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Feasibility of a Creative Writing Intervention in an Advanced Cancer Population: A Single Arm, Consecutive Cohort Study

Primary Purpose

Primary Malignant Neoplasm of Lung, Primary Malignant Neoplasm of Gastrointestinal Tract

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
First Session
Second Session
Third through Sixth Sessions
Sponsored by
Dartmouth-Hitchcock Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Primary Malignant Neoplasm of Lung

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Participant must plan to receive follow up care at Dartmouth-Hitchcock.
  2. Participant must have a lung or GI primary cancer diagnosed in the last 3 months.
  3. Participant must have non-curable cancer as judged by the primary oncologist.
  4. Participant must be comfortable conversing in English (reading and writing in English is not required).
  5. Participant must be cognitively intact as judged by their responsible clinician.
  6. Participant must have access to a working telephone and be willing and available to participate by this modality as needed.
  7. Participants may be on anti-depressants and/or anxiolytics as long as the dosing has remained stable over the preceding 2 weeks.

Exclusion Criteria:

  1. Participant is expected to die in 6 months or less as judged by the responsible clinician.
  2. Participant must not have already worked with the staff writer at Dartmouth Hitchcock prior to enrollment in this study.
  3. 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.
  4. Participant must not have uncontrolled physical symptoms.

Sites / Locations

  • Dartmouth-Hitchcock Medical Center

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

One

Arm Description

Creative writing and questionnaires interventions: First Session, Second Session, Third through Sixth Sessions

Outcomes

Primary Outcome Measures

Feasibility of a creative writing intervention in an advanced cancer population
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.

Secondary Outcome Measures

Full Information

First Posted
October 8, 2015
Last Updated
November 16, 2018
Sponsor
Dartmouth-Hitchcock Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02575898
Brief Title
Feasibility of a Creative Writing Intervention in an Advanced Cancer Population: A Single Arm, Consecutive Cohort Study
Official Title
Feasibility of a Creative Writing Intervention in an Advanced Cancer Population: A Single Arm, Consecutive Cohort Study
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
January 14, 2016 (Actual)
Primary Completion Date
July 12, 2018 (Actual)
Study Completion Date
September 4, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dartmouth-Hitchcock Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
Detailed Description
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. 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. In addition, the investigators will carefully record accrual rate with associated reasons for declining and number of patients able to complete the full planned intervention with the creative writing. In planning for a larger pilot study next and given the survey burden is high in this study, the investigators will plan to use a subset analysis in order to see which factors were significantly affected by the creative arts intervention

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Malignant Neoplasm of Lung, Primary Malignant Neoplasm of Gastrointestinal Tract

