute sessions, advanced GI cancer patients and caregivers are directed to resources for practical and health information and contact information for psychosocial services. Sessions include an orientation to the patient's medical center and treatment team, education regarding common quality-of-life concerns experienced by cancer patients and caregivers, and an overview of medical center and community resources for addressing these concerns. The therapist also describes resources for addressing financial concerns and methods of evaluating health information available via the Internet and other modalities. Participants receive handouts summarizing session topics and are asked to review them as homework.
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Outcome Measures
Primary Outcome Measures
- Fatigue Interference subscale of Fatigue Symptom Inventory [2 weeks post-intervention]
Seven items are rated on 11-point scales (0=no interference to 10=extreme interference) that assess the extent to which fatigue in the past week interfered with general level of activity, ability to bathe and dress, normal work activity (including housework), ability to concentrate, relations with others, enjoyment of life, and mood. Higher scores indicate greater fatigue interference. This is the primary outcome for patients.
- Short-form of Zarit Burden Interview [2 weeks post-intervention]
Twelve items are rated on 5-point scales (0=never to 4=nearly always) that assess personal strain and role strain due to caregiving. Higher scores indicate greater caregiving burden. This is the primary outcome for caregivers.
Secondary Outcome Measures
- PROMIS Sleep-Related Impairment [2 weeks post-intervention]
This 8-item measure assesses the perceived interference of sleep problems with activities, mood, and cognition (e.g., difficulty concentrating or completing tasks). Each item is rated on a scale from 1 (not at all) to 5 (very much) with higher scores indicating greater sleep-related impairment. This is a secondary outcome for patients.
- PROMIS Ability to Participate in Social Roles and Activities [2 weeks post-intervention]
This 6-item measure assesses participants' ability to participate in social roles and activities. The items measure difficulty engaging in social and recreational activities as well as usual work (including housework). Each item is rated on a scale from 1 (never) to 5 (always) and is reverse coded such that a higher score indicates greater ability to participate in activities. This is a secondary outcome for both patients and caregivers.
- Acceptance and Action Questionnaire-II [2 weeks post-intervention]
This 7-item measure assesses psychological flexibility, or the ability to fully experience the present moment while persisting in actions aligned with personal values. Each item is rated on a scale from 1 (never true) to 7 (always true). Higher scores indicate greater levels of psychological inflexibility. This is a secondary outcome for both patients and caregivers.
- McGill Quality of Life Questionnaire-Revised [2 weeks post-intervention]
This 15-item measure evaluates physical, existential, and social well-being in patients with serious illnesses. Items are rated on 0 to 10 scales. This is a secondary outcome measure for patients.
- PROMIS Global Health [2 weeks post-intervention]
This 10-item measure assesses global health, including physical, mental, and social well-being. With the exception of pain, which is rated on a 0 to 10 scale, all items are rated on 5-point scales. This is a secondary outcome measure for caregivers.
- Value progress subscale of the Valuing Questionnaire. [2 weeks post-intervention]
This 5-item subscale assesses progress in living according to one's personal values, a construct related to activity engagement. Items are rated on 0 to 6 scales. This is a secondary outcome measure for patients and caregivers.
Eligibility Criteria
Criteria
Patient Inclusion Criteria:
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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 care at the Indiana University Simon Cancer Center or Eskenazi Health.
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Patient is at least 21 years of age.
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Patient can speak and read English.
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Patient has an eligible, consenting family caregiver (see criteria below).
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Patient has moderate to severe fatigue interference with functioning.
Patient Exclusion Criteria:
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Patient shows significant psychiatric or cognitive impairment that would preclude providing informed consent and study participation.
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Patient reports being able to do little activity on a functional status measure.
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Patient is receiving hospice care at screening.
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Patient does not have working phone service.
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Patient has hearing impairment that precludes participation.
Caregiver Inclusion Criteria:
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Family caregiver identified by a stage IV gastrointestinal cancer patient who meets the eligibility criteria.
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Caregiver has significant caregiving burden or distress
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Caregiver lives with the patient or has visited the patient in-person at least twice a week for the past month.
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Caregiver is at least 18 years of age.
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Caregiver can speak and read English.
Caregiver Exclusion Criteria:
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Caregiver shows significant psychiatric or cognitive impairment that would preclude providing informed consent and study participation.
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Caregiver does not have working phone service.
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Caregiver has hearing impairment that precludes participation.
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Patient declines study participation.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Eskenazi Health | Indianapolis | Indiana | United States | 46202 |
| 2 | Indiana University Simon Cancer Center | Indianapolis | Indiana | United States | 46202 |
Sponsors and Collaborators
- Indiana University
- National Cancer Institute (NCI)
Investigators
- Principal Investigator: Catherine E Mosher, Ph.D., Indiana University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 1904388865
- R21CA235788