Primary Malignant Neoplasm of LungNCT02575898
Feasibility of a Creative Writing Intervention in an Advanced Cancer Population: A Single Arm, Consecutive Cohort Study
A study testing First Session, Second Session and Third through Sixth Sessions in people with Primary Malignant Neoplasm of Lung and Primary Malignant Neoplasm of Gastrointestinal Tract, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Primary Malignant Neoplasm of Lung, Primary Malignant Neoplasm of Gastrointestinal Tract
- What is being tested?
- First Session, Second Session and Third through Sixth Sessions
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jan 2016to 4 Sep 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756
About this study
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.
Read the 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
- Being tested
- First Session, Second Session, Third through Sixth Sessions
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
First SessionOther
Creative Practice and Positive Re-enforcement
Second SessionOther
Disease Related
Third through Sixth SessionsBehavioural
Life Review and Legacy
| Study group | Role | What they receive |
|---|---|---|
| One | Other | Creative writing and questionnaires interventions:
First Session, Second Session, Third through Sixth Sessions Receives: Other: First Session; Other: Second Session; Behavioral: Third through Sixth Sessions |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 29 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2015 (estimated)
- Study start14 Jan 2016
- Primary completion12 Jul 2018
- Study completion4 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Primary Malignant Neoplasm of LungStudies of the same condition, open and under way.
- More trials run by Dartmouth-Hitchcock Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dartmouth-Hitchcock Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maxwell. T. Vergo, Dartmouth-Hitchcock Medical Center
- Investigators
- Max Vergo, MD, Principal investigator, Dartmouth-Hitchcock Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02575898
- Sponsor's protocol ID
- D15113
- Status last verified
- Nov 2018
- First submitted
- 8 Oct 2015
- Last updated
- 19 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 20818875Temel 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.
PubMed 21555700Greer 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.
PubMed 22203758Bakitas 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.
PubMed 25800768Bakitas 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.
PubMed 19690306Dionne-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.
PubMed 25800762Bohlmeijer 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.
PubMed 14677140Chochinov 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.
PubMed 16110012Ando 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.
PubMed 16967303Steinhauser 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.
PubMed 19021487Crogan 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.
PubMed 18321839Chochinov 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.
PubMed 21741309Puetz 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.
PubMed 23699646Korte 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.
PubMed 21995889Juliao 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.
PubMed 24735024
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of a Creative Writing Intervention in an Advanced Cancer Population: A Single Arm, Consecutive Cohort Study
- ClinicalTrials.gov ID
- NCT02575898
- Acronym / sponsor ID
- D15113
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
- Study start
- 14 Jan 2016 (actual)
- Primary completion
- 12 Jul 2018 (actual)
- Study completion
- 4 Sep 2018 (actual)
- First posted
- 15 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| One | Other | Other: First Session, Other: Second Session, Behavioral: Third through Sixth SessionsCreative writing and questionnaires interventions: First Session, Second Session, Third through Sixth Sessions |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| First SessionCreative Practice and Positive Re-enforcement | Other | One |
| Second SessionDisease Related | Other | One |
| Third through Sixth SessionsLife Review and Legacy | Behavioural | One |
Primary outcome
Feasibility of a creative writing intervention in an advanced cancer population
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2018.
- Background: PubMed 20818875Temel 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.
- Background: PubMed 21555700Temel 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.
- Background: PubMed 22203758Greer 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.
- Background: PubMed 25800768Bakitas 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.
- Background: PubMed 19690306Bakitas 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.
- Background: PubMed 25800762Dionne-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.
- Background: PubMed 14677140Bohlmeijer 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.
- Background: PubMed 16110012Chochinov 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.
- Background: PubMed 16967303Ando 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.
- Background: PubMed 19021487Steinhauser 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.
- Background: PubMed 18321839Crogan 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.
- Background: PubMed 21741309Chochinov 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Max Vergo, MD principal investigator
Dartmouth-Hitchcock Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing First Session, Second Session and Third through Sixth Sessions in people with Primary Malignant Neoplasm of Lung and Primary Malignant Neoplasm of Gastrointestinal Tract, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of a creative writing intervention in an advanced cancer population (time frame: 29 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02575898, which also lists 16 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2018.