跳至主要内容
临床试验/NCT07415564
NCT07415564招募中不适用

Symptom Management and Survivorship Plus Coaching to Reduce Symptom Severity and Improve Health Related-quality of Life (HR-QOL) for Breast, GI and Melanoma Cancer Survivors and Their Caregivers

University of Arizona1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2026年5月6日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
200
试验地点
1
主要终点
Symptom severity

研究概览

简要总结

The protocol will include a 10-week Symptom Management and Survivorship Handbook (SMSH) intervention to address informational needs for the management of physical and psychological symptoms, bundled with telephone delivered health coaching to address their symptom interference with physical, psychological and social functioning. The SMSH intervention, which includes both symptom assessment and management, is simple to implement, scalable, and evidence-based will be delivered to all survivors and caregivers (dyads) in this study, and will serve as an active control. In addition to the SMSH, intervention arm dyads will receive health coaching to address symptom interference and reduce social isolation. Symptom burden is more pronounced in marginalized populations such as Latina/o, rural, older age survivors and their caregivers.18-20 Many health disparities in these populations are underwritten by social isolation due to lack of access, disconnection from linguistically competent health care, mobility, and geographic proximity,21-23 and health coaching can address these issues.

The specific aims of the proposed feasibility study are to determine among survivors with metastatic or stage IV cancer and their caregivers (dyads):

Aim 1: Demonstrate SMSH plus health coaching feasibility (recruitment, retention, satisfaction (acceptability and appropriateness) for cancer survivors and their caregivers. Benchmarks: Recruitment 70% approached, Retention 75%, and participant satisfaction through qualitative exit interviews in week 11.

Aim 2: Collect preliminary data for the intervention impact on whether the SMSH + health coaching results in lowered burden of 24 symptoms (primary outcome) over weeks 1-10, and improved HRQoL (social, physical, psychological) (secondary outcome) at week 11, compared to SMSH alone.

Aim 3. Examine the enactment of self-management strategies in SMSH+health coaching versus SMSH alone.

The proposed pilot trial will provide proof of concept for the SMSH coupled with a live telephone delivered health coaching intervention to improve symptom management and HRQoL for metastatic breast, GI, and melanoma cancer survivors and caregivers. By addressing physical and psychological symptoms and survivorship using scalable, accessible interventions delivered via telephone, within reach of traditionally underserved populations, the findings have the potential to lay the foundation for the dissemination and implementation of a practical solution to meet survivor-caregiver needs both locally and nationally.

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
Triple (Care Provider, Investigator, 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

入选标准

  • for cancer survivors:
  • Age 18 or older
  • Diagnosed with metastatic or stage IV breast, gastrointestinal (GI), and melanoma cancer
  • Able to perform basic activities of daily living
  • Cognitively oriented to time, place, and person (recruiter determined)
  • Able to speak and understand English or Spanish
  • Access to a telephone
  • Has a caregiver in any relationship role (e.g., spouse, sibling, parent, friend) who can.
  • Inclusion criteria for the caregivers:
  • Age 18 or older
  • Able to speak and understand English or Spanish
  • Telephone access
  • Not currently treated for cancer

排除标准

  • Nursing home resident
  • Bedridden
  • Hospice care
  • Currently receiving a symptom management intervention

研究组 & 干预措施

Symptom Management and Survivorship Handbook (SMSH)

Active Comparator

Survivors and caregivers are mailed a printed Symptom Management and Survivorship Handbook (SMSH or Handbook), which has been shown to help survivors and caregivers manage symptoms in other studies. The SMSH includes a chapter for 24 common cancer symptoms (e.g., fatigue, depression, anxiety, sleep difficulties, pain, etc.) and provides tips and strategies to help with symptom management. The SMSH also includes lifestyle and behavior tips, survivorship guidelines, and surveillance guidelines. Survivors and caregivers are called by an interventionist via telephone once a week for 10 weeks to assess symptoms and make referrals to chapters in the handbook based on their reports.

干预措施: Symptom Management and Survivorship Handbook (Behavioral)

Symptom Management and Survivorship Handbook + Coaching

Experimental

Survivors and caregivers are mailed the printed Symptom Management and Survivorship Handbook (SMSH or Handbook), which has been shown to help them manage symptoms in other studies. The SMSH includes a chapter for 24 common cancer symptoms (e.g., fatigue, depression, anxiety, sleep difficulties, pain, etc.) and provides tips and strategies to help with symptom management. The SMSH also includes lifestyle and behavior tips, survivorship guidelines, and surveillance guidelines. Trained health coaches will call the survivor and caregiver separately each week for 10 weeks to assess symptoms, make referrals to SMSH, and use behavioral theory techniques to facilitate goal setting and symptom self-management.

干预措施: Symptom Management and Survivorship Handbook + Coaching (Behavioral)

结局指标

主要结局

Symptom severity

时间窗: 10 weeks

Assess whether SMSH combined with health coaching reduces the burden of 24 symptoms over 10 weeks compared to SMSH alone. Symptom burden will be measured using summary severity and interference scores from the Patient-Reported Outcome Common Terminology Criteria for Adverse Events (PRO-CTCAE). Severity is rated on a scale of 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe. Interference is rated on a scale of 0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much. Frequency is rated as 0=never, 1=rarely, 2=occasionally, 3=frequently, 4=almost constantly. As outlined in the PRO-CTCAE, frequency, severity, and interference questions will be asked for each item available. If frequency is "never," severity and interference will not be asked. Summary scores for severity and interference will be derived from the toxicity index (TI) developed by Rogatko et al. for CTCAE grades and applied to the PRO-CTCAE scores over weeks 1-8. Higher scores indicate worse outcomes.

次要结局

  • Health Related Quality of Life (HRQoL)(11 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Terry Badger

Professor

University of Arizona

研究点 (1)

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