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
One
Arm Type
Other
Arm Description
Creative writing and questionnaires interventions: First Session, Second Session, Third through Sixth Sessions
Intervention Type
Other
Intervention Name(s)
First Session
Intervention Description
Creative Practice and Positive Re-enforcement
Intervention Type
Other
Intervention Name(s)
Second Session
Intervention Description
Disease Related
Intervention Type
Behavioral
Intervention Name(s)
Third through Sixth Sessions
Intervention Description
Life Review and Legacy
Primary Outcome Measure Information:
Title
Feasibility of a creative writing intervention in an advanced cancer population
Description
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.
Time Frame
29 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Max Vergo, MD
Organizational Affiliation
Dartmouth-Hitchcock Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dartmouth-Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
20818875
Citation
Temel JS, Greer JA, Muzikansky A, Gallagher ER, Admane S, Jackson VA, Dahlin CM, Blinderman CD, Jacobsen J, Pirl WF, Billings JA, Lynch TJ. Early palliative care for patients with metastatic non-small-cell lung cancer. N Engl J Med. 2010 Aug 19;363(8):733-42. doi: 10.1056/NEJMoa1000678.
Results Reference
background
PubMed Identifier
21555700
Citation
Temel JS, Greer JA, Admane S, Gallagher ER, Jackson VA, Lynch TJ, Lennes IT, Dahlin CM, Pirl WF. Longitudinal perceptions of prognosis and goals of therapy in patients with metastatic non-small-cell lung cancer: results of a randomized study of early palliative care. J Clin Oncol. 2011 Jun 10;29(17):2319-26. doi: 10.1200/JCO.2010.32.4459. Epub 2011 May 9.
Results Reference
background
PubMed Identifier
22203758
Citation
Greer JA, Pirl WF, Jackson VA, Muzikansky A, Lennes IT, Heist RS, Gallagher ER, Temel JS. Effect of early palliative care on chemotherapy use and end-of-life care in patients with metastatic non-small-cell lung cancer. J Clin Oncol. 2012 Feb 1;30(4):394-400. doi: 10.1200/JCO.2011.35.7996. Epub 2011 Dec 27.
Results Reference
background
PubMed Identifier
25800768
Citation
Bakitas MA, Tosteson TD, Li Z, Lyons KD, Hull JG, Li Z, Dionne-Odom JN, Frost J, Dragnev KH, Hegel MT, Azuero A, Ahles TA. Early Versus Delayed Initiation of Concurrent Palliative Oncology Care: Patient Outcomes in the ENABLE III Randomized Controlled Trial. J Clin Oncol. 2015 May 1;33(13):1438-45. doi: 10.1200/JCO.2014.58.6362. Epub 2015 Mar 23.
Results Reference
background
PubMed Identifier
19690306
Citation
Bakitas M, Lyons KD, Hegel MT, Balan S, Brokaw FC, Seville J, Hull JG, Li Z, Tosteson TD, Byock IR, Ahles TA. Effects of a palliative care intervention on clinical outcomes in patients with advanced cancer: the Project ENABLE II randomized controlled trial. JAMA. 2009 Aug 19;302(7):741-9. doi: 10.1001/jama.2009.1198.
Results Reference
background
PubMed Identifier
25800762
Citation
Dionne-Odom JN, Azuero A, Lyons KD, Hull JG, Tosteson T, Li Z, Li Z, Frost J, Dragnev KH, Akyar I, Hegel MT, Bakitas MA. Benefits of Early Versus Delayed Palliative Care to Informal Family Caregivers of Patients With Advanced Cancer: Outcomes From the ENABLE III Randomized Controlled Trial. J Clin Oncol. 2015 May 1;33(13):1446-52. doi: 10.1200/JCO.2014.58.7824. Epub 2015 Mar 23.
Results Reference
background
PubMed Identifier
14677140
Citation
Bohlmeijer E, Smit F, Cuijpers P. Effects of reminiscence and life review on late-life depression: a meta-analysis. Int J Geriatr Psychiatry. 2003 Dec;18(12):1088-94. doi: 10.1002/gps.1018.
Results Reference
background
PubMed Identifier
16110012
Citation
Chochinov HM, Hack T, Hassard T, Kristjanson LJ, McClement S, Harlos M. Dignity therapy: a novel psychotherapeutic intervention for patients near the end of life. J Clin Oncol. 2005 Aug 20;23(24):5520-5. doi: 10.1200/JCO.2005.08.391.
Results Reference
background
PubMed Identifier
16967303
Citation
Ando M, Tsuda A, Morita T. Life review interviews on the spiritual well-being of terminally ill cancer patients. Support Care Cancer. 2007 Feb;15(2):225-31. doi: 10.1007/s00520-006-0121-y. Epub 2006 Sep 12.
Results Reference
background
PubMed Identifier
19021487
Citation
Steinhauser KE, Alexander SC, Byock IR, George LK, Olsen MK, Tulsky JA. Do preparation and life completion discussions improve functioning and quality of life in seriously ill patients? Pilot randomized control trial. J Palliat Med. 2008 Nov;11(9):1234-40. doi: 10.1089/jpm.2008.0078.
Results Reference
background
PubMed Identifier
18321839
Citation
Crogan NL, Evans BC, Bendel R. Storytelling intervention for patients with cancer: part 2--pilot testing. Oncol Nurs Forum. 2008 Mar;35(2):265-72. doi: 10.1188/08.ONF.265-272.
Results Reference
background
PubMed Identifier
21741309
Citation
Chochinov HM, Kristjanson LJ, Breitbart W, McClement S, Hack TF, Hassard T, Harlos M. Effect of dignity therapy on distress and end-of-life experience in terminally ill patients: a randomised controlled trial. Lancet Oncol. 2011 Aug;12(8):753-62. doi: 10.1016/S1470-2045(11)70153-X. Epub 2011 Jul 6.
Results Reference
background
PubMed Identifier
23699646
Citation
Puetz TW, Morley CA, Herring MP. Effects of creative arts therapies on psychological symptoms and quality of life in patients with cancer. JAMA Intern Med. 2013 Jun 10;173(11):960-9. doi: 10.1001/jamainternmed.2013.836.
Results Reference
background
PubMed Identifier
21995889
Citation
Korte J, Bohlmeijer ET, Cappeliez P, Smit F, Westerhof GJ. Life review therapy for older adults with moderate depressive symptomatology: a pragmatic randomized controlled trial. Psychol Med. 2012 Jun;42(6):1163-73. doi: 10.1017/S0033291711002042.
Results Reference
background
PubMed Identifier
24735024
Citation
Juliao M, Oliveira F, Nunes B, Vaz Carneiro A, Barbosa A. Efficacy of dignity therapy on depression and anxiety in Portuguese terminally ill patients: a phase II randomized controlled trial. J Palliat Med. 2014 Jun;17(6):688-95. doi: 10.1089/jpm.2013.0567. Epub 2014 Apr 15.
Results Reference
background
Citation
Tegner I, Fox J, Philipp R, et al. Evaluating the use of poetry to improve well-being and emotional resilience in cancer patients. J Poetry Ther 2009; 22: 121-131.
Results Reference
background

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Feasibility of a Creative Writing Intervention in an Advanced Cancer Population: A Single Arm, Consecutive Cohort Study

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