Feasibility of a Creative Writing Intervention in an Advanced Cancer Population: A Single Arm, Consecutive Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Feasibility of a creative writing intervention in an advanced cancer population
研究概览
简要总结
To assess the feasibility of a creative writing intervention in an advanced cancer population. Given it is a relatively simple intervention delivered by a non-clinician, the investigators are interested in better understanding its pattern of effect on patient psychological adjustment. The investigators aim to assess its feasibility in this study in order to inform a future larger study that will utilize a control arm.
详细描述
Participants will be recruited within 3 months of presenting with a new GI or lung primary, non-curable malignancy. After consent, the participants will meet with the staff writer, who is already part of the creative arts program, to determine the methods, themes and modalities of creative writing to pursue. These choices will be revisited each session, as patients move from one theme to another, and some patients may consistently choose a given modality such as letters, while others will choose variety.
Participants will meet with the staff writer one-on-one by scheduled appointment in the outpatient or inpatient setting at a minimum of once per month throughout a 6 month time period after enrollment. This appointment is preferred to be in person, but due to the rural setting may be conducted by telephone if needed. There will not be a protocol regarding the length of and number of visits during the 6 month study period, but these quantities will be recorded to use for analysis of effectiveness of the intervention.
Writing modality choices will include private thoughts and feelings in a journal, poetry, letters to oneself or loved ones and narrative writing about significant life events. All interventions will focus on a written product for the participant to have and potentially share with caregivers if they desire.
Every 3 months patients will be asked to complete the following series of questionnaires: ECOG PS, PGAC3, HADS4, DT5, CSE6, CD-RISC-107, PTGI-SF8, FACIT-Sp-Ex9, ESAS11 and PA10.
Patients will be followed for 9 months after enrollment or until death (whichever is soonest). If a patient decides to discontinue the creative writing intervention before 6 months, the reason will be recorded and they will continue in the study for 9 months or until death completing the questionnaires.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant must plan to receive follow up care at Dartmouth-Hitchcock.
- •Participant must have a lung or GI primary cancer diagnosed in the last 3 months.
- •Participant must have non-curable cancer as judged by the primary oncologist.
- •Participant must be comfortable conversing in English (reading and writing in English is not required).
- •Participant must be cognitively intact as judged by their responsible clinician.
- •Participant must have access to a working telephone and be willing and available to participate by this modality as needed.
- •Participants may be on anti-depressants and/or anxiolytics as long as the dosing has remained stable over the preceding 2 weeks.
排除标准
- •Participant is expected to die in 6 months or less as judged by the responsible clinician.
- •Participant must not have already worked with the staff writer at Dartmouth Hitchcock prior to enrollment in this study.
- •Participant with an activated durable power of attorney for health care or cognitive impairment that interferes with ability to understand prognosis as determined by the primary oncologist.
- •Participant must not have uncontrolled physical symptoms.
研究组 & 干预措施
One
Creative writing and questionnaires interventions:
First Session, Second Session, Third through Sixth Sessions
干预措施: First Session (Other)
One
Creative writing and questionnaires interventions:
First Session, Second Session, Third through Sixth Sessions
干预措施: Second Session (Other)
One
Creative writing and questionnaires interventions:
First Session, Second Session, Third through Sixth Sessions
干预措施: Third through Sixth Sessions (Behavioral)
结局指标
主要结局
Feasibility of a creative writing intervention in an advanced cancer population
时间窗: 29 months
Anyone completing the first intervention with the creative writer will be evaluable for the feasibility outcome. If the investigators see 50% of patients completing 3 months of the creative writing intervention then this would indicate the intervention should be examined in a larger pilot study.
次要结局
未报告次要终点
研究者
Maxwell. T. Vergo
Staff Physician, Palliative Care
Dartmouth-Hitchcock Medical Center