Telephone Support for Advanced Gastrointestinal Cancer Patients and Their Family Caregivers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 84
- 试验地点
- 4
- 主要终点
- Fatigue Interference Subscale of Fatigue Symptom Inventory
研究概览
简要总结
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 40 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.
详细描述
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 = 40 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
- •Patient is at least 21 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.
排除标准
- •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.
结局指标
主要结局
Fatigue Interference Subscale of Fatigue Symptom Inventory
时间窗: 2 weeks and 3 months 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. The seven items are summed with higher total scores indicating greater fatigue interference. The total score range is 0 to 70. This is the primary outcome for patients.
Short-form of Zarit Burden Interview
时间窗: 2 weeks and 3 months 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. The 12 items are summed with higher total scores indicating greater caregiving burden. The total score range is 0 to 48. This is the primary outcome for caregivers.
次要结局
- PROMIS Ability to Participate in Social Roles and Activities(2 weeks and 3 months post-intervention)
- Acceptance and Action Questionnaire-II(2 weeks and 3 months post-intervention)
- Patient-Reported Outcome Measurement Information System (PROMIS) Sleep-Related Impairment(2 weeks and 3 months post-intervention)
- McGill Quality of Life Questionnaire-Revised(2 weeks and 3 months post-intervention)
- PROMIS Global Health(2 weeks and 3 months post-intervention)
- Value Progress Subscale of the Valuing Questionnaire.(2 weeks and 3 months post-intervention)
研究者
Catherine Mosher
Associate Professor
Indiana University